chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is not feel good; redness; didn't Have any real terrible side effect but this is annoying; a huge egg on arm side; arm is quite swollen still; itchy; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm is not feel good), ERYTHEMA (redness), FEELING ABNORMAL (didn't Have any real terrible side effect but this is annoying), VACCINATION SITE MASS (a huge egg on arm side) and PERIPHERAL SWELLING (arm is quite swollen still) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 001A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, 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 experienced LIMB DISCOMFORT (arm is not feel good), ERYTHEMA (redness), FEELING ABNORMAL (didn't Have any real terrible side effect but this is annoying), VACCINATION SITE MASS (a huge egg on arm side), PERIPHERAL SWELLING (arm is quite swollen still) and PRURITUS (itchy). At the time of the report, LIMB DISCOMFORT (arm is not feel good), ERYTHEMA (redness), FEELING ABNORMAL (didn't Have any real terrible side effect but this is annoying), VACCINATION SITE MASS (a huge egg on arm side), PERIPHERAL SWELLING (arm is quite swollen still) and PRURITUS (itchy) outcome was unknown.            No Concomitant informations were reported.  No Treatment informations were reported.  This case concerns a female patient of an unknown age with no relevant medical history, who experienced the unexpected events of Limb Discomfort, Peripheral Swelling, Erythema, Pruritus, Feeling Abnormal, and Vaccination Site Mass. The events occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since the patient mentioned that similar problems were present in the second dose but faded quickly however the said events were not specifically mentioned hence a query will be raised. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-391833 (Patient Link).; Sender's Comments: This case concerns a female patient of an unknown age with no relevant medical history, who experienced the unexpected events of Limb Discomfort, Peripheral Swelling, Erythema, Pruritus, Feeling Abnormal, and Vaccination Site Mass. The events occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since the patient mentioned that similar problems were present in the second dose but faded quickly however the said events were not specifically mentioned hence a query will be raised. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient presented with region of redness measuring 6cm x 7cm at site of injection with warmth present
some soreness; injection site got inflammed; injection site got red and 6 inches round and 4 inches wide; injection site is "a little fever" and warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some soreness), VACCINATION SITE INFLAMMATION (injection site got inflammed), VACCINATION SITE ERYTHEMA (injection site got red and 6 inches round and 4 inches wide) and VACCINATION SITE WARMTH (injection site is "a little fever" and warm to touch) in a 75-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (some soreness), VACCINATION SITE INFLAMMATION (injection site got inflammed), VACCINATION SITE ERYTHEMA (injection site got red and 6 inches round and 4 inches wide) and VACCINATION SITE WARMTH (injection site is "a little fever" and warm to touch). At the time of the report, PAIN IN EXTREMITY (some soreness), VACCINATION SITE INFLAMMATION (injection site got inflammed), VACCINATION SITE ERYTHEMA (injection site got red and 6 inches round and 4 inches wide) and VACCINATION SITE WARMTH (injection site is "a little fever" and warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
suspected vaccination failure/I took the shingles injection and it caused me shingles; shingles on the injection sight, below my elbow. It was bad.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient took the shingles injection and it caused the patient to had shingles on the injection sight down elbow. The patient stated that it was so bad. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Patients (R) deltoid is swollen red - red area continues around to axilla. Fever to 101.7, aching occurred 12 hrs after immuniz assoc'd with hand swelling in deltoid R>L.
Dizzy, lightheaded, headache, chills, muscle and joint pain, weakness, extremely tired.   Well I laid in the bed with two blankets and took tylenol. Once I was done freezing and with the fever it felt like my skin was on fire. I was in so much pain that night that I couldn't move without crying. After I slept that night and about 7 hours the next day I finally started to feel better.
received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Patient did not report side effects, so far.
Patient received Pneumovax 23 into left arm and Shingrix into right arm, around 6:40 pm on 7/18/19.  Patient awoke during the night after (early am 7/19/19 feeling nauseous, but was able to go back to sleep.  Upon awaking in morning 7/19/19 - left arm was swollen, red, and hot to the touch in an area about the size of her hand. Patient states that the arm was very stiff and sore and that she could barely move her left arm. Pt did report stinging on injection at time shot was given, but no other trouble until awoke in the morning.
Large red blotches to face and arms 15 minutes after receiving DTaP. No respiratory distress. Sent to ER. See attached reports.
muscle pain on her leg; fever; soreness in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain on her leg), PYREXIA (fever) and VACCINATION SITE PAIN (soreness in the injection 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain on her leg), PYREXIA (fever) and VACCINATION SITE PAIN (soreness in the injection arm). At the time of the report, MYALGIA (muscle pain on her leg), PYREXIA (fever) and VACCINATION SITE PAIN (soreness in the injection arm) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
This non-serious initial spontaneous case was received by other-non health professional on 17-Oct-2017, concerns a 41-year-old, female pregnant patient. On 17-Oct-2017, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch no., expiry date and manufacturer: not reported). The patient did not experience any adverse events (reported as "no reactions") after administration of influenza vaccine. It was reported that, she did not want to speak with anyone and reported only to notify about the shot and to get on the registry. The reporter did not provide the seriousness assessment.
No adverse event. Flu vaccine labeled for adult use only administered in error to a 12 year old.
Extremely painful at the time of injection. Warm to touch later with some soreness. By the next day it was very sore, even with Ibuprofen. It continued to be very sore and got to the point that it hurt to move my arm in certain ways. The pain was from the injection site down the deltoid muscle. I could NOT lay on my left side in bed, it would hurt too bad. I could not lift my arm up in front of me, any higher than shoulder high with out much pain.  It is finally starting to feel somewhat better, after two months. But, at times it still bothers me. I do believe this pain is from the injection.
rash, itching 1wk p/vax;Engerix-B site itched for 3 days p/inj;scratched site then rxn occurred;
Left thigh cellulitis that started 1 day, post vax. Keflex given.
Started out as chills which became convocess chills, She had headaches, body aches and muscle aches. She had moderate GI pain meaning her guts hurt along with diaherra. She had a foreign lump in her right arm is long and swollen.  She said under her chin and neck areas are swollen and painful on the right side and it very much hurts when touching.
I had dizziness, vertigo. I saw my doctor about 2 weeks after I was having it. My doctor advised that it sometimes happens that and to callback if it did not get better. I called back because it was not getting better, the doctor prescribed physical therapy. I did have an ear infection last year so they might contribute it to that. In the last 2-3 months I have 3-5 more serious dizziness spells.  They are usually very mild. They did prescribe medication for me to take for it.
very bad laryngitis; very bad cough; running a temperature, fever of 100.3 to 100.7/temperature of about 100; felt a bit tired, exhausted; chills; stomach issues, diarrhea out of the blue; extraordinarily sick; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (stomach issues, diarrhea out of the blue), ILLNESS (extraordinarily sick), LARYNGITIS (very bad laryngitis), COUGH (very bad cough) and PYREXIA (running a temperature, fever of 100.3 to 100.7/temperature of about 100) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement. Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE (Pneumonia vaccine.) and FLU VACCINE VII (Flu vaccine.). Concurrent medical conditions included Antinuclear antibodies present. Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Knee replacement.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 30-Mar-2021, the patient experienced DIARRHOEA (stomach issues, diarrhea out of the blue), ILLNESS (extraordinarily sick), PYREXIA (running a temperature, fever of 100.3 to 100.7/temperature of about 100), FATIGUE (felt a bit tired, exhausted) and CHILLS (chills). On an unknown date, the patient experienced LARYNGITIS (very bad laryngitis) and COUGH (very bad cough). At the time of the report, DIARRHOEA (stomach issues, diarrhea out of the blue), ILLNESS (extraordinarily sick), PYREXIA (running a temperature, fever of 100.3 to 100.7/temperature of about 100), FATIGUE (felt a bit tired, exhausted) and CHILLS (chills) was resolving and LARYNGITIS (very bad laryngitis) and COUGH (very bad cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 100.3-100.7 (abnormal) Fever of 100.3 to 100.7. On an unknown date, Influenza virus test: positive (Positive) Tested for the flu which was positive.. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient also stated that they were sensitive to ingredients such as the ingredient starting with a "P" in vaccinations, but never had an anaphylactic shock. Patient had a history of autoimmune antibodies but never diagnosed and mentioned they had antinuclear antibodies that might had been triggered by the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received on 16 Jul 2021. contains patient medical history, lab data, new events added.
After eating, I began to get a scratchy throat and feeling fatigued.  After going to bed, I woke up at 3:00 am coughing, and could not go back to sleep. I eventually fell back asleep, and woke feeling terrible, and congested in the chest.  I took airborne and throat lozenges for most of the day at work.  After work, on my drive home, I began to feel worse.  My skin was sore, and I felt feverish.  Once I got home, I laid down and did not want to move at all.  I woke up 3 hours later and was very ill with flu like symptoms.  I went to the store and bought some Alka Seltzer for cold and cough.  I took it before bed, and felt much better the next day.  I still have mild symptoms of congestion and fatigue on Sunday, 11/06/2016.
Red spots appeared on entire body including the face. No treatment. Spots do not seem to bother baby.
Information has been received from a licensed practical nurse concerning a 32 month old white male with no know drug allergies and a past medical history of Haemophilus B (examined by hemologist - no treatment) who on 6/7/02 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy that day included a first dose of MMR, a third dose of poliovirus vaccine inactivated, and a third dose of hepatitis B virus vaccine (+) HIB conjugate vaccine. There were no other concomitant medications. On 1/29/04 the patient developed a rash around the neck that spread to his trunk area and limbs, increasing in quantity. The patient was afebrile. The outcome was reported as unknown. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a licensed practical nurse indicated that there was no change in the patient's condition and no new data to provide. Additional information is expected.
This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 68 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Injury" (ongoing); "arthritis" (ongoing); "antibody count lowered" (ongoing); "Fell" (ongoing). The patient's concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "antibody count lowered". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I had a light case of COVID; On 22APR2022 I got shingles again in a different spot.; I recently got shingles on 03APR2022; Caller is a consumer reporting an AE after being separately vaccinated with ZOSTAVAX and an additional unspecified shingles vaccine.; This spontaneous information has been received from a 81-year-old female patient, reporting on herself.  The patient's medical history was not reported, however she stated that had a pacemaker. Her concurrent conditions were not reported. She reported that was allergic to penicillin, clindamycin, and sulfa drugs. The concomitant medications were reported as ''I took a whole lot of medication''.  On an unknown date in 2016 (also reported as ''a few years ago'' and ''maybe five or six years''), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose lot #, expiry date, and route of administration were not provided); and then separately received another dose of an unspecified shingles vaccines  (manufacturer unknown) (extra dose administered) (strength, lot #, expiry date, and route of administration were not provided), both administered as ''protection to getting shingles''.   Moreover, on an unknown date, the patient stated that since being vaccinated with zoster vaccine live (ZOSTAVAX) she experienced ''light case of COVID'' and received unspecified treatment and sought medical attention. On 03-APR-2022, she had shingles, so she went to the emergency department (ER). There, she was placed on treatment with antiviral medication (valacyclovir) 1 gram three times (3x) daily, for ten days. On 22-APR-2022, she got shingles again in a different spot, and received another 10-day round of treatment with valacyclovir. No additional information was provided. At the reporting time, the status of the subject was not recovered.  The causal assessment between zoster vaccine live (ZOSTAVAX) and the events was unknown.  On 09-MAY-2022, additional information was requested.
No adverse symptoms reported; and the fourth dose of GARDASIL 9 was administered; This spontaneous report was received from an administrator referring to an 18 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 05-NOV-2015, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # L025737, expiration date 31-JAN-2017; strength, dose and route were not reported) for prophylaxis. On 08-JAN-2016, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # L019297, expiration date 18-AUG-2017). On 12-MAY-2016, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # M003659, expiration date 20-SEP-2017). On 15-JUN-2020, the patient was vaccinated with the forth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S028737, expiration date 03-APR-2022) (extra dose administered). No adverse symptoms were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028737; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 10-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Achy at the injection site mild temperature for about 1 day. Blood Clots the week of July 20, 2021, in both lungs. July 29, 2021, woke up at 4am because I couldn't breathe. Ambulance took to me to ER. I had nose bleeds. End of 2019 I was sick and was put on a nebulizer for a month. Doctors couldn't figure out what was wrong with me. End of 2020 I had a bad cold and was tested for COVID and anti-bodies and both tests were negative. Sinus, cold and allergies.  2 weeks later got tested for COVID negative but positive for antibodies in November of 2020. February 1st, I got my first shot of the vaccine. I use a CPAP machine at night.
Approximately 2 days post vax, this pt cried hysterically for approximately 2 days. He was seen by doctors who said he "was fine." The reporter stated that he "was not fine because he was losing his balance a lot and banging his head on the floor. They examined him and said he was fine. As the weeks continued all these behaviors continued." The reporter stated that she took him to a neurologist who dxed him as PDD/Autism. The neurologist suggested that the pt be put in a program for these types of conditions. The reporter stated "my son was fine before he took this vax." She also reported that the pt was seen by an allergist who did a blood test and the "MMR came out with a positive reaction." The reporter stated, "My son is allergic to the vax" and the allergist confirmed that he is allergic to MMR." The reporter also stated that the doctor gave her a letter stating that her son should not received the vax again. "He is improving with the program. He still loses his balance but it was worse before, his speech is okay and his hearing is fine." The reporter consulted another physician and told that the child would always have PPD/Autism. The reporter wanted "people to know that the vax could cause this." She also stated that her son cried hysterically for 4-6 months and could not stop. Upon medical review this is considered to be an "other medical event." FU indicates diagnosis to be autism.