chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; some were inadvertently administered 0.5ml of Moderna Magenta Vial for ages 6 months through 5 years instead of Moderna bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (some were inadvertently administered 0.5ml of Moderna Magenta Vial for ages 6 months through 5 years instead of Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (some were inadvertently administered 0.5ml of Moderna Magenta Vial for ages 6 months through 5 years instead of Moderna bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (some were inadvertently administered 0.5ml of Moderna Magenta Vial for ages 6 months through 5 years instead of Moderna bivalent booster) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (some were inadvertently administered 0.5ml of Moderna Magenta Vial for ages 6 months through 5 years instead of Moderna bivalent booster).    Concomitant medication information was not provided.  It was reported that out of the 36 patients who were in a COVID vaccine clinic on 15-Oct-2022 for receiving the bivalent booster doses, some were inadvertently administered 0.5 ml of Moderna lot of Magenta vial that was intended for ages 6 months through 5 years, and some were given the correct Moderna Bivalent vaccine from blue cap grey label vial.   Unfortunately the wrong vials were grabbed in the midst of administration and the nurse had not noticed at what point the error occurred. They understood that if the patients were given the pediatric doses, they could administer the correct bivalent formulation to those patients, but they had no way of knowing exactly who it would be. On the other hand if the patient did actually receive the correct bivalent dose, then another dose would not be indicated for them.  It was reported that no adverse events were reported after vaccine was administered.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2022: Live follow up receive contain : updated event verbatim, and updated narrative.
bilateral arm redness at injection site. cold sores (3) located on bottom lip. No opening eruptions on sores.
Information has been received from a nurse practitioner concerning a female patient who on 17-NOV-2009 was vaccinated with her first dose of PNEUMOVAX 23 (Lot number: 662747/1086X). The reporter mentioned that 24 hours after administration of vaccine on 18-NOV-2009 the patient experienced a fever, chills, headache, body aches, redness and an induration at the injection site. At the time of reporting, reporter was requesting a lot check be conducted. It was unknown if the patient sought medical attention. Patient outcome has not been reported. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 25 September 2012 at 10:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). In September 2012, at an unspecified time after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site tenderness. The healthcare professional reported that a female subject received a dose of FLULAVAL and developed injection site reaction consisting of redness, swelling, and tenderness. The largest diameter of the redness was approximately three inches at the widest point. It is not known when reaction began, but the nurse was made aware by the subject on 27 September 2012. No other events noted. At the time of reporting the injection site redness, swelling injection site and injection site tenderness were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Chills, fever, fatigue,  and nausea.  Lasted approximately 12 hrs. Treated with acetaminophen,  2 pills/4 hrs. Fever slowly reached 102.4 but quickly diminished over 1 hour.
Patient developed a debilitating headache requiring 0 days bedrest. Patient stated headache was very severe.
On the same day of vaccination patient was observed having a seizure.  He also later after recovering for the seizure complained of chest pain.
Injection site reaction - soreness, swelling, redness Headache, chills, fatigue
I originally received the J&J vaccine in March 2021 and had no side effects. My family is traveling to  in December so my husband and I went to receive our booster shots.  Moderna was available and we went to a local pharmacy  to get that booster The following day I experienced the usual reported side effects - headache, nausea, vomiting/dry heaves, fever (101.4) and chills. Then I started to experience extremely high blood pressure (while I had fainted twice in the previous week because my BP was too low - around 70/50 it was then presenting at 200+/100+),extreme anxiety, uncontrollable shaking (my doctor told me it was called psychogenic movement disorder as a result of extremely high anxiety. If these had been reported side effects, I may not have gone to the emergency room, as at the time I was unemployed.At the time I was admitted my BP was 208/108.
local rxn vs cellulitis (rash, swelling @ inj site);Keflex 250mg BID x 10 day
2nd dose of vaccine was 3/10/2021. Was newly pregnant at the time of the second dose. Miscarried on 3/17/2021 at almost 6 weeks.
Immediate burning sensation in length of both arms and both legs. Lasted one week. Reemerged 7 weeks later with severe intensity. Severe burning at injection site, upper lateral right arm, and lateral side both legs, right elbow and forearm, crown of head, face, bridge of nose, severe burning on tops of feet and hands. Numbness and tingling soles of feet and palms of hands. Sensation of having been hit by a hammer in fingers. Shaking from pain. Blurry vision in lateral side of right eye. Extreme dizziness. Room spinning sensation. Tachycardia at 140 pulse at rest.
pain in left arm, and not able to hold anything of medium or heavier weight.  Severe pain on bending arm
AFTER GIVING THE GARDASIL VACCINE LIKE 15 SECONDS LATER PATIENT STARTED FEELING DIZZY. I CALLED FOR WATER FOR PATIENT WITHIN SECONDS PATIENT STARTED HAVING SEIZURES LIKE SYMPTOMS(SHAKING,LEGS AND ARMS PARALYZED). HE WAS VERY PALE AND NON RESPONSIVE. WE THEN LET PATIENT SMELL AMMONIA COUPLE OF SECONDS AFTER PATIENT BECAME ALERT STILL PALE WITH TWITCHING. TOOK OXYGEN LEVEL AND BLOOD PRESSURE VITALS WHERE FINE ,PATIENT WAITED IN THE OFFICE ADDITIONAL 20-30 MINUTES WITH DOCTOR AND NURSING STAFF THEN RELEASED TO GO HOME.
Vaccine - PNEUMOVAX 23 admin. (R) deltoid 1/3/17. Pt. at office. 1/6/17 reports swelling and redness (R) anterior and posterior arm. Reports symptoms improved since 1/3/17.
It was an error. the pt signed up for fluzone, but was given fluzone plus moderna. Fluzone wasnt given in the series. Moderna was given. the dr office was notified and the pt will follow up for further evaluation.
Acute onset of PAC's and PVC's.  Holter, ECHO and Stress test performed.  PAC's and PVC's confirmed. No arterial occlusions found.  Placed on ACE Inhibitors for 6 months.  PVC's and PAC's resolved
Thursday evening after vaccines slight headache, was a little achy. Friday and Saturday pt felt the same, slight headache and achy, Sunday, pt was feeling even better, however around 4 PM patient fainted unexpectedly without any forewarning. Followed by full blown instant migraine (most severe she has ever had) that lasted all night. Pt took IMITREX Sunday evening (95 mg), which did not completely resolve the headache then pt had 2 incidents of vomiting and did not feel well all night. Pt felt better Monday but was shaky, no appetite, Tues pt felt better but not completely well with what she considered a normal headache. Patient has had some degree of headache each day including up to the time of this report. Today, 1 week later, patient is having increased thigh/ muscle pain, lameness, and headache and is feeling worse than yesterday, headache is much worse.
Within 5 minutes after administration of all listed vaccines patient reported feeling "light-headed". Pt sat down in a chair and within 1 minute the patient had fainted et began to shake as if having a small seizure. Episode lasted approximately 20 seconds et pt woke up. After having pt lay down for 10-15 minutes she had fully recovered.
Mom was up with patient around 2-3AM on 01/30/2009 and no problems.  When mom was up with patient around 6-6:30AM, he had a fever of 103.5F--gave him Tylenol and the fever came down to 102.5F, but within a hour the fever was back up to 103F--patient started to seizure and the ambulance was called.  Patient was transported to Hospital--a CAT scan, spinal tap, blood cultures and bloodwork was done. The CAT scan came back as normal, but before all the results were back, patient was transported to another Hospital.  At Hospital, an EEG was done right away and at 4:30PM he was to have a MRI done.  Patient was admitted to the general ped. floor for care--patient's fever broke on Friday--discharged on Sunday.  Mom reports today that all results came back as normal--following up with family dr. today and neurologist on 03/02/2009.  Mom reports no other problems since Friday.  2/12/09 Received ER medical records of 1/30/09. FINAL DX: seizure, r/o meningitis Records reveal patient experienced irritability, fever since morning & then seizure x 30-45 seconds.  EMS took to ER.  Appeared well in ER but fever 103.4.  Tx w/IV antibiotics & transferred to higher level of care.  3/27/09 Received hospital medical records of 1/30-2/1/2009. FINAL DX: new onset seizures Records reveal patient experienced fever 103.3 at home & noted to have right neck twitching, upper extremity jerking, staring lasting 10-15 secs & immediately returned to baseline.  Irritability increased.  Had been transferred from outlying ER.  Neuro consult done.
KINRIX 1 DS/0.5ML was  administered to a patient at inappropriate age; This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th June 2021, the patient received Kinrix (intramuscular) .5 ml and Kinrix Pre-Filled Syringe Device. On 28th June 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, 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 details were reported as follows: The 11 years old patient was administered with 0.5 ml of Kinrix dose which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary reporter. The reporter consented to follow up. This case has been linked with US2021152836,US2021152845 and US2021152833 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152836:same reporter US-GLAXOSMITHKLINE-US2021152845:same reporter US-GLAXOSMITHKLINE-US2021152833:same reporter
Red rash right middle arm. 10 x 12 cm diameter . no warmth minimal edema. Allegra 1 day sample
77 y/o F w/PMHx of HH, HTN, osteoporosis, adrenal insufficiency, scoliosis, PMR, GERD, nephrolithiasis, RA, pancreatitis, postherpetic neuralgia, sleep apnea, hx of blood clots   Pt received her 4th covid vaccine (4/26/22) or 6 days ago Several hours later she developed a fever, nausea, vomiting, her lips and mouth started swelling Within several days of receiving the shot, She developed cold sores in mouth and lips Feels like burnt the inside of her mouth She is in terrible pain  She was "down for 3 days" and was so weak couldn't get out of bed She had no issues with the first 3 shots   Taking transdermal fentanyl, tramadol and flexeril for scoliosis She cannot tolerate benadryl due to an upset stomach She has allegra and magic swizzle on hand   No VS or PE as telephone appt Pt does not sound in distress over the phone but does sound like she is in a lot of pain
Patient had soreness and redness at injection site starting Wednesday 9/15 at 9pm. Soreness gradually got better and was completely gone by Monday 9/20. Redness got progressively larger and when patient presented on 9/21/21 at 11:45am the red circle around injection site was 5 inches in diameter
pain on left side of foot penetrating through the foot; very tired; This is a spontaneous report from a contactable consumer (patient).  A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 08:00 (Batch/Lot number was not reported), age at vaccination of 30-years-old, as single dose, for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing high blood pressure, drug hypersensitivity from an unknown date and unknown if ongoing (sulfa allergy), drug hypersensitivity from an unknown date and unknown if ongoing (Penicillin allergy), rubber sensitivity from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported; amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported.  The patient previously took sulfur and experienced drug hypersensitivity, keflex [cefalexin monohydrate] and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received BNT162B2 dose 1, administered in Arm Left on 04Feb2021 08:00 (Batch/Lot number was not reported), for covid-19 immunisation.  On 25Feb2021 16:00, the patient experienced pain on left side of foot penetrating through the foot and very tired. No treatment was given for the events. The patient had not recovered from the events.  Information about lot/batch number cannot be obtained. No further information expected.
Severe pain in neck.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac diseases. The patient had known allergies to wheat and gluten. Concomitant medications included B Hydroc (MANUFACTURER UNKOWN), vit d (MANUFACTURER UNKNOWN), venlafaxine hydrochloride (EFFEXOR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and pseudoephedrine sulfate, loratadine (CLARITIN D); all from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm on 27Feb2021 at 16:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 13:00, the patient experienced severe pain in neck. Therapeutic measures were taken as a result of reported event and included treatment with chiropractic and acupuncturist appointments. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events of neck pain was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
As part of the administration's actions, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized.
Rash developed around injection site later the day of administration of ZOSTAVAX vaccine. Patient states that is painful and itches. It is a red, irregular, spotty rash.
Feet and toes hurt since being vaccinated; Difficult to walk; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0181) via an unspecified route of administration in the right arm on 15Jul2021 at 14:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient's relevant medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 19Jul2021, the patient experienced feet and toes hurt since being vaccinated, making it difficult to walk.  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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feet and toes hurt and difficult to walk was not recovered at the time of this report.
PATIENT STATES THAT SHE HAD REDNESS IN IMMUNIZED ARM 3 INCHES IN DIAMETER. IT WAS WARM TO THE TOUCH, BUT NO FEVER WAS PRESENT. THE AREA WAS ITCHY AND SORE FOR 3 DAYS AND HAS SINCE RESOLVED.
Had arrived home - made bagel and began to "hurt" "bottom stomach". "Ate bagel" - mom suggested to go to bathroom - no improvement. Returned to clinic - stated feels like getting headache - encouraged to rest at home, keep up fluids and call doctor for meds prn if "cramps" continue (has not started period yet). Site asymptomatic L arm. to call with mom. "OK" "thank you". 1430 - LMOM - to give us a call prn - "if worse" seek doctor's advice - just checking to see how doing. 9/9/09 830A LMOM - hope doing OK. Call prn if question.
Patient developed urticaria at the site of injection within 3 minutes. the welts involved most of the deltoid and spread down tot eh mid upper arm.  the welts were not itchy and patient had no symptoms of anaphylaxis. VS remained stable. patient was given Benadryl 25 mg immediately and observed for 1 hour. Within 30 minutes, the welts disappeared an a macular rash remained
Patient was given 0.2ml of Pfizer vaccine with 1.3ml NS. No adverse outcome.
Left arm - redness - swelling - 11cm x 9cm. - warm to touch.
Had my two shot/The last shot was in January of this year/I now have Shingles / suspected vaccination failure; I now have Shingles; I am in pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In January 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and less than 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2 doses of Shingles vaccine and both times he/she had a reaction (unspecified). At the time of reporting, the patient had shingles and was in pain. The patient stated that he/she could not recommend the shot as it did not work for him/her. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR108657:same reporter
This spontaneous report as received from a female patient of unknown age reporting on herself. Approximately in MAY 2010 ("about 3 weeks ago") the patient was vaccinated with ZOSTAVAX (route and lot number not reported). Approximately in MAY 2011 ("approximately 1 year after") after receiving the vaccine the patient experienced a case of shingles. The outcome of shingles is unknown. Additional information is not expected.
Pt developed fever, chills and a headache for about 24 to 28 hours, post vax.
On 06/19/09 pt received Tdap.That same evening pt noticed her upper left arm at the location the immunization was given became red, painful and she had a fever of 99 degrees.Her whole body felt achy which significantly improved after taking tylenol 1 gram 4 times a day. Over last 24 hours, she has noticed some mild itching and increase redness of the skin. Began Claritan every 4-6 hours and applied cold compresses 10-15 min prn.WBC 5.2.No antibiotic prescribed. On 07/01/09 symptoms improved, arm still itchy and slightly red. Continues with Claritan and cold compresses.
Had Hives, and red itchy rash 6 days post vaccination, slowly improving.