chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received second dose of vaccine after 35 days of first dose; This spontaneous case was reported by a physician assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of vaccine after 35 days of first dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 007C21A) for COVID-19 prophylaxis.     It was reported that the patient did not have any allergies to medication, food and other products.Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. Patient did not experienced a similar event in the past.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of vaccine after 35 days of first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of vaccine after 35 days of first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.   This case was linked to MOD-2022-607744 (Patient Link).
Arm pain, induration, erythema and swelling. Chills, tactile fever.
inj site swollen w/erythema & induration 5cm x 5cm in size;
My state health department encouraged me to report this.  I am unsure of the approximate dates of onset.  My 5 yr old daughter developed a rash 3-4 weeks after her second h1n1 vaccine.  It has continued approximately 3 weeks to date.  It has not yet been diagnosed.  About 10 days into the rash, she developed a fever and was diagnosed by rapid test with influenza A.  She began tamiflu.  The rash is still constant, spreading to her back of neck and elbows and forearms.  I am uncertain whether this is a side effect of vaccine.  Please help.
Exactly one week after 1st vaccine of Moderna given at Health Clinic. I developed what is being called "Moderna arm." My arm was sore, with a large red, swollen circle at the injection site. I developed an itchy rash that started at the top of my scalp in the morning and then spread to my entire body by the afternoon. The rash looked like chicken pox/hives and lasted for 3 days.
Severe lower back pain mimicking kidney infection/stone pain at belt line. Unable to walk/breathe/sit or turn.
I had a metallic taste in my mouth.  I felt faint . EMT kept me  for observation for about an  hour and a half. I was given water. When I went home I had the same reactions as my first dose but worse.  I wasn't eating, I didn't want to move. I was in  intense pain. About 10 days after second vaccine I  noticed that my middle finger was tingling.  Heart was racing . I had nerve pain. My primary care provider sent me to the ER.  My right arm and hand started turning black. They kept me  over night. I was told to take baby aspirin once a day  Refereed to see a blood disorder doctor for clot I started passing clots in urine.  Had to go back to ER  During my next period I was having break through bleeding  and it was very painful.  About a month ago my period seemed to be going back to normal.
My left eye swelled shut exactly 24 hours following the shot in my left arm. It didn?t completely resolve until 48 hours after onset
Facial paralysis - Bell's Palsy, left; paresthesias within 48 hours of immunization followed by rapidly progressive facial motor weakness; treated with oral steroids and valacyclovir for 7 days beginning 3 days after immunization; partial resolution (~50%) of symptoms at post-vaccination day 15.
Patient states few days after immunization had chills and face and eyes became itchy. Took ZYRTEC to help with itching. Noticeable rash appeared next day on cheeks. Very itchy.
As with 2nd dose, the day of was fine, following day horrible. Could not stand because of extreme dizziness. Fainted both for 2nd and 3rd doses. Lasted all day. Second day like having mild flu. Third day better, still some arm pain, fatigue, headache.
t102 on 10SEp92; t104 on 11SEP92 taken to hosp ER-blood work; 13SEP92 rash appeared taken to MD-MD felt was result of MMR;
did not experience any symptoms; was inadvertently administered one dose each of Proquad and Varivax/that the patient was meant to be given MMR II and Varivax; was inadvertently administered one dose each of Proquad and Varivax/that the patient was meant to be given MMR II and Varivax; was inadvertently administered one dose each of Proquad and Varivax/that the patient was meant to be given MMR II and Varivax; This spontaneous report as received from a physician refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 04-FEB-2020 (reported as "today"), the patient was inadvertently vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, route of administration, lot # and expiration date were not provided) and one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, route of administration, lot # and expiration date were not provided) instead of being vaccinated with and varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported).
patient received the PFIZER-BIONTECH COVID-19 MRNA VACCINE and then tested positive for COVID; patient received the PFIZER-BIONTECH COVID-19 MRNA VACCINE and then tested positive for COVID; This is a spontaneous report from a contactable pharmacist.  A 40-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: Unknown), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history included high body mass index (BMI) from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 22Dec2020, the patient received the PFIZER-BIONTECH COVID-19 MRNA VACCINE and then tested positive for COVID; and showed symptoms. The events were assessed as medically significant. The clinical course was reported as follows: The 40-year-old female patient, with comorbidities "like high BMI", received the Pfizer BioNTech COVID vaccine on 18Dec2020 and she had tested positive for COVID on 22Dec2020 and she was showing symptoms; however, they were not severe. The pharmacist did not describe the symptoms. In response to further probing, the pharmacist stated, "can I do this tomorrow because I need to call patient and ask her about if they have an opinion regarding the monoclonal antibodies treatment." The pharmacist wanted to know if there was information on consumers receiving antibodies after receiving the vaccine. The pharmacist stated the patient was eligible for antibody treatment. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 22Dec2020.  The clinical outcome of the events was unknown.  The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.; Sender's Comments: The reported  tested positive for COVID after immunization with BNT162B2 is considered related to the administration of the suspect, BNT162B2.
This spontaneous report was received from a registered nurse and refers to 60 patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot number L024993, expiry date 17-OCT-2017 (doses, route and anatomical sites of injection were not reported). Concomitant therapies were not provided. Information regarding the temperature storage, duration of excursion and previous excursions were not reported. No adverse effects were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & devel an inj site rxn characterized by redness, swelling & induration;pt also exp flu like sx which caused pt to leave work early;pt recovered;
Broke out in gives all over my body. Took Benadryl orally and applied Benadryl gel to skin.
PT CHOSE FLUZONE-PF.  INJECTED VACCINE.  PATIENT BLED MORE THAN USUAL.  I NOTICED A SWELLING AT INJECTION SITE.  ASKED PATIENT TO WAIT 10 MINUTES TO BE MONITORED.  AFTER 10 MINUTES CHANGED OUT BANDAID AND NOTICED SWELLING HAD WENT DOWN.  PATIENT MENTIONED SHE THOUGHT SHE MAY HAVE A SLIGHT ITCH.  GAVE PATIENT MY BUSINESS CARD AND TOLD HER TO CONTACT ME IF ANYTHING ELSE OCCURS AND ALSO TO FOLLOW UP WITH HER MD.
Muscle is contracting very hard at the site of the injections; Muscle is twitching; Muscle is shaking; Muscle is jumping and moving; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Muscle is contracting very hard at the site of the injections), MUSCLE TWITCHING (Muscle is twitching), TREMOR (Muscle is shaking) and MUSCLE TWITCHING (Muscle is jumping and moving) 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 14-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION (Muscle is contracting very hard at the site of the injections), MUSCLE TWITCHING (Muscle is twitching), TREMOR (Muscle is shaking) and MUSCLE TWITCHING (Muscle is jumping and moving). At the time of the report, INJECTION SITE REACTION (Muscle is contracting very hard at the site of the injections), MUSCLE TWITCHING (Muscle is twitching), TREMOR (Muscle is shaking) and MUSCLE TWITCHING (Muscle is jumping and moving) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitant medication was reported.  No treatment information was reported.
Vomiting; Hacking cough; Sore throat; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 27May2021 at 11:45 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetes, high cholesterol, high blood pressure and cat scan dye allergy. Concomitant medication included first dose of varicella herpes zoster vaccine (MANUFACTURER UNKNOWN) received on an unknown date in Apr2021. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 13May2021 at 11:45 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. The patient previously took phenobarbital (MANUFACTURER UNKNOWN), phenytoin (DILANTIN) and mesuximide (CELONTIN); all on unknown dates for unspecified indications and experienced drug allergy. The patient received other vaccine within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 27May2021 at 17:00, the patient experienced vomiting, hacking cough and sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vomiting, hacking cough and sore throat were resolving at the time of reporting.   Information on lot/batch number has been requested
Chest tightness day 1 and 2. Diarrhea day 3.
About 3 days after vaccine patient reports noticing that her neck was severely stiff and painful. Patient says she could not turn neck at all. This went on for 3-4 days and then she states it started to ease up and she now has more motion but it is still painful at times. Patient also reports she sometime gets chills and hot flashes, but patient has checked temperature and no fever to report.
CHIEF COMPLAINT:   pt reports left sided chest pain with radiation to his back. having a hard time breathing and states "its too quick".  "i think its my oxygen". O2 79% at triage.   HISTORY OF PRESENT ILLNESS:     pt with covid19 test from home.  Reports has had several days of cough congestion and chest tightness.  He denies any lower extremity edema or pain.  He reports being vaccinated x2 against the COVID-19 virus.  Has not had his booster shot.  The history is slightly limited by the patient shortness of breath.  He was placed on oxygen just prior to me being called to the bedside to evaluate him.  Fever and chills. Denies nausea, vomiting, diarrhea, or abdominal pain. No headache, photophobia, stiff neck, or rash reported.
The night after the shot, I have extremely vivid and lucid dreams. The following week on June first, I notice that the texture of food felt different. I was still able to taste, but my tongue felt numb, almost. On June 3, my eye began to hurt...like I had something in it. I added a couple eye drops and took some Advil, and that seemed to work. On June 4th, my eye became worse, and eye drops were not helping. On the morning of June 5th, I noticed my smile was off and I could not drink out of a straw properly.  Food textures were still off and my eye was much worse. I went to the Urgent Care, and they advised me to go to the ER to rule out anything neurological. The symptoms I was and still am experiencing, and was diagnosed with was Bell's Palsy. I have never had this happen before and rarely get sick. During this time I have had not other illness.
Usual chills, headache, fever and neck pain beginning at 10:00 pm.  Woke up at 6:00 am with throat swelling. Went to emergency room
After vaccine I got a rash on different spots on my body. It went away. Then I got my second vaccine dose, 1/29/21 and rash came back again. It has been coming back and going away and still I have it right now. I'm afraid to tale a booster now. I use cocoa butter to get rid of it.
swollen, red, elevated skin temperature at sites of injections on legs refusal to breast feed prolonged crying
Began with a headache, then progressed to sore neck-back and sides, progressed into swollen glands and soreness in neck, jaw and around ear area. Jaw became very sore. Opening mouth to eat became difficult. Headache had subsided 24 hours after neck episode began. From beginning of episode to current (3/22/2021), which is slightly over a week the adverse effects have gradually lessened. However, slight soreness in the front of neck, glands and jaw. Seems to lessen each day.
Information has been received from a certified nurse midwife concerning a female patient who on an unspecified date was vaccinated IM with the second dose of GARDASIL and experienced swelling of the lips, face and eyes. In addition, the patient had broken out in hives. The patient sought unknown medical attention. Allergy testing was performed with unspecified result. Vaccine with GARDASIL was discontinued. At the time of report the patient's status was improved. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 17-APR-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 24-OCT-2016, the patient was treated at a medical group for blistering vesicular outbreaks that were diagnosed as severe shingles. The patient has been prescribed valacyclovir and gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Have reaction on bottom right side of leg; have swelling at leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (Lot number: ER8731) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose.), for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 29Apr2021, outcome "unknown", described as "Have reaction on bottom right side of leg; have swelling at leg". Therapeutic measures were not taken as a result of peripheral swelling.  Additional information: Patient received his second dose of Pfizer at around 1 o'clock close to 2 today (29Apr2021) and went home. About three hours later at 5 o'clock, patient had a reaction on bottom right side of his leg. He was asking if this was because of the shot as he had swelling at leg.  No follow-up attempts are possible. No further information is expected.
It still has fever in the injection site; I broke out in hives and it still has fever in the injection site; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO182) via an unspecified route of administration in the left arm on 19Jul2021 at 10:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included heart problems but still waiting on her test results. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (BAYER CHILDREN'S ASPIRIN) from on an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: TR8765) via an unspecified route of administration in the left arm on 28Jun2021 at 10:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient also took codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 23Jul2021 at 09:00, the patient experienced broke out in hives and still it had fever in the injection site 4 days after. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events which included treatment with over-the-counter allergy medication. The clinical outcome of events broke out in hives and still had fever in the injection site was recovering at the time of this report.
Systemic: palpitations-Severe, Systemic: Tachycardia-Severe, Additional Details: patient came in seeking 2nd vaccine on 9/28/21. Discussed with patients of risk and advised patient to see doctor prior to recieving 2nd shot
Patient experienced what felt like a fever at 2 AM on 6/20/12. She experienced painful, pressurized headaches, neck pain, inner ear pain in left ear, and felt that the room was spinning badly twice early in the morning. The site of injection was very painful and sensitive to the touch. There was no change in coloration or texture to the skip at site however.
Booster; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 16Nov2021 (Lot number: FE3590) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: 26Mar2021, when the patient was 70 years old, for Covid-19 immunization, reaction(s): "Diarrhea"; Bnt162b2 (Dose 2), administration date: 19Apr2021, when the patient was 70 years old, for Covid-19 immunization, reaction(s): "Diarrhea". The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Booster"; DIZZINESS (non-serious) with onset 16Nov2021, outcome "not recovered", described as "dizziness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness.  additional information: Caller stated that she started a supplement for her eyes a month before the vaccine. Caller states she was not on any prescription medications. States she got all 3 doses in her right arm/shoulder muscle. States she got it around 1:30-2pm.   Follow-up attempts are completed. No further information is expected.
(R) arm red, hot and swollen. Pt. tx with KEFLEX 250mg/5ml 7ml TID x 10 day.
7/21 Pt got tingling at the injection site. It was warm to the touch. A day or 2 later, she got a blister patch on the skin - PT goes to 7/23 clinic - Got 2 antibiotics - red patch reduced to a finger tip size. Blister dry up after 12 days.
This spontaneous report as received form a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Patient is a 70 year old female with a PMH of TBI with residual memory loss, visual deficits and unsteadiness who was admitted on 2/18/2021 with diarrhea and weakness. Patient tested positive for COVID-19 on 2/18/2021. She was not hypoxic and CRP was mildly elevated. Steroids and remdesivir were not indicated during the admission. Diarrhea improved overnight with IV fluids. Patient was discharged to home on 2/19/2021
Skin Reaction - bumps, redness, itching on face, neck, trunk and arms.  Swollen, primarily upper body.  Reaction began 1 day after receiving vaccines. Given Decadron 8mg IM, followed by Medrol Dose pak and Benadryl 50mg qid.  Patient was being deployed 2 days after reaction began.
Extreme pain in arm where shot was administered. Pain began to radiate and has not subsided 48 hours later.