chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days after receiving the vaccine, the front of my neck developed a very itchy, warm rash, my lymph glands on the right side of my neck swelled so much that it was difficult to swallow even liquids without pain, and I had a fever of about 100. The itchy area on my neck continued to worsen, and despite the application of OTC anti-itch medications and me taking Benedryl, it got larger and warmer, and the itching became even more severe. At one point my throat was so swollen, I started to think it was closing up and that I'd need to go to the hospital. The discomfort continued into the next day when I contacted Teledoc, and was prescribed an antibiotic, and prednisone, which helped. The itching is still present, but managed by regular spraying of an aerosol cortisone. And the swelling has gone, but there are slight scars like one would get from a scrape. My throat is much better, and my fever is gone.
Narrative:  86 year old male, received first dose of COVID-19 vaccine (Moderna) on 1/15/2021. PMH HTN, COPD, BPH, hard of hearing. Colon resection 2019 and colostomy placed. No patient medical records post-vaccination. Patient expired 2/8/2021.
Patient was experiencing arm pain around injection site with a lump where moderna was given. She mentioned that she has burning of the chest/sternum area  radiating down to left arm with little to no effect when using ibuprofen for relief. It has been continuous since when she has reported having symptoms
3-4 hrs post immun had red, sore arm, inc steadily until 48hrs-went to ER for rx given ATB; said red streaks were from swollen area; Took 7 days to subside;
This is a spontaneous report from a contactable physician via a Pfizer sales representative.  A 34-month-old male patient received PREVNAR 13 (lot #: R41774), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had multiple episodes of pneumonia and otitis after use of product on an unspecified date (eventually got tubes). The reporter discovered that his immune system didn't respond to the PCV 13 vaccine series. The patient was given a booster of PPV 23 and repeated his immunoglobulin levels which was much improved on an unspecified date. The outcome of all events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Child received the DTaP and Prevnar and an instant splotchie redness appeared on the face and neck. We gave 1/2 tsp Zyrtec kept child in office and he did recover very well all redness went away. Child had no temp and was acting normal. No distress.
p/vax & devel some itching on scalp;temp elevated, inc itching  on feet;c/o chest discomfort, diff breathing;wheezes;BP 124/62;emesis;itchy scalp;
upset stomach; Chills; fatigue; threw up; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), CHILLS (Chills), FATIGUE (fatigue) and VOMITING (threw up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019M20A/014M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, ATORVASTATIN, DULAGLUTIDE (TRULICITY) and VITAMIN D2 for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), CHILLS (Chills), FATIGUE (fatigue) and VOMITING (threw up). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), CHILLS (Chills), FATIGUE (fatigue) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not specified.
Sore arm, fatigue, rapid heart rate, palpitations, chest tightness, chest pain within 24 hrs. Lower leg pain began about 4 days later. Headache off and on, muscle, joint pain. Continued heart rate and chest tightness continued. Went to ER for evaluation.
Blood clot in her leg; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age (reported only as 72) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient believed she may have a blood clot in her leg since an unspecified date. She had the second vaccine dose scheduled on an unknown date. Event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of Pneumovax 23. Within a few hours after the administration, the patient experienced severe arm pain extending from the injection site to the elbow. The patient also experienced difficulty moving the affected arm which has caused significant disability. The patient was examined in their physician's office and was prescribed an unspecified pain medication. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of 4 reports from the same source. Additional information has been requested.
PATIENT IMMEDIATELY FAINTED AFTER VACCINE ADMINISTERED. PATIENT WAS UNCONCIOUS FOR 20 SECONDS. PATIENT IMMEDIATELY AWOKE AND WAS INSTRUCTED TO LIE FLAT ON THE FLOOR FOR ABOUT 10 TO 15 MINUTES. PATIENT WAS GIVEN WATER.
The day after getting the vaccine the patient felt extremely tired, had extreme body and joint pains, and was unable to really get out of bed for several days after getting the vaccine. Adverse affects have lasted longer than a week and are still going on today.  Labs were done to rule out other causes. Tylenol and Advil, rest and time.  Pt told not to get the second dose of the shot.
Dizziness, nausea, headache, fever, chills - all on 4/10, ended 4/11  large swollen area at injection site, itchy - has been present since 4/10 with some growth on 4/11, still present on 4/13
Shingles confirmed by my Dermatologist. My spouse, who was vaccinated on same day developed shingles 24 hours after me. Treated with Valacyclovir.
On 04/03/2022, I developed a mild headache, itchy eyes and feeling down in the mouth (dryish). That night, I woke up several times feeling off and having mild nausea. On 04/04/2022 I had a mild temperature going up to 99.4 and mild dizziness and nausea which I treated with acetaminophen. I had a scratchy throat that I treated with Vicks Vaporub. On 04/05/2022, I developed a mild productive cough, slight sore throat with mild pain and dryness. I treated with Zicam Tablets and Vicks Vaporub. On 04/06/2022, I had a continuing productive cough and dry throat. Mild runny/stuffy nose and eye pressure in both eyes. I treated the symptoms with Vicks Vaporub and Zicam Tablets. I tested positive on 04/06/2022 at the Clinic and she gave me Benzonate, Flonase, Guaifenesin and I used Saline Nasal Mist. She also told me to keep my electrolytes up to stay hydrated. I took the medicine as prescribed. I had a mild cough that lasted until about 04/20/2022. I was feeling fine during the day most of the episode. I felt completely fine by about a month afterwards.
Pregnant at time of vaccine -  due date June 8, 2022, baby born still at 3 lbs 1 oz exactly one week after booster vaccine.  On March 25th, 2022, I felt decreased fetal movement. I went to the doctor and they confirmed my baby's heart had stopped beating. I delivered my baby stillborn at an estimated gestational age of 29 weeks and 3 days on March 26, 2022.
Pt fainted after receiving GARDASIL (within 30 seconds).  Also received MENACTRA prior to GARDASIL.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Excruciating headache, weakness, fatigue, nausea, muscle and joint pain
pt exp inconsolable crying, swelling, redness, fever & twitching/jerking of limbs;sx were reported to MD but no action was taken;twitching & jerking became more pronounced p/2nd dose;
sshl and tinnitus that remaind today.   hearing came back after taking steroids.   have had mild dizziness.
pt recv vax 25FEB98 & had pain, swelling 2hr p/vax;returned to clinic 2MAR98 for eval, had indurated, tender area inj site, + warmth;tx w/keflex for cellulitis;
nasal drainage; Clammy; Sinus's bothered me; Cough; Felt like I was getting the flu; Chill; I had no energy and stayed in bed some; I felt bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt bad), RHINORRHOEA (nasal drainage), COLD SWEAT (Clammy), SINUS DISORDER (Sinus's bothered me) and COUGH (Cough) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20I) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart failure and Cancer (allergic to chemicals, because of being sensitized when I had radiation for cancer in nineteen eighty -five, that those symptoms became intensified.) in 1995. Concurrent medical conditions included Allergy to chemicals (allergic to chemicals, because of being sensitized when I had radiation for cancer in nineteen eighty -five, that those symptoms became intensified).   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I felt bad), RHINORRHOEA (nasal drainage), COLD SWEAT (Clammy), SINUS DISORDER (Sinus's bothered me), COUGH (Cough), INFLUENZA LIKE ILLNESS (Felt like I was getting the flu), CHILLS (Chill) and FATIGUE (I had no energy and stayed in bed some). At the time of the report, FEELING ABNORMAL (I felt bad), COLD SWEAT (Clammy), SINUS DISORDER (Sinus's bothered me), INFLUENZA LIKE ILLNESS (Felt like I was getting the flu), CHILLS (Chill) and FATIGUE (I had no energy and stayed in bed some) had resolved and RHINORRHOEA (nasal drainage) and COUGH (Cough) had not resolved.            No Concomitant Medication was provided.  Patient never had nasal drainage, before. After the injections, patient had them constantly. Nasal drainage have lessened but continued to happen.  No treatment  was provided.   This case was linked to MOD-2021-023021 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: follow up received, new event added
immed intense pain inj site;nausea&poor color w/in 10min lasted 20-40 min;antihistamine given-fatigue;fully recovered 14MAY;
Severe fatigue, muscle pain, headaches,  swollen cervical and axillary nodes for over 1 month. From about 1/18/21 until now.Swelling in lymph nodes has subsided some in the last week and the fatigue has also subsided some.  I saw my primary Dr, on 2/17/21 for a routine check up and he did note my lymph nodes were all swollen. I told him my symptoms and he stated I could be having an immune response to the COVID vaccine. I had none of the above symptoms before receiving the COVID vaccines.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 27-JUL-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K020214, expiration date 25-MAR-2016 (strength, dose, route of administration and anatomical location were not provided). No adverse effects were reported. Additional information has been requested.
During Observation period member complained of itching in throat and arms and upper body, felt hot and dizzy. PO Benadryl 25 mg administered - symptoms continued to worsen with patient complaining of increased throat "burning" and tight feeling in chest. Administered additional 25 mg benedryl PO and member transported to hospital via EMS
This spontaneous report was received from a healthcare professional via an article published online by unknown source, which was brought to the attention of global safety by a sales representative. It concerns an unspecified number of adult patients of unknown age and gender; whose concurrent conditions, medical history or concomitant medications were unknown. On an unknown date, the patients were vaccinated with zoster vaccine live (manufacturer unknown) as shingles vaccine or with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) as chickenpox vaccine (dose, route of administration, lot number and expiration date were not reported). On an unknown date, within 24 days after of vaccination, the patients developed symptoms of keratitis. At the reporting time, the outcome of keratitis was unknown. The causality between ZOSTAVAX and keratitis was not reported. Upon internal review, the keratitis was considered a medically significant event. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information is not expected as no consent was given to contact the reporter. Sender's Comments: US-009507513-1702USA002429.
Erythema and induration approx 30 mm immediately post injection of Varivax vaccine. Observation and cool application-parent contacted later no problems. Slight erythema and inudration persists.
Patient presented to my pharmacy tonight 10/22/18 complaining of itchiness and hives. She was in otherwise good health. Patient got a shot last week around 8PM on Monday night (10/15/18). She was reported no ill effect immediately after the vaccination but she started to notice some itchiness and some small raised bumps on her right arm after about 3 hours. She reported no other signs of an allergic reaction other than hives. Over the course of the last week the itchiness and the hives spread from her right arm to her left and the intensity of the itch increased as well to the point where she is having trouble sleeping. The patient has never had a problem with a flu shot before and reports no known allergies. She had only tried a single tablet of BENADRYL with no real effect. I suggested to try a higher dose and to see if an topical anti-itch cream on the affected area. I also instructed her to look for signs of an serious allergic reaction including difficulty breathing, swollen lips or tongue or any worsening of the hives, abdominal cramping or bronchospasms. The patient has no PCP at this time but I did instruct her to seek out medical care if there was still no relief or if there was any worsening of her symptoms.
Pt was seen for well child visit. No other vaccines given. No medication given, 3 days prior or after vaccine. No change in diet either. Covered in hives and severe swelling. Eyes swelled shut. No respiratory problems or other reactions. Treatment with Benadryl; 2 tsps every 4 hours for 3 days.
Vaccine was mixed with incorrect amount of diluent  (mixed with 0.18mL instead of 1.8mL).  Patient was administered the vaccine.  No adverse events noted after the administration.
Localized erythema, swelling, tenderness.  Treatment: Cool compresses, NSAID Outcome: Unknown at this time.
PATIENT WAS ORDERED HIBERIX VACCINE BY AT HIS WELL-VISIT.  HE WAS INSTEAD MISTAKENLY GIVEN BY RN ROTARIX VACCINE IM USING HIBERIX DILUENT INTO LEFT THIGH.  PARENTS WERE IMMEDIATELY NOTIFIED THAT SAME AFTERNOON AFTER VACCINE COUNT WAS NOT ACCURATE.  FAMILY WAS TOLD TO WATCH FOR SIGNS AND SYMPTOMS OF RASH, BRUISING, MUSCLE SWELLING OR EDEMA.  NO REACTIONS HAVE BEEN NOTED BY PARENTS.  BOTH HIBERIX AND ROTARIX VIALS LOOK VERY SIMILIAR.  ERROR DUE TO HIBERIX AND ROTARIX VACCINE VIALS LOOK SAME OR SIMILAR.
My son (23 years) had 1 shot of Moderna's COVID vacccine and has myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (My son (23 years) had 1 shot of Moderna's COVID vacccine and has myocarditis) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 MYOCARDITIS (My son (23 years) had 1 shot of Moderna's COVID vacccine and has myocarditis) (seriousness criterion medically significant). The patient was treated with COLCHICINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (My son (23 years) had 1 shot of Moderna's COVID vacccine and has myocarditis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter stated that her son (23 years) had 1 shot of Moderna's COVID vaccine and had myocarditis and they won't let him get the 2nd shot. 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.  Company comment  This spontaneous case reported by a consumer, concerns a 23 years old male patient with no relevant medical history reported, who experienced the expected, serious, medically significant AESI of MYOCARDITIS (My son (23 years) had 1 shot of Moderna's COVID 19 Vaccine and has myocarditis) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that he was on colchicine. No further clinical information on comorbidities, risk factors, symptoms, labs, diagnostics and concomitant medications details were available in the report. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 23 years old male patient with no relevant medical history reported, who experienced the expected, serious, medically significant AESI of MYOCARDITIS (My son (23 years) had 1 shot of Moderna's COVID 19 Vaccine and has myocarditis) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that he was on colchicine. No further clinical information on comorbidities, risk factors, symptoms, labs, diagnostics and concomitant medications details were available in the report. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Pt. had redness, rash, chills, and joint pain. No treatment (except blankets and time).
Day 1 thru 7 lots of pain  Felt like a brick hit arm.  Day 7 thru  10 had a rash at injection site about the size of a hot pad, very itchy.  I have an allergy to bee stings and I had the same reaction to vaccination as I do w/ bee stings except w/ the 7 day delay.
Woke up at 2 am with 102.5 degree fever.  Fever persisting
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter informed that in the facility where she worked it seems there had been temperature excursions with her freezer. It had been happening for weeks since April 2022. She would like guidance on what to do. She stated that in total there were 49 patients affected, but this number was including the Pfizer vaccines that they had, so she was not sure how many patients were affected and received the Moderna Covid 19 vaccine. The patients received Moderna vaccine in the facility between 21-Apr-2022 to 18-Jun-2022. Storage condition at the time of the excursion was frozen. Expiration dates were unknown and lot numbers included 065K21A and 045L21A. Maximum temperatures reached: 30 Fahrenheit Degrees Minimum temperatures reached -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The vials now stored in frozen. Visual inspection did not note any vaccine state change. Number of vials/doses impacted was not sure. No treatment information was reported.
Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a female patient (age not reported) who experienced Immediate post-injection reaction, resting tremor, Nervous system injury and pain while she received vaccine INFLUENZA VACCINE. The patient's past vaccination(s) included a flu vaccine, the patient's past medical history and concomitant medication were not provided, at the time of the event, the patient had ongoing chronic Neutropenia (a week immune system). On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, post vaccination, patient developed immediate reaction and spent a few hours in the emergency room  in extreme pain. She stated that the vaccine totally ruined her life, she would woke up at night in pain and felt that her entire body was still under attack and reported that this also happened 21 years ago with an unknown therapy. No lab test was reported. Final diagnosis was Immediate post-injection reaction, resting tremor, Nervous system injury and pain. It was not reported if the patient received a corrective treatment. On an unknown date, patient recovered from the events.