chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weakness; Fatigue; Feels feverish 99.1- 99.3; Difficulty breathing; Sorenesss in arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), PAIN IN EXTREMITY (arm), ASTHENIA, FATIGUE, and PYREXIA (Feels feverish 99.1- 99.3) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 002B214) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing) and PAIN IN EXTREMITY (arm). On 28-Apr-2021, the patient experienced ASTHENIA, FATIGUE, and PYREXIA (Feels feverish 99.1- 99.3). At the time of the report, DYSPNOEA (Difficulty breathing), PAIN IN EXTREMITY (arm), ASTHENIA, FATIGUE, and PYREXIA (Feels feverish 99.1- 99.3) had not resolved.            The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was not applicable.  Concomitant medications were not provided. Treatment information was not provided.
Woke up with dizziness in the morning, felt like the room was spinning along with nausea. Subsided after a few hours
Patient received shot and 5 months later felt faint clammy, sweating, nauseous and dizzy-laid down felt better and called 911 and she went to hospital. Called in afternoon and was fine.
Received pneumonia vaccine on Friday 11/9/07, on Saturday night I was up during the night and could not sleep, left arm was sore but not red. Sunday I had muscle aches and fever up to 100.8,I took Tylenol extra strength for pain and fever around the clock. Last night 11/10/07 fever broke and muscle weakness stopped. Today 11/11 I put ice on the site, area is red about two inches around the sight. Left message on my Doctor's answering service Monday 11/11/07 regarding these symptoms.
I got a test and it was positive and I had my vaccines; got a test and it was positive and I had my vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: I got a test and it was positive and I had my vaccines (clarified as Pfizer COVID 19 vaccine) and before I had my vaccine, the first time I got it I did not feel anything. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "I got a test and it was positive and I had my vaccines"; COVID-19 (medically significant), outcome "unknown", described as "got a test and it was positive and I had my vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: I just took the test, my test is negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that consumer stated three days ago, may be a week ago, he got a cold you know continue working then my wife told me, you might have a corona so go get a test. I got a test and it was positive and had my vaccines (clarified as Pfizer COVID 19 vaccine) and before had my vaccine, the first time I got it I did not feel anything. Patient was treated with Paxlovid. Patient took the test again, test was negative. Patient was taking Paxlovid for two and half days and asked can I stop this since adverse event occurred due to use of Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. There was no concurrent condition or medical history reported. The nurse reported that improperly stored LIQUID PEDVAXHIB (lot # L012838, expiration date 10-MAR-2018; Lot # K008679, expiration date 05-MAR-2017) (dosage, strength and route not reported) were administered to the unspecified multiple patients on unknown dates. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) 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 ILLNESS (sick). At the time of the report, ILLNESS (sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported Treatment information was not provided.   This case was linked to MOD-2021-297570 (Patient Link).
Edema and erythema to right extremity (in entirety) within several hours of vaccine with gradual increase in severity involving entire distal extremity. Tx elevation, ice, compress and Keflex tid.
I received the Pfizer Bivalent COVID-19 booster on 9/16/2022. On 10/21/2022, I developed a cough, fatigue, and nasal congestion. I basically felt like I had a cold. The symptoms continued over the next few days. I took home antigen tests on both 10/21/2022 and 10/22/2022 and got negative results both times. However, when I tested on 10/23/2022, the result was positive. When I tested myself on 10/28/2022, it was still positive. On 10/31/2022, though, I got a negative result. Within 2 days of getting my first positive result, I contacted my doctor and was prescribed PAXLOVID. I never had any symptoms besides cough, fatigue, and nasal congestion. I never had a fever. At the time of this writing, I feel that I have made a complete recovery and have no residual symptoms.
THE PATIENT WAS SITTING IN A CHAIR AFTER THE SHOT AND SLUMPED OVER TO THE SIDE. SHE WAS PALE IN THE FACE. WE RAN OVER AND WERE ABLE TO WAKE HER UP. SHE BEGAN TALKING SOON AFTER. WE ASKED IF SHE HAD ANYTHING TO EAT THAT DAY AND SHE REPLIED NO. WE PROVIDED HER WITH COLD GATORADE TO DRINK WHILE WE SAT AND TALKED TO HER. AFTER 40 MINUTES OF SITTING AND TALKING SHE WAS ABLE TO STAND UP SAFELY AND LEAVE THE PHARMACY. THE REACTION WAS CONSIDERED TO BE A FAINTING SPELL WHILE SITTING IN A CHAIR AFTER THE SHOT
TERRIBLE PAIN; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 30-JUL-2021, the patient experienced terrible pain. On 30-JUL-2021, the patient experienced fever. On 30-JUL-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, fatigue and terrible pain was not reported. This report was non-serious.
FF2593 vial specified expiration date of 11/2021. The pharmacy notified team vial expired 11/24/2021. The vaccine administered 11/29/2021.
04/28/2013 Moderate other Client had a fever of 101 F degrees on 4/19/13 (doctor prescribed amoxicillin), 102 on 4/26 and 103 on 4/27. Parent noticed numerous small, flat, non-sleeping, non-itchy red dots on the client's back, chest, and belly on 4/28. This rash became blotchy-looking on 4/29. Client was symptom free on 5/1/13.
Nausea and vomiting, chills and sweating, diarrhea, stomach cramps and pain, aching all over. Lasted about 3 days.
Moderna COVID-19 Vaccine EUA.  I experienced a fever of 101 degrees over 36 hour period, chills, nausea, body aches, and severe headache that affected vision.
TINGLING OR NUMBNESS EXTENDING FROM  INJECTION TOWARD LEFT ELBOW. FOR THE FIRST COUPLE OF DAYS IT WAS WORSE AFTER TWO WEEKS IT LESSENED. THIS WAS REPORTED TO US 11/10/2009 Follow-up: Left arm partially paralysis. Still is.
During observation period (15 minutes) patient became unresponsive.  Maintained airway and stayed upright in chair but began drooling and did not respond to Dr. or nurse.  Patient was unresponsive for approximately 5 minutes, during which time 911 was called and patient became conscious. Patient vomitted upon becoming responsive, scant amount.  Patient was hypotensive during episode and at arrival of medics (90/50 approx.).  Patient with recent history of hypotension and per spouse patient was due for his Midodrine.  Patient was taken to local hospital for evaluation.
Headache, Myalgia, shivering, arm soreness Narrative:  Other Relevant History:
Patient stated was not feeling well then was observed on the floor, patient his head. vital signs were taken, assessment done by EMS and transported to the hospital for falling. Alert and conscious when on the stretcher,
Woke up marble size knot on my shoulder blade that hurt and a stopped up ear that won?t pop open. All on the left side of my body.
Sinus surgery 12/12/09 - Few days later (L) chest wall pain and subsequent (L) shoulder pain. ER visit 12/28/09 - CBC, chem profile, cardiac enzymes - all NL -EKG, chest CT for PE- NL. Neuro consult 3/23/10. Dx. Parsonage Turner Syndrome.
VACCINE WAS ADMINISTERED 9+1/2 HOURS AFTER THE VIAL WAS PUNCTURED.
Developed UTI symptoms the following morning.  UA showed elevated WBC.  Seen at Urgent Care and given Antibiotics.  UTI has progressed to Right kidney pain.   UTI symptoms and onset time are similar to that experienced the day after 2nd dose of Moderna vaccine.
the area around it is deep red and is almost down to the elbow; the whole area where the shot is given is dark; COVID arm; the whole area where the shot is given is very pronounced; it is very hot - left arm; itching very badly at injection site and it continued to spread; rash at injection site and it continued to spread; arm was a little swollen - left arm; arm was very sore - left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very sore - left arm), VACCINATION SITE ERYTHEMA (the area around it is deep red and is almost down to the elbow), VACCINATION SITE DISCOLOURATION (the whole area where the shot is given is dark), TYPE IV HYPERSENSITIVITY REACTION (COVID arm) and VACCINATION SITE SWELLING (arm was a little swollen - left arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04CB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sciatica (sciatica on right side.).    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was very sore - left arm) and VACCINATION SITE SWELLING (arm was a little swollen - left arm). On 16-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (the area around it is deep red and is almost down to the elbow), VACCINATION SITE DISCOLOURATION (the whole area where the shot is given is dark), TYPE IV HYPERSENSITIVITY REACTION (COVID arm), VACCINATION SITE SWELLING (the whole area where the shot is given is very pronounced), VACCINATION SITE WARMTH (it is very hot - left arm), VACCINATION SITE PRURITUS (itching very badly at injection site and it continued to spread) and VACCINATION SITE RASH (rash at injection site and it continued to spread). On 14-Apr-2021, PAIN IN EXTREMITY (arm was very sore - left arm) and VACCINATION SITE SWELLING (arm was a little swollen - left arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (the area around it is deep red and is almost down to the elbow), VACCINATION SITE DISCOLOURATION (the whole area where the shot is given is dark), TYPE IV HYPERSENSITIVITY REACTION (COVID arm), VACCINATION SITE SWELLING (the whole area where the shot is given is very pronounced), VACCINATION SITE WARMTH (it is very hot - left arm), VACCINATION SITE PRURITUS (itching very badly at injection site and it continued to spread) and VACCINATION SITE RASH (rash at injection site and it continued to spread) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information included Eczema Cream.
Vaccinations 12/27/01: Hep B, MMR, and Td.  Alopecia started 1/25/2002. Alopecia scalp & eyebrows continues 4/14/2004.  Nurse follow up on 06/21/04 states: "Review of medical records confirms diagnosis of alopecia areata."
patient received a dose of pentacle but the nurse made an error and used saline diluent for the hib component instead of using the dtap/ipv as the diluent, with no reported adverse event'; Initial information received on 02-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who  received a dose of pentacle but the nurse made an error and used saline diluent for the hib component instead of using the dtap ipv as the diluent, with no reported adverse event while receiving vaccine [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 01-Feb-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ571AA via intramuscular route in unknown administration site.  On an unknown date the patient received a dose of pentacle but the nurse made an error and used saline diluent for the hib component instead of using the dtap ipv as the diluent, with no reported adverse event (wrong product administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received a dose of pentacle but the nurse made an error and used saline diluent for the hib component instead of using the dtap/ipv as the diluent, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient received a dose of pentacle but the nurse made an error and used saline diluent for the hib component instead of using the dtap ipv as the diluent, with no reported adverse event.  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 the 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.
administration of 2-doses of the Shingrix adjuvant to a patient; administration of 2-doses of the Shingrix adjuvant to a patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number AB377, expiry date 29th September 2023) for prophylaxis.   On 25th October 2022, the patient received Shingrix. On 25th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comments: The licensed practical nurse reported the administration of 2 doses of the Shingrix adjuvant to a patient. The nurse stated that they used 2 vials of the Shingrix adjuvant to administer 1 dose of Shingrix vaccine and they only used the adjuvant and did not use the lyophilized portion of the Shingrix vaccine. The reporter did not consent to follow up. Additional Supportive Information: The patient received only 2 adjuvants of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
No additional adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 01-APR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T024831 was confirmed to be valid, expiration date 18-NOV-2022, (dose, route and site of administration were not reported) for prophylaxis. The administered dose was exposed to the temperature from 47 degrees Fahrenheit (F) to 77 F (46.6 F) for 42 minutes. There was no previous temperature excursion. The call was because of a digital data logger. No additional adverse effect was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T024831; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001896: US-009507513-2104USA001895: US-009507513-2104USA001897:
After about 10-15 minutes giving the booster dose of Moderna, patient was seen going unconscious in a seat in our observation area.  My self and another bystander made sure he was safe and then he quickly came back to after a few moments.  He was sweating profusely and was dizzy and took a couple of minutes to realize what happened.
Breakthrough Case of COVID-19; Nasal Congestion, Dry Cough, Low Grade Fever, Headache. I was given vitamin C and Zinc by the Dr.
Employee reported about one week after her injection that she developed a swollen upper lip that then developed into mucosal blistering. States it was swollen to the bottom of her nose.  Also states she developed tinnitus for 2 days during the same time period. She took Benadryl for 2 nights.
pt woke up w/sore neck behind the rt ear, pain felt radiating to shoulder area & could not lift head off pillow on 10NOV95;neck felt hot but denies fever;Took Ibuprofen 3 tabs q 4 hrs on 11NOV95 & placed ice pack on neck;
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient developed shingles following 1st dose of Shingrix vaccine. The reporter consented to follow up. No additional information was avaialble from registered pharmacist at the time of reporting. This case is linked with US2020024269, reported by same reporter.
Patient reports feeling sick for 4 days starting the day after her first dose. Reported she had fever, pain in her teeth, jaw and into ear, severe headache, exhaustion/fatigue, GI issues that she felt that was on par with having mononucleosis, and swelling of hands and feet.
4th dose given. Mother did not remember prior booster dose. Enter today's dose into Immunization registry   at that time, discovered teenager had one booster dose in Jan 2022.  Mother stated I totally forgot I took her for a booster dose.
Patient presented to for second dose appointment on 3/29/21. Pt. had CDC vaccination card that indicated he received Moderna, lot# 028L20A on 1/27/21. Patent reported to vaccinator he was at that clinic for his second dose Moderna vaccine. Vaccinator administered Moderna vaccine in pt's left deltoid patient waited alloted observation time and left the facility. Pt's record was pulled after pt exited the facility. Record indicated pt received Pfizer on 1/27/21. Facility contacted and stated pt did receive Pfizer and proof of immunization record was inaccurate.
Increased pain and swelling at injection site, pain with shoulder movement. Rx: MEDROL dose pack, pain meds.
24 hours after child received immunizations, mother noted redness increased warmth, swelling and some hardness in area of left deltoid. This morning 48 hrs after admin. No hardness noted at site, but some rubor and calor still remain. Seen at clinic here. Mother states child never c/o discomfort, no fever noted. Mother gave Tylenol x 2.
This is a spontaneous report from a contactable consumer, the patient. A 55-year-old [non-pregnant] adult female received a dose (unspecified dose number) of BNT162B2 (solution for injection; Lot unknown and expiry not provided) as a single dose via unspecified route in the left arm on 27Apr2021 at 12:30 (at 55-years-old), for COVID-19 immunization. Relevant medical history included penicillin allergy. Concomitant medications sans indication, posology and therapy dates included fluoxetine hydrochloride (PROZAC), and bupropion hydrochloride (WELLBUTRIN SR). The patient denied any COVID diagnosis prior to vaccination. The patient was not pregnant at the time of vaccination and denied receiving any other vaccine within four weeks of this vaccine. On 14May2021 the patient began to experience smelling cigarette smoke when none was there. The patient stated that sometimes it makes her choke a little. The patient also began to experience extremely painful and swollen breasts since 14May2021. The patient has not been tested for COVID since the vaccine. The outcome of the events smelling cigarette smoke when none was there, makes her choke a little, and extremely painful, swollen breasts was not recovered.   Information on the Batch/Lot number has been requested.
On 1/2/00, the pt was dx with autism by his preschool psychologist. The pt sought unspecified medical attention.
Developed  Covid arm after 24 hours , severe pain, redness, swelling . , continuing over  4 days . Fatigue , body aches. No fever.