chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash at the injection site which is spreading down her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site which is spreading down her arm) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site which is spreading down her arm). At the time of the report, VACCINATION SITE RASH (rash at the injection site which is spreading down her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medications was not given.
Information has been received from a registered nurse concerning an 8 year old male with reactive airways disease, a pertinent history of pneumonia, and no drug reactions or allergies, who on 04-AUG-1999 was vaccinated, intramuscularly, with the first dose of Varicella (Lot #1545H). On 31 Jul 2002 a second dose of Varivax (Lot #0376L), was administered. Concomitant therapy included VENTOLIN (albuterol). On 27-JAN-2007 the patient developed less than 50 chicken pox lesions. The patient's father recently had chickenpox. Unspecified medical attention was sought. At the time of the report the patient was not recovered. There was no product quality complaint. There was no lab diagnostic studies performed. Additional information has been requested. 02/11/2010 Follow up information received from a registered nurse who reported that hte patient was seen on 29 JAN 2007 with a two day history of an itchy rash that started on the face and spread to his back. There was some scabbing. Thirst to forty lesions were presented on face, chest, legs and back. Some new vesicles were present. Treatment included isolation until all lesions were scabbed and Avenno baths. At the time of reporting the outcome was unknown. The lot # for the 04-AUG-1999, first dose of VARIVAX was initially reported as lot # 628011/1545M. Follow up information indicated the associated number as Lot # 629263/03083. The patient's six year old siblikng (WAES# 0705USA01699), developed chickenpox after their first dose of VARIVAX. This is one of several reports received from the same source. Additional information is not expected.
I think she said that she has pain in her legs and cramping; couldn't talk because of her throat; I think she said that she has pain in her legs and cramping; This is a spontaneous report received from a non-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 number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCLE SPASMS (non-serious), outcome "unknown" and all described as "I think she said that she has pain in her legs and cramping"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "couldn't talk because of her throat".  Additional information: The patient was barely audible. She said she could not talk because of her throat and a reaction to the vaccine. I think she said that she has pain in her legs and cramping.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a 56 year old male consumer (reporting on himself), with a current condition of diabetes. On 14-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H019042, exp date 17-JAN-2014) (dose reported as 1 rod, every 3 years, subcutaneous route). Concomitant therapy was not reported. In July 2013, the patient got shingles after receiving the ZOSTAVAX vaccine. He stated it was isolated to his left ear. The patient did not sought medical attention and no treatment was given for the adverse event. Laboratory diagnostic studies were not performed. Additional information has been requested.
Information has been received from a pharmacist concerning an 87 year old female who on 07-DEC-2007 was vaccinated with ZOSTAVAX. On 18-DEC-2007 the patient developed shingles. The patient's shingles persisted. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
Information has been received from an 83 year old male female with asthma, hypothyroidism, hypercholesterolemia, osteoporosis, hypertension and drug allergies to PRONESTYL, THEODUR, quinidine, ACTONEAL, EVISTA, FELDENE, and VICODIN, who on 08-AUG-2007 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included SYNTHROID, ZESTRIL, ezetimibe (MSD), FLOVENT, albuterol (inhaler), calcium (unspecified) and vitamins (unspecified). About six weeks (19-SEP-2007) after she received the vaccine, she developed a left sided headache. She described the pain as being located behind her left ear and radiated to the back of her head. She was examined in the office by her primary care physician who referred her for a neurological evaluation. She underwent diagnostic studies that included: sedimentation rate (normal) and an MRI of the brain (normal). The patient was referred to a pain management clinic, but the headache resolved on 01-JAN-2008, without requiring the pain management evaluation. Additional information has been requested.
Uncontrollably vomiting; Nausea; Diarrhea; Headache; Chills; This is a spontaneous report from a contactable consumer (patient).  A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 14Aug2021 at 16:00 (Batch/Lot Number: 59267-1000-01) (age at vaccination 13-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took omnicef [cefdinir] and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications  within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced uncontrollably vomiting, nausea, diarrhea, headache and chills on 15Aug2021 at 18:00. The adverse events resulted in emergency room/department or urgent care for fluids, EKG and Zofran. Therapeutic measures were taken for all the events. The outcome of the events was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
3"x3" swollen, hard, red, painful, hot area right upper outer deltoid area. Tetracycline 500 mg bid x 10 days, Ibuprofen 600 mg bid pc prn #60.
Large rash/hives on injection site arm.  Treated with oral (benydryl) and topical (2% diphenhydramine hydrochloride) allergy medication and anti-itch cream (1% hydrocortisone).  Lasted 2 weeks.
Admitted to hosp 8/23 with fever, chills, arm pain - cellulitis rt triceps area. Infectious disease doctor consulted. Ancef 10mg every 8 hours. Benadryl 25mg IVG 6 hours for itching.  10/9/07 Reviewed hospital medical records which reveal patient experienced fever, chills, & right upper arm pain.  Admitted 8/24-8/27/07.  Fever on admit 103.  RUE injection site w/hematoma, erythema & warmth.  Tx w/IV antibiotics.  ID consult done.  Improved & d/c to home on continued oral antibiotics. FINAL DX: nonischemic cardiomyopathy, recent ICD implantation, 8/21/07; RUE cellulitis, resolving; hx of COPD; dyslipidemia.
deviation for dosing schedule; This spontaneous case was reported by a non-health professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (deviation for dosing schedule) in a 55-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 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (deviation for dosing schedule). On 29-Mar-2021, PRODUCT DOSE OMISSION ISSUE (deviation for dosing schedule) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received and contains no new significant information.
2nd dose given a week early ( 1st dose administered on 7/9/22)   There was no medical or any other adverse reaction. vaccine just administered to soon , Parents made a wear and will follow up with PCP on 7/25/22.
p/vax pt devel serum sickness & was hosp x 2 days;tx w/cortisone;all sx have now resolved;
5 hours after injection I experienced chills, muscle aches, muscle weakness, swelling, warmth to injection site. Three to four days later experienced weakness in the arm and hand shaking and when trying to lift objects. Could not steady my left hand. Baseball size swelling and hardness at injection site.
Chills; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021BZIA and 030AZIA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Nasal swab) on 26-Nov-2020. Concurrent medical conditions included Drug allergy (Doxycyline, Leviquin) and Food allergy. Concomitant products included SIMVASTATIN and ROSUVASTATIN for High cholesterol, COLECALCIFEROL (D3), MAGNESIUM, ZINC PICOLINATE and CURCUMIN for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Low grade fever, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) outcome was unknown and FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) Low grade fever.         This case was linked to MOD-2021-072898 (Patient Link).
Awoke on 1/8/21, about 18 hours after injection with body aches and aching joints persisting for the rest of the day, taking ibuprofen every four hours. 1/9/21 I woke with moderate itching of scalp, body aches continue. Throughout the day I had large itching whelps at different places on my body.  At 11:00am my temperature was 100.5, at which time I also had moderated chills for about an hour. I took ibuprofen and tylenol and benadryl at 4 hour intervals.  after the chills stopped (about an hour) symptoms began to calm down.  Sunday I woke with no symptoms at all.
7 days after the injection, the site became swollen, tender and red again and this time it is also itchy. It is not more swollen than the day after the injection.  The redness had totally gone away and came back.
On Aug. 16, 2016 I went to see my Primary Doctor - for my Diabetic check-up. My appointment was at 11:00 A.M. She was pleased with all my lab results, checked my feet, heart, lungs, Blood Pressure (a little high), temperature, etc. Everything was good and before she left the room, Doctor said she was giving me a new pneumonia shot, (PCV 13). Nothing was discussed, as to what reaction, if any I could have, so I thought is was a regular pneumonia shot. The Doctor left and her asst. (she was new to me and I can't remember her name) came in and gave me the PCV 13 shot in my left arm, handed me my papers and said to see Dr. in 6 months. My sister, was with me and we left the office a little before 12:00 p.m. We went to lunch and within an hour, I was feeling cold, tired and not very hungry. By the time (4:00 P.M.) I arrived home I had the chills and was very sleepy. The next day, Aug 17th, early morning hours, I started coughing, was hot and cold and ran a fever (102-103 degrees) and I only ate to take my diabetic meds. I think it was on Aug 19th that I called and reported my symptoms to my Dr. Doctor never called me back and I wasn't getting any better, in fact I was having trouble breathing. I called and got an appointment to see a Nurse Practitioner on Aug 30th 10:40 A.M. She sent me to the emergency room right away. They did an X-Ray and CAT Scan of my lungs, blood work, urine test and put me on oxygen. They told me I had right lung pneumonia and transported me to medical center on Aug 30th, 2016. I was discharged, on 9-4-16 around 12:00 P.M. and the discharge papers said I had pneumonia of right middle lobe due to infectious organism. Since I am never sick, I don't even get a cold and have never ran a reaction to any shot I was given (I get a flu shot every year and even got the swine flu shot, years ago). This reaction has really thrown me for a loop. I still have a cough and feel run down. I have an appointment with Dr. on Tue. 9-27-16 at 11:20 A.M. I hope I am feeling better. I know in my heart this shot made me sick, since I am never sick and within 4 hours of getting this shot, I was ill. I just wonder how many other cases there have been. I hope I will make a full recovery.
This spontaneous report as received from a pharmacist refers to 2 patients of unknown age. The patients was vaccinated with ZOSTAVAX (lot# unspecified). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients experienced injection site reactions after receiving ZOSTAVAX included mild swelling, warmth and redness around injection site. No treatment information was reported. The outcome of mild swelling, warmth and redness around injection site was unknown. The patient had sought medical attention via spoke to the pharmacist. Additional information is not expected.
Breakthrough case admission after 3 vaccines  Moderna 2/28/21 lot# 010A121A;  Moderna 3/28/21 lot# 018B21A;  Moderna 12/12/21 lot# 060H21A;  Pfizer 11/27/22 lot# GH9703
SEVERE RASH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced severe rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe rash was not reported. This report was non-serious. This case, from the same reporter is linked to 20210407409.
Heart Palpitations,  chills and fever , significant pain in right arm, swelling, and reddened area that is hot, raised, and hard below injection site.  Prompted medical attention Monday - Dr. advised ER.
I noticed pain in my L axillary area the night of Tuesday December 29th but didn't think anything of it. The pain woke me up and I noticed a very large lump in the middle of my axillary region. It is still there and very painful. I went to my doctors on December 30th and she said to just monitor it for the next 4-6 weeks.
Pt rec'ed PCV13 on 9-15-15. Pt noticed area was sore - red - hot - painful - had office visit 9-23-15.
Right arm sore/ pain. No bruising, no erythema, no lump/ nodule appreciated.    Systemic-  Body aches, fatigue, weakness, chills, headache, nausea  Patient was treated for left ear infection.   All started the night of the vaccine given.
Coughing, sore throat, fatigue,  fever 99 degrees, lasted about 5 days
About 15 hours after the injection I developed sudden onset of chills, headache, nausea, dizziness and low back pain. The site of the injection was also throbbing. I had no side effects prior to this. It was severe enough that I had to call off of work. Symptoms resolved about 6 hours later. I have had no further symptoms since that time.
This spontaneous report as received from a health care professional refers to a 10 month old male patient. On 04-JUN-2013, the patient's grandmother was vaccinated with a dose of ZOSTAVAX. On 29-JUN-2013, the patient broke out with chickenpox. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
It started off as a sore arm and there was a red nodule on my left arm near vaccination site. The redness spread substantially. It covered more than half my arm. It spread through sixty percent circumference of my arm. It started to blister as well. The physician's assistant I saw stated it was a reaction to the vaccination site. She prescribed a steroid cream and she told me to take an OTC antihistamine. She also prescribed an antibiotic if it started to strengthen which I didn't end up needed.
PHENOMENA, HAIR LOSS, HAIR AND SKIN DRYNESS, ASTHMA WORSENED, COPD, APPETITE DECREASED, HEARING AND EYE SIGHT WORSENED RAPIDLY,  OSTEOPOROSIS, ABILITY TO SMELL DECREASED,  RAPID SEVERE AGING,  QUALITY OF LIFE DECREASED EXTREMELY
Information has been received from a nurse referring to unknown number of patients of unknown age and gender. Information about patients' concurrent medications, concurrent conditions and medical history was not reported. The nurse reported that since 09-MAR-2016 the patients were vaccinated with doses of MMR II (dose and route not reported, lot number K024825 with expiration date 02-DEC-2016 and lot number L005291 with expiration date 17-FEB-2017) that had been improperly stored (temperature: 47.1F and time frame: 30 minutes). It was reported that there was a previous temperature excursion with 48.7F for 30 minutes. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
chills, shakes, was increasingly sore, and a fever of 103.5 degrees; chills, shakes, was increasingly sore, and a fever of 103.5 degrees; chills, shakes, was increasingly sore, and a fever of 103.5 degrees; They believed it was a bad batch of PENUMOVAX; They believed it was a bad batch of PENUMOVAX; temperature up to 103 degrees/fever of 103.5 degrees.; severe swelling in her arm; This spontaneous report was received from a physician via a company representative concerning a female patient of unknown age. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On 05-MAY-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided).  On an unspecified date in May 2017, the patient had a bad reaction to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23): experienced temperature up to 103 degrees (scale not provided) (body temperature increased) and severe swelling in the arm (peripheral swelling). On 08-MAY-2017, she was seen by the health care professional (HCP), with chills, shakes (tremor), was increasingly sore (pain) and a fever of 103.5 degrees (scale not provided). She was treated at that time with acetaminophen (TYLENOL). The physician stated they believed it was a bad batch of  Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23), because he had other patients experience unspecified reactions as well, and normally you don't saw that kind of reactions from Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The outcome of body temperature increased, pain, tremor, chills and peripheral swelling was unknown. The reporter considered body temperature increased, pain, tremor, chills and peripheral swelling to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2104USA001602:
numbness in left 4/5 finger on 4/26/21 Narrative:  Numbness and tingling in l 4/5 fingers on 4/26/21. Injection site pain l arm on 4/24, 4/25/21 has resolved.
Vaccine administered around 10:20AM; RPH chatting with patient for several minutes before vasovagal response (with possible seizure activity) ~10:23AM.  911 was called and patient was given ammonia smelling salts under the nose, stabilized in a supine position, and monitored in the patient immunization room until the emergency medical technicians arrived around 10:45AM.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported) and a dose of MENACTRA vaccine (dip toxoid). Subsequently the patient experienced hives. Unspecified medical attention was sought. At the time of this report, the outcome of the patient was unknown. No further information is available.
Varicella injection L arm,  Area red, indurated, warm to touch and hard. Measures 6 1/2 cm L  x 6 1/2 cm W. No drainage. Patient has no temperature. Varicella injection given in L arm SQ on 7/30/08 at 1212. Mom noticed area within 24 hrs of vaccine. Benadryl and cool compresses to be applied to area per FAC.
Received Janssen vaccine 4/6.  Started menstrual cycle 12 hours after vaccine even though had just completed last cycle 1 week prior.  Normally cycles are 28-30 days apart.  They have not been quite as regular since Covid and has had some shorter periods between normal cycles.  After the vaccine bleeding was heavier than normal with large clots but by end of last week had changed color and looked like it was ending.  Today had no discharge upon awakening but again has a small amount of bright blood.  Of course, there is concern for coagulopathy related to the vaccination.  No leg pain, no shortness of breath.  Has had HA off and on since had Covid but no worse now than in previous weeks.  Left ear pain has been painful since Covid but now has pain in both ears when that occurs.  Quit taking ibuprofen last week for discomfort and switched to Tylenol.
approximately 30 minutes after receiving vaccination i began to develop  tongue and lip swelling as well as difficulty swallowing and breathing , i then proceeded immediately to the nearest er
Patient received flu shot  and Covid Moderna (Spikevax) in the same arm. Left arm. Flu shot on top. Spikevax on bottom.  Patient felt fine during the day and then around 10:30pm on 10/02/2023 patient's arm started to hurt and turn a bright red.  She noticed swelling as well.  Pain was shooting  up her shoulder.  Patient applied an ice pack and applied hydrocortisone cream to the red area.  As the week went by patient her arm got redder and darkened to a brown color.  The injection site swelled more and the area was very raised.  By 10/07/2023 @ 9:30am patient noticed the redness and swelling going down.  Patient states that when she moves her arm there is a sharp pain going up her arm.
Swelling, Extreme Pain, heat at the site, electrical pain that radiated down to the hand, temporary paralysis of arm, blurred vision and extreme fatigue.
Approximately 5-10 minutes after vaccines, skin lesions like hives. Child flushed, scratching at the site at which MMR had been administered. Resolved after 5-10 minutes. Given Benadryl; no respiratory distress.