chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menveo powder reconstituted with non-GSK sterile diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA728A, expiry date 30th September 2023) for prophylaxis.   On 28th September 2022, the patient received Menveo. On 28th September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 28-Sept-2022 Reporter's comment: The licensed practical nurse called to inquired that how to proceed and when they can revaccinate. The reporter did not consent to follow-up. Additional supportive information: The patient was inadvertently administered Menveo lyophilized powder component reconstituted with a unapproved non-GlaxoSmithKline sterile diluent, which led to wrong solution used in drug reconstitution.
Heaviness in chest, rapid and slow heart beats. Heart beat may be fluttery at times. Happens for increments of time - not steadily feeling the same symptoms. She described 4 hours on and then off for most of the rest of the day.  No swelling of feet/ankles/hands. No fatigue other than that the first day after the shot. No abnormal injection site reaction.
Patient called the pharmacy at about 1 pm, 1 hour after receiving the vaccine that she was experiencing "a reaction." Described hives/vague topical symptoms. I instructed patient to take oral Benadryl and to continue to monitor her symptoms. Instructed her to contact urgent care/emergency services if symptoms worsened. Patient said ok and hung up. I asked her to provide updates when she could. Followed up by phone with her 6 hours later, no answer. I left a voicemail asking for updates as soon as possible.
Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Child patient (age and gender not reported), who experienced egg allergy for her son with FLUZONE, nurses reported "getting the flu" and egg allergy for her son with FLUZONE QUADRIVALENT while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date (on 2018-2019, reported about her family's flu vaccination), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported (expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious egg allergy for her son with FLUZONE (food allergy) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious nurses reported "getting the flu" following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious egg allergy for her son with FLUZONE QUADRIVALENT (contraindication to vaccination) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was also a case of contraindication to vaccination as egg allergy leads to hypersensitivity following administration of the vaccination. Other relevant tests included No Lab data was reported. Final diagnosis was egg allergy for her son with FLUZONE QUADRIVALENT, nurses reported "getting the flu" and egg allergy for her son with FLUZONE. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for egg allergy for her son with FLUZONE, as Unknown for nurses reported "getting the flu" and as Not Applicable for egg allergy for her son with FLUZONE QUADRIVALENT. List of documents held by the sender: None.
Patient states she felt tired on 3-3-14, but on 3-4-14 she had diarrhea, fatigue, nausea and headache. No swelling or soreness at site of injection or respiratory problems. Symptoms resolved on 3-5-14, no medical care was needed.
Information has been received from a licensed practical nurse concerning a approximately 9 year old patient who on 29-JUN-1998 was vaccinated with VARIVAX (Merck). On approximately 11-OCT-2006, the patient experienced approximately 50 lesions. At the time of the report, the patients' outcome was unknown. This is one of several reports received from the same source. No further information is available.
For the first two shots, I received the Moderna covid vaccinations. At around the 12-hour marker for both shots, I got very ill (vomiting, chills, fever, body aches) but had mostly recovered by the 24-hour mark.   For the booster shot, I received the Pfizer booster shot since it had been 9 months since my last dose of the covid vaccine.  I passed the 12-hour marker for the booster without anything unusual happening, I was less sick than I was with the first two Moderna shots. But I had a fever that kept creeping up to about 102 degrees Fahrenheit and at around the 24-hour marker I noticed blisters forming on my lips. I have no history of cold sores or anything similar showing up prior to this regardless of stress or illness. They're just now starting to heal 3 days after they appeared, but they were incredibly swollen for a few days,  blistering, and scabbing over.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L018503, expiration date 16-MAR-2017; lot # L022795, expiration date 05-NOV-2016 and lot # L024132, expiration date 21-JAN-2017) (dosage, strength and route unknown) (temperature: -10 degree Centigrade, time frame: over a two day period with a cumulative of 12 hours (2 cycles)). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
A mother reported that her son received Acel-Imune and subsequently, developed a fever and trembling. He recovered. Follow-up information received on 4/13/00, identified the pt. He remained recovered.
Numbness in left hand then generalizing to right hand and bilateral feet.  No weakness or motor changes.
4/4/08 Patient started having vomiting with every feeds.  Initially diagnosed as gastroenteritis.  Went to Emergency Dept 4/4/08, 4/6/08, and our office 4/7/08.  Diagnosed with intussucsception 4/8/08.  Unable to be reduced by radiology, and required surgery.  Had surgery for intussusception 4/8/08 and appendectomy. 9/11/08-records received for DOS 4/8-4/14/08-DC DX:Intussusception status post reduction and appendectomy. Presented with 4 day history of vomiting after every feeding, crying and increased fussiness.  Post operatively had increased distention and had NG tube placement after two episodes of bilious emesis on 4/9/08. Abdominal US and x-ray and barium enema did not revealed repeat intussusception. NG removed tolerating fluids.
pt recv vax 3OCT96 & w/in 48hr pt devel acute kerato conjunctivitis;tx by optometrist who prescribed med;pt recv 2nd dose of vax & eye cult were positive for herpes simplex virus but indicated
EMPLOYEE CAME IN FOR THE H1N1 NASAL LIVE VACCINE ON 10/8/09, SHE CAME BACK ON 10/20 AND RECEIVED THE INJECTABLE H1N1. DID NOT UNDERSTAND THAT SHE WAS NOT TO GET THE SECOND VACCINE. NO ADVERSE REACTION REPORTED.
dental work done that involves a local anthesia after the first dose of moderna vaccine; 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 TOOTH DISORDER (dental work done that involves a local anthesia after the first dose of moderna vaccine) 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 TOOTH DISORDER (dental work done that involves a local anthesia after the first dose of moderna vaccine). At the time of the report, TOOTH DISORDER (dental work done that involves a local anthesia after the first dose of moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Initial report received from healthcare professional on 24 October 2013. A 51-year-old female patient whose medical history and concomitant medications were not reported, received FLUZONE ID (lot number UT4719BA and expiration date 02-APR-2014) intradermal in left deltoid (does number not reported) on 19 October 2013. On 22 October 2013, patient had arm pain, pain and swelling after injections,. When she abducts the arm the area around the injection site pulls. Swelling and pain has bone down but still pulls with movement. Patient had mild swelling of left deltoid and slight indurated area. Laboratory investigation and corrective treatment were not reported. As of this report, the patient had not recovered from the events. Documents held by sender: none
Patient had immediate numbness in arm of vaccination which progressed to spinal pain from the neck to thoracic area.
Right deltoid-injection site with redness, warmth, circular area.  Local cellulitis-antibiotic given.
18FEB neck pain, headache, & T 101.4; 19FEB TO ER dx full blown mumps w/parotitis both sides, pain & knots in neck; 20FEB measles-like rash fr head to mid chest; 23FEB knots on palms hand & fingers. painful w/tingling, burning. Panniculitis
itchiness all over her body; Rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness all over her body) and RASH (Rash all over the body) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRURITUS (itchiness all over her body) and RASH (Rash all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness all over her body) and RASH (Rash all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
MMR and Varicella were ordered and MMRV and Varicella were given. Dr. called the patients mother and explained that MMRV and Varicella were given instead of the MMR and Varicella that were ordered. She also informed mother that there is an increased risk of fevers from the Proquad (MMRV) and that there is unlikely to be a risk from the higher dose of Varicella.
chills, nausea, fever, muscle fatigue, could not sleep, body aches, rash on face. started around 9:30 p.m on February 6, ended around 6:30 on February 7. Rash on face began around 11 a.m on Feb. 8.
3/16/21 Chills, fever lasting for a day and a half 99.7F, fatigue, achy,  3/17/21 vomited once, fatigue, fever 100.4, achy
7 hours later felt faint 16 hours after injection had mild headache Day after injection had nausea for most of the day and sporadic twinges of dull aches in random joints.
MOM STATES 10/29/2009 AT BREAKFAST CHILD HAD ITCHING, HIVES AND SWELLING OF HANDS AND FEET. MOM GAVE BENDADRYL, TOOK CHILD TO EMERGENCY ROOM AND WAS TOLD IT WAS PROBABLY FROM THE H1N1 VACCINE. MOM CALLS 10/30/2009 AFTERNOON AND STATES CHILD HAS SMALL AMT OF SWELLING AND HIVES ON HANDS BUT FEET ARE WORSE WITH SWELLING AND HIVES. MOM WAS INSTRUCTED TO GIVE BENADRYL AT THE ER. 11/6/09:  ED Records received for date of service 10/29/09.  Dx:  Gastroenteritis. Assessment:  Presented with a 6 day history of Abd. pain N&V and diarrhea.  Pt. had returned to school and was given the H1N1 vaccine the day before presenting in the ED.  A rash (hives) was noted the morning of the visit, treated with Benadryl at home and resolved.  The hives re-appeared on the hands and feet in the ED and Benadryl was again given.
warm around the injection site; red ring around vaccination; arm soreness; a ball started to form in her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a ball started to form in her arm at the injection site), PAIN IN EXTREMITY (arm soreness), VACCINATION SITE ERYTHEMA (red ring around vaccination) and VACCINATION SITE WARMTH (warm around the injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's medical history was not reported.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE MASS (a ball started to form in her arm at the injection site). On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 23-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red ring around vaccination) and VACCINATION SITE WARMTH (warm around the injection site). The patient was treated with PARACETAMOL (TYLENOL) in January 2021 for Adverse event, at a dose of UNK dosage form. On 31-Jan-2021, VACCINATION SITE MASS (a ball started to form in her arm at the injection site) had resolved. On 06-Feb-2021, PAIN IN EXTREMITY (arm soreness), VACCINATION SITE ERYTHEMA (red ring around vaccination) and VACCINATION SITE WARMTH (warm around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included her high blood pressure medication. The patient thinks that the vaccine did not hit the muscle and formed "skin popping," like what IV drug users experience with injections and abscesses. The ball lasted for 9-10 days until the patient started to massage the area and it went away.
Feeling of flushing, lightheadedness, dizziness, 3 minutes after vaccine given. She had to lie down and close her eyes. Was able to sit up about 5 minutes later. Consistent with a vasovagal syncope.
Nauseous from 6:30am to 11:30am Took two extra strength Tylenol at 8am Fatigue all day
two arteries clogged/two blocked arteries; heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) and in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown) and in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "neutropenia" (unspecified if ongoing), notes: prior to receiving the vaccines; in which her "immune system is shot.". The patient's medical history, reported also as family history included: "heart attack" (unspecified if ongoing), notes: cardiac family history. The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2022, outcome "unknown", described as "heart attack"; CORONARY ARTERY OCCLUSION (medically significant), outcome "unknown", described as "two arteries clogged/two blocked arteries". Therapeutic measures were taken as a result of coronary artery occlusion. Clinical course: Patient asked if it is the estrogen within the Estring that contradicts patients who have a history of heart attacks. Patient wanted to know if she could use Estring if she had a heart attack. She is asking if she should use Estring if she has had a heart attack in the past. She stated that her cardiologist told her estrogen can cause blood clots, but her other HCP is insisting that estrogen doesn't cause blood clots. She has had 5 Pfizer Covid-19 vaccines (presentations were not specified) and her doctor is advising her to receive a 6th vaccine. She is asking if she should receive a 6th vaccine. She feels like she is receiving a vaccine every 6 months. She confirmed that she had neutropenia prior to receiving the vaccines, however she did have a heart attack last year after she received the Pfizer Covid-19 vaccines. She had stents placed due to two arteries clogged. She has a family history of this and does not believe the vaccines were the cause of her heart attack. She doesn't believe the heart attack was related to the COVID-19 Vaccines. She had stents placed because she had two blocked arteries. She has a cardiac family history.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events MYOCARDIAL INFARCTION and The suspected drug is assessed as Unrelated .
35 pts recvd 3 doses of Engerix-B & did not respond; each non-responder is scheduled to receive 2 booster doses;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2014, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Shot was given at 11:45 am. Patient started to feel numb both arms. Tingling of left arm and left hand, tingling chest and both legs within 10 min of shot. She saw black/white spots at 12:45pm. Called EMT and they took her to the hospital.
always get a sore arm where I get the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FF2588, Expiration Date: 28Sep2021), in arm for covid-19 immunisation. The patient's relevant medical history included: "hip replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin for hip replacement, notes: caller had to go to a dentist appointment and because caller had hip replacement caller usually takes 4 antibiotics., had to take amoxicillin due to history of a hip replacement. Vaccination history included: Bnt162b2 (Dose: 1 Pfizer BioNTech COVID-19 vaccine 30mcg/0.3mL , Lot number: EN5318 , Expiration date: 31May2021 , NDC number: Unknown), for COVID-19 Immunization, reaction(s): "always get a sore arm where I get the shot"; Bnt162b2 (Dose: 2 Pfizer BioNTech COVID-19 vaccine 30mcg/0.3mL , Lot number: EN6203 , Expiration date: 30Jun2021 , NDC number: Unknown), for COVID-19 Immunization, reaction(s): "always get a sore arm where I get the shot". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "always get a sore arm where I get the shot".  Additional Information: Reporter had hip replacement and usually takes 4 antibiotics. She confirmed that her 4 prior doses were all the Pfizer BioNTech COVID-19 vaccine and mentioned that she always got a sore arm where she got the shot.
Throwing up 6 x in 24 hrs and then 2 x next day-1 x next 3 days-low fever and diarrhea. She did not play the first day and then some after that. She was completely better after 1 week.
patient experienced ENZYMES UP; This spontaneous case was reported by a consumer and describes the occurrence of ENZYME LEVEL INCREASED (patient experienced ENZYMES UP) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced ENZYME LEVEL INCREASED (patient experienced ENZYMES UP). At the time of the report, ENZYME LEVEL INCREASED (patient experienced ENZYMES UP) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Enzyme level test: Enzyme level increased.         No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.