chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Doses were given at a 0.2mL dosage from presentation with the dark pink cap with yellow border were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border.; All doses were given at a 0.2mL instead of 0.25 mL; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Doses were given at a 0.2mL dosage from presentation with the dark pink cap with yellow border were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border.), UNDERDOSE (All doses were given at a 0.2mL instead of 0.25 mL) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Doses were given at a 0.2mL dosage from presentation with the dark pink cap with yellow border were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border.) and UNDERDOSE (All doses were given at a 0.2mL instead of 0.25 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Doses were given at a 0.2mL dosage from presentation with the dark pink cap with yellow border were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border.), UNDERDOSE (All doses were given at a 0.2mL instead of 0.25 mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Doses were given at a 0.2mL dosage from presentation with the dark pink cap with yellow border were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border.) and UNDERDOSE (All doses were given at a 0.2mL instead of 0.25 mL).    No concomitant medications were reported. 12 patients were administered 1st doses of bivalent Moderna from 24-APR-2023 to 28-APR-2023. Patients were between 6m-5y of age. No treatment information was provided.  This case was reported for patient 5 of 12 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:(patient 1)
At site of injection, patient had red, raised area approx. 2"x2 1/4".
Tinnitus developed in a kit ten days and has not stopped ?it continues to get worse without any relief.  Never had tinnitus prior to the Pfizer booster.
Severe headache onset, mild muscle aches, and fatigue starting 6am, the morning following vaccine, diminishes with ibuprofen and Tylenol but does not go away. Still ongoing at 4pm the day following vaccine.
Patient presented with left arm swollen from shoulder down to elbow, hot to touch, and patient stated loss of sensation in fingers and it was tight.  Dr. prescribed Prednisone 60mg for 7 days and Lidex 0.05% ointment-apply to the area bid-tid.
Hours after vaccination my arm swelled and itched really bad.  I also noticed it looked like the shot was given on top of my small pox shot. I reported to the pharmacy. Daily since vaccine I have had intense muscle twitching and itching.  This has continued since the months following the vaccine.  As of today it continues.  I have a HUGE dent in my arm where the vaccine was administered.  It seems as if it continues to get worse.  Something is going on with this arm as that shoulder hurts daily.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Pt repoted symptoms about 10 minutes after receiving vaccine. Pt was very pale, had cold sweats and felt like he was going to faint.  Pt reported that he could not see. Pt reported feeling nauseated.  Pt seemed to improve after he layed down and feet were elevated.  Pt was taken to the hospital via ambulance.  I cannot get ahold of pt to see if his conditon improved/worsened.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 15-month-old female patient who received KINRIX (batch number T325H, expiry date 17th FEBRUARY 2017). Concomitant products included influenza vaccine, measles, mumps rubella and VARIVAX. On 29th OCTOBER 2015, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. On 30th OCTOBER 2014, 1 days after receiving KINRIX, the patient experienced fever. On an unknown date, the patient experienced inappropriate age at vaccine administration. The patient was treated with Ibuprofen. On an unknown date, the outcome of the fever and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the fever to be related to KINRIX. Additional details provided were as follows: The case was previously reported to a doctor. Prior receiving the vaccine, the patient's body temperature was 37.6 degree C. On 29th OCTOBER 2015, the patient received the 1st dose of KINRIX. After further investigation, the nurse notified that, the patient in advertently received the vaccine at an age of 15 months. This led up to an inappropriate age of vaccination. On the same day, the patient also concomitantly received other non-GSK vaccines, which included MMR, Flu and VARIVAX vaccines. On 30th OCTOBER 2015, 1 day after vaccination, the parent of child called the office and reported that the patent's body temperature was 99 to 100 degree F (37.2 to 37.8 degree F). The doctor told the patient's father to give the patient Ibuprofen. The reported lot number (T385H) for KINRIX vaccine did not exist and was updated to T325H according to sales database.
Around 1:30 pm experienced tingling in face, numbness in face and lips, heart racing and feeling faint, progressed through the evening with feeling sick like I had the flu, fatigue and pain in abdominal and back. Very tired. Through the night started having choking and wheezing and shortness of breathing and needed to use albuterol inhaler to breathe at two separate times through the night. In the morning entire face was swollen with lips and eyes swollen and ulcer on tongue. Called dr and they advised antihistamines with follow up to doctor in office. Followed up on Monday and Tuesday with physician and was prescribed an epi pen and advised to not get another vaccine.  I was also severely ill on the second shot.
I received my 2nd booster shot on 05/12/2022 and my COVID symptoms started on 05/21/2022 in the morning around 8-9:00AM runny nose , and i got really tired. I couldn't stay awake. cough , headache, sore throat.  on 05/22/2022 i did home test which was negative and 05/24/2022 it was negative.  i also went to health department in the evening  on 05/24/2022 . and i received my test result on 05/25/2022 was positive. I did telehealth with my doc he prescribed me oral medication, inhaler. i am in the process of recovery.
sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy".  Additional information: The reporter is the wife speaking about her husband. Caller reported that the reporter and her husband experienced sleepiness after the first dose Pfizer Covid shot. No further information provided by the caller.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain/ soreness at injection site; swelling at injection site; erythema at injection site; Headache; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-NOV-2023, the patient received Shingrix. On 02-NOV-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain/ soreness at injection site), injection site swelling (Verbatim: swelling at injection site), injection site erythema (Verbatim: erythema at injection site) and headache (Verbatim: Headache). The outcome of the injection site pain, injection site swelling, injection site erythema and headache were not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and headache to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, injection site erythema and headache to be related to Shingrix.   Additional Information: GSK receipt date: 04-NOV-2023 The patient received a dose of Shingrix and had headache, pain, swelling, soreness, erythema at injection site. The symptoms were treated. The reporter consented to follow-up.
Miscarriage And pocket of blood in uterus - 6/4 2nd dose - 6/18 Bleeding in between cycle  - 6/30
On or about 12/20 -23 he developed headache, fatigue, and arthralgias. Symptoms persisted and he did not feel well. On 12/26 he developed a slight fever and a vesicular rash on his extremities, with one lesion on his face and a few on his trunk. Total number of lesions was less than 20. He went to a local urgent care clinic and was diagnosed with chicken pox and a secondary infection to the injection site. He was treated with high dose acyclovir and cephalexin and feels much better at this time. He has one more day of antibiotics to take. He has a few small scabbed skin lesions and some mild edema at the injection site, but overall feels fine.
bilateral leg and arm weakness occuring starting on 10/21. Progression to difficulty walking and numbness in feet.  Patient was diagnosed with Guillian barre syndrome based on studies and physical exam findings. Required IVIG treatment for 5 days. She required PICU for monitoring of decreasing NIFs on days 2-3 of hospitalization. She plateaued on day 3-4 of hospitalization and improved on day 5-6.
The evening after I received the vaccine I started to experience severe nausea. I was unable to move without feeling nauseas. I called my provider and he prescribed me anti-nausea medicine. The symptom lasted for about 2 days.
Arm was initially very sore.  Experienced headache, fatigue for a couple of days after vaccine. On 9th day after vaccine I noticed a red splotchy circular rash that was hot / feverish to touch surrounding vaccine site. Rash went away for a few days and returned on 14th day after vaccine, also have had sporadic sharp / deep pains in arm near vaccine site. I am continuing to pay attention to any changes.
Arm became infected with blisters in center. Red, warm, swollen; Arm became infected with blisters in center. Red, warm, swollen; Arm became infected with blisters in center. Red, warm, swollen; Arm became infected with blisters in center. Red, warm, swollen; Arm became infected with blisters in center. Red, warm, swollen; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW1067 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 12May2021 13:00at the age of 63-years-old as DOSE 1, SINGLE for Covid-19 immunization. Medical history included immune system disorder from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing, covid-19 from an unknown date Concomitant medication(s) included immunoglobulin human normal (GAMMAGARD SD) taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with Covid 19 and was not tested for Covid-19 Since the vaccination. On 14May2021 the patient experienced arm became infected with blisters in center. red, warm, swollen. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Therapeutic measures were taken as a result of arm became infected with blisters in center. red, warm, swollen, arm became infected with blisters in center treatment included told to put hydrcodicene on it. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Moderna Vaccine EUA- Booster dose: At vaccine clinic, giving booster (3rd dose 0.25ml) Moderna vaccine to long term care employee at 8:10.  During requested 15 minute waiting period patient developed about 1/2 dollar round red area around injection site and was feeling something in her elbow.  She reports on her 1st dose she had a swollen red arm later in the day and the elbow was feeling similiar. Administered Benadryl dose at 8:26.  Continued to monitor patient for 20 minutes afterward.  At 8:50 patient reported she was still a little itchy.  Her red area was lighter in color.  I asked if she would like an Epi-pen dose and she refused.  I continued to check on her for 15 minutes and she left the facility on her own.  Went to ED 12/2/21 at 1904, where patient reported itchiness of throat and small papular rash noted. Patient received  IV Benadryl, Pepcid and Solu-Medrol, which improved her symptoms. Doubt anaphylaxis since not given epinephrine. Continued on a Medrol Dosepak and continue taking over-the-counter Benadryl and Pepcid.
Patient's wife states his arm was very red and painful at the injection site and complained of malaise. Injection site was red and tender for 5 days.
Aches, Fever, Fatigue, Disorientation on 4/4/21. Fatigue, Disorientation on 4/5/21
Information has been received from a pharmacist referring to a 62 year old female patient. There were no pertinent medical history and drug reactions or allergies. On 06-DEC-2015 the patient was vaccinated with one dose of ZOSTAVAX (lot # L032397, expiration date 26-NOV-2015, 0.65 ml, subcutaneous). Concomitant therapies included SYNTHROID, TOPROL XL, paroxetine, pravastatin, isosorbide dinitrate and XANAX. On 07-DEC-2015, the patient developed redness and itching at the injection site. On 09-DEC-2015, the patient returned to the pharmacy for medical attention. No treatment was given for the events. No lab diagnostics studies were performed. At the time of report, the events had not yet resolved and has been getting steadily worse. The causality between the events and ZOSTAVAX was unknown. Additional information has been requested.
Swelling in the entire arm, extreme pain in the injection site, headache, minor hives on legs.
Patient had a about 3 inch red, raised area, warm to touch, slight temperature elevation to 100.0 F/per mouth, slight scratchy throat with some itching.  Benadryl given for itching, cool compress applied to area and Tylenol given for fever, follow up 3 days then resolved.
Blood Clot's small in distal region of lungs bilateral  3 days after injection of vaccine
Vaccine manufactured expiration date was 8/31/22. Vaccine was administered to patient on 9/30/22 after expiration date. No adverse reaction was reported by the patient.
heart fluttering, a really bad one; premature ventricular contractions; all sweat; dizziness; weakness; A spontaneous report, was received from a consumer, concerning himself, a 59 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial flutter and PVCs.  The patient's medical history included bladder surgery. concomitant medications was not included by the reporter.  On 24 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 003B21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 24 MAR 2021, 10 hours after first dose, the patient experienced sweats, dizziness, fluttering heart/increased heart rate  and was seen at the ER  and  then transferred to ICU, she was told that she had 360 bpm atrial heart rate and PVCs.  The patient stated that two years ago he was under anesthesia for bladder surgery and had something similar where the patient had rapid atrial heart beat which wasn't this long and the doctor stated that it was related to the anesthesia .  The action taken with mRNA-1273 was not reported.   The outcome of the events was considered as unknown.; Reporter'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. Further information has been requested.
My arm feels like there is a bad bruise and the muscle feels sore when I move around. It appears red blotchy and visibly swollen. It is also warm to the touch. Read online people who experience this use antihistamines to treat so I applied topical Benedryl. No difference yet.
Headaches - after 1st vaccine 8/18/15 - pt reported x 2-3 days. After 2nd vaccine 10/28/15 pt reported 1 wk of headaches.
Information has been received from a physician via company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. ON 25-NOV-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "10x 1 sdv" (Lot No. K001631, exp 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 72 and 40. The lowest recorded temperature was 28. The highest temperature recorded was 47. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved This is one of several reports received from the same reporter. Additional information has been requested.
got a third dose of Moderna vaccine and was not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (got a third dose of Moderna vaccine and was not immunocompromised) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (got a third dose of Moderna vaccine and was not immunocompromised). At the time of the report, OFF LABEL USE (got a third dose of Moderna vaccine and was not immunocompromised) had resolved.            No relevant concomitant medications were reported. Treatment medication was not reported.
No other AEs or PQC reported.; expired dose of PNEUMOV AX 23 was administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported.  On 22-SEP-2021, the patient was vaccinated with an expired dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, subcutaneously, lot # S024808 was confirmed to be valid, expiration date 02-JUN-2021, for prophylaxis (site of administration was not reported). No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Pt states feeling very sore, body aches, nausea, diarrhea, back pain.
10/21/2020 - Fever: 101.1, headache, chills, felt poorly, tenderness at injection sites 10/22/2020 - no fever 10/23/2020 - mild fever, no higher than 99.3
Pt had first Phizer Covid shot on Dec 23. Three days later started to feel weak, and body aches and jaundice. I see her in emergency for weakness realted to her new anemia.  Her hemoglobin was 12 on Nov 30  ,  Dropped to 7. 4 when I see her  Jan 12.  Her bilirubin todal on  Jan 12 2021 is 6.4.  Impression ; New onset symptoms and findings of  hemolytic  of anemia / autoimmune reaction  starting  few days after receiving first Covid shot. .  Hemoblobin eventually declined to 4.0  Feb 1.  She tells me treated with eppogen shots and prednisone and not Feb 18 .  Hemoglobin now 9.9  , and she is feeling better per phone conversation with her on 02-20-2021. She tells me there was never any history of bleeding during this event.
received a dose of Bexsero instead of the intended hepatitis B; This case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th August 2022, the patient received Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 15th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: 24-Aug-2022 Reporter's comment: The patient received Bexsero vaccine in left deltoid. The GlaxoSmithKline field representative reported that an office manager reported to them that the patient received a dose of Bexsero instead of the intended hepatitis B. The consent to follow-up was granted. Additional Supportive Information: The patient received Bexsero instead of the intended hepatitis B, which led to wrong vaccine administered.
Expired product administered; No additional adverse event reported; This spontaneous report was received from a consumer concerning to a 15-month-old female patient. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On an unspecified date, the patient was vaccinated with an expired dose of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (lot number, expiry date, dose, anatomical location, route of administration and dose description was not reported) for prophylaxis (expired product administered). Reporter did not know exact expiration date, but she said it was expired 6 days ago. No additional adverse event reported, and no further information provided.
Headache lasted ~12-16 hours the day after dose. Felt tired/out of it/in a haze for ~12-16 hours the day after dose. Body was achy for ~12-16 hours the day after dose. Left arm swelled and got red and bruised below the injection site. This was noticed ~30 hours after the dose and lasted for 12 days.