chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she developed histamine issues or reactions; swelling of her stomach lower area (abdomen); swelling in her arm pit, close to the lymph node and the interior of her arm.; she stated to have shortness of breath and recently; nose bleeding; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "she developed histamine issues or reactions"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "swelling of her stomach lower area (abdomen)"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in her arm pit, close to the lymph node and the interior of her arm."; DYSPNOEA (non-serious), outcome "unknown", described as "she stated to have shortness of breath and recently"; EPISTAXIS (non-serious), outcome "unknown", described as "nose bleeding".  Additional information: Caller was a consumer who wanted to report side effects after receiving the second dose Pfizer-BioNTech COVID-19 Vaccine. Caller stated that 3-4 months after receiving the vaccine, she developed histamine issues or reactions. She stated to experience swelling of her stomach lower area (abdomen) that looks like pregnancy, and this causes problems to wear her usual clothes. Also, she reported to experience swelling in her arm pit, close to the lymph node and the interior of her arm. Finally she stated to have shortness of breath and recently, nose bleeding, which had never had in her life. Caller wanted to know if these side effects have been reported before.  The lot number for bnt162b2 was not provided and will be requested during follow up.
swollen throat; feels that the voice goes away; feels dizzy; her head turns; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swollen throat), SPEECH DISORDER (feels that the voice goes away), DIZZINESS (feels dizzy) and VERTIGO (her head turns) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PHARYNGEAL SWELLING (swollen throat), SPEECH DISORDER (feels that the voice goes away), DIZZINESS (feels dizzy) and VERTIGO (her head turns). At the time of the report, PHARYNGEAL SWELLING (swollen throat), SPEECH DISORDER (feels that the voice goes away), DIZZINESS (feels dizzy) and VERTIGO (her head turns) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vial was initially stored in the refrigerator on 04-Nov-2021. Vial did not underwent any temperature excursions. It was reported that some doses were administered on 05-Nov-2021 and other doses were on 12-Nov-2021. There were no  adverse event as a result of this misadministration, patients were monitored.  No treatment medication was reported by reporter.
My 7 month old eyes were flickering he had trouble breathing and kept falling out. The event lasted about 3 minutes. I called 911 to get help. He was taken to hospital. Doctors believe he may have had a seizure but were unsure because they didn't see it. He has to follow up with a neurologist.
Multiple red raised bumps like rash in underarm area. No itching.  Lasted about 2 weeks.  Nothing since 2nd dose
20 y/o patient received the pediatric dose; 20 y/o patient received the pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 20-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   On 15th February 2022, the patient received the 1st dose of Engerix B pediatric 10 ug. On 15th February 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were unknown.       Additional Information: GSK Receipt Date: 25th March 2022 Reporter's Comments: Office Manager stated that a 20 year patient received the pediatric dose (10 mcg) of Engerix-B back in February 2022 and was at the office today to get the 2nd dose.  The reporter asked how to proceed since he received the pediatric dose for the first dose. No lot number or expiry available as the first dose was administered at a different facility. The health care professional declined follow up. Additional Supportive Information: The pediatric dose of Engerix-B administered to 20 year patient, which led to inappropriate age at vaccine administration and underdose.
Rash sm. pinpoint red bumps. Dr feels this is unlikely a reaction to H1N1 vaccine.
Patient called 04/19/19 stating she had reaction to the SHINGRIX vaccine received on 04/17/19. She said her left arm became very swollen, red, hard, "indurated". She stated she took BENADRYL. As of this AM, she stated swelling has gone down but still red at injection site. She denied any shortness of breath or swelling anywhere else. I paged her Dr. who was on call for the office she advised that patient go to urgent care for evaluation. I called patient back and she said she appreciated the call and that she is a nurse and knows what to look for.
High fever of 101 for 48 hours. Chills. Soaked with sweat but after 48 hours fever went back down to normal. Muscle aches especially right arm. My arm still isnt normal  after over a week. Im having second thoughts on the 2nd shot. I didnt take any pain killers but they might help with the second shot.
Information has been received from a physician concerning a female who in June 2007, was vaccinated with her first dose of Gardasil, intramuscularly.  In June 2007, the patient experienced fever, swollen glands and "white platelets in her throat."  Subsequently, the patient recovered from fever, swollen glands and "white platelets in her throat."  The patient did receive her second dose on 12-AUG-2007 and the physician was waiting to hear from the patient to see if the AE reappeared.  The patient planned on completing the series.  Additional information has been requested.
SEVERE HEADACHE DURATION APPROX 24 HOURS FROM ONSET LATE PM 10/15 LOW GRADE FEVER DURATION APPROX 12 HOURS ONSET LATE PM 10/15 SLIGHT NAUSEA, NO VOMITING, INTERMITTENT  MINOR FATIGUE DURATION APPROX 24 HOURS FROM ONSET LATE PM 10/15
pt recvd vax;on 20nov in pm,devel t of 104;apap given at noc;21nov seen at clinic for inc t;tests done,on bactrim;22jan seen by MD,while in ofc had sz;adm to hosp x 2 days;spinal tap done,fever broke & out;felt inc t & sz not related to vax
After the vaccine I had Fibromyalgia where it put me in a flare, all of a sudden I had pain all over my body the next day. I also had a stroke 9 days after getting the vaccine.
muscle pain in the left deltoid; didn't look but it felt like it went into the muscle; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (about 10 years before reporting). Concurrent medical conditions included tinnitus.   On 8th September 2020, the patient received the 1st dose of Shingrix. On 8th September 2020, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 9th September 2020, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix shot in the left deltoid.  The patient asked if it was given intramuscularly, the patient stated that, he said he was not sure because he did not look but it felt like it went into the muscle, which led to intramuscular formulation administered by other route. The patient had muscle pain in the left deltoid which occurred the following day and resolved after 3 to 4 days.  The reporter did not have the lot/exp of the shot because he did not know what he did with the paperwork but he did provide his pharmacy's name and location. The reporter did not consent to follow up. This is 1 of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220483:same reporter (reporter´s case) US-GLAXOSMITHKLINE-US2020AMR222096:same patient
A report was received from a health professional on 11/27/01 concerning a 77 year old female patient who experienced Bell's Palsy which was considered medically significant (OMIC) 21 days after receiving the Fluvirin vaccine on 10/30/01. The patient received influenza vaccine on 11/3/98 and 11/4/00 without incidence. The patient was diagnosed with breast cancer in 1980, which is currently in remission. For the treatment of this cancer the patient has for years been taking Raloxifene Hydrochloride and Megestrol Acetate orally on a daily basis. The patient has also , for an unspecified period, been taking hydrochlorthiazide orally on a daily basis, for the treatment of hypertension. On 11/20/01, the patient experienced constriction of the mouth and difficulty swallowing. On 11/21/01, the patient was seen by a physician, was diagnosed with Bell's Palsy, and Prednisone was prescribed with some improvement. On 11/27/01, the patient was seen by her regular physician for follow up. The diagnosis of Bell's Palsy was again confirmed as the patient presented with lip drooping, however swallowing had improved. Prednisone for an additional two weeks was prescribed. The reporter was assessed the relationship of Fluvirin to the event as probable.
1st dose 3/6/2021: large red welt that was itchy, hot to the touch, raised and very painful. Lasted about a week. I also has fatigue for several days after.  2nd dose 4/9/2021: same symptoms as first dose but the day after I had a headache, mild body aches, chills and fatigue.
After 8 days of receiving dose 1, I experienced swelling in my lips and face.  It was not initially correlated to the vaccine util the 2nd dose.  After 4 hours of receiving the second dose I experienced swelling in the lips, face and tightness in throat.
Shingrix mixed with normal saline and administered; Shingrix mixed with normal saline and administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2021, the patient received Shingrix. On 18th October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The Shingrix mixed with normal saline and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Expired dose administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was not experiencing any symptoms.  No concomitant medication details was reported.  No treatment medication details was reported.
The patient after receiving the three immunizations starting experiencing signs of anaphylaxis and close to faining. 911 was called and Epinephrine 0.3mg IM administered. The police and EMS showed up, monitored him. After about 30 minutes being observed, the patient declined to go to hospital and was released. He was transported home by his wife.
Developed 1 inch diam bruise at injection site on left arm;  red raised itchy rash on both upper arms shoulder to elbow.  No treatment.
Report of body aches, HA, nausea, dizziness, fever and vomiting  1 day post vaccination. Treatment: Ibuprofen Outcome: symptoms resolved, No interference with ADL.
Extreme exhaustion since vaccine date. Sleeping in excess of 12 hrs a day. Began with body aches 10 days after vaccine.
lung nodule formed; Immediately after the second shot, I started experiencing shortness of breath; very bad rash; asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jul2021 as dose 2, single (Lot number: ew0185) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "known allergies penicillin" (unspecified if ongoing), notes: known allergies penicillin; "cholesterol" (unspecified if ongoing); "if covid prior vaccination Yes" (unspecified if ongoing), notes: if covid prior vaccination Yes. Concomitant medication(s) included: ARMOUR THYROID taken for thyroid disorder; ATORVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0169, Location of injection: Arm Left), administration date: May2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "Immediately after the second shot, I started experiencing shortness of breath"; ASTHMA (non-serious) with onset Aug2021, outcome "not recovered"; PULMONARY MASS (medically significant) with onset Aug2021, outcome "not recovered", described as "lung nodule formed"; RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "very bad rash". The events "lung nodule formed", "immediately after the second shot, i started experiencing shortness of breath", "very bad rash" and "asthma" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of pulmonary mass, dyspnoea, rash, asthma.  Clinical course: Immediately after the second shot, she started experiencing shortness of breath, asthma, lung nodule formed and very bad rash. Patient scheduled for surgery to have the nodule removed. For AE treatment she have been seeing a lung specialist. No other vaccine in four weeks. Other medications in two weeks thyroid (armour), cholesterol (atorvastatin). Covid prior vaccination and covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300082818 Same reporter, patient/ different event;
After receiving vaccines pt developed local red rash at each injection site. Pt denied itching or burning at site. Pt was treated with BENADRYL 25mg PO and observed for 30 minutes. Rash subsided.
Patient states she has a small raised "bump" on the back of her neck and one behind her right ear. Also complains of headache and low back pain.
Severe swelling at injection site day after cellulitis.  8/10/09 ER records received DOS 7/25/09. Assessment: Cellulitis surrounding injection site. Patient presents with erythema, swelling, pain - right thigh. Thigh is warm. Pruritis.
muscle aches; Fatigue; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2021, the patient received the 1st dose of Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced muscle pain, fatigue and pain in arm. On an unknown date, the outcome of the muscle pain, fatigue and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, fatigue and pain in arm to be related to Shingrix.  Additional details were provided as follows:  The case was reported by the patient for himself. The age at vaccination was not reported. The patient's limited demographic information was available.  The patient experienced muscle aches, fatigue and arm soreness post vaccination. The symptoms were ongoing at the time of reporting. The reporter did not consent to follow up.
Had vaccine my friend now is suffering with Shingles/Suspected Vaccination failure; Had vaccine my friend now is suffering with Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient received Shingles vaccine and at the time of reporting, he was suffering with shingles. The reporter stated that he/she understand that you had to get follow up, but why did not they tell them about that. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Employee had complaints of itching, rash to thighs, left upper arm at site of vaccine, forearms and neck on 2/24/18. Reports had a Varicella vaccine on her left upper arm, and a MMR shot on right upper arm, both on 2/12/18. Stated that she was also treated by her MD with a one time dose of DIFLUCAN  on 2/19/180. No rash was ever noted to the right upper arm, MMR vaccine injection site. Used OTC AVEENO baths. Followed up in the employee health office, rash disappeared by 3/1/18.
Patient received vaccine on 11/15/05 and noticed a rash on 11/16/05; slightly raised, reddened rash bilaterally on lower extremities (from mid-calf to ankle). Neck and forearms were itchy without visible rash noted. Patient felt achy and voice was hoarse on the night of 11/15/05. 11/18/05 Still has rash on lower extremities.
Narrative: Patient reported feeling flushed and 6/10 headache about 30 minutes after receiving first dose of COVID-19 vaccine. No hives, swelling, or other skin irritation. No dizziness, SOB, CP, N/V/D. Reports eating prior to appt and drinking water all day. Symptoms resolved about 1 hr. after vaccine administration and pt. left for home.
Information has been received from a physician concerning a 10-year old white female with no known drug allergies and no past medical history who on 28-Aug-1997 was vaccinated with a second dose of varicella virus vaccine live (Lot #622850/0537E). There was no illness at the time of vaccination. Concomitant therapy that day included a second dose of measles-mumps-rubella vaccine (Lot #622896/0740E), and a second dose of diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid (Tri-immunol) (Batch #445539). On 16-Oct-2003 the patient developed widely scattered red papules, described as less than 20 lesions- one with a vesicle and several were scabed. It was noted to be varicella post vaccination. There were no relevant diagnostic tests or laboratory data reported. The outcome was reported as recovered. No further information is expected.
Confirmed Breakthrough  1st  Dose - 3/24/2021 - Moderna - 007a21b 2snd dose - 4/21/2021 - Moderna - 043b21A
3 pts recvd 3 doses of Engerix-B & were determined to be non-responders;
About 24 hours after first dose, patient reports that both her knees were red and itchy. The next day, the knees were normal. Also, patient reported that 9 days after first dose, the injection site on her arm had become itchy, red and warm.
pt recvd vax & 5-6 mins later exp flushing on face, neck, arms & chest; tx w/DPH & APAP;
pt recvd vax;leg swelling & crying despite pre-immun apap,cold compress given;at 5pm mom indicated persistent crying & refusal to take feeding;to er where  pt had spinal tap & IV fluids; returned 6-7 hrs later;
First time ever using PENTACEL did not mix the HIB, so patient was only given DTaP and polio portion. (Had no idea I needed to mix the solution and neither did second nurse verifying shots).