chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states that 24 hours after receiving vaccine he developed a round hard mass at site of injection. It was painful. It was not warm to touch and not red on skin. He denies fever. The mass remained for several weeks and was uncomfortable to sleep on and when lifting weights with his left arm. The mass now 3 months later is about half the size and no longer painful but still there in his left deltoid upon flexion of his muscle.
Decreased feedings, stiffening up, blood in stool, fussy, vomiting. Went to ER initially, transferred to hospital. Diagnosis of Intussusception. Therapeutic enema x 3 attempts, surgical intervention required to reduce intussusception.
Myopericarditis -diffuse ST elevations on EKG with elevated troponin. Cardiac MRI shows inflammation and area of fibrosis in septum.  Started on motrin 600mg QID. S/p 1x IVIG, 2x IV solumedrol, transitioned to PO prednisone course for 3.5wks, ASA 81mg daily.
Patient was waiting after her vaccine and she was standing.  She all of a sudden fell, was out of consciousness for 10-15 seconds and then woke up.  She was responsive but still out of it.   We elevated her feet and kept talking to her until EMT's arrived.  They arrived about 7-10 minutes later and took her to Hospital.
FLUSHED SKIN BACK OF TONGUE FEELS SWOLLEN    1100 PATIENT GIVEN BENADRYL BY MOUTH. AFTER 30 MINUTES, PATIENT FELT OK, AND LEFT WITH HUSBAND WITHOUT OTHER COMPLAINTS
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-JUN-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (lot number, dose and route were unkonwn). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
the injected arm was very sore to lift above shoulder level.; the injected arm was very sore to lift above shoulder level.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 10:00 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ECHINACEA; MULTIVITAMIN [VITAMINS NOS]. The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "the injected arm was very sore to lift above shoulder level.".  Additional Information: The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hives; cat allergy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and ALLERGY TO ANIMAL (cat allergy) in a male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives) and ALLERGY TO ANIMAL (cat allergy). At the time of the report, URTICARIA (hives) and ALLERGY TO ANIMAL (cat allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
felt tired; chills; some joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired), CHILLS (chills) and ARTHRALGIA (some joint pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Cancer (NOS) (No Change reported for this condition whether it was improved of worsening) and Polyp removal (No Change reported for this condition whether it was improved of worsening). Concurrent medical conditions included Seasonal allergy, Fruit allergy (multiple allergies including grapes,) and Drug allergy (colonoscopy "Prep" medication.). Concomitant products included VITAMINS NOS, VITAMIN D NOS and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Apr-2021, the patient experienced FATIGUE (felt tired), CHILLS (chills) and ARTHRALGIA (some joint pain). At the time of the report, FATIGUE (felt tired), CHILLS (chills) and ARTHRALGIA (some joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications was provided by the reporter.   This case was linked to MOD-2022-559985, MOD-2022-559987, MOD-2022-559986 (Patient Link).
No adverse event; Patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose).    No concomitant medications were reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-651842 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651842:
tiredness; soreness; nausea; Extremely painful, sharp pain in center/right side of chest; Extremely painful, sharp pain in center/right side of chest and upper back (between shoulder blades).; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 10:00 (at the age of 40-year-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, left kidney and appendix removed in 1982 due to cancer. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and cetirizine hydrochloride (ZYRTEC) from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 08Mar2021 at 12:00 (at the age of 40-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 02Apr2021, the patient experienced extremely painful, sharp pain in center/right side of chest and upper back (between shoulder blades) that came and went in waves for about three hours, 14-17 hours after the vaccine. On 02Apr2021 at 17:45, the patient also experienced more normal reaction of tiredness, soreness and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events extremely painful, sharp pain in center/right side of chest and upper back (between shoulder blades) was resolved on 02Apr2021 while that of the events tiredness, soreness and nausea were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Patient received COVID-19 Vaccine 12/19/2020 at 7:30 am.  Did well during the 15 minute observation period.  Upon returning home started to experience dizziness.  Patient has history of (Persistent Postural Perceptual Dizziness (PPPD and Vestibular migraine.
Fever swollen glands Narrative:  Employee reports fever and swollen glands "axillary lymphadenopathy". No medications were reportedly taken. Has not fully recovered as of this report.
It was reported that an 18 y.o. male PT received a Menomune A/C/Y/W-135 vax, administered SC on 9/27/01 at 14:47. The next day the PT complained of a fine, red rash on his arms mainly. Scarce on legs, no rash on trunk. Complained of slightly itching. Medicated w/oral Benadryl 25 mg at SHC. The PT reportedly recovered from this experience.
Reporting an administration error. Moderna was accidentally given to 17 yr old. Parents were contacted and informed. Choose not to complete the series.
Hives; Rashes; Itching started 2 or 3 months after vaccine; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 19-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 26May2021 (Lot number: EW0183) at the age of 19 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes and "Allergy" (unspecified if ongoing), notes: known allergies: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0183, Route of administration: Unspecified, Anatomical site: left arm), administration date: 05May2021, when the patient was 19 years old, for COVID-19 immunisation.  The following information was reported: URTICARIA (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Hives"; RASH (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Rashes"; PRURITUS (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Itching started 2 or 3 months after vaccine". The events "Hives", "Rashes" and "Itching started 2 or 3 months after vaccine" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, rash and pruritus.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment included Benadryl and Xyzal for urticaria, rash and pruritus.
Cephalocaudal erythematous macular/papular rash w/cluster on face/trunk and upper extremities.
Patient: Mother state that following vaccine. Patient was taken to hospital and diagnosed with an allergic reaction.
Left arm swelling and redness at injection site and extending distally. Discomfort and warmth at the site.Seen by own Md who suggested she show to health dept staff.
At injection site: extreme soreness, hot to touch for 3 days, itch on 4th day. Lungs and airways felt constricted and painful to breathe for two straight days, third day mild pain/constriction. Body cold yet injection site felt hot, then would feel like my whole body was on fire. Headache pretty much continuous for 3 days, dizzy for 2 days, upset raw feeling upper abdomen for 2 days.
In on 10/17/11 for Varicella #2, Hep A #2, and HPV #2. Mother noticed that afternoon redness & swelling in (R) arm at injection sites. Called and was advised to use cool compresses and TYLENOL or MOTRIN. By the next am (10/18/11) swelling had increased, had fever, area was red & hot to touch, (+) pain. Sought tx at medical center. was started on ABX.
MEMORY LOSS (SOMETIMES CAN'T REMEMBER THINGS); SORENESS THROUGHOUT THE BODY; INSOMNIA/CAN'T SLEEP; PAIN IN RIGHT ELBOW IS GETTING WORSE; CHILLS AFTER WIPING AWAY SWEAT AT NIGHT; HEAVY SWEATING AT NIGHT (DESCRIBING IT AS LITERALLY SWEATING BUCKETS, HAVE TO SLEEP ON TOWELS AND CAN'T SLEEP); This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no medical history, no known drug allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUN-2021, the subject experienced heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep). On 27-JUN-2021, the subject experienced soreness throughout the body. On 27-JUN-2021, the subject experienced insomnia/can't sleep. On 27-JUN-2021, the subject experienced pain in right elbow is getting worse. On 27-JUN-2021, the subject experienced chills after wiping away sweat at night. On 13-JUL-2021, the subject experienced memory loss (sometimes can't remember things). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep), memory loss (sometimes can't remember things), soreness throughout the body, insomnia/can't sleep, chills after wiping away sweat at night, and pain in right elbow is getting worse. This report was non-serious.
Large swelling on the shoulder and arms. Feels hot and red and itchy. No pain. Cold compress does not help.
redness, arm pain (muscle pain- can still move arm regularly), severe swelling (entire upper arm), dizziness (had to lay down).
called in to ask if she can still have 2nd dose of Moderna vaccine; Rashes all over body; my arm is still numb; cant even lay on that arm that had injection; my legs feel floppy its like totally numb; could not remember simple words; i got really tired; giant lymph nodes on my chest; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (my arm is still numb), LIMB DISCOMFORT (cant even lay on that arm that had injection), HYPOTONIA (my legs feel floppy its like totally numb), APHASIA (could not remember simple words) and FATIGUE (i got really tired) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Scarlet fever. Concurrent medical conditions included Seasonal allergy, Allergic to cats and Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and COLLAGEN for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced HYPOAESTHESIA (my arm is still numb), LIMB DISCOMFORT (cant even lay on that arm that had injection), HYPOTONIA (my legs feel floppy its like totally numb), APHASIA (could not remember simple words), FATIGUE (i got really tired), LYMPHADENOPATHY (giant lymph nodes on my chest) and PYREXIA (Fever). In July 2021, the patient experienced RASH (Rashes all over body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (called in to ask if she can still have 2nd dose of Moderna vaccine). At the time of the report, HYPOAESTHESIA (my arm is still numb) had not resolved and LIMB DISCOMFORT (cant even lay on that arm that had injection), HYPOTONIA (my legs feel floppy its like totally numb), APHASIA (could not remember simple words), FATIGUE (i got really tired), LYMPHADENOPATHY (giant lymph nodes on my chest), PYREXIA (Fever), RASH (Rashes all over body) and PRODUCT DOSE OMISSION ISSUE (called in to ask if she can still have 2nd dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller also reported that she had fever and rashes all of the body 3 weeks ago. It was like she had Scarlet Fever which she had before.  No treatment medication were reported.
Pt received one dose of Moderna COVID vaccine on 3/26/2021 and was subsequently hospitalized and tested positive for COVID on 4/1/2021
chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. At the time of the report, CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-745839 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745839:same patient spikevax 2023-24
Pain in right arm at injection site, down to the outer elbow. Achy shoulders.  Achy right armpit.
Day after injection: sore arm, headache, extreme fatigue.  Chills. No fever
initial administration: 5/23/2022 @1606 2nd booster shot administered, initially tolerated 5/24/2022 @07:31, soreness to injection site of left arm first noted 5/24/2022 @12:00  soresness and swelling to injection site, pink color to area of injection noted 5/25/2022 @0300 patient complains of soreness to site with redness and swelling 5/25/2022 @0651 Physician notified regarding reaction to covid vaccine; notes extensive redness (2 cm x 8-10 cm) sitting anterior to patient's glucose monitor (CGM) which was removed. MD started patient on oral antibiotics (septra DS 1 tab po bid) x 10 days (note pt's previous allergy history to prevnar)
pt states he has had pain/discomfort in the left arm since the booster and is still continuing to have discomfort and difficulty fully raising his arm 1 month later. Pt will follow up with MD and continue ibuprofen or acetaminophen otc for pain relief
Patient presented to the pharmacy with complaints of arm pain, progressively worsening over the past week after vaccination. He states the pain stated 1-2 days after receiving the vaccine, and has gotten worse over time. He described the pain as sharp, seering, shooting pain in his right shoulder (site of vaccination).
Pt received flu shot, then HPV-9. Within 2 min. pt had syncopal event that lasted approx. 1 min.
This is a 1-year-old female who was admitted with a history of fever, vomiting and rash. Physical examination on admission has shown irritable child. Patient was initially admitted and started on intravenous antibiotics for tonsillitis. However, in view of increasing serum bili and high transaminases, antibiotics were withdrawn. Antihistamines were given for treatment of rash. Patient was monitored carefully and was placed on low fat diet. She improved over the next 4-5 days and showed decrease in irritability. Icterus, rash disappeared and the tonsillar congestion resolved. She was discharged home and also showed progressive improvement of biochemical markers of liver involvement. Diagnoses: Acute tonsillitis. Hepatitis, possibly viral or drug induced, improving. 1/2/07. DC DX:Acute tonsilitis. Hepatitis viral or drug induced. C/O Fever, vomiting, rash and irritability.
Tonight, I am still having side effects; Shortness of breath; what feels like an anxiety attack; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Tonight, I am still having side effects), DYSPNOEA (Shortness of breath) and ANXIETY (what feels like an anxiety attack) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Tonight, I am still having side effects), DYSPNOEA (Shortness of breath) and ANXIETY (what feels like an anxiety attack). At the time of the report, VACCINATION COMPLICATION (Tonight, I am still having side effects), DYSPNOEA (Shortness of breath) and ANXIETY (what feels like an anxiety attack) outcome was unknown.            No relevant concomitant medications were reported.  Treatment medication was not provided by the reporter.