chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021 at 10:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 10:26 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 73.34 and 73.42. Concomitant products were not provided. On 28-Feb-2021, Excursion time was 09 AM, temperature was 27 and Excursion time was 01 PM, temperature was 26, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021 (For Batch: 014M20A). On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45 (Batch: 014M20A). On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021 (Batch: 019B21A). The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
pt recv vax 1996 & OCT97 pt devel a mild case of chicken pox;duration was less than 1wk;
Pt is 15 years old.  She received a booster shot of Moderna (0.25 ml). However she was not old enough for the booster dose, nor the moderna vaccine. Per patients father, she became very ill.  Patient was taken to the ER due to intense vomiting. She received IV fluids and stablizied. She has been discharged.
Information has been received from a registered nurse concerning a 17 year old female with no medical history who on 19-JUL-2006 was vaccinated in the right deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F).  Subsequently on approximately site that lasted approximately 60 to 90 seconds and her arm became red and painful enough to cause the patient to cry.  The patient subsequently recovered from the pain in the extremity, erythema, and injection site irritation.  Additional information has been requested.  The registered nurse also reported that the patient's sister experienced pain in the extremity, erythema,and injection site irritation following vaccination with HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F).
Vaccines given on 6-11-19 in earyl afternoon, on evening of 6-11-19 started to have slight reddness , on morning of 6-12-19 pt awoke with swelling from left upper arm progressing down left arm to elbow. Redness, and warmth to arm, pt had temp of 99.8, when seen in our office around 2:00 pm.   Redness and edema from antecubital fossa  to the top of the shoulder and halfway aroud the arm, involving only the anterior aspect. A line of demarcation was drawn.  Pt was instructed to elevate arm about heart level, take zyrtec 10mg by mouth twice daily until improves. Pt is to call  if spreading reddness. Immunizations were given at Facility in Dr. office.
doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Immunizations given 9/24. On 9/24 at 2120 became apneic and needed PPV C positive pressure ventilation) a few times. Then after recovered placed in nasal cannula and then at midnight 9/25 placed back on NCPAP. After 33 hours was able to come off cpap and go back to room air.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL vaccine (yeast) then fainted. The physician reported that they followed the procedure for when a patient faints and then the patient came to and was fine. The patient is not going to continue the rest of the series. This is one of several reports received from the same source. Additional information has been requested.
Sharp pain at injection site for 48 hours. Anaphylaxis approx. 15 minutes after injection. Treated by OTC medication (antihistamine & bronchodilator).
Recieved Influenza vaccine 10/13/10 left deltoid area. Complained after he left office that his arm is hurting, had stomach and head pain.  On 10/14/10 mom noticed large area around injection site red, warm and painful.  Patient had a similar reaction after receiving flu shot last year.
Patient developed a sterile abscess at the vaccination site, first noted within 2 weeks of the vaccine administration.
The patient had no adverse reaction to the vaccine. The 12 year old patient was inadvertently given the vaccine manufactured for patients 5 - 11 years of age. The parent was informed of the administration error as soon as it was detected. Per the CDC guidance on COVID-19 Vaccine Administration Errors, if a person aged 12 -17 yrs is given the 5-11 years formulation, the Pfizer BioNTech Vaccine formulated for persons 12 years and older should be administered 21 days after the first dose. The patient received the correct second dose on 12/03/2021. To avoid further errors, the two formulations of the vaccine are stored in distinct containers and in different areas of the refrigerator. Brightly colored, easily recognizable Pediatric labels are affixed to the syringes containing the pediatric formulation to distinguish them from those for persons 12 years and older.  Providers are also reminded to always verify the age of the patient and the appropriate vaccine to administer.
Arm pain, chest pain, shortness of breath, earache, headache, and swollen nodes.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' current condition, concomitant therapies or medical history provided. On unknown dates, patients were administered an unspecified number of improperly stored dose of ROTATEQ orally, lot number L037921, expiration date: 31-MAY-2017, (dose was not reported0. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 29 degree Fahrenheit for 1 hour on unknown date. Data logger was involved. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact physician.
Patient came in for a COVID Bivalent Booster. Received a Primary in error.
8 hrs after receiving flu vax & PNEUMOVAX in (R) arm she developed temp 100.6 & pain, pain, swelling, erythema increased & assoc. with chills. Today area of injections 40 cm swelling, erythema & at 20 cm below this similar sized area of erythema, warmth, induration. No vaccine given at this site.
Like a light case of the flue; Joint pain; Headache; Fatigue, stayed in bed; Fever of 101.3 °F; Muscle ache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Like a light case of the flue), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (Fatigue, stayed in bed) and PYREXIA (Fever of 101.3 °F) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included RIVAROXABAN (XARELTO), GABAPENTIN, ATENOLOL, TRAMADOL and LINACLOTIDE (LINZESS) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Like a light case of the flue), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (Fatigue, stayed in bed), PYREXIA (Fever of 101.3 °F) and MYALGIA (Muscle ache). On 06-Mar-2021, INFLUENZA LIKE ILLNESS (Like a light case of the flue), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (Fatigue, stayed in bed), PYREXIA (Fever of 101.3 °F) and MYALGIA (Muscle ache) had resolved.            Treatment medication included Tylenol and Advil.  Action taken with mRNA-1273 in response to the event was Not Applicable   This case was linked to MOD-2021-218872 (Patient Link).
once I got my shot I got muscle pain in my entire back. It has lasted 7 days. If I move around it goes away but as soon as I stay still it?s starts hurting. Not quite as bad as the first day but still very painful
2/14/12 Pt. received TDAP, hep A, INFLUENZA & PPD. She reported having temp of 103 degrees. Soreness at area where TDAP injection site, muscle aches & noted a enlarged cervical lymph node on (L) side (TDAP given left deltoid).
Light headed, hot, dizzy. Started within 5 minutes of vaccination. Provided apple juice and water to patient. Felt better after 25 minutes.
No adverse effects reported; Dose of VARIVAX reconstituted with expired dose of STERILE DILUENT and admnistered to patient; Dose of VARIVAX reconstituted with expired dose of STERILE DILUENT and admnistered to patient; This spontaneous report was received from a medical assitant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was not provided.  On 27-APR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot number R023504, which has been verified to be valid, expiration date unknown by the reported but validated as 16-AUG-2020) for prophylaxis (dosage schedule, vaccination scheme, route of administration and anatomical site of vaccination were not reported). According to the medical assistant, the administrated dose of the vaccine was reconstituted with an expired sterile diluent (lot number N028746, which has been verified to be valid, expiration date reported and validated as 17-MAR-2020) (expired product administered and product preparation error). Additionally, the medical assitant reported that the sterile diluent had no temperature excursions.  No adverse effects were reported.
06/22/2010 MILD, Other, 6/19/10 Temp of 100.6. 6/21/10 Upset stomach: Quarter sized red spot on (LA) warm to mother's touch.
The patient presented to the emergency department on 11/5 with left leg swelling. The patient was diagnosed with a deep vein thrombosis (DVT).
2" by 2" hardness on palpation + tenderness on palpation;no swelling or erythema;noticed hardness on 15MAR99;
BOWEL ISSUE; SORE ARM; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: unknown) dose was not reported, administered on 13-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced bowel issue. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bowel issue, sore arm, and low grade fever on MAR-2021. This report was non-serious.
I felt fine for nearly 12 hours after the jab and was on a walk when very suddenly had severe chills and felt poorly and wasn't sure I could get home. I felt a little nauseous, and my gut was upset. I had chills, fever, and then began to have painful muscle aches on my backside. My sleep was significantly disrupted - I woke up at midnight two nights in a row after my fever broke, then had disrupted sleep the whole rest of the night, waking up at least once an hour, the second night in significant pain from muscle aches. I didn't feel well enough to get out of bed for about 40 hours, would get chills if I got up for more than a couple minutes. I began to feel better second morning after symptoms began, took two Tylenol, then improved  rapidly  with no further side effects.
REGULAR COLD FOR 7 DAYS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced regular cold for 7 days. Laboratory data (dates unspecified) included: COVID-19 virus test false-positive Bianax test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from regular cold for 7 days. This report was non-serious.
This spontaneous prospective pregnancy report as received from a physician referring to a female patient who is currently 34 year old. The patient's concurrent conditions and medical history were not reported. The patient was pregnancy with the date of last menstrual period was 19-AUG-2015 and the estimated date of delivery was 25-MAY-2016. The pregnancy outcome was pending. On 02-MAR-2016, the patient was vaccinated with GARDASIL (dose, frequency and route were unknown) in error. The woman was indicated to received Tdap. The physician stated that the medical assistant who made the error didn't tell her why the error occurred. The physician was not able to provide the lot number and expiration date of the dose of GARDASIL that the patient received at the time of this call. The patient had not experienced ill effects from this event and she was "feeling fine". Additional information has been requested.
Information has been received from a physician concerning a 24 month old female pt who in approx Sept 2004, at 12 months of age was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. This week, on approx 21Sep05 the pt experienced breakthrough varicella and came to the office. The child had a few lesions and no fever. It was a mild case and no treatment was given. At the time of the report the pt was recovering. The pt's twin brother (WAES0509USA04036) also developed breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information has been requested.
Lower back pain. I was also very tired on the day I took the vaccine and I spent the day laying down and remember I had minor pain on the arm at vaccination site. Lower back pain has not stopped since the vaccine. No idea if this is related or not to the vaccine, but I wanted to document it.
ON THE EARLY MORNING OF 09/11/2017 PATIENT BEGAN TO HAVE INTERMITTENT BOUTS OF SCREAMING, ABDOMINAL PAIN AND NON BILIOUS VOMITTING AND THEN ONE EPISODE OF BLOODY CURRANT JELLY STOOL. MOM IS A NURSE PRACTIONER AND CONTACTED ME AT 0730. AT THIS POINT, PATIENT WAS IMPROVED AND TOLERATING MORNING FEEDS WITHOUT VOMITTING OR ABDOMINAL PAIN, I DID NOT INSTRUCT HER TO GO TO ER AS PATIENTS SYMPTOMS RESOLVED. MOM INSTRUCTED TO OBSERVE CLOSELY AND PRESENT TO ER ASAP IF SYMPTOMS RETURNED. MOM OBSERVED ALL DAY AND PATEINT HAS CONTINUED TO HAVE NO FURTHER SYMPTOMS OF INTUSSUSCEPTION.
Pain at the injection site; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (injection site soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (injection site soreness). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (injection site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   No treatment medications provided by the reporter.
Wk following vax, legal guardian reported child exp convuls; wakes fr sleeping, screaming & rolling on the floor, but is fully aware, eyes are open; not hospitalized nor seen in the clinic; hx of convuls secondary to utero cocaine exposure;
a rash in left armpit.; This is a spontaneous report from a contactable consumer. This 85-year-old male consumer reported that he received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 22Jan2021 14:30 (Batch/Lot Number: EL9262) as unknown dose, single, [SINGLE DOSE] for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced a rash in left armpit on 02Feb2021 08:00. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was reported as not recovered.
only received one dose of gardasil 9; NO ADVERSE EVENT; This spontaneous report was received from a pharmacist referring to a 17 years old female patient. The patient's concurrent condition, concomitant medications, pertinent medical history, drug reaction/allergies were not reported. On an unknown date, the patient received only one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) of one dosage form (strength, lot number, expiry date, route of administration were not reported) for prophylaxis at age 12 (inappropriate schedule of product administration). No adverse effects were reported. Outcome of the events was unknown. There was no product quality complaint (PQC) present.
12/8 - 9:30 pm: chills start but no fever 12/8- 11:00 pm: slight fever of 99-100 12/9 - 1:30 am: woken up because legs and arms and tingling and numb. Adjusted sleeping position but no relief.  12/9 - 5:00 am : leg tingling and numbness gone but wrist numbness had gotten worse. Felt like someone was squeezing my wrists.  12/9 - 9:00 am to 7:00 pm: numbness and tingling gone in limbs. Headache and body aches for remainder of day
A 44 year old male vaccinated at 14:00 on 11/6/01 (do not know which vaccine vial used, but presumed to be same as 11/5). On 11/15/01 recheck revealed primary response along with 4cm area of redness extending down medial arm from vaccine site. Recheck on 11/16/01 revealed only faint redness of medial arm in area previously described, 5-6 erythematous "rays" noted extending from vaccine site in all quadrants. Pt was afebrile and site was not tender. Because of previous 3 cases of presumed cellulitis among 11/5/01 and 11/6/01 vaccinees, the pt was treated with cephalexin as a precaution. Recheck of site on 11/19/01 revealed afebrile pt with no real change in appearance of site. On 11/20/01, e-mail from pt stated that scab had fallen off, "all is looking fine" and no other problems. Clinical dx: probable lymphangitic response to vaccine, r/o early cellulitis.
lient's tongue became swollen within 20 min. of vaccination.  Swelling did not resolve by 4:00pm, client seen at urgent care.  Client treated with Prednisone 60 mg PO x1; client prescribed Benadryl Q 4-6 hrs. x2 days, Prednisone 20 mg PO BID x5 days.  Client developed generalized pruritis and lip tingling approximately 12 hrs. post-vaccination.  Tongue swelling improved but not fully resolved at this writing  (72 hrs. post-vaccination).