chrisvoncsefalvay/vaers-outcomes huggingface dataset:
knot/swelling/swollen lymph node above the L clavicle; Left arm hurt; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Left arm hurt) and LYMPHADENOPATHY (knot/swelling/swollen lymph node above the L clavicle) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20(?)) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (Left arm hurt). On 11-Jan-2021, the patient experienced LYMPHADENOPATHY (knot/swelling/swollen lymph node above the L clavicle). On 02-Jan-2021, VACCINATION SITE PAIN (Left arm hurt) had resolved. At the time of the report, LYMPHADENOPATHY (knot/swelling/swollen lymph node above the L clavicle) outcome was unknown.        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.; 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.
Itchy rash; Red rash all over the body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash all over the body) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash all over the body). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash all over the body) outcome was unknown. Unknown          Treatment included Tylenol and Benadryl
Student reported to school nurse that he started with a painful lump approx 2.5 inches in size anterior axillary, starting approx 12 hrs after receiving MENACTRA vaccine. He states discomfort on raising arm, but no fever or redness. SNT examined but did not feel a nose, just edema. SNT spoke with school MD and suggested parents watch for developing redness or fever, and if this develops over the weekend, or the lump or pain increases then he should be seen by his PCP. SNT relayed message to dad. Symptoms lessened and as of 11/14, 1 week s/p vaccination, the SNT reported to me that he has improved, with swelling and pain just about gone.
5 minutes later, tingling in chin, very dry mouth, felt like couldn't swallow, tingling on right side of face and scalp.  Took 2 benadryl (provided by pharmacist), at ER (Hospital) given 2 prednisone tablets and famotidine.  Filled prescriptions for same.  Less severe symptoms continued to recur. On Tuesday, July 6, at an appointment with my GP, Dr., I was given a shot of steroids.  The hope is that the symptoms will stop.
Rapid onset of nausea. I felt like I was going to vomit. Upon standing, I experienced moderate dizziness (6 on scale of 10) and a tingling sensation in my face. Tingling lasted about 20 seconds. Dizziness lasted about 2 minutes. As I was walking to place to lie down, my hearing became subtly muffled as though someone was stuffing cotton into my ears; lasted only 2-3 minutes. Six hours later, I'm still feeling a little nauseated with very mild body aches. I'm assuming this will pass in the next 24 hours because the CDC website warns of possible side effects lasting 1-2 days.
Kinrix given to a 16 month old patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2022, the patient received Kinrix .5 ml and Kinrix Pre-Filled Syringe Device. On 9th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comment: The nurse reported that the 16th month old patient inadvertently received dose of kinrix vaccine. The vaccine administration facility was same as the primary reporter. Additional supportive information: A 16th month old patient inadvertently received dose of kinrix vaccine, which led to Inappropriate age at vaccine administration. The reporter consented to follow-up.
Intake note 3-21-17: Right leg, red and swollen, warm to touch. OV notes 3-21-17: 12 mo old with "red spot on leg" x1 day.   At site for MMR vaccine 8 days ago.  Earlier today was "more bumpy".  No fevers, good appetite, drinking well, slightly fussy (his baseline), cutting teeth.  Starting new foods- pasta, milk, eggs. Mom cautious of abx - sister with c diff. Hx not straightforward for local injection reaction- delayed, ? cellulitis from injection - will start Keflex. Mom to monitor closely. mom wants to limit abx.  Reassess at 5 days by phone. Pt Plan: Please start antibiotic as directed.  Please use cool compress at least 5 times per day. Recommend trial of Benadryl as well 3 milliliters by mouth every 6-8 hours as needed for swelling.  Medication can make sleepy. Phone call on 3-24-17 at 11:00 am: Mom R/C & said the redness & swelling is going down but still present. Concerned w/ loose stools, had 3 dirty diapers yesterday. To try adding yogurt to diet. ABX, diarrhea & yogurt teaching done. Mom stated understanding.
pain in injection site during administration; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in injection site during administration) and MYALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 036A21A) for an unknown indication.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site during administration) and MYALGIA (sore arm). On 12-Apr-2021, VACCINATION SITE PAIN (pain in injection site during administration) had resolved. At the time of the report, MYALGIA (sore arm) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.
Within 12 hours of receiving the second dose I started with severe joint pain, intolerance to cold and increased pre-existing tinnitus.
ON 10/1/22 WOKE UP TO NOT FEELING WELL. SLEPT ALL DAY. THEN WOKE UP ON 10/2/22 AND MY EYES WERE SWELLED SHUT AND HAD HIVES ALL OVER MY BODY. 4 DAYS LATER AND STILL HAVING HIVES AND EYES ARE STILL SWELLED.
Pt received ZOSTAVAX at local pharmacy & developed red, swollen & hot area at injection site with 3 blisters.
Febrile, GI upset including diarrhea, Malaise, Muscle aches, joint aches.
Patient reported stating feeling nauseous to observation nurse , LVN at 0910 AM. Patient had an emesis episode X1. Vital signs included T 96.2, B/P 124/85, HR 87, RR 18, and o2 98 at 0910 AM. Observation nurse notified supervisor on site on patient status at 0912 AM. Second set of vital signs taken at 0920 AM included T 96.5, B/P 135/92, HR 80, RR 20, and o2 97. Patient stated having no history of chronic illnesses. Currently patient does not display any s/s of distress/discomfort. MD notified via telephone by the supervisor on site as per ordered cleared to leave observation area. Patient instructed to contact HCP/and or go to ER if presents s/s of distress or worsen.
pt recv vax;diffuse hives,facial edema & flushing;given dph,solumedrol;tx w/ prelone; to er w/ hives & facial edema;
cold sweats and nausea in the evening, then at 3am woke up to go to the bathroom, blacked out and hit his head. then very confused and disoriented. Ambulance came and took him to the hospital.
Chills, headache, fatigue for going on day three.  Huge swollen area under left armpit (apparently swollen lymph node), about the size of an egg.  Very painful as well.  I doubt this had anything to do with my reaction but the tech was rushed, way behind schedule, and the shots hurt worse than I have ever experienced before.  Usually I do not even feel them.
Heart palpitation; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitation) and DYSPNOEA (Shortness of breath) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PALPITATIONS (Heart palpitation) and DYSPNOEA (Shortness of breath). On 09-Jan-2021, PALPITATIONS (Heart palpitation) and DYSPNOEA (Shortness of breath) had resolved.        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.   Patient took no medications for treatment nor called any health care provider. No laboratory test was reported.  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. Further information has been requested; 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. Further information has been requested
Information has been received from a registered nurse (RN) concerning a 16 week old patient who was vaccinated PO with the first dose of Rotateq. It was unknown if medical attention was sought. No adverse event was reported. No further information is available.
Induration, redness, malaise, total body itching, pain in armpit, enlarged axillary lymph nodes, fever from 15 min after shot and ongoing.
Yesterday she slept for 36 hours; her head was just killing her; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-years-old female patient received bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Left on 11Jun2021 15:40 (Batch/Lot Number: EW0191; Expiration Date: 30Sep2021) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation at clinic (61-years-old at the time of vaccination). The patient medical history concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of bnt162b2 for covid-19 immunisation. It was reported that, she had her second Pfizer shot on Friday(11Jun2021) and at night she had such a bad headache, yesterday (12Jun2021) she slept for 36 hours and her head was just killing her. She did not knew was that normal or not. Consumer was informed about the Pfizer medical information department. The clinical outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Bell's Palsy; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's Palsy.  The patient's medical history was not provided. Relevant concomitant medications were not reported.   The patient received the first dose of the Moderna COVID-19 vaccine (Batch number not provided) on 05 Jan 2021 in left arm for prophylaxis of COVID-19 infection  On 02 Feb 2021, prior to the onset of event, the patient received their second dose of mRNA-1273 (lot/batch: 028L20A) intramuscularly in left arm for COVID-19 infection.  On 26 Feb 2021, the patient experienced Bell's Palsy which was considered as medically significant event.  Laboratory details was not provided.   Treatment information was provided as Valacyclovir HCl, Methylprednisolone and Bupropion, vitamin D, biotin.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event Bell's Palsy was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
FEELING DIZZY AND WOOZY BY THE DAY; CHILLS; SORE ARM; BODILY WEAKNESS; BAD HEADACHE ON SOME PARTS OF HEAD; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient has not had any vaccines in a very long time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 30-AUG-2020, Laboratory data included: PCR (NR: not provided) Negative.  On 09-APR-2021, the subject experienced feeling dizzy and woozy by the day. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced bodily weakness. On 09-APR-2021, the subject experienced bad headache on some parts of head. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, bad headache on some parts of head, bodily weakness, sore arm, and feeling dizzy and woozy by the day. This report was non-serious.
12.10.20 Arm began to have soreness,. On 12.16.20,  he had seen a doctor about having a colonoscopy, ate lunch , around 5pm same day, his speech began to slur. He started acting different by taking a  top to put on a coffee cup. He was able to answer, but was still acting out of it.  He began to act as if he was doing dishes, but nothing was in his hands. He went to sit down on the couch and then laid his head back on the couch, and started slurring again.  I called 911 for him. Ambulance  came and stated that patient could of had a UTI.  We could not go to the hospitals due to the high risks of Covid. He went to  Hospital, stayed from Wednesday to Friday afternoon.  Unable to see a doctor. He can not drive a car, he has to just lay around and rest.
This spontaneous report was received from a registered nurse (who was also an immunization official) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced an unspecified temperature excursion. It was not reported whether a data logger was involved or if there were previous temperature excursions. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014586:
Pain in Rt. arm this was arm flu shot was given in...We suggested that he elevate arm.....took tylenol.
Memory loss, joint pain, extreme fatigue, vision difficulty. Treatment for Lyme started 7/26/02, MD treatment for symptoms prior were varied.
Initial and follow-up information has been received from a 25 year old female consumer with allergy to PERCOCET, for the Pregnancy Registry for GARDASIL, who on 08-NOV-2007 was vaccinated with the first 0.5 ml dose of GARDASIL. On 08-JAN-2008 the patient was vaccinated with the second dose of GARDASIL. As of 25-FEB-2008, the patient reported that she was 10 weeks pregnant. The patient reported in follow-up that on 16-SEP-2008 she delivered a healthy 8 pounds 13 ounces boy. The baby had a complete unilateral cleft lip and palate, which was diagnosed prenatally on ultrasound. The patient reported that she was prepared for this finding and she had already scheduled follow-up for the baby for surgery (dates not provided). The patient reported that both she and the baby were doing well, no problems for herself. Additional information has been requested.
pt recvd measles vax on 13AUG92; approx 12 days p/vax pt devel an elevated temp to 101.4 w/muscle stiffness, photophobia & nausea; had no cough coryza, conjunctivitis or rash;
Fever, flu-like aches, diarrhea, chills, fatigue, nausea
The pt developed a high fever that did not require treatment. Her dad says that the child's fever was 106F on the evening the shots were given. She was taken to the ER and Motrin was given.
Additional dose for immunocompromised patient given at 19 day interval instead of recommended 28 day interval, deeming the dose invalid.
arm is still in a lot of pain; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (arm is still in a lot of pain) in a patient of an unknown age and gender 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 MYALGIA (arm is still in a lot of pain). At the time of the report, MYALGIA (arm is still in a lot of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Patient did not have an adverse event, but his booster dose was administered 2 months early (3 months after he received his 2nd covid 19 vaccine)
No adverse event; Dose 1 Date Administered was July 2022 and Dose 2 Date Administered was 12Sep2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Date Administered was July 2022 and Dose 2 Date Administered was 12Sep2022) and NO ADVERSE EVENT (No adverse event) in a 5-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 vaccination.     No Medical History information was reported.   In July 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Date Administered was July 2022 and Dose 2 Date Administered was 12Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Date Administered was July 2022 and Dose 2 Date Administered was 12Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Date Administered was July 2022 and Dose 2 Date Administered was 12Sep2022).    No Concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2022-644904 (Patient Link).
Moderately dizzy so had to lie down for half an hour or 45 minutes before it let up enough to drive. Dizziness persisted for a week, lessening each day; Mild nausea with it; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO151) via an unspecified route of administration in the left arm on 09Apr2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, arthritis, osteoporosis, gluten intolerance and known allergies to some fruits and cow dairy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ursodeoxycholic acid (URSODIOL), pancreatin (CREON) and levothyroxine sodium (LEVOTHYROXIN), all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 10:00, the patient experienced moderately dizzy so had to lie down for half an hour or 45 minutes before it let up enough to drive and experienced mild nausea with it. Dizziness persisted for a week and was lessening each day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with self prescribed meclizine (MECLOZINE) for 2 days. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy was resolved on 16Apr2021 and nausea was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.