chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gap between 1st dose and 2nd dose is more than 35 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gap between 1st dose and 2nd dose is more than 35 days) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A and 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gap between 1st dose and 2nd dose is more than 35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gap between 1st dose and 2nd dose is more than 35 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was not reported.  No treatment medication was not reported.   This case was linked to MOD-2022-589275 (Patient Link).
Patient developed shingles rash on 11/11/16, 6 days after vaccine given. She went to Dr. and prescribed valacyclovir 500mg - 2 tabs by mouth 3 times a day for 1 week. Patient self treated with hydrogen peroxide and triple antibiotic before MD visit. Rash not resolved as of 11/18/16.
Reconstituted lyophilized component with 1% Xylocaine; Reconstituted lyophilized component with 1% Xylocaine and administered the doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number L4472) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted lyophilized component with 1% Xylocaine) and inappropriate dose of vaccine administered (Verbatim: Reconstituted lyophilized component with 1% Xylocaine and administered the doses).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-MAR-2023 The licensed practical nurse reported that, they reconstituted Shingrix lyophilized component with 1 percent Xylocaine and administered the dose to patient back in early February 2023. The reporter mentioned for each patient was attempt at first dose of Shingrix. The reporter was unable to provide any vaccine or patient details. The reporter called to inquire that how to proceed. The reporter did not consent to follow-up. The reporter reported that, they reconstituted Shingrix lyophilized component with 1 percent Xylocaine and administered the dose to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023034623:same reporter US-GSK-US2023034624:same reporter
Developed rash under right arm, slowly spread over next 12 days to both arms, sides of breasts, lower back, inner thighs. Extremely itchy. Dematologist diagnosed as reaction to vaccine.
Information has been received from a physician concerning a patient's daughter who on unspecified date was vaccinated with GARDDASIL (lot # unspecified). The day after receiving GARDASIL the patient experienced depression. Unspecified medical attention was sought. At the time of this report, the patient has not recovered from the depression. No further information was available. No additional information is expected or available.
Diarrhea; Stomach cramping; This case was reported by a other health professional via other manufacturer and described the occurrence of diarrhea in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included binimetinib (Mektovi) unknown (batch number W002993, expiry date 12th January 2020) for malignant melanoma.   Concurrent medical conditions included malignant melanoma, globulin and allergy to chemicals.   On an unknown date, the patient received the 1st dose of Shingrix. On 7th January 2020, the patient started Mektovi (oral) 45 mg at an unknown frequency. On an unknown date, the dose was changed to an unknown dose and frequency. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced diarrhea and stomach cramps. The patient was treated with loperamide hydrochloride (Imodium) and hyoscyamine. The action taken with Mektovi was unknown. On an unknown date, the outcome of the diarrhea was recovered/resolved and the outcome of the stomach cramps was unknown.   It was unknown if the reporter considered the diarrhea and stomach cramps to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine and Metkovi vaccine and experienced diarrhea and stomach cramping. The provider decreased the dose of Metkovi until it was temporarily interrupted for two to three days and the diarrhea subsided. Gradually, the provider increased the dose until the patient was back on Metkovi. The patient had been feeling much better at time of reporting.
Very mild tinnitus worsened drastically a day or two after the 2nd dose. It occurred a day or so after 2nd vaccine. Don't know if there was any increase after 1st dose but if so, not significant.
Shakes, chills, temperature, joint and muscle ache and pain, nausea, vomiting, fatigue.
I have hard, hot and red where they vaccinated me My Dr. told me it is cellulitis but I have muscle spasm headache and the left side of my head is throbbing. And the area itches me.
The eczema on my upper back and shoulders broke out in hives after two hours of receiving the vaccine. The next morning, my skin had sharp small pains where the hives were.; The eczema on my upper back and shoulders broke out in hives after two hours of receiving the vaccine. The next morning, my skin had sharp small pains where the hives were.; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 19:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and eczema. The patient did not receive any medication within two weeks prior to vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The eczema on the patients upper back and shoulders broke out in hives on 08Apr2021 at 21:00, after two hours of receiving the vaccine. The next morning on 09Apr2021, her skin had sharp small pains where the hives were. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The patient underwent tests and investigations which included COVID-19 test on 05Apr2021, and the result was negative. The clinical outcome of the events the eczema on upper back and shoulders broke out in hives after two hours of receiving the vaccine; the next morning, skin had sharp small pains where the hives were was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccine on 02/05/21 with slight soreness at site which resolved within 48 hours. On morning of 02/18/21 the Patient began itching on her left arm in area of vaccination site and found a raised red "hive" approximately 5x5" at the site of the vaccination. She is currently applying anti-itch cream to the site and having some relief with this. Patient denies any other symptoms. Referred Patient to make an appointment today or tomorrow with her PCP and if she can not get in to call our clinic back and we'll get her in so that we can see her arm. Patient also advised to call back if she develops any other symptoms.
Developed anxiety 2weeks after shot, episode lasting a full day crying and anxious, went to ER,  symptoms are unexplainable I never had before, no life stress
I have vaginal herpes and get mild outbreaks about 2x/year.  The morning after the vaccination (yesterday), I noticed a mild outbreak, and took a Valtrex.  I took another that evening.  This morning, the outbreak has not resolved nor gotten any better.  I took another Valtrex.  Then I read in the news about a possible herpes side effect from the vaccine.
VACCINE WAS STORED IN FREEZER LONGER THAN MANUFACTURER RECOMMENDED, CAUSING ITS ADMINISTRATION TO BE BEYOND THE USE DATE.
Information has been received from a registered nurse concerning a 21 month old white female patient with a pre-existing medical condition of Asthma and no other medical history, who on 10/10/2003 at 13:40PM was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live.  Concomitant vaccine therapy administered at 13:40PM was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live.  Concomitant vaccine therapy administered at 13:40PM on 10/10/2003, included a fourth dose of pneumococcal vaccine, administered intramuscularly in the right thigh.  On 07/06/2004 in the AM the patient developed a rash.  She was seen in the physician's office on 07/16/2004 with a one week history of rash.  On examination she had 2 discrete vesicles on her abdomen and crusting numerous macules/small vesicles at various stages on her chest, abdomen, and back.  The patient was positive for itch.  The physician diagnosed chicken pox.  She was discharged from the physician office to home and instructed to isolate until lesions crusted and symptoms resolved.  The patient was also instructed to follow up as needed.  There were no laboratory or diagnostic tests performed.  The patient did not have adverse events following prior vaccinations and she was without lesions at the time of vaccination.  The patient recovered on 07/23/2004.  No additional information is expected.
Two days after receiving second Moderna vaccination, patient reported arm swelling, warmth and tenderness at the injection site. Patient reported a 5 cm red "splotch" on arm below injection site. Patient was advised to use cold packs and NSAIDs if needed.
Information has been received from a physician concerning a 12 year old female who on 11 Oct 2006 was vaccinated with the first dose of 0.5mL of Gardisil (Lot # 653937/0637F). On 21 Oct 2006, the patient developed a know on the arm with no rash and no redness. On 24 Oct 2006, the patient developed throbbing pain around the arm that the injection was administered. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested.
left foot got swollen and purple; pain in leg; can't put a shoe neither walk; foot hot as fire; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left foot got swollen and purple), PAIN IN EXTREMITY (pain in leg), GAIT DISTURBANCE (can't put a shoe neither walk) and BURNING SENSATION (foot hot as fire) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A2114) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (left foot got swollen and purple), PAIN IN EXTREMITY (pain in leg), GAIT DISTURBANCE (can't put a shoe neither walk) and BURNING SENSATION (foot hot as fire). At the time of the report, PERIPHERAL SWELLING (left foot got swollen and purple), PAIN IN EXTREMITY (pain in leg), GAIT DISTURBANCE (can't put a shoe neither walk) and BURNING SENSATION (foot hot as fire) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  The treatment medication was Ibuprofen.
This case was reported by a other health professional via call center representative and described the occurrence of joint pain in a 87-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 29th September 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced joint pain and swelling of knees. On an unknown date, the patient experienced circumstance or information capable of leading to medication error and incomplete course of vaccination. On an unknown date, the outcome of the joint pain and swelling of knees were recovered/resolved and the outcome of the circumstance or information capable of leading to medication error and incomplete course of vaccination were unknown. It was unknown if the reporter considered the joint pain and swelling of knees to be related to SHINGRIX. Additional details were provided as follows: The day after receiving SHINGRIX, the patient developed arthritis type pain in the joints and knee swelling that was lasted for 7 to 8 days. The patient would probably not come back for the second dose of the series, which led to circumstance or information capable of leading to medication error and incomplete course of vaccination. Consent to follow up was provided. The medical assistant did not have the vaccine details because the SHINGRIX was administered by another health care provider.
Recurring pain in right leg and top of right foot after sitting or lying down, subsiding within 5 minutes.
8/7/03: Non stop crying one hour. 8/9: 102.5 temp, ear infection-possible onset from troubled immune system from immunizations; 8/10: 105.8 temp, ER visit, antibiotic (no help). 8/11: 105.2 temp, ER visit, antibiotic-Bactrim.
Patient received first dose COVID vaccine on August 10, 2021. Shortly after she developed symptoms of left upper chest pain that she described as pin prick needles. Later she was hospitalized on August 26, 2021 for evaluation of her symptoms which were later diagnosed as myocarditis.
*11/3/2021 vaccination *04/21/2022 Left to go to travel, Husband complained of sinuses but I didn't feel anything. 04/25/2022 I started to not feel well. Slept a lot on way home. Temp was pushing over 100 the following morning. *4/26th/2022 tested COVID positive. Given 5 day dose of medication. Fever went away after 1st day. End of April I started to feel better. **Could be a 1 or 7 for the first number on the vaccination lot #. 'Not clear'.
Administered 1st covid 19 vaccine to pt (pfizer), while pt was in post vaccination waiting area pt informed us that she was feeling light headed and not right.  I placed pt in supine position with legs elevated and monitered her her vital signs, which remained stable throughout incident.   Also placed ice packs behind neck and on forehead while she was laying down, and provided her with bottle of water.  Patient stated that she suffers from anxiety and had not eaten anything since the morning time, states not diabetic.  Patient never lost consciousness during entire time.  Patient didn't want us to call ambulance, her husband was notified and he came to the store to get her and take her home.
Thrush; This spontaneous case was reported by a consumer and describes the occurrence of   in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer stage III and Breast cancer (breast cancer 2 years ago).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant FU TCR added on 13-JUL-2021 : contact information and event outcome  updated. On 14-Jul-2021: Follow up correspondence attached
contract COVID-19 after 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contract COVID-19 after 2 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 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 COVID-19 (contract COVID-19 after 2 doses). At the time of the report, COVID-19 (contract COVID-19 after 2 doses) outcome was unknown.            No concomitant drug details were reported. No treatment information was provided.  Company comment: This case concerns a patient of an unknown age and gender, with no medical history provided, who experienced non-serious unexpected event of COVID-19. It was reported that the patient developed COVID-19 after receiving the both doses of the vaccine. The temporal relationship between the reported event and vaccination with the mRNA-1273 vaccine cannot be determined as the start date of the event, as well as exact dates of vaccination were not disclosed. The outcome of the event was unknown and no information regarding the clinical course of the event was provided.  Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no medical history provided, who experienced non-serious unexpected event of COVID-19. It was reported that the patient developed COVID-19 after receiving the both doses of the vaccine. The temporal relationship between the reported event and vaccination with the mRNA-1273 vaccine cannot be determined as the start date of the event, as well as exact dates of vaccination were not disclosed. The outcome of the event was unknown and no information regarding the clinical course of the event was provided.  Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.
73 year old received a dose of Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 73-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy.   On 15-JUL-2023, the patient received the 1st dose of Bexsero. On 15-JUL-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: 73 year old received a dose of Bexsero).  The outcome of the inappropriate age at vaccine administration was 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: 14-SEP-2023 The pharmacist stated that she had a 73 year old female patient who has had a splenectomy requested a dose of Bexsero as ordered by her physician. She stated that the patient already had 1 dose of Bexsero given on 15 July 2023 at a different location. Pharmacist did not have the lot number / expiration date of the dose and did not have the patient initials. At the time of reporting, a second dose had not been administered. 73 year old female patient received Bexsero Inappropriate age at vaccine administration The reporter consented to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (site of injection became red, itchy and swollen), VACCINATION SITE SWELLING (site of injection became red, itchy and swollen) and VACCINATION SITE ERYTHEMA (site of injection became red) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.  No Medical History information was reported. On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (site of injection became red, itchy and swollen), VACCINATION SITE SWELLING (site of injection became red, itchy and swollen) and VACCINATION SITE ERYTHEMA (site of injection became red). At the time of the report, VACCINATION SITE PRURITUS (site of injection became red, itchy and swollen), VACCINATION SITE SWELLING (site of injection became red, itchy and swollen) and VACCINATION SITE ERYTHEMA (site of injection became red) had not resolved. Patient stated that she was taking edible marijuana prescribed by her doctor for pain this week so she was not sure if that was what is causing the side effects. The  concomitant medications on use were not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up contains possible NNI
Face swelled up, difficulty breathing, fever. Went to ER got Benadryl. Symptoms got worse as time went on about 2hrs after the shot. Congested
I was out of town, I had driven for about 12 hours, I spent the day relaxing, I went fishing, I got a sunburn on my knees and chins. My feet swelled up considerably and wound up with a really bad feeling that night. Feeling of dread that I felt my blood pressure was bad, I felt I was going to pass out. When I got home I bought a blood pressure cuff and it was 195/110-118 so it was really high. When I went to the doctor they gave me more medication and it has lowered a bit since then but not where it should be. I don?t know if it was because of the sunburn or for driving that long. But it happened after getting the vaccine.