chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case described the occurrence of injection site pimples in a 4 month old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. This report was received from the patient's mother and has not bee verified by a physician or other health care professional. On 5/12/03 the patient received the second dose of Infanrix in the right thigh. On that date, she also received injections of inactivated poliomyelitis virus vaccine and Haemophilus influenzae type B conjugate vaccine. At an unknown time post-immunization, the patient reportedly experienced little pimples at the Infanrix injection site. The pimples resolved after three weeks. The mother declined to provide additional information and declined to grant authorization to contact the vaccine provider.
Patient received the varicella vaccine SC on right arm Wednesday A.M. On Thursday P.M., he noticed the site was swollen, red, and hot to the touch. He also became nauseated & vomited. When patient was seen in the office Friday A.M. the swelling measured 3 1/2 inches by 3 1/2 around. Pt was advised to ice the area and take Benadryl as needed.
Tingling hands and feet, chest pain, light headedness,  headache, light sensitivity.
It stated with a week later after the vaccination, I felt really dizzy and very bad headache, very bad heart palpitation, I got up went to the bathroom and next thing I remember I woke up on the floor and my wife called EMS,  I had blood on my left side of my forehead. Paramedics  checked my BP 188/70 I was admitted to the hospital and my BP stayed that way until I got released. I was given two Antibiotics for a 5 day treatment. when I was released from the ER my BP was down to 153/84. This morning I had my stitches removed and my left eye is still swollen. Still I am having the same symptoms.
08/29/22 presents to EC ED for "shortness of breath". PMHx of "CABG x3 8/13/2022, HTN, Hep C, HPL, Hepatocellular carcinoma s/p Liver transplant (2015), Chronic back pain"
Patient just got finished with therapy of anti viral for shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Patient just got finished with therapy of anti viral for shingles) 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 HERPES ZOSTER (Patient just got finished with therapy of anti viral for shingles). At the time of the report, HERPES ZOSTER (Patient just got finished with therapy of anti viral for shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient had shingles after first dose of the moderna vaccine and finished with therapy of anti viral for shingles.
pt recvd vax & devel  t night of vaxs; & persisted to day of the sz; had prior febrile sz this was longest sz; unconsiousness & out come suggest illness was viral;
Felt like face and lip were swelling after 1st dose; Felt like face and lip were swelling after 1st dose; Chest heaviness after 1st dose; Severe shortness of breath after 1st dose; Dizziness after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING FACE (Felt like face and lip were swelling after 1st dose), LIP SWELLING (Felt like face and lip were swelling after 1st dose), CHEST DISCOMFORT (Chest heaviness after 1st dose), DYSPNOEA (Severe shortness of breath after 1st dose) and DIZZINESS (Dizziness after 1st dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced SWELLING FACE (Felt like face and lip were swelling after 1st dose), LIP SWELLING (Felt like face and lip were swelling after 1st dose), CHEST DISCOMFORT (Chest heaviness after 1st dose), DYSPNOEA (Severe shortness of breath after 1st dose) and DIZZINESS (Dizziness after 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 50 milligram. At the time of the report, SWELLING FACE (Felt like face and lip were swelling after 1st dose), LIP SWELLING (Felt like face and lip were swelling after 1st dose), CHEST DISCOMFORT (Chest heaviness after 1st dose), DYSPNOEA (Severe shortness of breath after 1st dose) and DIZZINESS (Dizziness after 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 202/116 (High) 202/116. On an unknown date, Heart rate: 134 (High) 134.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received on 29-JUL-2021, contains event outcome updated.
This spontaneous prospective pregnancy report was received from a physician referring to a 16 year old female patient with asthma, bipolar disorder, blindness unilateral and drug allergies to DEPO-PROVERA. Concomitant therapies included albuterol. On 21-JAN-2015, the patient was vaccinated with her first dose of GARDASIL (lot#, dose and route not reported) and on 04-NOV-2015 (inappropriate schedule of drug administration) with the second dose of GARDASIL (lot# L016428 and expiration date: 30-JUL-2017; dose and route not reported). On 09-MAY-2016, the patient was in the office for her annual physical and was vaccinated with the third HPV vaccine dose with GARDASIL 9 (lot # L044475 and expiration date: 12-MAY-2017) (interchange of vaccine products) intramuscularly. Later in the day, after the third dose was administered an unspecified rapid urine pregnancy test was performed and was positive (vaccine exposure during pregnancy). No treatment was given. The LMP was reported as the first week of April 2016. The pregnancy outcome was outcome pending. Additional information has been requested.
Red swollen eyes, runny nose, congestion, fatigue, and small amount of shortness of breath. Lasted about two days
On 1/5/2021 my left arm got very itchy & very hot to the touch up to 3in around the vaccine site It lasted for about 48hrs.
pt returned to have TB test read & stated arm was sore; lt arm swollen, warm to touch & sl reddened; no fever;
Testicular swelling after AVA #4. This service member recently returned from deployment to Turkey. His unit's administrative NCO SGT contacted the VHC to report that this member had had some adverse events after the Anthrax vaccine and inquired if he should receive an exemption to the next AVA which is due in 6 months. On the evening of shot, he developed pruritic rash on posterior neck and upper back, resolved by morning. Since he was in the field, he did not have access to a mirror to inspect the rash. He developed testicular swelling with pain and discomfort 1-2 days after shot. Symptoms lasted 2-3 days, then resolved. He did not seek medical care, therefore has no documentation of this event. He reported the symptoms later to the Flight surgeon who encouraged him to report them to the VHC.
Patient reported to ER with 2-3 weeks of increasing shortness of breath. Patient found to be tachycardic in the 150's with atrial fibrillation RVR. Unable to control HR with oral medication and patient was started on an IV cardizem drip and admitted to the ICU for close monitoring. Patient on echocadiogram was found to have a poor EF when compared to nuclear stress 1 months ago and new echo showed right heart strain. CTA of the chest still pending to evaluate for possible pulmonary embolic despite patient being compliant with Pradaxa, anticoagulant.
1st Hep A and B in 2016, 2nd HepB in 2017; 1st Hep A and B in 2016, 2nd HepB in 2017; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   Concomitant products included HEPATITIS B VACCINE, HEPATITIS B VACCINE and HEPATITIS A VACCINE.   On an unknown date, the patient did not receive the 3rd dose of Hepatitis B vaccine and the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine and not applicable after receiving Hepatitis A vaccine, the patient experienced incomplete course of vaccination (Verbatim: 1st Hep A and B in 2016, 2nd HepB in 2017) and incomplete course of vaccination (Verbatim: 1st Hep A and B in 2016, 2nd HepB in 2017). The outcome of the incomplete course of vaccination and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 13-APR-2023 The patient stated that a patient received first dose of an unknown hepatitis A vaccine and hepatitis B vaccine on 19th December 2016. The second dose of hepatitis B was given on 20th January 2017.  This was at another facility.  The reporter opted out of providing additional information and follow-up due to being short on time. This was being reported as a possible adverse event due to the unknown vaccine brand names. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 3rd dose of hepatitis B vaccine, which led to incomplete course of vaccination. Till the time of reporting, the patient did not receive 2nd dose of hepatitis A vaccine, which led to incomplete course of vaccination.
Weight gain; This case was reported by a consumer via interactive digital media and described the occurrence of weight gain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced weight gain. On an unknown date, the outcome of the weight gain was unknown.   It was unknown if the reporter considered the weight gain to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix on an unknown date and experienced weight gain. Consent to follow up was not possible as no contact details were available.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program. A 68-year-old male patient received the 2nd dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0150, expiration date: Jul 31, 2021), at the age of 67, in right arm, on Apr 2, 2021, at 09:45, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6206, expiration date: Jun 30, 2021), at the age of 67, in left arm, on Mar 12, 2021, approximately scheduled for 09:45 am, for COVID-19 immunization; and had several reactions: pain in the upper part of the left arm/left arm strain. The patient had pain in extremity (second dose: right arm pain), with outcome of unknown. No therapeutic measures taken as a result of pain in extremity. Additional information: The patient had no prior vaccinations within 4 weeks. No follow-up attempts possible. No further information expected.
Pt got immunizations Hep A #2 and Varicella #2 on 5/9/08. He noted some mild swelling and redness of (R) upper extremity, where both shots were given, on 5/10 and 5/11. Yesterday 5/12/08, redness and swelling resolved, but petechial rash appeared at (R) upper extremity where shots were given and remained today. Pt feeling well and CBC WNL.
Paralysis of Face; Leg Muscle Spasm; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Paralysis of Face) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced FACIAL PARALYSIS (Paralysis of Face) (seriousness criterion medically significant) and MUSCLE SPASMS (Leg Muscle Spasm). At the time of the report, FACIAL PARALYSIS (Paralysis of Face) and MUSCLE SPASMS (Leg Muscle Spasm) outcome was unknown.      Concomitant medication was not provided.  Treatment information was not provided.  Company Comment: This case concerns a 30-year-old male patient with no relevant medical history, who experienced the expected event of Facial Paralysis. The event Facial Paralysis occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as there's no information available about the second dose. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 30-year-old male patient with no relevant medical history, who experienced the expected event of Facial Paralysis. The event Facial Paralysis occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as there's no information available about the second dose. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Severe diarrea and vomiting that begin late on Day 2 after receiving the second Pfizer covid-19 vaccine dose.  Conditions lasted for over 36 hours.   Drinking any liquids including water to stay hydrated during this time was not possible.  Plain water created a severe gastro reaction too.  Slowly recoved by going on a liquid diet on Day 4 and small bites of solid food Day 5.  Week long body fatigue and dehydration as well.
Patient presents with ? Breathing Problem     started yesterday afternoon     Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 80y.o. male with PMH of COPD, currently smoker, CAD with history of quadruple bypass and prostate cancer presenting with progressively worse SOB since late yesterday afternoon.  Patient admits to feeling tired, anorexic, noting chills, shortness of breath.  Patient normally able to walk half a block without having to take a breath.  Today patient was unable to walk to his bathroom without feeling tired.  Patient did not take any medication that made him feel better, his home Spiriva without rescue inhaler.  Activity made his shortness of breath worse.  Denies chest pain, palpitations, abdominal pain, nausea, vomiting, fever or chills, or orthopnea.  Follows with pulmonologist cardiologist.  Smoked 10 cigarettes a day for the past 50 years.   ED COURSE: Vitals: BP 107/63, HR 65, RR 24, Temp 97.5 and SpO2 94% on room air.  Labs: Significant for D-dimer 106, WBC 2.1 (chronic) and COVID-positive.  Imaging:  CXR: Diffuse increased bibasilar interstitial opacities, some felt to be chronic from underlying emphysema however given the change from 2010 cannot exclude superimposed infectious process.  Stable left upper lobe 1 cm nodular density from 2011. Bilateral lower extremity duplex: No evidence for DVT at the level of the popliteal veins.
3:30 pm Eyes blurry and itching.  Then started wheezing, coughing and shortness of breath.  Eyes very swollen.  Seen in the Emergency Department at 6:25pm.  Given SoluMedrol 125 mg IV, Benadryl 25 mg IV, Pepcid 20 mg IV, Provental Aerosol Rx. Pulse rate 135. 147/85, Pulse Ox 90%. 12/10/08-records received for DOS 10/22/08-DC DX Hypersensitivity reaction to flu shot with late hypersensitivity reaction with potentiating bronchospasm and early anaphylaxis which improved. Presented to ED with breathing complaints and swallowing difficulty.
short generalized tonic clonic sz w/fever (1 minute) 104 fever also had mild acute ear infection-Amoxicillin;
18 Aug 2011. 20 second episode of staring, sticking tongue out, clonic activity limbs. Then cried 10 mins. Healthy baby. No episodes since.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 304 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 07-MAY-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Received injection on 1.12.  Felt fine.  On Jan. 18 my left arm began to throb and a painful rash appeared.  2 days later it is still there.  Concerned about taking 2nd injection.
This spontaneous report as received from a nurse refers to a 2 year old male patient. No medical history provided. On 06-JUN-2013 the patient was vaccinated with VAQTA (lot # H010437, exp date: 28-FEB-2015). No concomitant medications were reported. On 06-JUN-2013 the patient was vaccinated with improperly stored vaccine. No adverse events were reported. Additional information has been requested.
Patient filled out vaccine consent form for COVID19 vacccine. Patient had only ever received pfizer vaccines and the most recent dose on her paperwork was 11/2021. We were only offering Moderna, so pharmacy student had a lengthy conversation with patient about switching manufacturers. About 30 minutes after the vaccine was given, patient's husband called to ask why she received a COVID vaccine when she came in for an influenza vaccine. She had already received a pfizer bivalent booster on 09/16/2022. She is currently having no symptoms or adverse effects.
PT WAS GIVEN COVID19 VACCINE THAT EXPIRED ON 3/14/23.
A physician reported that his grandson received a vaccine on 5/24/00, on 5/25/00 he developed an ear infection and fever. The reporter indicated that he was not able to determine if the ear infection was present at time of vaccination. The pt recovered.
Almost immediately after vaccine was administered patient developed a welt at injection site. After 30 minutes measured 3cm X 4.5cm. Benadryl spray and ice were applied within 10 minutes of injection.
Information has been received from a physician concerning a 4 yr old pt who in 2000 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced breakthrough chickenpox with 10 lesions and no fever. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that she did not have access to any information that the letter was asking for. Additional information is not expected.
20 min after vaccine administration experienced tightness to jaw, body heaviness, noticed mouth deviated.
Had a temp the night before vaccines: exam in office was normal and no temp: vaccines given, that night 2 spells and went to ED and DX of Otitis Media and vomiting.  / of 2 febrile seizures.  Rx with Augmentin in ED.  Exam 2 days later was normal except for a viral like exanthem on the trunk, TMs were normal on that exam
pt.recvd. vax 01JUN89 & developed arthritis in wrist.subsequently developed allergies to various food.Pt exp.pain in wrist only p/ eating 1 of foods he had allergies to.Developed pruritus & difficulty in routine duties.Tx w/ meds.
Body aches all over and a headache; Body aches all over and a headache; Even "my" fingers and toes were hurting; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 04May2021 at 13:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included one a day prenatal vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 13Apr2021 at 13:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 01:15, about 12 hours after shot, the patient experienced body aches all over and a headache and even the patient's fingers and toes were hurting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches all over and a headache and even "my" fingers and toes were hurting was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Shot was higher on upper arm than usual, & more painful. Since then I haven't been able to lift arm without significant pain in shoulder (no problem before). Doctor diagnosed bursitis. I have had 2 cortisone shots, with temporary relief for few weeks. Have just started PT. Have had shots in that arm no problem through out life. This one felt like it hit something.
pt presented with failure to thrive and increased aphasia, neuro work up done.  Pt transferred to hospice Deceased on 06/28/22
> 50 mosquito bite type lesions (no vesicles) on both sides of the body. No itching.  Has continued since Oct 24 for a total of 13 days to date.