chrisvoncsefalvay/vaers-outcomes huggingface dataset:
recently released from Hospital after taking a test; Rash on body, breakout all over my body; Allergic reaction to Iodine; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (recently released from Hospital after taking a test) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). On 23-Apr-2021, the patient experienced IODINE ALLERGY (Allergic reaction to Iodine). On 25-Apr-2021, the patient experienced RASH (Rash on body, breakout all over my body). On an unknown date, the patient experienced HOSPITALISATION (recently released from Hospital after taking a test) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (recently released from Hospital after taking a test), PAIN IN EXTREMITY (Sore left arm), IODINE ALLERGY (Allergic reaction to Iodine) and RASH (Rash on body, breakout all over my body) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       On 23-Apr-2021, the patient received an iodine media contrast (type unspecified) which was considered a suspect product.  No concomitants were provided. No treatment was provided.  The patient reported, she had just recently been released from the hospital after taking a test in which they injected iodine for procedure. Up to that time, she had never known that she was allergic to iodine and had a very bad reaction (breakout all over her body).  On 23-Apr-2021, patient underwent a CT scan (unspecified), result unknown.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  however the concomitant use of iodine contrast media could be a confounder. further information has been requested   This case was linked to MOD-2021-245524, MOD-2021-245524 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Upgraded case to serious (hospitalization), updated action taken for Moderna vaccine, added event and case details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  however the concomitant use of iodine contrast media could be a confounder. further information has been requested
Gave seasonal flu vaccine in patients left deltoid muscle, vaccination was not attached well to needle, patient only received part of the dose, when I returned to revaccinate patient had a huge knot where injection had occurred and started feeling tightness in chest and extremities. Gave EPI PEN, called EMS within minutes.
Information has been received from a registered nurse concerning a 12 month old female who in the morning of 17-FEB-2006 was vaccinated with the first dose of VARIVAX (Merck) (lot number:  650223/0426R) 0.5 ml subcutaneously on right arm.  On 22-MAR-2008 the patient developed chickenpox.  The patient had less than 50 lesions in total, and the lesions were limited to the patient's truck and face.  No other symptoms were noted.  Medical attention was sought by phone call to the office.  The outcome was reported as recovered on 27-MAR-2008.  Additional information is not expected.
Patient received Tdap on 9/29/08.  Called on 10/2/08 reporting over past few days arm very sore, painful at night, "swollen area on neck above clavicle" - declined to be evaluated.  Called patient on 10/8/08 and left message to see how she is feeling - have not received call back from patient.
Pt. complained of dizziness, excessive pain in arms, hands and legs. Also, "tingling" and occasional "numb" feeling in legs. Also developed "chills" 3 days after vaccination. Evaluated by PMD x 2 and also had numerous other medical problems noted at visits. No pain at injection site-only in extremities. No signs of local reaction or swelling, etc.
Information has been received from a mother concerning her 14 year old daughter with asparaginase, ceftazidime, ZOSYN allergies and a history of acute lymphoblastic leukaemia, who was vaccinated with the first "recommended" dose of GARDASIL "2 or 3 months ago'. There was no concomitant medication. At that evening the patient had side pain, a month of irregular period and had skipped her last 2 periods. There were no labs or diagnostic tests performed. The patient called the physician for medical attention. The patient had not recovered at time of reporting. Follow up information received from a physician concerning a 17 year old female patient with penicillin, cephalosporins allergies and a history of aspergillosis and acute lymphoblastic leukaemia, mental retardation, who was vaccinated with the first dose of GARDASIL (lot # 665768/1354Y) in the right deltoid on 01-FEB-2010. She received her second dose (lot # 662299/1099Y) in the right deltoid on 26-APR-2010. The patient had side pain the night after the first vaccination on 01-FEB-2010 and missed her periods. The reporter felt that this was due to the vaccination. The patient had the second dose without reported side effects. The outcome was not reported. Additional information has been requested.
Erythema polymorphus; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA MULTIFORME (Erythema polymorphus) in a male 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 ERYTHEMA MULTIFORME (Erythema polymorphus) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (Erythema polymorphus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided.  Treatment information was not  provided.  Company Comment : This case refers to a male patient of unknown age with no known medical history who experienced the unexpected event of Erythema Multiforme. The event occurred on an unknown date and it is not clear if it was before or after the Moderna Covid-19 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case refers to a male patient of unknown age with no known medical history who experienced the unexpected event of Erythema Multiforme. The event occurred on an unknown date and it is not clear if it was before or after the Moderna Covid-19 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Narrative:  NO ADR-PT RECEIVED MODERNA VACCINE FROM AGENCY THEN PFIZER VACCINE FROM COUNTY FIRE DEPARTMENT WITHOUT AGENCY KNOWLEDGE OR NOTIFICATION.
Swelling, redness, pain (later itching) at injection site.  Area of swelling is approximately diameter of a baseball on day 5.
pt recv vax 11AM & mom gave APAP since that time pt started to cry; mom came back to clinic 230PM w/baby crying & rt thigh redden & sl swollen; ice compress was applied;
PATIENT HAD PFIZER VACCINE Dose 1 date: 12/31/2020,  Dose 2 date: 01/21/2021, AND TESTED POSITIVE TO COVID.
pt dx w/sz @ time p/had shot;noticed was forgetting things;would become real shaky, nervous feelings, it was uncontrollable, dizziness;pt stated when was asleep felt like going into a coma;pass out feeling;
This spontaneous report as received from a medical assistant refers to one unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant therapies were not reported. On 24-AUG-2016, the patient received a dose of improperly stored PROQUAD (lot # L033698, expiration date: 28-AUG-2017) (dose and route of administration were not provided). There were no adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, lot# and route of administration were not reported). On an unknown date the patient had his spleen removed after receiving PNEUMOVAX 23. The outcome of the event was unknown. Upon internal review the event of patient had his splenectomy was determined to be medically significant. Additional information has been requested.
Patient came to office 5-26-09 + reported she had warmth + redness to injection site 5-20-2009 which resolved; then on 5-22-2009 she began to have shoulder pain radiating down arm to elbow; she has also been picking strawberries + cherries.
Traumatically swollen lymph node under right ear/jaw.  Taken to pediatrician's office to be diagnosed with cervical adenitis.  Prescribed 4ML of Augmentin twice daily for 10 days.  Just dispensed dose number 9 -- absolutely no reduction in swelling, but no increased swelling either.
Pharmacist initially injected patient with a syringe that contained no vaccine. Upon realization, pharmacist immediately explained what happened to patient and administered correct dose in opposite arm per guidelines.
To be clear, I am presuming at this point that this is vaccine-related as I don't have any other valid explanation for my symptoms. I began experiencing itchiness in random body locations sometime in the morning on Wednesday, December 22, 2021 (almost exactly 2 weeks after receiving my Covid booster - Moderna). After not thinking much of my itchiness, I realized I was actually breaking out in hives (or urticaria) at random intervals over my whole body. They would appear in a location, last an hour or so, slowly fade and disappear, only to reappear shortly thereafter in a new body location. I took Benadryl at night, but that did nothing for my daytime symptoms and the itchiness was awful. I sought medical attention via my PCP on Monday, December 27, 2021. She and I discussed varying degrees of treatment and we decided together to just try OTC Claritin before trying steroids. The Claritin did and continues to help manage the symptoms at a tolerable level but I do continue to have breakthrough hives. Throughout all of this the hives have been consistently worse at night between bedtime and dinner. The only other explanation aside from the vaccine that I thought may have been the cause was a women's PMS vitamin supplement called FLO Vitamins that I began taking daily about 6 days prior to my symptom onset. I have not taken these in over 2 weeks now and yet my symptoms persist. I have also noticed that I experience Dermatographia along with the hives, where my skin is now extremely sensitive to any abrasion and causes redness and hives in any minimally scraped or abraded area (for example, I reached behind the couch to get something and my forearm rubbed against the couch as I did this and had a massive area of redness and hives in that location for about an hour subsequently). I have never in my life experienced hives or Dermatographia prior to my symptom onset on December 22, 2021. I have had no recent environmental changes, nor do I suffer from any food or topical allergy normally.
had immediate swelling @ site;knotted up in a lump;become reddened as time progressed;
reaction on upper torso to sweat. Break out in hives from sweating  blister up and scabbing over lasting several days
This spontaneous report was received from a nurse refers to a 09-week-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with improperly stored RECOMBIVAX HB, lot # N006321, expiry date: 08-NOV-2019 and ROTATEQ, lot # M042170, expiry: 22-JUN-2018; dosing details were not reported, both for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patient were vaccinated with MMR II, lot number of Vaccines for Children (VFC) Vaccines J007929, expiration date 28-JUN-2015 (dose and route was not reported) that had a temperature excursion. Patients were also vaccinated with improperly stored TD. No adverse effects were reported. The reporter was unable to provide any patient information or dates of vaccination. This is one of several products received from the same reporter. Additional information has been requested.
Inappropriate age at vaccination; Infanrixadministered instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 22-year-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th August 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th August 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-September-2022 Reporter's comment: This case was reported by nurse. Nurse reported that a male patient received an Infanrix vaccine instead of Boostrix. This error happened on 15th August 2022. Additional supportive information: As patient received Infanrix vaccine instead of Boostrix. which led to wrong vaccine administered and inappropriate age at vaccine administration. Reporter did not consented to follow up.
Stiff arm; slightly sore/stiff arm; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 28March2021 at 10:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Mar2021, the patient had only a slightly sore/stiff arm and the patient could still do her workouts without any problems. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The ice helped the patient with the pain and stiffness. The clinical outcomes of the events stiffness and pain in arm were recovering at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient experienced syncope approximately 2 minutes after receiving their vaccination and collapsed to the ground and smacked their head on the floor, bottom lip appeared white and discolored. Patient was lethargic with faint breathing, temperature was 97.1, hyperhidrosis, hot to touch. 911 was called, EMTS arrived at the scene. Oxygen was given and cold packs. Patient was then taken to the hospital. At the scene, the parents reported to EMTs that the patient had a fever approximately 3 days ago for 2 days.
This spontaneous report was received from a nurse and refers to a 15 month-old Black male patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 28-JUN-2017 at 19:04, the patient was vaccinated with improperly stored VARIVAX, in the right thigh (lot # M047662 with the expiration date of 02-DEC-2018; first dose, exact dose and route of administration were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The patient was concomitantly vaccinated with a dose of M-M-R II. The administered dose of VARIVAX experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1706USA009938:
This case was reported by a nurse via call center representative and described the occurrence of arthus reaction in a 16-month-old male patient who received INFANRIX (batch number PT2RK, expiry date 7th July 2019) for prophylaxis. On 15th September 2017, the patient received INFANRIX On an unknown date, unknown after receiving INFANRIX, the patient experienced arthus reaction (serious criteria GSK medically significant), swelling, hypersensitivity and erythema. On an unknown date, the outcome of the arthus reaction, swelling, hypersensitivity and erythema were unknown. It was unknown if the reporter considered the arthus reaction, swelling, hypersensitivity and erythema to be related to INFANRIX. Additional details were provided as follows: The patient had experienced hypersensitivity, after receiving INFANRIX in 2017. Allergist was trying to narrow down ingredients to determine allergy.
arm hurting, radiating pain, irritated band around arm 6 inches, heart palpitating, hand issues
Fever to 102.9, fevers first started 12 hours after administration.  Requiring constant antipyretics to decrease
I woke up in the morning with diaherrea and a huge cold sore on my bottom lip.
Left upper thigh was red, warm, swollen & itchy shortly after the injections.  He was in pain & wanted to be carried because his legs were weak.  Around 8pm on 6/1, he was having difficulty breathing.  He was wheezing & coughting.  By 6AM on 6/2, he sounded like he had a whooping cough.  Breathing became progressively worse.  Around 8pm he vomited.  Wend to MD on 6/3 (AM) & was Dx with bronchitus & given a breathing treatment in the office.  He was also given scripts for Zithromax, Predisone, & Albutrol.  Began meds on 6/3, but continued to get worse & vomited again the night of 6/3 in the middle of the night while sleeping.  On 6/4 he was still coughing & having some breathing problems.  He was out of daycare/school from 6/2-6/4 & was picked up early on 6/5.  He was still & is still having breathing problems & coughing.  They are getting better, but the breathing problem are still there.  We will return to MD on 6/8 at 4PM.  6/9/09 Medical records received DOS 6/1//09 6/3/09. Assessment: Acute bronchospasm, bronchitis. Post vaccination: Coughing, wheezing and difficulty in breathing. Chest pain. Nasal congestion with post nasal drip. Scattered rales.  Follow-up: He has had continued complaints of leg pains and continued breathing problems with wheezing and coughing. On 3/8/10 he was again dx with bronchitis. We had to get a nebulizer w/ compressor. He was given steroids again, an antibiotic and albuterol for treatment. On 6/10/10 he was again dx w/ bronchitis. This time he is taking Amoxicillin, Albuterol and MUCINEX. We have an apt w/ an allergy specialist on 6/29/10. Prior to the vaccine he had no breathing problems. Now it seems like we go in for breathing problems frequently. The medications used to treat the breathing problems change his behavior and he complains that they make him "crazy", which I would interpret from a 5 yr old that it makes it difficulty for him to focus and think.
This spontaneous case was reported by an other health care professional and describes the occurrence of CROHN'S DISEASE (Crohn's disease) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease). The patient was treated with VEDOLIZUMAB (ENTYVIO) ongoing from January 2022 for Crohn's disease, at an unspecified dose and frequency. At the time of the report, CROHN'S DISEASE (Crohn's disease) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was respiratory therapist and had questions about the vaccine as he was on biologic medicine. Patient started Entyvio for Crohn's disease in Jan-2022. He took all the Moderna shots and never got sick. His last booster was in Sep-2021. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: Upon internal review on 08-Apr-2022, significant correction was performed. The case was updated to valid. Event included (Crohn's disease). Suspect product was recoded with company product dictionary.
Child developed a fine papular erythematous rash to trunk and to extremities post vaccination 15min
Information has been received from a pharmacist referring to a 60 year old female patient with asthma. The patient had no allergies. On 25-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot # reported as L011534, expiration date 03-JUL-2016, 0.65 ml, subcutaneously in the left arm. There was no concomitant medication. On an unspecified date in July 2015, the patient's left arm was hot and swollen at the injection site. The patient went to local urgent care center (unspecified name). The urgent health care provider told the patient she had an infection (at injection site) and prescribed doxycycline for treatment. The patient was not hospitalized. On 27-JUL-2015 (yesterday), the patient called the pharmacy and stated her situation. The outcome of injection site infection was reported as not resolved. Additional information has been requested.