chrisvoncsefalvay/vaers-outcomes huggingface dataset:
could not sleep; headache; Nausea; felt sick to stomach for 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (felt sick to stomach for 36 hours), INSOMNIA (could not sleep), HEADACHE (headache) and NAUSEA (Nausea) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine since 01-Jan-2013, Penicillin allergy, Glaucoma since 01-Jan-2013 and Thyroid activity decreased since 01-Jan-2021. Concomitant products included RIZATRIPTAN BENZOATE (MAXALT) for Migraine headache, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Thyroid activity decreased.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (felt sick to stomach for 36 hours), HEADACHE (headache) and NAUSEA (Nausea). On 06-Feb-2021, the patient experienced INSOMNIA (could not sleep). The patient was treated with LATANOPROST, TIMOLOL MALEATE (LATANAPROST/TIMOLOL) on 01-Jan-2013 for Glaucoma, at a dose of .005 % once a day; PARACETAMOL (TYLENOL) at a dose of 1 dosage form; ACETYLSALICYLIC ACID (ASPRIN) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form; KETOROLAC TROMETHAMINE (TORADOL) at a dose of 1 dosage form and METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]) at a dose of 1 dosage form. On 07-Feb-2021, ABDOMINAL PAIN UPPER (felt sick to stomach for 36 hours), INSOMNIA (could not sleep), HEADACHE (headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: The follow up information received contain significant information: outcome of events changed from unknown to recovered and resolved, other relevant history added , treatment medications and concomitant medications added.
Patient called with redness and pain with moving arm.  Patient seen by physician.  left shoulder pain, swelling subsequent to Pneumococcal 23 immunization 1/17/2020   She has stiffness, pain, difficulty getting dressed. No generalized rash, no swelling lips, face, tongue, or mouth.  She is worse from 3 days ago.
4/19/21 dyspnea on exertion, leg pain. 4/26 private MD. PE normal. 5/3 Emergency Department.  BP 168/111. RR 16. o2 Saturation 96% L leg swollen. dDagnosis: Acute pulmonary embolism without acute cor pulmonale. RX: rivaroxaban
Given on 2/9/10, on 2/10/10 in pm mom noticed 1/2" hard welt 2" long -(redness) 2/12/10 recheck on child. Looks much better, redness going away.
07/22/03: Temperature: 102, pain, erythema, swelling, increased axillary lymph nodes, warm to touch at site, headache.  07/25/03: Erythema 15x14cm, mild induration, tender axilla lymph nodes left arm.
pain at the injection site with both doses; swelling at the injection site with both doses; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hip surgery (had hip surgery in January 2020). Concurrent medical conditions included degenerative joint disease.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with degenerative hip disease in September 2019. The reporter stated that, after vaccination with 1st dose of Shingrix, the patient experienced pain and swelling at the injection site. The reporter consented to follow up. This was 1 of 2 linked cases, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR213732:Same reporter
Pt came to pharmacy states she woke up today with rash on the body (trunk). Consult pt to take 2 BENADRYL and contact or seek medical attention if worsen. Pt called back 4 hours later. State rash & itch worsen and body in pain. I ask pt to go to emergency room for medical attention.
Almost 48 hours after the vaccine I woke up with hives flush to my skin along my R&L arms, under my arms, on my left hand, insides of both thighs, and around my ankles. My skin felt hot but minimally itchy. The insides of my hands and burn when I wash them and they feel really sore. The bottoms of my feet also felt like they were burning when I took a shower. Nothing in my diet or hygiene products have changes. I took a half dose of Benadryl at 11am today and the hives are still there along with the pain in my hands when washing them. I coordinated with my PCP and they recommended self monitoring and Benadryl.
Patient's mom made an appointment today.  Patient has 2 3/4inch x 1 mm wide area of red/black-dry.  Mom said discharge was present a few days ago.
Dose of Moderna vaccine leaked at of syringe onto patients arm; Unable to determine amount leaked; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Dose of Moderna vaccine leaked at of syringe onto patients arm) and UNDERDOSE (Unable to determine amount leaked) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 040B21A) for COVID-19 vaccination.     The patient's past medical history included Vitamin D deficiency and Splenomegaly. Concurrent medical conditions included Hyperlipidemia. Concomitant products included ATORVASTATIN from 06-Jan-2021 to an unknown date for High cholesterol, OMEPRAZOLE from 06-Jan-2021 to an unknown date for Indigestion, VITAMIN D3 from 06-Jan-2021 to an unknown date for Vitamin D deficiency.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 13-May-2021, the patient experienced DEVICE CONNECTION ISSUE (Dose of Moderna vaccine leaked at of syringe onto patients arm) and UNDERDOSE (Unable to determine amount leaked). On 13-May-2021, DEVICE CONNECTION ISSUE (Dose of Moderna vaccine leaked at of syringe onto patients arm) and UNDERDOSE (Unable to determine amount leaked) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 16 Apr 2021,patient received first dose and there were no side effects. On 13 May 2021,received second dose and during vaccination needle became detached from syringe and unknown amount of drug dripped on to patient's arm.  Action taken with mRNA-1273 in response to the events was not applicable. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: non significant follow up document added
pt recv vax 7JUL98 & child had a sz on 14JUL98 just 7 days p/vax;had a temp around 101 that quickly went to 105;seen in ER;
This infant had vaccine, 5 hours after vaccination she had hives, and facial swelling. The patient had to be seen again. She improved with Benadryl.
Patient experienced slight tingling in the fingers approximately 1 minute after the injection. The tingling lessened over time but has not completely gone away after 24+ hours.
"COVID Arm" - large red rash on arm. Hot to touch, not raised or bumpy. 8 days after injection, lasted 2.5 weeks
Pt. woke on 9-17-12 with a red rash over body. No pain, fever or swelling. Dr. prescribed BENADRYL.
Burning sensation in feet 1 week after second dose of Moderna vaccine. As of 8/20/21, has pins and needles sensation in fingers, along with burning sensation in feet and pins and needles sensation in toes
DTP/OPV/HIB/HBV were given 29OCT92 2PM pt found dead 30OCT92 approx 9AM of apparent crib death;
Wednesday had bumps on feet, hands, & face; gums became sore; On Saturday top part of body began hurting-sensitive to touch or clothing; some itching all over on Friday; bumps gone on Monday; gums better; no c/o tiredness; poss temp;
Arm was red again; arm was hot as fire and incredibly itchy; arm was hot as fire and incredibly itchy; Redness; Bruise at injection site; Swelling (arm); This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Redness), CONTUSION (Bruise at injection site), PERIPHERAL SWELLING (Swelling (arm)), VACCINATION SITE ERYTHEMA (Arm was red again) and SKIN WARM (arm was hot as fire and incredibly itchy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced ERYTHEMA (Redness), CONTUSION (Bruise at injection site) and PERIPHERAL SWELLING (Swelling (arm)). On 24-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm was red again), SKIN WARM (arm was hot as fire and incredibly itchy) and URTICARIA (arm was hot as fire and incredibly itchy). On 20-Jan-2021, ERYTHEMA (Redness) had not resolved, PERIPHERAL SWELLING (Swelling (arm)) had resolved. At the time of the report, CONTUSION (Bruise at injection site), VACCINATION SITE ERYTHEMA (Arm was red again), SKIN WARM (arm was hot as fire and incredibly itchy) and URTICARIA (arm was hot as fire and incredibly itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Benadryl. No concomitant medication were provided by reporter.   Reporter did not allow further contact
Patient sustained area of erythema that began as dime shaped and increased to circular swelling of 2.5 inches in diameter with associated tenderness.
Pt stated he was 18 years old upon arrival.  Pt and his father requested J&J single dose vaccine for him.  Consent form was signed by patient.  Year of birth was noted.  Upon documentation, pt is noted to be 17 years old and at time of vaccination was approximately 1 month before his 18th birthday.  Pt received vaccine May 14,2021, he turns 18 on later date.  Follow up with patient completed.  No adverse event reported.
hives on face from mango sap; 6 weeks and 2 days past second dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on face from mango sap) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6 weeks and 2 days past second dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives on face from mango sap) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6 weeks and 2 days past second dose). At the time of the report, URTICARIA (hives on face from mango sap) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6 weeks and 2 days past second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment with steroids taken pertained to the events experienced.
Pharmacist reported that her patient had Covid after the 1st Moderna Shot( do not know the date); This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Pharmacist reported that her patient had Covid after the 1st Moderna Shot( do not know the date)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Pharmacist reported that her patient had Covid after the 1st Moderna Shot( do not know the date)). At the time of the report, SARS-COV-2 TEST POSITIVE (Pharmacist reported that her patient had Covid after the 1st Moderna Shot( do not know the date)) 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.   No treatment information was provided.
Pt right leg swelled up to knee to hip and became hard and red. Pt was admitted to hospital for concern of cellulitis.
Flushed face and tingly face and neck starting 3 or 4 hours after injection. Sharp, tingly pain at each joint on the arm where I received the vaccine every time I moved it (shoulder, elbow, wrist, each join in all my fingers) starting 3 or 4 hours after the injection.
Right ear echoing. When people talk it would vibrate. My ear also seemed clogged at first, but now after 7 days continues the same.
Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old male patient who received expired first dose of vaccine DAPTACEL lot B4947AA, expiry date: 31-Mar-2018 (also reported as 05-Mar-2018) via intramuscular route in the left thigh on 23-Jul-2018 due to cut on right ring finger. The patient's past medical history includes cut on right ring finger. It was a case of actual medication error due to expired vaccine used. It was reported that Child was cut with a piece of glass. Parents had chosen to never immunize the child and this was the first vaccination the child has ever received. Patient was suggested to wash with soap and water, keep cut covered and monitor for any signs of infection as corrective treatment. It was unknown if the patient had experienced any adverse event or not, it was reported that there were no signs of infection in the cut. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. It was reported the patient received a first dose of RECOMBIVAX HB (lot#, expiry date, dose, frequency, route and indication not reported) on 19-AUG-2013 and would like to receive the second dose of RECOMBIVAX HB (lot#, expiry date, dose, frequency, route and indication not reported) "now" (20-FEB-2014). No adverse symptoms reported. Additional information has been requested.
Adverse event started on 9/22/2021 with breathing issue. Inhalation discomfort, later in the day felt sick but no fever. Thursday was a little better, Friday was same as Wednesday regarding breathing then developed localized left sided left center radiating chest pain. Went nextdoor to emergency department. EKG showed elevated ST wave, they ordered a STEMI which lead to a cardiac catherization. This did not revea a heart attack but pericarditis. I was admitted and still had breathing discomfort the following day. I was given a large dose of aspirin fell asleep then woke up with no more breathing discomfort. Sent home on aspirin, cholesterol med and a beta blocker in addition to colchisine for inflammation.
TOOK SECOND DOSE OF VIVOTIF ONE DAY LATE; This spontaneous case report (PVX2019-2969) was received from a nurse on 03-Dec-2019. It described a 35-year-old female consumer who "took second dose of Vivotif one day late" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever.  Case report: The consumer took the first dose of Vivotif on 25-Nov-2019 and the second dose of Vivotif on 28-Nov-2019, which was one day late according to the schedule. It was reported that she took the remaining doses of Vivotif according to schedule.  The action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of reported event was unknown.  Company Comment: A consumer took second dose of Vivotif one day late (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took second dose of Vivotif one day late (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Redness and swelling to (L) arm with itching. BENADRYL.
feeling low level malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 41 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administered in arm, administration date 27Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feeling low level malaise".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
the ran a fever of 102 and was very tired with redness in her eyes, I gave her childrens acetaminophen
Stayed home from work the Monday I got the shot as well as the following Tuesday. Woke up Wednesday with my By Sunday the 16th I began having pressure and some irritation.  Went to urgent care Monday the 17th.  They said I had pink eye.  I immediately began using the prescribed eye drops.  It's important to mention no one in my family has or had pink eye nor have I knowingly come in contact with it.  By Friday the 21st there was no improvement from the medication and I began t developed severe light sensitivity and blurry vision.  I went back to urgent Care 5/22.  They prescribed a different medication for pink eye and referred me to an eye specialist.
Patient received vaccine and shortly after developed redness, swelling, pain similar to cellulitis  in the days after.  She was treated by PCP with Keflex and symptoms did resolve.
Patient's nose and eyes are swollen; Patient's nose and eyes are swollen; ears are hurting; experiencing severe injection sight pain; This spontaneous report was received from a patient's mother and refers to a 11 years old male patient. His concomitant therapies included cetirizine hydrochloride (ZYRTEK). No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.   On an unknown dates, the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported) for Human papillomavirus (HPV) prevention. On 08-OCT-2021, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported) for HPV prevention. The anatomical location for the three doses was reported as arm - 2 times left arm and 1 right arm. On 09-OCT-2021, the patient experienced adverse events: his nose and eyes were swollen, ears were hurting and he was experiencing severe injection site pain. The patient sought medical attention. No treatment was given for adverse events. The outcome of the events was reported as not recovered/not resolved.        The causality assessment between the events and the suspect therapy was not provided.
Patient experienced dizziness, pain and weakness in arm (L)/shoulder area within minutes after the vaccination. Pain in shoulder throughout night into next day, limited movement (Left shoulder).
When client awoke at 5 am he noticed red rash covering the abdomen and upper legs, extreme itchiness, complains of itchy throat but denies respiratory difficulty. Went to medical facility and advised of allergic reaction to vaccination recently received; no other new allergens in patient's environment; has taken ibuprofen, Benadryl, and prednisone; advised to return to health care provider if conditions worsens.
Large amount of swelling of left deltoid with redness and warmth.  Seen in urgent care 10/11/08.  Symptoms about 50% better by 10/13.
No adverse reaction occurred. Patient received a Moderna vaccine that expired 03/27/22. Manufacture was contacted the response was: The vaccine administered  lot number 059H21A maintained the activity necessary to  protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  No further treatment necessary.
Sx onset 8/2/22. Treatment includes oxygen monitoring and Paxlovid.
Menstrual Cycle has lasted so far 12 days longer than normal  Originally started on 9/4/21 before the shot on 9/9/21.  Normal cycles last 5 to 7 days previously before the shot
The vaccine was administered on the following date: 1/8/21 and at approximately the following time: 4:00PM   The symptoms began 30 minutes after administration of the vaccine.  The symptoms were: cough, throat itching and throat swelling + redness. No body itching, rash, or face/lip/tongue swelling.   She presented to the ED for her reaction The treatment of the reaction was:   o Antihistamines: benadryl IV o Steroids: solumedrol IV o Epinephrine: 1 dose    Currently ongoing cough but other symptoms resolved.