chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from the patient's husband referring to his wife, a 29 year old non-pregnant female patient. The patient had not any pertinent medical history, concurrent condition nor had been taking any concomitant medication. On 19-JUN-2017, reported as approximately "3 weeks ago on Monday", the patient was vaccinated with one dose of PNEUMOVAX23 subcutaneously for pneumonia prevention (strength, Lot # and expiration date were not reported). On unspecified day in June 2017, reported as "2 or 3 days" after his wife vaccine administration, the patient began to develop symptoms that started off as a rash on the back of her neck and shoulders and then the rash progressed down to her arms and chest area. Then, the husband said his wife's rash proceeded to get worse and she developed sores in the rash which got infected. Also, since an unknown day in June 2017, reported as since getting the vaccine, the patient had been feeling some fatigue. On 10-JUL-2017, the patient went back to see the physician, who administered the vaccine, for a follow-up visit because her symptoms were not getting any better but the physician did not think these symptoms were related to PNEUMOVAX 23 and the doctor prescribed her an unspecified topical cream to help treat the infection. On 11-JUL-2017, at morning, when the patient woke up, her face was slightly swollen. The following morning, on 12-JUL-2017, again when the patient woke up, her face was really swollen and also the sides of her neck were swollen and on the back of her neck a baseball size area had become swollen, raised up and that baseball size patch also felt hot to the touch as if a fever had developed. After this, on this same date at morning, the husband took his wife to the emergency room. Over there, some blood work was ran and a Magnetic Resonance Imaging (MRI) was performed and all test results came back to normal. Here, a prednisone shot was given and the patient was released with no hospitalization occurred. At the reporting time, the patient was not recovered from the events. The patient's husband did not provide the causality assessment between the events (local swelling, fatigue, rash, skin lesion, dermatitis infected, pyrexia and swelling face) and vaccination with PNEUMOVAX 23. Upon internal review, local swelling, swelling face and pyrexia were considered as a medically significant events as they were treated in ER with prednisone.
Daptacel and pentacel being given at the same time, with no reported adverse event; Initial information received  on 26-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of an unknown age and gender and Nurse had administered diphtheria/tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] And diphtheria-15/tetanus/5 AC Pertussis Vaccine [Daptacel] being given at the same time, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect diphtheria/tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine via unknown route in the upper thigh of their left leg And diphtheria-15/tetanus/5 AC Pertussis Vaccine (suspension for injection) (strength, expiry date and lot number: not reported) via unknown route in upper thigh of their right leg for immunization and given at the same time, with no reported adverse event (vaccine coadministration) (latency: same day). There will be no information available on the batch number for this case.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event
Left eye got swelled up; Stye; Vaginal infection; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the first of two reports. This report is for the events related to the first vaccine dose.  A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration in the right arm on 05Apr2021 at 09:45am (Batch/Lot number: Unknown, at the age of 43 years) as a single dose for COVID-19 immunization at a pharmacy drug store. Medical history included migraines. The patient has no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were reported as none. The patient did not receive any other medications within 2 weeks of vaccination. Clinical course included: On 05Apr2021 at 09:45am the patient received the first dose of BNT162B2. On 08Apr2021, 3 days after the first dose of BNT162B2, her left eye swelled up. She went to the ophthalmologist and was told she had a stye. She was prescribed Neomycin and Polymyxin B Sulfates and Dexamethasone ophthalmic. The same day she woke up with what she thought was a vaginal infection. She went to the gynecologist and was prescribed Diflucan. The patient fulfilled both treatments and was fine. The events resulted in a visit to physician or other health professional office, urgency or emergency room/department. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events left eye swelled up, stye and vaginal infection was recovered.  Information on the lot/batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021577114 same report/patient/vaccine, different dose/AE.
I got a rash in the area where the 1st vaccine was  after my 2nd shot. Went to my primary and was given an antibiotic. took pill for couple of days and it cleared up  after a day and a half.
Information has been received from a physician concerning a 18 year old female patient who on 27-JUN-2007 and 25-JUL-2007 was vaccinated with a dose of GARDASIL (lot number, route and site not reported) which had been pre-drawn and stored in the refrigerator for up to one week.  No adverse effect was reported except for "it always stings." It was unknown if the patient sought medical attention.  The outcome was not reported.  This is one of several reports received from the same source.  No further information is available.
patient received their first dose of the Pfizer covid immunization. during observation, the patient got extremely red and lost consciousness. upon waking up, the patient began having cold sweats and lost color in this face, the patient then lost consciousness again and began shaking. 911 was called. the patient was moved to the ground with the help of a fellow team member. blood pressure was taken and was 106/62. heart rate was around 60. patient began getting color back but remained on the floor until the paramedics came.
1) Child who previously slept through night has so far spent two weeks waking up screaming several times per night, beginning the night after she was vaccinated. 2) Fever (102.6) began the day of the vaccination.  Two weeks after vaccination, fever still comes and goes despite common causes ruled out by physician. 3) Rash covering entire body began six days after vaccination.
Systemic: Allergic: Rash Generalized-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Medium, Systemic: Tachycardia-Severe, Additional Details: Patient was feeling nervous but was ready to get the shot. She explained she allergic to some oral medications but no vaccines have given her issues. After getting the shot she felt like her heart was racing and when we checked her heart rate it was 158-162. She usually takes her BP medicine in the evening she said. The Paramedics were called and took her to the ER. BP was 148/80.
lung irritation: feels like he needs to cough, like an asthma feeling; lung irritation: feels like he needs to cough, like an asthma feeling; feeling not very good; dry cough; arm soreness at the injection site; arm soreness (a little); 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 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: GH9702) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "mild arm soreness"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "mild arm soreness"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "mild arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2022, outcome "unknown", described as "arm soreness (a little)"; VACCINATION SITE PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "arm soreness at the injection site"; COUGH (non-serious) with onset Oct2022, outcome "unknown", described as "dry cough"; MALAISE (non-serious) with onset Oct2022, outcome "unknown", described as "feeling not very good"; RESPIRATORY TRACT IRRITATION (non-serious), ASTHMA (non-serious) all with onset 29Oct2022, outcome "unknown" and all described as "lung irritation: feels like he needs to cough, like an asthma feeling".  Additional information: The reporter wanted to know if after receiving the Pfizer-BioNTech COVID-19 Vaccine, Bivalent Booster dose (12 and older), have people experienced lung irritation like it feels like the patient need to cough but cannot. It was sort of like an asthma like feeling, needs to cough, dry cough. Also has arm soreness at the injection site. The patient received the booster dose on 28Oct2022 (bivalent booster) and started feeling not very good (at about 28 hours) dry cough. arm soreness (a little). The patient states the other 3 Pfizer vaccines he previously received caused him mild arm soreness. The patient has read the list of side effects before he had the vaccine and again after he had the vaccine. The patient was having a side effect but he is not sure if it is from the vaccine or maybe he caught COVID. On 29Oct2022, the next day after he received the booster, he reports lung irritation that feels like he needs to cough, like an asthma feeling. The patient has had four Pfizer COVID vaccines total and does not suspect anything was wrong with the vaccine, it could be that he has caught COVID and does not specify if he has caught COVID.
Pain in the arm, soreness; Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and PAIN IN EXTREMITY (Pain in the arm, soreness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001176) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FOLIC ACID (FOLATE), COLECALCIFEROL (VITAMIN D 3) and OMEPRAZOLE (LOSECA) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm, soreness). On 05-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in the arm, soreness) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Internal review on 19-Jul-2021 resulted in updates to the pregnancy details.
Pfizer-BioNTech COVID-19 Vaccine EUA  Patient received vaccine and shortly after was in a chair and experienced a syncopal episode. Pt was caught by staff member, and lowered to the floor.  Patient reportedly had two syncopal episodes with brief periods of tremoring. Patient reportedly has prior syncopal history. Patient was A&O x4 when med response arrived. Patient was lying on floor with feet up on chair.  Patient had unsteady gait and required multiple staff members' assistance. Patient was then transported to emergency department. While in the elevator, patient had her 3rd syncopal episode. Patient syncopal episode lasted for approximately 20 seconds. Patient regained consciousness and was brought into emergency department.
10/25/12 9:15 AM Dizziness, shortness of breath, nausea; 10/26/12 10:00 AM Dizziness, shortness of breath, nausea, fainted at department store, pain, swelling in right upper arm, raised hot skin at injection site, very itchy, raised red lump measuring 3 inches by 3.5 inches circumference and about .25 inch high. Redness, swelling, itching, pain lasted 5 days. Shortness of breath, dizziness lasted 3 days.
A report has been received from a Health Professional concerning a 16 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 14-Apr-2014. Health Professional reported that patient received expired FLUMIST QUADRIVALENT (Expiry date: 07-Apr-2014) on 14-Apr-2014. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious. Corrected Report 19-May-2014: Key ingredient of the suspect drug changed to Q/LAIV.
Developed redness & soreness at injection site in the first day.  Day the redness and soreness involved 3/4ths of my upper arm.  On Day 4 I had intensive itching and by Day 7 all the symptoms disappeared.
Lymph nodes in right axillary area are extremely swollen. It?s painful to lift arm due to this
cough, congestion, sore throat, headache, ear pain, sinus congestion starting on 10/19/21
PATIENT IS UNDER 18 AND RECEIVED MODERNA. PATIENT HAD NO ADVERSE EVENTS OTHER THANUNDER AGE
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with dose 1 of ROTATEQ (oral, lot # was not reported). On an unknown date the patient experienced rotavirus infection. The patient sought medical attention and received an unspecified treatment. The outcome of rotavirus infection was unknown. Additional information has been requested.
No adverse reaction. This is a medication error. Patient is over age 7 so should have received Tdap not Dtap for dose #5.
Hives on earlobes, itchy neck and chest, sneezing, eczema flair up.
Patient noticed a red dot after receiving his influenza vaccination and some pain at injection site. One month later he reported the red dot to the vaccine administrator. Two months after receiving the vaccine he visited the MD regarding the "red dot".  He reports the MD said it was a reaction to the influenza vaccine.
Fever, achy, dehydration.  07/28/2008 MR received for o/n stay 7/16-17/2008 for observation for Fever, Dehydration, Otitis Externa and hx of Otitis Media with perforation. Pt received Pneumovax 7/15/08 at PCP when being tx'd for R otitis media with perforation as well otitis externa. Started on abx. the following day pt presenter ER with c/o fever, not eating/drinking, feeling off balance, achy and having a H/A. 5 lb wt loss in 24 hrs. ROS (+) for fever, ear pain and popping, ear drainage, congestion, cough, lightheadedness, and sore throat. PE (+) for ear canal swelling, RLQ abdominal tenderness and tenderness of R deltoid.  Otology consult reveals mild dizziness and slightly decreased hearing. Tx with IVF and abx to f/u as outpt.
Booster shot (Pfizer with first 2 Moderna).  Shot given high up on shoulder no pain in area but pain under arm noticed at midnight.  Next day noticed massive lump swelling with pain and soreness to touch under right armpit.  Severe all over body ache and ringing in left ear.  Dizziness and nausea the first night of sleep seems to be getting better as far as body ache but not cleared.  Lump seems to be getting worse.  Preventing me from normal exercise activities like weightlifting with any significant amount of weight.
vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14-Oct-2022 and 15-Oct-2022; No adverse event; Moderna COVID-19 vaccine was given as first dose after the 30 day refrigeration mark; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was given as first dose after the 30 day refrigeration mark), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14-Oct-2022 and 15-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In October 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was given as first dose after the 30 day refrigeration mark). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14-Oct-2022 and 15-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was given as first dose after the 30 day refrigeration mark), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14-Oct-2022 and 15-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was given as first dose after the 30 day refrigeration mark) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14-Oct-2022 and 15-Oct-2022).    No concomitant medication was reported.  The doses were administered on 14-OCT-2022 and 15-OCT-2022 for 2 different patient. Vial size was 2.5 milliliter. The vial did not undergo any temperature excursions. Per Moderna CMC lot analysis regarding doses administered on 14-Oct-2022 and 15-Oct-2022, Moderna cannot guarantee patients received full protection against the COVID-19 virus.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-661765 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2022: Live follow up received narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661765:MOD-2022-661765 (patient case)
Arm sore and body aches. I had chills and felt like I had a fever. I was coughing a lot and realized something was wrong. I noticed a rash on both eye lids and my eyes were swollen. I went to urgent care and they gave me a cream Hydrocortisone 1% for the eyes and an inhaler albuterol pump and steroids Montelukast sodium tablets.
Angioedema around both eyes approx 36 hours after shot. Prior to this, experienced arm pain around injection site and minor headache/fatigue. Angioedema took 3 days to go away. Saw Dr. and he recommended antihistamine.
SIDE EFFECTS OF VACCINE SUCK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced side effects of vaccine suck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects of vaccine suck was not reported. This report was non-serious.
Weakness of left arm and neck, began resolving next day, in retrospect mom believes happened with previous vaccine 1st in series, but she didn't make the connection.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 12-NOV-2012 at 06:42, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
rash on trunk & extremities began 8 days p/vax appears like a typical MMR rash;
This spontaneous report was received from a health care professional refers to an unspecified number of patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored GARDASIL 9 lot # L017407; expiry: 15-AUG-2017. M-M-R II, K021152/ expiry. 02-NOV-2016, lot # L011528/ expiry: 03-APR-2017 was within recommended storage range at 32F. No adverse effects were reported. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 64 year old female patient with asthma, hypothyroidism, vitamin D deficiency, osteoarthritis. The patient had drug reactions/allergies to adhesives, AUGMENTIN (reported as "AUGMENT"), doxycycline, morphine, Sulfa, shellfish and cefuroxime. On 05-JUN-2014 the patient was vaccinated with PNEUMOVAX 23 (injection, 0.5ml one dose, lot # J008799, expiration date 15-APR-2016) intramuscularly. Concomitant therapies included QVAR, RHEUMATREX (reported as "RHEUMATRIX DOSE PACK"), omeprazole and PREMPRO. On 05-JUN-2014 the patient experienced itchiness, soreness and a hard lump at the injection site area after receiving PNEUMOVAX 23. The patient contacted medical office for medical attention and was treated with BENADRYL, ADVIL and a cool compress. No lab diagnostics studies were performed. The outcome of events were unknown. Causality assessment was not provided by the reporter. This is one of several reports received from the same reporter. Additional information has been requested.
The parent stated that the pt experienced an elevated temp to 105 with Motrin being given at 4 hours. The pt went to the ER with unknown labs. This event lasted 48 hours.
Patient states no symptoms yesterday. 30APR21, he woke up and came to work. Began to experience blurred vision, dizzy, body aches, and a headache. Patient denies not eating or drinking in the last 18h. Ate dinner, drank water. Patient has not taken any medication for symptoms.
Severe, Symptomatic Aortic Stenosis -S/p Successful Transcatheter Aortic Valve Replacement with 23 mm Edwards S3 Ultra via R transfemoral approach Severe, Symptomatic Aortic Stenosis -S/p Successful Transcatheter Aortic Valve Replacement with 23 mm Edwards S3 Ultra via R transfemoral approach  Hospital admission within 6 weeks of receiving the COVID vaccine.