chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was also red; my arm is red again where I received the shot; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (arm was also red) and INJECTION SITE ERYTHEMA (my arm is red again where I received the shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 08-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (my arm is red again where I received the shot). On an unknown date, the patient experienced ERYTHEMA (arm was also red). On 29-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, ERYTHEMA (arm was also red) had resolved and INJECTION SITE ERYTHEMA (my arm is red again where I received the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided. Treatment information was not provided.
Patient stated she had a "fever, bad rash, and pain from her shoulder to her elbow".  Her fever is now gone but she continues to have some pain and a rash.  She contacted her dr and was put an zithromax and prednisone.
Vaccine was administered beyond the beyond use date. Patient was monitored with proper follow up. No abnormal side effects or adverse reactions were present.
Pt was given Pfizer booster dose 9 days before the recommended CDC guideline date.  Patient due for booster dose on 2/4/22.
Had a very bad headache mostly front of head (eyes and forehead area); Slight discomfort in the abdominal area; Slight discomfort in the abdominal area and lower back; Had a mild fever; Had a mild fever with chills / chills again / continued having chills; Would feel very hot and start sweating / feeling hot seconds after; Would feel very hot and start sweating; Felt pain in the injection site (left arm); Felt pain in the injection site (left arm) with limited mobility in the arm; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 06May2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. 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 medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 23:00, after the second dose of Pfizer, on the same night after vaccination, the patient experienced mild fever with chills all over and seconds later she felt very hot, started sweating and then got the chills again. She also felt pain in the injection site (left arm) with limited mobility in the arm. On 07May2021, in the morning, she had a very bad headache, mostly front of her head (eyes and forehead area) and continued having chills and felt hot seconds after. She also felt slight discomfort in the abdominal area and lower back. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild fever with chills all over / chills again / continued having chills, would feel very hot and started sweating / feeling hot, felt pain in the injection site (left arm) with limited mobility in the arm, very bad headache mostly front of head (eyes and forehead area) and slight discomfort in the abdominal area and lower back was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Initial unsolicited case received from a physician on 04-AUG-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of ADACEL (batch number was unknown) instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (batch number not reported) (expiry date, dose, dose in series, route and side of administration was not reported for all vaccines) in the arm on an unknown day in early JUN-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had swelling and redness from the shoulder to the elbow of her arm with induration at injection site. The patient required a visit to the doctor. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. Laboratory investigations and corrective treatment were not reported. On an unknown date, the patient was recovered from all the events (reported as symptoms had all resolved). 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 erroris 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. List of documents held by sender: none.
4 doses of the Moderna COVID-19 vaccine administered after the refrigerated 30-day Use By Date; 4 doses of the Moderna COVID-19 vaccine administered after the refrigerated 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna COVID-19 vaccine administered after the refrigerated 30-day Use By Date) and PRODUCT STORAGE ERROR (4 doses of the Moderna COVID-19 vaccine administered after the refrigerated 30-day Use By Date) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna COVID-19 vaccine administered after the refrigerated 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (4 doses of the Moderna COVID-19 vaccine administered after the refrigerated 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna COVID-19 vaccine administered after the refrigerated 30-day Use By Date) and PRODUCT STORAGE ERROR (4 doses of the Moderna COVID-19 vaccine administered after the refrigerated 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patients did not had any acute or chronic illnesses. The patients had no allergies and had not tested positive for COVID-19. The patients was not taking any concomitant medication.  The patients did not received any other vaccine within 1 month prior to Moderna and at the time of the vaccination. The 1 vial of batch number 058H21A was initially stored in the refrigerator on 18-Jan-2022. The vial did not undergo any temperature excursions. They administered 4 patients in their deltoid muscle, the Moderna COVID-19 Booster dose 0.25ml on the 25-Feb-2022 after the refrigerated 30-day Use By Date policy. The patients was not experiencing any symptoms.  No treatment medication given.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2022: Non-significant follow-up includes reporters email address details.
Is this vaccine safe to receive while breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Is this vaccine safe to receive while breastfeeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Is this vaccine safe to receive while breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Is this vaccine safe to receive while breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a patient who received BOOSTRIX. Co-suspect products included BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose and BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX and not applicable after receiving BOOSTRIX, the patient experienced allergic reaction, extra dose administered and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the allergic reaction, extra dose administered and circumstance of information capable of leading to medication error were unknown. It was unknown if the reporter considered the allergic reaction to be related to BOOSTRIX. Additional details were provided as follows: The healthcare professional stated that the patient with an allergy to horse serum had an allergic reaction, extra dose administered and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the allergic reaction, extra dose administered and circumstance or information capable of leading to medication error were unknown. It was unknown if the reporter considered the allergic reaction to be related to BOOSTRIX. Additional details were provided as follows: The healthcare professional stated that the patient with an allergy to horse serum had an allergic reaction to BOOSTRIX several years ago. The age at vaccination was not reported. The patient would like to receive BOOSTRIX but was concerned about horse serum content, this was the circumstance of information capable of leading to medication error of extra dose administered. No patient data or vaccine information was available. No specific details about the allergy were given.
Patient fainted within 5 minutes  after injection. Patient experienced a syncope event passed out. Patient regain conscious within a minute. Patient may have injure her head upon falling.
Headache; Fever; Body Aches; 1st dose of the vaccine 19Mar2021, no 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), MYALGIA (Body Aches) and PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine 19Mar2021, no 2nd dose yet) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine 19Mar2021, no 2nd dose yet). On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Body Aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 UNK. On 26-Jul-2021, PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine 19Mar2021, no 2nd dose yet) had resolved. At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Updated events.
Vaccine (Varicella) received 1-30-14 early afternoon. By 6:30 pm on same day client noted "quarter to fifty-cent" sized circles with dark edges on abd, chest, sides of body, and back. Referred to PCP or Urgent Care.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 14-MAY-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # 0384AE, expiry date 02-NOV-2014), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Facial muscle spasm; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 21Jul2021 at 14:15 (at the age of 17-year-old) as a single dose and the  second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fa6780) via an unspecified route of administration in the left arm on an unspecified date in 2021 as a single dose for COVID-19 immunisation. Medical history included asthma, seasonal allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included levocetirizine dihydrochloride (XYZALL) and multivitamins (MANUFACTURER UNKNOWN) for unknown indications, started from unknown dates and unknown if ongoing. The patient was allergic to shellfish, ragweed and mold. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jul2021 at 21:00, the patient experienced facial muscle spasm. It was unknown whether any therapeutic measures were taken as a result of the event facial muscle spasm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event facial muscle spasm was unknown at the time of this report.
Patient received the Pfizer Covid Vaccine today.  As patient was returning to her chair from getting the immunization, patient began to turn white and feel faint. She alerted me to the situation as she was coming into the pharmacy after administering the vaccine to the patient.  The patient told her dad she thought she was about to pass out. As I was approaching the scene, the patient's body went limp and color drained from her skin.  The dad had his daughter and together we gently laid her on the floor.  The patient was still breathing.  The dad and I both starting trying to get the patient's attention.  She started blinking her eyes. All the while, I monitored her breathing (watching her chest rise and fall, as well as listening for breaths, and feeling for her pulse). I applied cold compresses to patient head and neck. As she was coming to, I found out she had not eaten anything today.  We got the patient a water and a small bag of popcorn from the pharmacy. After sitting up on the floor for a moment, patient wanted to get in the chair.  Dad and I moved patient to the chair.  Patient was coherent and answering appropriate questions, and stated she wanted to try a soda and something to eat. He got the patient a Sprite and a protein bar. Patient sipped on the Sprite and took two bites of protein bar.  Then patient started turning pale and going limp.  Dad and I moved patient back to lying down, and this time I had him bring the CPR air mattress out for patient to somewhat lay on.  I continued to monitor breathing, and although breathing was shallow, patient never stopped breathing, blinking her eyes, or answering questions...as this was the only way we told patient we would not call 911. Patient's blood pressure remained steady at 86/57 with a pulse of 72. I continued to monitor patient for another 10-15 minutes before trying to sit patient up again. Once patient was upright, she sipped the sprite some more and kept ice packs. After another 10 minutes, patient said she felt ok and wanted to go home. Dad and I told her she would have to continue to talk with her dad all the way home to be sure she was staying coherent. He retrieved a wheelchair from the front of the club and the patient's brother pushed her to the front of the store with dad.   As a side note, dad did tell me that patient has had these fainting spells previously and been to the ER for them. They had told him as long she was breathing and talking with eyes open, no need to come to ER.
Not able to walk; Knees very weak; Knees very swollen; Swollen in the legs; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Not able to walk), ASTHENIA (Knees very weak), JOINT SWELLING (Knees very swollen) and PERIPHERAL SWELLING (Swollen in the legs) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Heart disease, unspecified, Overweight, Osteoporosis and Arthritis.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced GAIT DISTURBANCE (Not able to walk), ASTHENIA (Knees very weak), JOINT SWELLING (Knees very swollen) and PERIPHERAL SWELLING (Swollen in the legs). At the time of the report, GAIT DISTURBANCE (Not able to walk), ASTHENIA (Knees very weak), JOINT SWELLING (Knees very swollen) and PERIPHERAL SWELLING (Swollen in the legs) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event , included blood pressure medications and heart medications.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-059390 (E2B Linked Report).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product. US-MODERNATX, INC.-MOD-2021-059390:
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL. Subsequently, following the second vaccination, the patient experienced irregular periods. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Patient has second Pfizer covid vaccine on 4/12/21, patient had chemotherapy treatment infuse through L portacath on 4/14/21. Patient called office with complaints of arm pain on 4/26/21. Ultrasound on 4/26 was read as: partial, nonocclusive thrombus within superficial left cephalic vein at the antecubital, midportion. Patient was initiated on oral anticoagulation therapy
Information has been received from a health professional concerning a 66 year old female physician with no allergies or medical history on 10-NOV-2006 was vaccinated IM in the left deltoid with an 0.65 ml dose of Zostavax (lot # 652936/0981F). Concomitant therapy included ULTRAM. Twenty-four hours later, on 11-NOV-2006, the patient developed a fever of 101 degrees. Her left arm and deltoid injection site injection site became red, swollen, and hot to the touch. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. The patient recovered on 12-NOV-2006. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Initial information has been received from a medical assistant concerning a 66 year old female physician with no allergies or medical history who on 10-NOV-2006 was vaccinated SC (previously reported as IM) in the right (previously reported as left) deltoid with an 0.65 ml dose of ZOSTAVAX (lot # 652936/0981F). Additional information received from the physician indicated that the reaction was a reaction to the influenza virus vaccine (unspecified) (manufacturer unknown) (lot # 71829) and not ZOSTAVAX (Merck) (lot # 652936/0981F). No further information was reported. Additional information is not expected.
covid injection #1 on 12/23/20. 5 days later on 12/28/2021 woke up with nausea and diarrhea. Had vasovagal symptoms of lightheaded, blurred vision, hearing changes, and weakness of legs while standing. was in healthcare setting working at the time. Initial vitals 87/60, drank apple juice and rested, BP came up 15 min later to 100/75. At approx. 7pm on 12/28/2020 developed chills which turned into sweats with myalgia's and arthralgia's, took 1g Tylenol, at 9pm fever still 101.7*F. Fever lasted approx 8 hours. Nausea resolved. Diarrhea lasted about 36 hours.
Rash over body that gets worse with heat. Rash started about 5 days after vaccine and has never went away. The spots look like targets on legs, arms, panty lines.
pt recvd vax; devel 5-6 spots 7 days p/ inject;F/U:26sep95 devel chicken pox lesions;
Menstrual cycle irregularities after the second vaccine dose; This is a spontaneous report from a contactable consumer (patient) via company representative. A patient of unspecified age and gender received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included tozinameran taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection), first dose via on an unspecified date as single dose for covid-19 immunisation and no reaction on previous exposure to drug. On an unspecified date, the patient experienced menstrual cycle irregularities after the second vaccine dose. The outcome of the event was unknown.  Information on Lot/Batch information has been requested. .
Reports that on 12/3/09 at 1130 she received both the H1N1 and PNEUMOVAX 23 in her right upper arm. When the pt left the clinic after waiting 15 min she noted redness that extended beyond the Band-Aid which she reported to the nurse and was instructed to apply warm moist heat. The pt denied rash, itching, SOB, difficulty breathing/swallowing or angioedema. When the pt arrived home she applied heat and took MOTRIN. By 2200 the pt noted that her upper right arm was painful (3-4/10). There were several (3-4) 2-3 cm red, raised, slightly itchy lesions that covered an area of about 12cm by 6cm. Pt denied generalized urticaria, angioedema, difficulty breathing/swallowing, abd pain or diarrhea. The pt took BENADRYL and MOTRIN. In the am of 12/4/09 the upper right arm had 3-4 distinct areas of redness which were not raised or pruritic. The pain had subsided. The pt took 2 more doses of BENADRYL that day. The next am the lesion were gone.