chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product temperature excursion issue; expired product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (expired product administered) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (expired product administered). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (expired product administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She stated that her team already knows the recommended temperatures and wanted to know if the vials were still okay to be used because they were administered to 118 patients. Concomitant medications were not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-383410 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-383410:MASTER FILE
1st shot 8/31/2021; left arm; no symptoms except tender arm for about 48 hours. 2nd shot given 8/31/2021 right arm. 9/1/2021 large lymph node, about the size of a clementine orange below my right armpit and beside my right breast; very painful and still present; same size 9/3/2021 @8:46pm.  Lump on right collarbone; very tender to the touch. (Side effects that passed are fever for about 48 hours after the shot , very fatigued, headache, nauseous when I ate and extremely achy body, sore arm at injection site; right arm.) 9/3/2021- COVID Arm (I think) I noticed it this morning as I could not really sleep last night.  My right arm is hot to the touch at the injection site and itches terribly. There is about a 4 inch red, inflamed, area.  It is extremely painful even when not touching it.
Pt reported "fuzzy vision" and feeling weak after the vaccines listed in this report. She also looked clamy and pale. I asked when was the last time she ate something and she stated just recently within the hour. I offered her some orange juice and she also had some orange glucose tablets, so she took a few of those. I offered her water to drink and told her to sit for about 5 or 10 minutes and let me know how she feels after ingesting the glucose from either juice or glucose tablets to make sure we didn't need to send her for further evaluation. Her family then basically carried her out of our store even though I asked them to wait around so we could follow up and see if her condition improves. I tried to call the patient around 7pm to check on her and no answer on cell phone.
It was reported that a 31 year old male received Fluzone SV 98-99 USP on 10/26/1998. Reportedly sometime after the vaccination the pt experienced " swollen arm, erythema, swollen lymph nodes left arm site of injection' From additional information received on 11/23/1998 it was reported that the pt recovered from this experinece.
Swollen - Red - sore left arm. Swelling past the elbow. Patient contacted her provider, who prescribed PREDNISONE 50 mg for 5 day plus ADVIL PM. Getting a bit better. Pt. contacted Pharmacy on 5-24-17 and said that she will verify with her provider. RPh called provider and patient on 5-25-17 to follow up.
Booster; Pain and swelling in armpit.; Pain and swelling in armpit; Injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Dec2021 (Lot number: FD7218) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, brand=Pfizer , Batch/Lot No: EW0167, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03May2021, when the patient was 18 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, brand=Pfizer, Batch/Lot No: EW0153, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 06Apr2021, when the patient was 18 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Dec2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (non-serious) with onset 19Dec2021, outcome "recovering", described as "Pain and swelling in armpit."; PERIPHERAL SWELLING (non-serious) with onset 19Dec2021, outcome "recovering", described as "Pain and swelling in armpit"; VACCINATION SITE PAIN (non-serious) with onset 19Dec2021, outcome "recovering", described as "Injection site pain". Therapeutic measures were not taken as a result of axillary pain, peripheral swelling, vaccination site pain.
TDAP: (L) arm (deltoid) became very painful & non-functional x 3 wks. with associated bruising extending to elbow. Also developed high fever (>103) x 4 days.
itchy; red giant round area the size of a mosquito bite measuring 4 inches long by 3 inches wide; some soreness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red giant round area the size of a mosquito bite measuring 4 inches long by 3 inches wide) and VACCINATION SITE PAIN (some soreness at site of injection) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (some soreness at site of injection). On 18-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red giant round area the size of a mosquito bite measuring 4 inches long by 3 inches wide). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 10-Mar-2021, VACCINATION SITE PAIN (some soreness at site of injection) had resolved. On 20-Mar-2021, VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red giant round area the size of a mosquito bite measuring 4 inches long by 3 inches wide) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
Sustained Rapid heart rate reported by nurse on 11/23 after my son played outside - I picked him up and took him to the ER? he had blood work done and an X-ray? then was transported to a local ER about 45 min away for further evaluation due to elevated cardiac numbers.  Numbers went back down and he was released? awaiting follow up with doc. Note - he had a flu shot on 11/18.
Very high blood pressure. Very high heart rate. Treated with aforementioned medications, and increased BP and HR.
Post vax, the pt developed a very large local reaction. Some numbness. Gradual resolution. No lab work done.
Redness and inflammation down to the elbow. Using Ice/heat combo as treatment. Symptoms resolving slowly over days.
Awful headache within 23 hours of the event followed by eye pain (it hurt to look left & right) for days.  The original headache was in the sinus and forehead area.  At 7 days, the headache shifted to along the occipital nerve, which remains at time plus 16 days.  The patient (myself) has been treating the headaches with OTC anti-inflammatory drugs.  The patient went to the ER at on day 13 and received an IV of Reglan which helped alleviate the headache for approximately 20 hours.  It has since returned and continues to be treated with OTC Motrin - 400mg to 800mg per 4 hours.  The pain persist at a 1/10 to 2/10 even while medicated.
Paresthesia, increased full body weakness. Diagnosed with Guillain-Barre 2 days after his second SHINGRIX vaccine.
Child went to school after appointment, returned home around 3 pm. Took a nap until 5-530 pm. Woke up screaming his thigh hurt, didn't want to walk. Father states was "a little red and little swollen". Ice applied and rest. At bedtime child had no complaints. On 3/21/18 he C/O thigh hurting and was swollen. Took to ER - DECADRON given. Advised to use MOTRIN and ice. As of 1 pm - Father states he's walking and no complaints.
Information has been received from a health professional concerning a 62 year old male with bronchial asthma who on 17-FEB-2007 was vaccinated with PNEUMOVAX 23 (lot# unknown) 0.5mL injection. Concomitant therapy included montelukast sodium (MSD).  On 27-FEB-2007 the patient experienced hypertension.  The reporter felt that hypertension was not related to therapy with PNEUMOVAX 23.  At the time of reporting the patient is recovering.  Additional information is not expected.
Booster; Got a terrible case of shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "Booster"; HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "Got a terrible case of shingles".  The lot number for bnt162b2 was not provided and will be requested during follow up.
I had a back x-ray on 25OCT2022 and an MRI on 18NOV2022 I had physical therapy as well plus a Neurosurgeon, did an exam and scheduled surgery for 19DEC2022 but on 08DEC2022 I had to go in for an emergency surgery due to not being able to void and tremendous pain plus numbness, tingling, and inability to stand or walk. I had a catheter for four days. I was up for thirty minutes to two hours every night to urinate and started taking FLOMAX. On 18FEB2023 I also tested positive for COVID-19. My symptoms were respiratory issues congestion, coughing and in addition, fatigue which lasted a long time.
Patient described a small welt rising shortly after injection. By next day it was bigger, red and warm to the touch. She describes her arm as feeling tired and heavy. She reports tenderness in the area of her shoulder/clavical - lymph node? Reports no fever, no problems breathing, no rash on other areas of body.
Sudden pain shooting down my right leg in the middle of the night around 4 am. Lasted all day and symptoms were improved with Advil
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 23-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had four  temperature excursions: 336, 1172, 80, and 152 hours respectively. The lowest recorded temperature was 30 (-1.111111111 Celsius degrees) and -3 (-3 Celsius degrees). The highest recorded temperatures were 47 (8.333333333 Celsius degrees) and 59 (15 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 2 hours after vaccination, patient went to lunch and noted her face was numb, and could not feel when she chewed. Denies shortness of breath, chest pain, wheezing, or rash
Skin rash, rash, urticaria, pruritus and red, bumpy, itchy rash across top of chest. Triamcinolone, hydroxyzine, triamcinolone.
Pt recv vax on 10/27/98; 8 hr post vax pt exp fussiness & unconsolable
Tinnitus started within 6 days post vaccine and has persisted 24x7 with some intermittent worsening. Has impacted on my work (I'm a nurse practitioner/therapist, and personal daily life. Never had any symptoms prior to this.
The patient became acutely short of breath and was unable to speak momentarily. She was waiting the requisite 15 minutes and once we evaluated her she was administered an Epi-pen immediately. In a few minutes, her breathing returned to her baseline and she was able to speak in full sentences. Clinically, her BP was stable and she was not tachycardia. Pulses were strong.  Also, given 25 mg Benadryl at the time. She
Began with HA 30 mins. after vaccine, By 10:00 pm N/V-Hives at that time, Pruritis felt fever, Begin Recovery 12:30 to 1:00 AM
Vial was refrigerated on 30-Jun-2022 and was administered to the patient on 01-Aug-2022; No adverse event; Patient administered vaccine beyond its use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vial was refrigerated on 30-Jun-2022 and was administered to the patient on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was refrigerated on 30-Jun-2022 and was administered to the patient on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vial was refrigerated on 30-Jun-2022 and was administered to the patient on 01-Aug-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.) and PRODUCT STORAGE ERROR (Vial was refrigerated on 30-Jun-2022 and was administered to the patient on 01-Aug-2022).    No concomitant medications information was reported. On 30-Jun-2022, the vial was initially stored in refrigerator and vial did not undergo any temperature excursions. No treatment medications information was reported.
This spontaneous report as received from a 26 year old female lab technician refers to herself with no medical history. Between the end of October 2013 and the beginning of November 2013, the patient was vaccinated with a dose of GARDASIL (route, dose, lot # and indication not reported) in the left arm. She reported that she developed a sore left arm the day after vaccination with GARDASIL and it lasted about 1 month then recovered. The patient did not seek medical attention and no treatment was given. Additional information has been requested.
Arm a little bit swollen at the injection site; red mark at the injection site; She believes she started to run a fever; chills; tired; Excruciating joint pain even on her fingernails; Body pains; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm a little bit swollen at the injection site), VACCINATION SITE ERYTHEMA (red mark at the injection site), ARTHRALGIA (Excruciating joint pain even on her fingernails), MYALGIA (Body pains) and PYREXIA (She believes she started to run a fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for Angina pectoris, VITAMINS NOS for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ARTHRALGIA (Excruciating joint pain even on her fingernails), MYALGIA (Body pains), CHILLS (chills) and FATIGUE (tired). On 05-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Arm a little bit swollen at the injection site), VACCINATION SITE ERYTHEMA (red mark at the injection site) and PYREXIA (She believes she started to run a fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, CHILLS (chills) had resolved. On 06-Mar-2021, VACCINATION SITE SWELLING (Arm a little bit swollen at the injection site), ARTHRALGIA (Excruciating joint pain even on her fingernails), MYALGIA (Body pains) and PYREXIA (She believes she started to run a fever) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red mark at the injection site) and FATIGUE (tired) outcome was unknown.            Action taken with mRNA-1273 in response to the events were Not Applicable.   This case was linked to MOD-2021-230178 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received on 23-jun-2021 no new information was updated.
Headache; Nausea; Muscle pain; Muscle spasms; Cramps; Fever; Hot and cold chills; Shortness of breath; Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161) via an unspecified route of administration in the right arm on 14Apr2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 22:00, the patient experienced headache, nausea, muscle pain, muscle spasms, cramps, fever, hot and cold chills, shortness of breath and difficulty breathing. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, muscle pain, muscle spasms, cramps, fever, hot and cold chills, shortness of breath and difficulty breathing were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Muscular Fatigue Headache Fever  Chills Pain in the arm and armpit where the vaccine was applied (it's a constant pain)  Itching
pt recvd vax;devel urticaria on 11jul95;it was noted that pt had similar rxn in the past to MMR;md felt that cause of urticaria was the neomycin component of both vax;
This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 19-year-old male patient who received ENGERIX B pediatric. Co-suspect products included ENGERIX B pediatric and ENGERIX B pediatric. On an unknown date, the patient received 1st dose of ENGERIX B pediatric .5 ml, the 2nd dose of ENGERIX B pediatric .5 ml and the 3rd dose of ENGERIX B pediatric .5 ml. On an unknown date, an unknown time after receiving ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B pediatric, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B pediatric. Additional detail were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient was studying in college and had previously received all 3 pediatric doses of ENGERIX B. The patient underwent laboratory tests and found that he did not have any antibodies against hepatitis B antigen. Thus, leading the patient to be a therapy non-responder. No side effects were reported.
Weight loss; Weakness; Things didn't taste right; Fever; Vomiting; Fatigue; Muscle aches; Nausea; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 01-Jun-2020 to 21-Jun-2020.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature: 99.3-100 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2021: Non Significant information was received.Upon internal review, change the outcome of the events from unknown to recovered.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded