chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; Dose 1, 2, 3 (booster) received BNT162b2 then dose 4 and 5 received Moderna Biovalent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6207), on 03Apr2021 as dose 2, single (Lot number: ER8734) and on 06Oct2021 as dose 3 (booster), single (Lot number: FF2590) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 29Apr2022 as dose 4 (booster), single (Lot number: 059M21A) and on 21Oct2022 as dose 5 (booster), single (Lot number: 044D224), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Apr2022, outcome "unknown", described as "Dose 1, 2, 3 (booster) received BNT162b2 then dose 4 and 5 received Moderna Biovalent"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Aug2023) Negative; (09Aug2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 30Jul2023 to 03Aug2023.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 22-OCT-2016 to 31-JAN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot #: M018957 with expiration date: 22-NOV-2017 dosage schedule were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The administered vaccines experienced temperature of (48 grades Fahrenheit), more than 46 grades Fahrenheit but less than 77 grades Fahrenheit for 24 hours and on 02-DEC-2016 (33 grades Fahrenheit), between 32 grades Fahrenheit and 36 grades Fahrenheit for 60 hours. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA003016: US-009507513-1702USA004995: US-009507513-1702USA004996:
Pt recvd MMR vax daughter subsequently exp an arthritis like rxn; no further details were provided;
Next day after vaccination BOTH knees were aching and this continued on post vaccination for several months until I went to the PRIVACY Physician to  check out this development, xrays were taken ,  Previous to the vaccinations neither knees were in pain.  I had to corticosteroid injections which relieved the issue until the my third vaccination when it occurred again .  I have continues stiffness and pain in both knees.  Please note prior to these vaccinations I had NO pain in my knees.
Patient started with chills and shaking. Patient's son called pharmacy. We had them check BG and it was 98 despite patient eating 2 hours before. Had family give small glass OJ and recheck BG in 15 minutes, was only 114 but chills had gotten better. Patient also experienced fever near 100, myalgia, nausea and vomiting. We instructed family to use comfort care (ie Tylenol for fever; Pedialyte for electrolytes) and if patient stayed same or got worse by end of the night, to take patient to ER for more comfort care. Instructed them to call back next day if they had any questions. Did not hear back from family.
lips swelled; right hand swollen; itchy; hives on skin and scalp; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (lips swelled), PERIPHERAL SWELLING (right hand swollen), PRURITUS (itchy) and URTICARIA (hives on skin and scalp) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     Concomitant products included CALCIUM and VALSARTAN for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced LIP SWELLING (lips swelled), PERIPHERAL SWELLING (right hand swollen), PRURITUS (itchy) and URTICARIA (hives on skin and scalp). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. At the time of the report, LIP SWELLING (lips swelled), PERIPHERAL SWELLING (right hand swollen), PRURITUS (itchy) and URTICARIA (hives on skin and scalp) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Other relevant medication history included vitamin d. No treatment information was provided.    This case was linked to MOD21-022057 (Patient Link).
Change in behavior, became extremely hyperactive and talking excessively and her attention span was very short. It was a drastic change from her previous behavior.
Patient reported a tender lump on the left side of neck that was tender to the touch.  The lump presented exactly 1 week after the 1st vaccine dose, and it was noticeably swollen.  At the time of 2nd dose, the lump was no longer visually noticeable, but could still be felt to the touch.  The residual lump is no longer tender to the touch.
at injection site redness; at injection site: redness, swelling; at injection site: redness, swelling, itchiness; at injection site: redness, swelling, itchiness, and warmth; This is a spontaneous report from a contactable healthcare professional (patient). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 12Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included allergies to oranges and pineapples and many food sensitivities and latex sensitivity from an unknown date and unknown if ongoing. Concomitant medication included clarithromycin (CLARITIN), ergocalciferol (VIT D), zinc, vitamin C and vitamin B complex. The patient previously took flexeril [cyclobenzaprine hydrochloride], naproxen and Z-pak and experienced allergies. The patient previously had first dose of BNT162b2 in left arm on 23Dec2020 for COVID-19 immunization. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Jan2021, the patient experienced at injection site: redness, swelling, itchiness, and warmth that continues to increase. The diameter of redness and swelling is approximately 2 inches. Half of my surrounding arm area is warm to the touch and the redness is very itchy. Other side effects have greatly diminished. The outcome of the events was not recovered. No treatment was given to the patient for the events.   Information on the lot/ batch number has been requested.
All side effects details have been documented using  V-Safe.  Also called VAERS and left multiple messages with no call back.  Below are only the high level issues which are still lingering but not as severe.      1)  Initial deep throbbing/vibrating sensation in left lower calf that started 14 hours after vaccination.      2)  Sypmtom #1 above continued non-stop for 3 days straight, both daytime & night time.      3)  Sharp bone pains started to occur in the left foot/ankle.      4)  Bone pain moved over to right foot/ankle,       5)  Started getting a warm/cooling sensation in both lower calves/feet.   Similar feeling to rubbing Vicks on those area and the              warmth/cooling sensation you get after it's applied.       6)  Bone pain moved to left hand/wrist.       7)  Bone pain moved to right hand/wrist.       8)  Still experiencing bone pain in both feet with soreness and fatigue in those areas.  It's not as severe or occurring on a daily basis              but still happening four weeks after vaccine.       9)  Still experiencing some bone pain in hands and wrist but predominantly on the left side.
random body rashes from my feet to my neck for 15 days now. None on the genitals.  Itchy and skin welts without even touching it. I've changed my diet, changed detergents, stopped taking all vitamins, nothing helps. they come and go all day and night. On 7/13/21 between 3pm-10pm my whole head went tingly, itchy, and semi-numb, including when I flossed my teeth.
Raised warm slightly itchy areas on injection upper arm.  One area is about 2.5 inches diameter and the other is about 2 inches diameter.   Treating with occasional ice pack and hydrocortisone cream once a day.
only liquid portion of Pentacel was administered/no AE; Initial information was received on 22-Jun-2020 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves patient (unknown demographics) to whom only liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was administered because administrator failed to reconstitute it (batch number and expiry date not reported) unknown route in unknown administration site on an unknown date for prophylactic vaccination(product preparation issue).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to Inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Noted after immunization for COVID Moderna Bivalent had been administered and was being documented that dosage was not correctly administered (vial look to contain less than expected for a 2 dose vial). Confirmed with staff CMA that a 0.3 ml dose had been administered instead of 0.2 ml.   Immediately sought assistance and reported it to Dr. who consulted with staff. Was informed to follow proper incident protocols and can advise parent that there is no medical concern to the extra 0.1 ml. However, to please advise monitoring and to please let us know if anything comes about.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-JUN-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dose, route and site of administration were not reported) and M-M-R II, albumin status recombinant human albumin (rHA), lot # L027434, expiry date 22-JUL-2017 (does, route and site of administration were not reported) which was also improperly stored. There were no adverse effects reported. Administered vaccines experienced following temperature excursions: on 14-MAY-2016 6 degrees Fahrenheit (F) for 1.5 hours, on 20-MAY-2016 5.9 degrees F for 5.5 hours, on 08-JUN-2016 6.9 degrees F for 3 hours 50 minutes, on 09-JUN-2016 8.2 degrees F for 9 hours 50 minutes and on 10-JUN-2016 6.6 degrees F for 1 hour 50 minutes. The freezer returned to proper range in between all excursions. Data logger was involved. This is one of several cases received from the same source. Additional information has been requested.
Right arm @ injection - no rash. Above inj pain, swelling, warm to touch; pt could lift on right side - (couldn't tolerate pressure). Couldn't lift right arm above head for 1 week. Below inj was redness (3 inch or more diameter of redness & swelling. General fatigue. Overall, lasted 2 wks
Pt devel fever about 24 hrs p/recvd Hep B vax-Engerix 1st dose; fever up to 103.3 otherwise no other sx x/lethargy; fever resolved in 72 hrs;
patient received IPOL, that was no longer suitable for use due to a temperature excursion, with no reported adverse event; Initial information received  on 09-Mar-2022 regarding an unsolicited valid non-serious case received from another health professional.  This case involves a 3-year-old child, male patient who experienced patient received ipol, that was no longer suitable for use due to a temperature excursion, with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 08-Mar-2022, the patient received a  dose of suspect IPV (VERO) suspension for injection, 1.5 ml, dose 5, lot U1C51M via subcutaneous route expiry date 17-June-2023 via subcutaneous route in the left thigh for Immunization. Patient has taken the vaccine previously.  On 08-MAR-2022 the patient developed a non-serious event "patient received ipol, that was no longer suitable for use due to a temperature excursion, with no reported adverse event" (product storage error) following the administration of IPV (VERO) latency 1 day.  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received IPOL, that was no longer suitable for use due to a temperature excursion, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient received ipol, that was no longer suitable for use due to a temperature excursion, with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain @ inject site on lt arm, immediate @ time of vax; has remainded painful @ same site since; PE-neg;
Fever 102, red streaks, hot to to touch (LD), flushed face. Tx with KEFLEX.
After searching in Google it seems I have "Covid arm": site of vaccine is swelling, reddish and itchy. It's been 2 weeks I received the first Moderna dose.
Covid + after the 1th shot; Lungs burning; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid + after the 1th shot) and LUNG DISORDER (Lungs burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy and Blood pressure. Concomitant products included LISINOPRIL for Blood pressure management.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced LUNG DISORDER (Lungs burning). On 29-Jan-2021, the patient experienced COVID-19 (Covid + after the 1th shot). At the time of the report, COVID-19 (Covid + after the 1th shot) and LUNG DISORDER (Lungs burning) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test: positive (Positive) tested Covid + on Jan 29. On an unknown date, X-ray: normal (normal) patient received clear x-ray.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Patient was scheduled to get second dose of vaccine on 15-Feb-2021.
swelling and a knot at the injection site; Two pea sized knot's in her arm/ a knot at the injection site; injection site in that area Warm to touch; injection site area hard; injection site in that area Painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Two pea sized knot's in her arm/ a knot at the injection site), INJECTION SITE WARMTH (injection site in that area Warm to touch), INJECTION SITE INDURATION (injection site area hard), INJECTION SITE PAIN (injection site in that area Painful) and VACCINATION SITE SWELLING (swelling and a knot at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity (obese) and Blood pressure high (high blood pressure).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE MASS (Two pea sized knot's in her arm/ a knot at the injection site), INJECTION SITE WARMTH (injection site in that area Warm to touch), INJECTION SITE INDURATION (injection site area hard) and INJECTION SITE PAIN (injection site in that area Painful). On 16-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling and a knot at the injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Two pea sized knot's in her arm/ a knot at the injection site), INJECTION SITE WARMTH (injection site in that area Warm to touch), INJECTION SITE INDURATION (injection site area hard), INJECTION SITE PAIN (injection site in that area Painful) and VACCINATION SITE SWELLING (swelling and a knot at the injection site) outcome was unknown.            No Concomitant medications was reported.   This case was linked to MOD-2021-079346 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up included, dosage regimen details, treatment medication and new event of swelling and a knot at the injection site added.
pt recv vax 28JUL97 & was seen by MD 30JUL p/developing lymphadenopathy described as a knot under the lt & rt ears;2AUG swelling progressed to involve the entire lt side of neck;pt hosp tx w/ATB;
Presented with rash on hands and feet, associated with pain and tenderness with an onset 11 days post vaccination with AVA, Typhoid, and SPV on 15 May. Pt also c/o chest pain, described as a heaviness over left breast area, eased with leaning forward, worsened with laying flat. Onset 8 days post vaccination. No radiation, n/c, no diaphoresis, ? SOB. Pain persisted for 1-2 days. Woke up with pain in chest but did not think much of it as he had a different type pain under his arm and left lateral rib cage area that was tender to touch. Rx steroids (40 mg x 5 then 20 mg x 5) for rash.
I have a large raised red rash near the injection site. It is itchy and hot. I have also had nerve pain in that arm.
Pt reported she had severe right arm pain which  began shortly after vaccination and continued for several days. She went to pharmacy at 4:30 PM to seek assistance. Pharmacist called and talked with another nurse.  He reported that she was anxious, complaining of arm pain and feeling cold and shaky but breathing appeared stable. Pharmacist  advised to tell patient to see PCP for symptoms or 911 if progresses to acute distress. Follow-up telephone was made but no return call from patient.  Pt returned for subsequent vaccines.  Reported arm pain improved after several days.  No other information obtained.  Pt is now travelling out of the country.
Moderna COVID-19 Vaccine EUA Woke up with headache, chills, body aches, tiredness,  upset stomach.  On second day (03/08/21) felt better but still not completely recovered.  Treated with aspirin.
It is an exacerbation and worsening of an existing auto-immune disorder.; my hands, inner elbows and upper arms flared with eczema; it has gotten worse over five days, now involving my left shin and my face; It is red, burning, itching; It is red, burning, itching; It is red, burning, itching; Other vaccine same date veccine date 10Nov2021; Other vaccine same date veccine date 10Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Nov2021 14:30 (Lot number: FH8028) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing); "eczema", start date: Oct2021 (unspecified if ongoing), notes: I recently had my first eczema episode, three weeks PRIOR to the vaccine). Concomitant medication(s) included: FLU, administration date 10Nov2021. The following information was reported: AUTOIMMUNE DISORDER (medically significant) with onset 11Nov2021, outcome "not recovered", described as "It is an exacerbation and worsening of an existing auto-immune disorder."; ECZEMA (non-serious) with onset 11Nov2021, outcome "not recovered", described as "my hands, inner elbows and upper arms flared with eczema"; CONDITION AGGRAVATED (non-serious) with onset 11Nov2021, outcome "not recovered", described as "it has gotten worse over five days, now involving my left shin and my face"; ERYTHEMA (non-serious), BURNING SENSATION (non-serious), PRURITUS (non-serious) all with onset 11Nov2021, outcome "not recovered" and all described as "It is red, burning, itching"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 10Nov2021 14:30, outcome "unknown" and all described as "Other vaccine same date veccine date 10Nov2021". Therapeutic measures were not taken as a result of autoimmune disorder, eczema, condition aggravated, erythema, burning sensation, pruritus. Additional information: Other medical history of Glaucoma, not related to this event. No known allergies. Facility type vaccine was pharmacy or drug store. Adverse event start time was 12:00 AM. Follow-up (17Nov2021): Follow-up attempts are completed. No further information is expected.
PC recvd from mom on 5FEB92 @ 1245 stating pt was fine until a couple hrs p/DTP/OPV/MMR while @ home pt fell out of chair into floor, eyes rolled back in head;