chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Severe Wheezing) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer (several years ago). Concurrent medical conditions included COPD (Chronic obstructive pulmonary disease). Concomitant products included AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN/CLAVULANIC ACID) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced WHEEZING (Severe Wheezing). At the time of the report, WHEEZING (Severe Wheezing) outcome was unknown.            The treatment history was not provided.  Patient had no events after first dose of COVID-19 vaccine, after second dose 4 weeks later experienced severe wheezing. The patient had Prostrate Cancer several years ago and  wants to know if patient should take a booster dose vaccine.
weakness; nausea; muscle pain; fever, pretty hot; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), NAUSEA (nausea), MYALGIA (muscle pain) and PYREXIA (fever, pretty hot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included OMEPRAZOLE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 ASTHENIA (weakness), NAUSEA (nausea), MYALGIA (muscle pain) and PYREXIA (fever, pretty hot). At the time of the report, ASTHENIA (weakness), NAUSEA (nausea), MYALGIA (muscle pain) and PYREXIA (fever, pretty hot) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-076479, US-MODERNATX, INC.-MOD-2021-076514, US-MODERNATX, INC.-MOD-2021-076575 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076479:1st dose vaccine - husband US-MODERNATX, INC.-MOD-2021-076514:2nd dose vaccine - husband US-MODERNATX, INC.-MOD-2021-076575:1st dose vaccine - Wife
Hospitalized 2 days with acute respiratory failure, treated with remdisivir and discharged home on oxygen
Information has been received from a registered nurse in a physician's office concerning a 20 year old patient with an allergy to sulfamethoxazole (+) trimethoprim who on 08-MAR-2007 was vaccinated with a first dose of Gardasil (lot # 655618/0186U) in the left deltoid at 11:00 AM. The nurse reported that the patient had received the second dose late (second dose was given on "01-OCT-2007"). No adverse experience is related to this event. No other information was available at the time of reporting. Additional information was received. Conflicting information was received regarding the number of doses of vaccine that the patient had received. The reporter indicated that this was the first dose of vaccine. On 10-MAR-2007, the patient experienced hives. On an unspecified date, the patient recovered. The reporter felt that the hives were serious medical intervention was required (Other Important Medical Event). No additional information is expected.
When retrieving  vaccines from the refrigerator, the MA grabbed the Pneumovax syringe instead of the Bexsero syringe. The patient was given Pneumovax in error. The patient remained stable and her condition did not change
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is the 1st of 3 reports. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arm swelling on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017169079 Same product/event/reporter, different patient;US-PFIZER INC-2017169080 Same product/event/reporter, different patient.
Pain in arm; Headaches; This is a spontaneous report from a non-contactable consumer. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in left arm, on 12Mar2021 at 10:00 (at the age of 56 years) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient received unspecified medications within 2 weeks of vaccination. On 12Mar2021 at 10:15 hours, the patient experienced pain in arm for about two days, headaches starting about 10 minutes after injection. still having multiple daily headaches eight days later. No therapeutic measures were taken as result of the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events pain in arm and headache were not recovered at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
25OCT91 pt returned today p/recving vax 18OCT91; pt noticed itching 23OCT91, later noticed swelling, redness & cont itching; today 6x10cm area of erythema, induration, swelling, mild tenderness in region; no previous problems from tet shots
Fine erythematous macules on entire body, associated with acute onset of fever, 9 hours after shots. Some erythema and mild swelling at left thigh injection site. No URI sxs.
My symptoms included a runny nose, sinus headache and pressure, and a general feeling of malaise. I was also wheezing a bit and my cough was horrible. I did not have a fever. My pulse ox was fine. I went to the doctor. I was diagnosed with a sinus infection and a COVID-19 infection. She prescribed a Z-PAK. I started it on June 07, 2022. She also prescribed dexamethasone. I started June 09, 2022. I was using my albuterol inhaler regularly. She prescribed guaifenesin with codeine as well. I followed up with my regular doctor when I got back home and required another Z-PAK.
Redness...raised bumps right below injection site...extremely itchy.   Over the counter benadryl ointment used on site for approximately 2 days.
This is the patient who passed away 2d after his second COVID vaccine. Of note, the 2/8 telephone note makes it sound like he was hospitalized at time of death - that is incorrect. His daugther  listed as EM contact works in the eye clinic here. He had mild illness, completed 10d isolation but missed his scheduled booster dose on 2/2 due to isolation. He was called on 2/5 when there was a booster visit cancellation and received his booster dose on that day. His daugther reported that he was doing fine and looking well on 2/7 AM, ate breakfast, shortly after stood up and just collapsed.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium, Additional Details: since second dose of shot, patient developed rash on face and neck that required visit to dr's office. she has also been having shortness of breath, generalized weakness, headache, and general tiredness. Patient is being treated with topical steroids, oral steroid, and antihistamine for rash which has been subsiding in appearance since starting therapy.
Family called at 4:44 am on 9-13-08. Pt had T -> 100.5 earlier in PM, (V) xT, and was listless and pale with decreased responsiveness. Sent to ER.   10/10/08 Reviewed hospital medical records of 9/13-9/27/2008. FINAL DX: streptococcus pneumoniae meningitis, right OM w/effusion, let hemiparesis & focal left-sided seizures, both secondary to strep pneumoniae. Records reveal patient experienced fever, rash 1 week prior that had resolved by admit, irritability, decreased appetite, sleepiness, projectile emesis & loose stool x 1 day, listless, pale.  Seen at outlying ER & transferred to higher level of care.  Admitted to PICU & tx w/IV antibiotics.  Developed respiratory distress & failure along w/seizures.  Intubated & tx w/antiseizure meds.  Neuro & ID consults done.
Patient with past medical history of COPD. She presented to the emergency department with cough, decreased appetite, SOB, and lethargy. She took an at-home Covid test which was positive, Covid PCR test on 5/28 in the emergency department was also positive. Subsequently admitted for management of Covid infection from 5/28-6/2.
EMS brought pt to ED at local hospital after a fall during the night and upper respiratory gurgling sounds; low O2 saturation; found to be positive for COVID; pneumonia; DNR; family took pt home with hospice from the ED; pt passed away in the home
I received the first dose in May 2021; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient missed second Shingrix shot. Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The follow-up would not be possible as no contact details were available. This case has been linked to US2022AMR003246, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR003246:same reporter
ACHINESS; CONGESTION; SINUS PRESSURE; ELEVATED BLOOD PRESSURE; COUGH; DRAINAGE; FATIGUE; SWEATING; NOT FEELING WELL; CHILLS; SLIGHT HEADACHE; SLIGHT NAUSEA; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 16:30 on right arm for prophylactic vaccination. Non-company suspect drugs included: ibuprofen ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for achiness. No concomitant medications were reported. On 27-MAR-2021 17:30, the subject experienced sweating. On 27-MAR-2021 17:30, the subject experienced not feeling well. On 27-MAR-2021 17:30, the subject experienced chills. On 27-MAR-2021 17:30, the subject experienced slight headache. On 27-MAR-2021 17:30, the subject experienced slight nausea. On 27-MAR-2021 17:30, the subject experienced low grade fever. On 28-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced congestion. On 29-MAR-2021, the subject experienced sinus pressure. On 29-MAR-2021, the subject experienced elevated blood pressure. On 29-MAR-2021, the subject experienced cough. On 29-MAR-2021, the subject experienced drainage. Laboratory data included: Blood pressure (NR: not provided) 146/89 mmHg. On an unspecified date, the subject experienced achiness. Treatment medications (dates unspecified) included: amoxicillin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ibuprofen was not reported. The patient recovered from sweating on 01-APR-2021, slight headache, and slight nausea on 28-MAR-2021, and low grade fever on 29-MAR-2021, was recovering from not feeling well, fatigue, congestion, sinus pressure, cough, and drainage, and the outcome of elevated blood pressure, chills and achiness was not reported. This report was non-serious.
Mini-stroke transient ischemic attack; Room spinning; Winking eyelids involuntarily; Felt like he was falling to his right side; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke transient ischemic attack), VERTIGO (Room spinning) and BLEPHAROSPASM (Winking eyelids involuntarily) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery. Concomitant products included POTASSIUM, FUROSEMIDE (LASIX [FUROSEMIDE]), WARFARIN, METOPROLOL SUCCINATE (TOPROL XL), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Mini-stroke transient ischemic attack) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), VERTIGO (Room spinning) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required) and BLEPHAROSPASM (Winking eyelids involuntarily) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required). The patient was hospitalized from 19-Mar-2021 to 21-Mar-2021 due to TRANSIENT ISCHAEMIC ATTACK. On 21-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (Mini-stroke transient ischemic attack), VERTIGO (Room spinning) and BLEPHAROSPASM (Winking eyelids involuntarily) 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 received vaccine in right non-dominate deltoid muscle to prevent COVID-19. Patient was admitted to hospital from 19Mar2021 to 21Mar2021 for a magnetic resonance imaging (MRI) and computerized tomography (CT) scan, with observation and Low-Dose Aspirin. Patient was feeling much better and his cardiologist recommended that he receives his second Moderna vaccine as soon as required and to take an extra Vitamin D supplement as a precaution. Scheduled second dose was due on 08Apr2021. Treatment included was low dose aspirin.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Redness on skin of right deltoid muscle. Slight swelling. Slight itching.
I experienced swelling under my skin above my left clavicle. I went to my PCP who ordered an ultrasound which revealed that my lymph nodes were inflamed. They suspect this was due to my vaccination as I otherwise do not seem to have any infections.
Beyond use date of 7/11/2022 and administered on 8/8/2022.
flu like symptoms; 48hs bedrest; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and BED REST (48hs bedrest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Dec-2020.  On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and BED REST (48hs bedrest).   At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and BED REST (48hs bedrest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, COVID-19: positive (Positive) Positive.   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.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
SEVERE chronic leg pain initiating in both legs with unbearable cramping pain in thighs. Spreading down in legs. Eventually dissipating from right leg but lingering in left leg. Initially hard to even walk down the stairs, had to stop and rest. Up all night in pain. Difficulty working from pain--heat, ice, aspirin do not alleviate the pain.
terribly sick; could hardly move her limbs because it hurt so bad; body aches; fever; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 19Apr2021 as dose 2, single (Lot number: EW0151) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (ongoing), notes: Heart Disease. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: ER8733), administration date: 29Mar2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "Terribly sick", "Fever", "headache", "body aches"; BNT162b2 (Dose 1, Lot: ER8733), administration date: 29Mar2021, when the patient was 57-year-old, for Covid-19 immunization, reaction(s): "could hardly move limbs because it hurt so bad", "Metallic taste"; BNT162b2 (Dose 1, Lot: ER8733, Dates for itchy rash on palm of hand and once in a while on the sides of fingers on that hand: (From: 29Mar2021 To: Ongoing)), administration date: 29Mar2021, when the patient was 57-year-old, for COVID-19 Immunization, reaction(s): "rash". The following information was reported: PAIN (non-serious) with onset 19Apr2021, outcome "recovered", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 19Apr2021, outcome "recovered", described as "could hardly move her limbs because it hurt so bad"; PYREXIA (non-serious) with onset 19Apr2021, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 19Apr2021, outcome "recovered"; ILLNESS (non-serious) with onset 19Apr2021, outcome "recovered", described as "terribly sick". The events "terribly sick", "could hardly move her limbs because it hurt so bad", "body aches", "fever" and "headache" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient thought she had Covid but when she had the test done it was negative. Caller stated she did not think it was correct. Caller stated it was a really bad experience. She was not feeling well because she was sick, so she was in her PJs, because she did not have to go in when she goes and gets a Covid test done, so she just wore a long sweater over her PJs. Caller stated she drives that way all of the time and on the way home she got lost and ended up somewhere and she did not know where she was at, she pulled in to a quick trip and asked how to get home. She stated when she pulled out of the quick trip, she did not think she stopped to look for traffic before she pulled out of the parking lot. Caller stated that scared her to death. Caller stated the date was unknown, but it was in the Winter time, not last winter but the winter before, so 2020.  Follow-up attempts are completed. No further information is expected.
1st symptoms - severe back pain on awakening on Sat 2/3 pain continued throughout day with rash beginning later on. Started "left side of spine traveled across waist and on its belly "outpatient". Monday 2/5 blister approved with additional croppy, saw doctor given Samvir, and Oxycodone diagnosed Shingles.
Information has been received from a pharmacist and a registered nurse concerning a 42 year old male with sickle cell anaemia who was vaccinated with Pneumovax 23 (Lot # 654982/0675F).  Subsequently the patient developed excessive swelling in the mid upper arm injection site, that was all the way down to the elbow that was 1 and 1/2 times the size of the normal circumference of the arm.  The area was warm to the touch, tender and there was pain with the swelling.  There was no fever and no induration at the site of injection.  The patient was instructed to take acetaminophen or nonsteroidal anti-inflammatory drug (unspecified) (NSAIDs) to manage the discomfort.  The patient sought unspecified medical attention.  At the time of the report, it was unknown if the patient recovered.  Additional information has been requested.
Very ill. Fever 102 degrees, no appetite, muscle aches, headache, light headed, unbalanced when standing, only sleeping. Symptoms eased second day a bit. Better by 3rd day, still low grade fever, still in bed. Today, 4th day: fever gone, but still weakness, light headed, headache, pain in right hip required ibuprofen for mobility.  This was my first Moderna. The first two jabs were Pfizer, and I was sick for only two days with only  the second jab.
Patient was given Pfizer (12+ years old) instead of what they thought we had which was Pfizer (5-11 yo). There were no adverse symptoms to the vaccine itself. Just wrong vaccine for age group was given.
Case number PHEH2013US008443, is an initial spontaneous report received from a pharmacist on 10 Apr 2013. This report refers to an unspecified age and gender patient. The patient medical history and concomitant medication was not reported. The patient was vaccinated with MENVEO (batch number: not reported), intramuscularly on an unspecified date. The reporter reported that, the patient received some of the MENVEO vaccine and small amount leaked out of the injection site. No more information was available.
This spontaneous report was received from a consumer reporting herself, to a female patient of unknown age, with allergy to niacin. Historical conditions included "cholesterol" and "other medical issues". On 08-FEB-2014 the patient was vaccinated with ZOSTAVAX (dose, strength and expiration date was not reported), 1 DF, route reported as "injection". Co-suspect therapies were not reported. Concomitant therapies were reported as "yes, unspecified by the reporter". The patient reported that on 09-FEB-2014, reported as 24 hours after being vaccinated with ZOSTAVAX, the patient developed an injection site reaction. The reaction was described as a "circle of redness" with warm around injection site. It is itchy and tender but doesn't hurt unless is pressed down on. Patient reported that on 10-FEB-2014, the reaction is expanded, and continues itching. The patient referred she seek medical attention when she called the pharmacist, and told her to took TYLENOL and BENADRYL. The outcome of injection site was unknown. The outcome of the reaction is expanded was reported as not recovered. Additional information is not expected.