chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received from a consumer on 09 OCTOBER 2012. A 62-year-old female patient, who was allergic to Advair, Flovent inhalers, Environmental, Perfume, PCN, Soy and had asthma at the time of vaccination, had received FLUZONE (batch number was unknown) intramuscularly on deltoid on 09 OCTOBER 2012. It was reported that the patient has a severe allergy to soy and premeditated with Benadryl (Diphenhydramine) and Allegra (Fexofenadine) before vaccination. On 09 OCTOBER 2012, i.e. after 30 minutes of receiving FLUZONE, the patient experienced red blotches at upper/lower extremities, trunk and under both breasts and some numbness left side of face. The laboratory investigations were not reported. As corrective measures the patient contacted her allergist who prescribed her 2 more Benadryl (Diphenhydramine) on an unspecified date. At the time of this report, the outcome was unknown. Documents held by sender: none.
Systemic: Dizziness / Lightheadness-Mild, Systemic: clenched fists----rigid muscles-Medium, Systemic: Shakiness-Mild, Additional Details: pt has anxiety w/ needles---possible panic attack
Patient claimed this was his first COVID 19 vaccination however upon processing vaccination we found that patient received Moderna 12/26/20 and 1/25/21. Patient marked NO on questionnaire if he had ever received a COVID 19 vaccine.
From initial information received on 05Jan04 from the pt's uncle, who is also a physician, regarding an adverse event occurring, it was reported that a female pt (age and date of
About two weeks later I noticed red spots on my legs. I went to a local dermatologist and he didn't know what it was but treated it as topical. The cream he prescribed did not help.The spots increased and spread. I went to Dr  who diagnosed it as Psoriasis. it continued to spread and i experienced a second outbreak. I will be starting UVB treatments next week. I firmly believe this autoamune disease is a direct result of the Moderna Covid 19 injections. I never, in 75 years have had this problem.
Premature infant on 1/2L NC O2 since 6/17/12. Off caffeine since 6/11/12. 2 month immunizations ordered. On 6/22/12 DTAP-Hepatitis B-IPV (PEDIARIX) given on 6/22/12 at 1750. On 6/23/12 (ACTHIB) & PREVNAR-13 given at 1225. Infant started to have bradycardic event at 1433 then apnea & bradycardic events at 1704, 1804, 1854, 2215, & 0120 that required tactile stimulation. Sleep study ordered. No apnea & bradycardic events since.
rash from the waist up; his lower lip is "raw." / The lip "raw" symptoms; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2020, the patient received the 1st dose of Shingrix. In October 2020, 10 days after receiving Shingrix, the patient experienced rash and raw lips. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the raw lips was not recovered/not resolved.   It was unknown if the reporter considered the rash and raw lips to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient himself. The age at vaccination was not reported. The reporter stated that he received dose 1 of Shingrix and 10 days later he developed a rash from his waist up and his lower lip was raw. He stated that he was treated by his doctor with steroids and the rash cleared up, but the lip rawsymptoms were continued. The reporter did not consent to follow-up.
PAIN ON SITE OF THE INJECTION THAT BECOME SEVER AND GOT WEAK. DAY 6
Itching all over skin and scalp. No rash. Large red area around injection site.
Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.; No adverse event; 12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.).    No concomitant medications was reported.  It was reported that patient received the Monovalent expired dose of vaccine, it was first booster dose of Moderna COVID-19 vaccine. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 12-Nov-2021. The vial did not undergo any temperature excursions.  No treatment medications was reported.
LARGE RED ITCHY WARM AREA AT INJECTION SITE, ABOUT 4 INCHES IN DIAMETER
Initial misuse report received from healthcare professional on 18 October 2013. This case is linked to case 2014SA045541 (same reporter after FLUZONE ID). The cases were received on 21 March 2014 at agency. A 13-year-old patient received a dose of FLUZONE ID (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
The symptoms started on the 22nd. I have been having head cold symptoms. I had a positive COVID-19 test on Sunday. I called my doctor due to my positive result. I haven't used anything to treat it. The symptoms are almost gone as of today.
Pt recv vax on 11/12/98; on 12/27/98 pt exp left eye field of vision changes; dx=repeat episode of optic neuritis; tx=Solumedrol IV
itching all over my body; reactions that causes me problems; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over my body) and ADVERSE REACTION (reactions that causes me problems) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 073M20A and 007B71A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, CLOPIDOGREL and ATORVASTATIN for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, 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 PRURITUS (itching all over my body) and ADVERSE REACTION (reactions that causes me problems). The patient was treated with METHYLPREDNISOLONE at a dose of 4 mg once a day. At the time of the report, PRURITUS (itching all over my body) and ADVERSE REACTION (reactions that causes me problems) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Headache, Nausea and red swollen site on arm at injection site.  Painful to touch feel hard spot on arm.
On 10/19/10 day after Flu vaccine, patient broke out in hives on legs, arms, chest & back, treated with CLARITIN and BENADRYL. Grade 2 allergic reaction.
she received her first dose, she experienced diarrhea; This is a spontaneous report from a contactable consumer (patient herself) received via Medical Information Team. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 25Jan2021 as an 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  On 26Jan2021, the 2nd day after receiving her first dose, she experienced diarrhea. The patient reported that 2nd dose of vaccine was scheduled on 22Feb2021. The outcome of the event was unknown.  Information on Lot/Batch has been requested.  Follow-up attempts are completed. No further information is expected.
Approximately 5 minutes after vaccination patient complained of "feeling like she was going to pass out". Patient felt shaky, sweaty, and complained of not hearing clearly. Patient was seated, blood pressure and pulse were attempted to be obtained- Meter failed to record BP- error reading. Distal pulse was not able to be obtained either. Patient remained conscious. 911 was called. 5 minutes later blood pressure was attempted again- same result- meter unable to record blood pressure. Patient remained conscious. After an additional 5 minutes (about 15 minutes after vaccination) EMTs arrived and obtained BP, pulse, and Blood sugar information on patient. Patient steadily improved over the next 15 to 20 minutes. Patient never lost consciousness. Patient refused to be transported to hospital.  EMTs left scene. Patient remained in pharmacy waiting area for 10-15 more minutes, then left to get a drink at coffee shop located within store. Patient's mother returned abouth 5 minutes later to state that patient was getting a headache and was going to treat with OTC medication.
I developed pericareditis 5 days after receiving the first dose of the Pfizer vaccine. The hospital dismissed the connection
the tip of her tongue started to feel numb; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 75-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 1 via an unspecified route of administration, administered in Arm Right (right upper arm) on 04Mar2021 (Batch/Lot Number: EN6199) (at the age of 75-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included: lacunar stroke from Jul2020 to an unknown date (She had a stroke 9 months ago-I have numbness in my fingers, toes, and side of face. It was a Lacunar stroke), heart burn and allergy to iodine (diagnosed with the allergy to iodine in the 80s.). Concomitant medications included: clopidogrel (75mg daily) lisinopril (2.5mg twice a day), atorvastatin (80 mg daily) and gabapentin (100mg twice a day, taken for pain from an unspecified start date to 17Mar2021). The patient went to the doctor yesterday, with the stroke she gets pain and numbness in the fingers Gabapentin was for the pain. It was told that she could take Tylenol and stop Gabapentin. The patient did not take any other vaccine within 4 weeks prior to Covid vaccine. There were no adverse events following prior vaccinations. On 04Mar2021, after 20 minutes of first dose of vaccine administration, the patient experienced the tip of her tongue started to feel numb that is still ongoing. They kept her there for 15 minutes and as she was leaving the tongue started to feel numb. She still has numbness. She is waiting on an appointment with the doctor as it was not going away. It is still there, but she is hoping it would go away. She has not been to the emergency. If she takes the other shot would her whole tongue to go numb. The patient was worried that it could get worse with the 2nd dose. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Tested positive for Covid 01/07/2022. Onset of symptoms 01/08/2022. Fever >103 F for 4 days, persistent cough, chills, difficulty breathing. Went to ER and received IV steroids on 01/11/2022. Returned to the ER 01/17/2022 due to chest pressure and difficulty breathing. Was held at the hospital until 01/19/2022.
Sever injection site pain - unable to move arm. Then generalized malaise, fatigue. Sever knee pain, legs pain, feeling shaky. Muscle weak in arms and legs. Extreme exhaustion.
This spontaneous prospective pregnancy report as received from a physician assistant refers to a 25 year old female patient. The patient was vaccinated with GARDASIL injection, dose 1 on 21-JUL-2010, dose 2 on 07-OCT-2010, dose 3 on 07-OCT-2011, respectively (each dose's lot #, expiry date, dose, route and indication unknown). The physician assistant reported that the patient was given the third dose of GARDASIL which she was pregnant. The LMP (Last Menstrual Period) and EDD (Estimated date of delivery) were unknown. No adverse events reported. Follow up information was received from the physician assistant's office. The pregnancy outcome was a full term vaginal delivery of a normal healthy newborn. Additional information is not expected.
Pt has had a series of 3 vaxs /w Engerix b & still has not developed titers
FACIAL HAIR WAS NOT GROWING THE SAME; This spontaneous report received from a health care professional via other manufacturer (Pfizer) concerned a 5 decade old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: smoker. Patient was health care worker. The patient had previously received tozinameran (Dose number in series 1) (form of administration was not reported, intramuscular and batch number: EK5730, expiry 6-JAN-2021) dose was not reported, administered to left arm on 16-DEC-2020 for covid-19 prophylaxis. On 16-DEC-2020 at 09:50 AM, patient experienced eye puffiness, light headedness, scratchy throat within 10 minutes after vaccination (Dose number in series 1). The patient was treated with epinephrine, famotidine and diphenhydramine hydrochloride for eye puffiness, light headedness, and scratchy throat in the emergency department. The patient felt completely back to normal within an hour and was released. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 01 total was administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 5 decade old. No concomitant medications were reported. On JUN-2022, the patient reported that facial hair was not growing the same (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of facial hair was not growing the same was not reported. This report was non-serious.
Johnson-Johnson COVID-19 Vaccine EUA-- on 3/31/21 client presented at clinic 0750 for vaccine, completed paperwork and COVID vaccine administered by guardsman and given time she may leave. She stayed longer due to questions and her sister getting vaccine also. I had to call PCP for sister to get vaccine due to medical issues. I could not get through to PCP informed her I would call her.  I called to tell them they would need to  call her sister's PCP At about 0846 she stated she was not feeling well. Stated she thinks her right side may be numb-tingling and right side of face. Informed her to go to ER if she thought she was having an allergic reaction or call 911. She stated she was in ER parking lot now. Stated her PCP wanted her to have this vaccine and she is allergic to Epinephrine, informed her to tell ER what she just told me and that she had received the COVID vaccine. At 3:00 PM client called and asked if predisone she got in ER would elevate her BP. She stated ER papers say paresthesia of skin, TIA vs allergic reaction to vaccine, work up TIA symptoms and sent home to follow up with PCP.
Patient received COVID-19 booster 9/26/2023 morning and initially had no complaints or side effects. Upon awakening 9/27/23 morning he was unable to stand. Patient brought to ED by EMS, paramedic reports that patient was able to stand w/ 2-person assistance only. Patient denies pain and reports numbness to both legs.  He denies any other concerning symptoms of illness such as fever or chills or nausea or vomiting.  He does not have any difficulty breathing or any chest pain.  He denies any pain in the legs but does report some possible decreased sensation generally. After he got the shot yesterday he states he did feel well and was up and walking using his cane. He reports a remote history of possibly having similar symptoms after a previous COVID booster shot as well.
pt taken to ER noc of vax for lt swollen thigh & cont screaming;APAP w/codeine given;settled down for about 2hr;pt cont to cry this AM & was taken to MD office;
Myalgia, Arthralgia, persistent pain on left shoulder Narrative:2 days after vaccine of the second of series, developed severe shoulder pain 7/10, continuous and relieved temporarily by Acetaminophen PM at night. He thought the symptoms will subside but hasn't. He is able to move the left arm aove shoulders even touching the opposite ear. The pain happens mostly at night, radiating to neck, back . Denied history of injury to left shoulder no prior pain on left shoulder
Day of vaccination: fine until approx 11:30 pm. I developed a hot/itchy rash on legs followed by a fever of 103, checked with a digital thermometer, and an intense headache. The headache was the worst I?ve ever had and both the headache and fever lasted until the next day. The next day I slept on and off with a 103 fever until 1pm when I finally took Tylenol. The fever and headache slightly receded to about 100 for about 3 hours and then came back and rose to 104. I took more Tylenol and it receded again and came back again. I took two more Tylenol before bed. The next morning I woke up at 7 am and luckily my fever had dropped to 100 and below and I no longer felt the need to take my temp. However my entire upper body felt as though I was in a car accident and had severe whiplash. My neck and head were so painful I couldn?t move them and the arm that I had received the injection was hot and very painful. My other arm was also sore but not as bad and both my hands hurt. My left armpit and a spot under my jaw on the left were also very swollen and painful. I spent the day either unable to move or in tears pacing because the pain was so bad. I periodically took 600 ml of ibuprofen to help alleviate the pain which I think helped a little. I applied an ice pack to my neck and heat pad to the top of my head and rotated a third ice pack between my hands, under my jaw and in my armpit. It was the most severe body pain I?ve ever felt. This lasted until I went to bed. The third day most of the intense pain from the day before was gone but I still had a pretty intense headache and serious stiffness in my neck and head. Which progressively became more intense throughout the day. I continued to use ice and heat and take Tylenol. This pain lasted and increased until going to bed.
This case was reported by a physician, via a GSK sales representative, and described the occurrence of swelling injection site in a 11-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 24 October 2011 the subject received 2nd dose of CERVARIX (details unknown). On 27 October 2011, 3 days after vaccination with CERVARIX, the subject experienced swelling injection site, injection site redness, injection site pruritus and injection site inflammation. The itching was described as "more than normal". At the time of reporting the outcome of the events was unspecified.
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date between 03-AUG-2015 and 06-AUG-2015, the patient was vaccinated with an unspecified dose of the VARIVAX (Merck) immunization series that was improperly stored (Lot # L005299, expiration date: 17-FEB-2017) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
mild-moderate dull Headache starting 3 days after vaccine for 5 days - currently has headache. Improved with otc Tylenol.
For the entire next day I had body aches, chills, headache, and loss of appetite.
felt hot probably had a fever but our thermometer didn't work.  chills, aches, felt like the flu. lasted about 24 hours
Patient said that she had a severe headache and body aches all throughout the night and next day. She also had increased urination. Very tired the next day and slept most of the day. She was feeling better when she called me on Monday 11/13/23.
p/ pt recv vax subsequently pt was found to be preg, test results norm. also 12 wks of gestation pt dx w/gonorrhea & pubic lice which were treated.
On the last one I had bad reactions/I had side effects from the last; my legs, felt like its been on the sun all day, can be sunburn; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (On the last one I had bad reactions/I had side effects from the last) and FEELING HOT (my legs, felt like its been on the sun all day, can be sunburn) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third 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 and 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 IMMUNISATION REACTION (On the last one I had bad reactions/I had side effects from the last) and FEELING HOT (my legs, felt like its been on the sun all day, can be sunburn). At the time of the report, IMMUNISATION REACTION (On the last one I had bad reactions/I had side effects from the last) and FEELING HOT (my legs, felt like its been on the sun all day, can be sunburn) outcome was unknown.            No concomitant medications were reported It was reported that the patient took 1, 2, 3 Moderna to avoid getting COVID.  No treatment medications were reported.
A 64 year old male pt was treated with Oncotice for bladder cancer since late 2003, since being diagnosed with bladder cancer, over a 1.5 year period of time, he had received Oncotice as two series of 6 instillations each, followed by a third series of three instillations, last administered 5-6 months prior to report of 9/19/05. Approx 1/2 year after receiving his initial Tice BCG treatments, he reported he was found to have an abnormal blood cholesterol (lot natural not elevated). Treatment with Oncotice was continued. Corrective treatment Rosuvastatin.