chrisvoncsefalvay/vaers-outcomes huggingface dataset:
area looked swollen and reddish for one testicle; area looked swollen and reddish for one testicle; Sore scrotum; Other testicle looked small like it wasn't there; This spontaneous case was reported by a health care professional and describes the occurrence of TESTICULAR SWELLING (area looked swollen and reddish for one testicle), ERYTHEMA (area looked swollen and reddish for one testicle), TESTICULAR PAIN (Sore scrotum) and TESTICULAR DISORDER (Other testicle looked small like it wasn't there) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included Orchiectomy. Concurrent medical conditions included Hypertension, Diabetes, Testicular cancer and Pancreatitis.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TESTICULAR SWELLING (area looked swollen and reddish for one testicle), ERYTHEMA (area looked swollen and reddish for one testicle), TESTICULAR PAIN (Sore scrotum) and TESTICULAR DISORDER (Other testicle looked small like it wasn't there). At the time of the report, TESTICULAR SWELLING (area looked swollen and reddish for one testicle), ERYTHEMA (area looked swollen and reddish for one testicle), TESTICULAR PAIN (Sore scrotum) and TESTICULAR DISORDER (Other testicle looked small like it wasn't there) outcome was 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.   Concomitant medications included hypertension medications 2 times, diabetic medications 2 times, pain medication, eye drops 4 times.  Treatment information included ice pack.
Pt received Pfizer Covid 19, but was only 11YOA. Pt had no adverse event, just not approved for pt age at this time.
16 year old male who had flu shot today at 6pm to left deltoid and went home. While in shower pt began having diffuse pruritis c generalized urticaria as well as throat swelling. No dyspnea, wheeze or stridor. Mother medicated c Benadryl 25mg PO X2 and urticaria/pruritis has resolved. Pt still c noticeable swelling of throat when swallowing only. Pt has had flu vaccine last 6-7 years s any adverse/allergic effect.  Prednisone 40mg PO.
Irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 HEART RATE IRREGULAR (Irregular heartbeat). At the time of the report, HEART RATE IRREGULAR (Irregular heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Pt accidentally received HPV (GARDASIL) instead of Hep B vaccine. Dr. notified, counseled pt father, answered all questions. Spoke with CDC instructed to watch for s/s of local reaction. None noted. Manufacturer notified.
It started with joint pain on left side at the elbow and wrist. Then it progressed to all-over body aches. Then every joint became achy, even spine and toes. One of the left lymph nodes at the base of the skull became swollen like a golf ball. Then the throat lymph nodes also became swollen. I had fatigue to the point of needing to nap throughout the day; this comes and goes. I have weakness in the hands. Most recently, I have had shortness of breath, even after doing nothing. I have had earaches recently. I tested positive for mono, even though no one in my life has it. This has all been going on for over 2 months now. The doctor says I display some of the symptoms of Guillain-Barre Syndrome. He says that if I display tingling in the extremities, I am to go to the ER. On 7/19/2021, I am going to have my spleen examined, because I have had nausea and pain in that area.
can't focus her eyes; Vision is all blurry; Like things moving; Words swimming around the page; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (can't focus her eyes), VISION BLURRED (Vision is all blurry), FEELING ABNORMAL (Like things moving) and APHASIA (Words swimming around the page) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 008B21A;) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (can't focus her eyes), VISION BLURRED (Vision is all blurry), FEELING ABNORMAL (Like things moving) and APHASIA (Words swimming around the page). At the time of the report, VISION BLURRED (can't focus her eyes), VISION BLURRED (Vision is all blurry), FEELING ABNORMAL (Like things moving) and APHASIA (Words swimming around the page) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant Medications also includes vitamins. Treatment information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-081449 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081449:Dose
Patient was given Pfizer vaccine and then asked to walk down the hall way to get vitals. While walking down the hallway patient reports that she felt "light headed" and like she was "seeing stars" but did not alert nursing staff. Once patient sat in chair and the MA put blood-pressure cuff on patient's arm, she started to feel even more faint and she slumped over and briefly lost consciousness. Another MA put ammonia under patient's nose and she instantly regained consciousness. Patient reported feeling a little weak. Patient drank water and returned to room. Patient was observed for 40 minutes afterwards, no additional syncopal events. Patient left feeling well.
Headache, Myalgia, Arthralgia, Fever, CoughWheeze, Diarrhea, Syncope, Lightheaded , headache, body ache, fatique, sore injection sit , Narrative:
Received PPV23 on 11/10/08 afternoon. States noticed "lump" to side of neck. States had some sinus irritation and ear pain prior to vaccination. Ear pain on same side of lump (lymphnode).
I started getting symptoms scratchy throat so I thought it was allergies. I took a COVID-19 test the next day that was negative. Then my symptoms progressed. I took another test that was also negative. I went to the doctor and was prescribed an antibiotic. The next day, I ran a fever of 101 and body aches. I had a headache also. I took another COVID-19 test that showed positive. I did have a cough with congestion. My ears were affected as well. I sent a message to my doctors office and was told that I did have fluid in my ears during the previous visit. I did have an ear infection. I went to an ENT and was prescribed Prednisone.
pt recv vax & mom reported that pt got stiff & passed out w/in a few minutes p/vax;pt recovered w/o tx w/no apparent after effects;
loss of hearing; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 07-FEB-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered from loss of hearing. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event loss of hearing was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event loss of hearing to be disability.  Upon internal review, loss of hearing was determined to be medically significant.
This dose is a second dose of Moderna vaccine administered to this patient  He is under the age of 18 and should have gotten Pfizer vaccine.  He got Moderna vaccine the first dose so we had to administer Moderna vaccine as a second dose.  He only  had mild flu symptoms with the first dose that lasted for 24 hours
Has a sick nauseated feeling all the time; Stomach hurts all the time; Has a sick nauseated feeling all the time; he's constipated; he can't drink or eat much, even drinking water is hard; He feels full very quickly; This is a spontaneous report from a contactable Consumer or other non-HCP. This consumer (patient) reported for a male patient:  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on an unspecified date, as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date, the patient experienced a sick nauseated feeling all the time, stomach hurts all the time, constipated, can't drink or eat much, even drinking water was hard and feels full very quickly. The reporter stated that the patient had the Pfizer vaccine a few weeks ago and ever since then patient stomach hurts all the time and it feels hard, patient can't drink or eat much, even drinking water was hard. Patient feels 'full' very quickly. Patient had a sick nauseated feeling all the time and he was constipated. Reporter queried if side effects are familiar for someone taking Pfizer. Reporter was informed about the Pfizer Medical Information department and offered the number. Reporter was also informed about the role of Pfizer Drug Safety. Reporter was provided with the number of Pfizer Medical Information. Reporter was informed about the role of Pfizer Drug Safety. The outcome for all the reported events was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 669646/1703Z, expiry date 09-DEC-2012) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. This is one of the many reports received from the same source. Additional information has been requested.
Child came to office with c/o pain & swelling of left shoulder/bicep pain. Area was tender, erythematous. Swollen 4" warm area, wrapping around upper left arm (deltoid) into posterior axilla. Consistent with cellulitis. Child had received 2 vaccines in this arm 2 days ago. Antibiotic was prescribed.
Day 1 symptoms major arm pain tiredness Day 2 symptoms major arm pain at injection site, headache, body aches and extreme tiredness  Day 5 symptoms flare up of bladder pain and back pain from Interstitial Cystitis   I am on Day  11 after first injection and still experiencing bladder issues
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L007228, expiration date 03-SEP-2016; lot # K020750, expiration date 30-APR-2016, dose and route unknown). No adverse effects reported. No PQC involved. Additional information is not expected because the reporter did not want to be contacted.
Within 72 hours, the patient developed pruritus not associated with dermatitis at the vaccination site.  Within 96 hours the patient had developed generalized pruritus on the upper extremities, especially the upper arms and the thighs.  Dermatitis was only secondary to excoriation.  No obvious angioedema or urticaria.  Limited dermatographia.  Skin is generally dry in the areas of pruritus.  No other symptoms suggestive of systemic anaphylaxis.  The patient does not have a history of previous urticaria, angioedema or atopic dermatitis.
Swelling of arm, coughing, diarrhea, headache, tiredness, change in personality.
Incorrect Vaccine given to patient. PROQUAD given instead of MMR. No adverse reaction noted at this time.
Next morning after getting a shot around 4am my head shook for a few seconds and stopped. And then about 4 days later I noticed a slight change of my hearing on my right ear. Went to get it checked and even had MRI done and no explanation. Only event that took place is the shot.
I was vaccinated on 6/1/23- over the next few days I had site soreness only ( no redness at site noted). On or about 6/8 evening I began to notice tenderness and rash under my hairline and on my left neck. Those on left neck appeared to be small  maculopapular like-no exudate, did not appear to be fluid filled however difficult to see due to area,.Over next day developed macular type-elevated lesions at left back of neck and into hairline that were pruritic and very tender.  A day or so late one appeard to have small blister like appearance -no exudate.A slight non sever shocking sensation intermittently that night. There was associate left neck soreness and the feeling of light" prickly" sensation over area as if one was wearing a wool item close to skin which lasted about a day NO fever or noted malaise, no other systemic symptoms in particular.  I decided to seek medical attention on or about day 5( 6/13) for concern of non healing and concern I had cellulitis. I was advised I had Shingles and no intervention was necessary as I had a mild case. I treated with OTC Calamine lotion and cortisone. I am improving - no new leisons noted and the ones present appear to be healing with much less itching.
Developed redness and swelling in left arm beginning the day after vaccination. Mom took child to the Emergency Department on 11/6/19 and was instructed to apply cold compresses alternating with warm compresses, give ibuprofen and consult primary physician if not improving. Mom called us 11/7/19 because redness and swelling now extended to his hand, he c/o discomfort and was having difficulty moving his arm. The primary physician was not available this day so directed her to go back to the ER. Spoke with mom today and she reports ER advised her to continue treatment and notify them if no improvement by 11/11/19. She reports today that symptoms are much improved.
Got the shots. Shingles in my eye now/Suspected vaccination failure; Shingles in eye now, after terrible stressful event; i had a terrible stressful event; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and stress. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and stress were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and stress to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Apr-2022 Reporter's comment: The case was received from consumer via interactive digital media. This patient self reported this case. The patient had shingles and then got the shots and here he/she with shingles in his/her eye at the time of reporting. The patient stated that stress brought them out and had terrible stressful event and they appeared. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 81-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The patient had Covid, but did not take Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200749765 similar report from same reporter
DILUANT GIVEN WITHOUT RECONSTITUTION WITH LYOPHILIZED POWDER.  CALL PLACED TO CLIENT TO ADVISE OF ERROR. ADVISED CLIENT THAT SHE WILL NEED AN ADDITIONAL VACCINE IN 4 WEEKS.
reaction when eating red meat products; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction when eating red meat products) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2022, the patient experienced VACCINATION COMPLICATION (reaction when eating red meat products). At the time of the report, VACCINATION COMPLICATION (reaction when eating red meat products) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Patient requested to receive Johnson & Johnson covid-19* vaccine.  Patient indicated that he had never received a covid-19 vaccine and this would be his first.  Upon billing the patients insurance it was discovered that the patient had already received both doses of Moderna vaccines on 03/06/21 and 04/04/21.  No adverse event noted.
This patient was reported to have secondary transmission, dehydration, fetal growth retardation, fever, varicella, vomiting, herpes zoster, pneumonia, and a respiratory condition. Information has been received from a mother who had experienced secondary transmission of varicella after her 12 month old daughter was vaccinated with varicella virus vaccine live. Two weeks after the child developed chicken pox (WAES # 01011852), the mother also got chicken pox. At the time, approximately 02/24/00, it was noted that the mother was in her first trimester of pregnancy. The mother was admitted into the hospital by her infectious disease doctor to monitor the fetus. The mother was unable to keep food down, was very dehydrated, developed shingles, pneumonia, and a temperature of 105 F. The patient was in the hospital about two weeks. After being in the hospital, the fetus that she was carrying "wasn't really growing" and then started growing later. As of 01/19/2001, the baby that she was carrying was 4 months old and was just in the hospital with respiratory problems. the mother also stated that "the baby doesn't keep down food but is still gaining weight". The mother stated "that she would like to know if all of this is related to the (varicella virus vaccine live) her oldest daughter got". Follow up information from the child's pediatrician stated that she indicated that because both the mother and the child had developed chicken pox at the same time, she felt that they must have both been exposed to the same source of wild type varicella and that the child's chicken pox had been modified because of the vaccine. In July 2000, the vaccinee was seen in the pediatrician's office for an 18 month visit, however there was no mention of the mother having to be hospitalized, nor any mention of the other adverse experiences which the mother described herself as having. No further information is available.
Patient is 5 years old and was supposed to be getting a second dose of the 5-11 yo Pfizer vaccine. Instead they got the 6mo-4yo vaccine. Their first dose was of the 5-11 covid vaccine.
First dose was given on 17Feb2021 / second dose on 29Jan2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 295S7, expiry date 9th October 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose receive on 17th February 2020, batch number KS43H, expiry date -unknown).   On 29th January 2021, the patient received the 2nd dose of Shingrix. On 29th January 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter called for information regarding validity of the administration of a second dose of Shingrix after almost 1 year since first dose. The patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter was not sure about sharing too much patient information and only provided date of birth and gender. The reporter consented to follow up.
This spontaneous report was received from a licensed practical nurse and refers to a 12 months male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneous route, right arm, lot # N019133, expiration date 22-NOV-2017 (strength and dose were not reported) for prophylaxis. Other suspect therapies included M-M-R II, left arm, subcutaneous route, lot number M045390,  HEPATITIS A VIRUS VACCINE INACTIVATED, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) and sterile diluent (MERCK STERILE DILUENT).  No adverse effects reported.