chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Fever >101 F; Red Injection site; Itchy injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever >101 F), INJECTION SITE ERYTHEMA (Red Injection site) and INJECTION SITE PRURITUS (Itchy injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever >101 F), INJECTION SITE ERYTHEMA (Red Injection site) and INJECTION SITE PRURITUS (Itchy injection site). At the time of the report, FATIGUE (Fatigue), INJECTION SITE ERYTHEMA (Red Injection site) and INJECTION SITE PRURITUS (Itchy injection site) outcome was unknown and PYREXIA (Fever >101 F) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information include ibuprofen tablets. No conc0mitant medication was reported.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded.  Fatigue, fever, injection site redness and injection site  itchiness are consistent with the product safety profile.
Woke up, got out of bed and by the time I reached the foot of the bed, the room spun and my body spun and fell to the ground.  I couldn't get up, walk and ease the dizziness and nausea.  I went to the ER since it was sudden and extreme - never had any problems with vertigo in my past - and am a healthy, avid daily runner/walker.  I passed the neurological tests and left with anti-dizziness and anti-nausea meds.
8/8/11 Received DTaP, IPV & MMRV vaccines. 8/9/11 Seen in ER with severe swelling, redness, warm to touch & painful LDT. Dx Local reaction to vaccination. Tx ice packs to area. 8/10/11 LDT much improved decreased swelling & redness, decreased pain.
Pt recv vax & devel cellulitis. Pt seen in ER & tx w/antibiotic therapy.
Unsure of Lot number. Difficulty reading handwriting on the vaccination record card.  I am a nurse and had nurses with me, so I did not go back to the facility for care. Numbness of anterior 1/3 of the tongue and felt  "distant" from surroundings within a few minutes of the injection. Symptoms progressed to numbness to the left side of the face and head. This sensation lasted a few minutes, then disappeared altogether. After about 30 more minutes, my entire tongue and head felt numb and I felt "distant" again. It became difficult to swallow as well. This too lasted a few minutes and disappeared altogether. I was left with a severe headache that lasted a few hours.
Per patient, a few hours after immunization she had a sore arm. Over the next couple of weeks, the soreness intensified. Patient had an appointment with an orthopedist and was diagnosed with SIRVA. Patient received a shot for the pain and has been working with a physical therapist since last October (10/2021).
A report has been received from a physician concerning a 3 year old, male subject who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 08-Sep-2014. Patient inadvertently administered expired FLUMIST QUADRIVALENT which started on 08-Sep-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Severe fatigue; Body soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Severe fatigue) and MYALGIA (Body soreness) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Severe fatigue) and MYALGIA (Body soreness). At the time of the report, FATIGUE (Severe fatigue) and MYALGIA (Body soreness) had not resolved.            No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-1273 with respect to events was not applicable.
Head pain, numbness and vomiting- brought to ER - dx with Subarachnoid Bleed-air flighted to hospital- aneurysm coil procedure, 4 days in ICU, 11 days in hospital
Uncontrollable itchiness / on the area she receive the vaccination; Rash on her arm, on the area she receive the vaccination; This case was reported by a nurse via sales rep and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site itching and injection site rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site itching and injection site rash were unknown.   It was unknown if the reporter considered the injection site itching and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at he vaccination was not reported. The patient received Shingrix and experienced uncontrollable itchiness and rash on her arm, on the area she received the vaccination. Benadryl was administered to this patient. No further details were reported. This case linked with US2020146796, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020146796:same reporter
Headache, dizziness, tongue feeling numb for weeks.  Following the shot, my thought process was diminished for months.
Back pain; Hip pain; Sciatica left side; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm left on 03Apr2021 at 08:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via unspecified route of administration in the left arm on 13Mar2021 (at the age of 58-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. On 05Apr2021, the patient experienced back pain, hip pain, sciatica left side. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with muscle relaxers and ant inflammatory drugs from an unknown date. The clinical outcome of the events back pain, hip pain, sciatica left side were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient received Shingrix in her left arm on 11/8/20 at 3:06pm.  On 11/9/20 at 9:45am she called the pharmacy to report that she was not feeling well.  She stated that she started around 7pm on 11/8/20 with a headache and neck ache.  She took Tylenol which did not help.  In the night, she had sweats, coughing and dreams.  She states that she works from home and did not take her temperature.  As of 9:45am she had repeated the Tylenol dose and was no longer sweating and starting to feel a little better.  She will call back if her symptoms worsen or do not improve in the next day or so.
Woke up nauseous, clammy, passed out but never vomitted,  Chills all day and achy all over.
3/15/04 Imm. Right arm reddened at immunization site 50x40mm - also swollen. Right arm reddened at immunization site deltoid 20x25 mm
Redness and swelling on both legs and ankles. Excessive crying x 45 minutes. Tsp Benadryl given PO. (R) leg little more redness.
Neuropathy in arm for 3 weeks; pins and needles sensation; This spontaneous case was reported by a non-health professional and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy in arm for 3 weeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 NEUROPATHY PERIPHERAL (Neuropathy in arm for 3 weeks) (seriousness criterion medically significant) and PARAESTHESIA (pins and needles sensation). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy in arm for 3 weeks) and PARAESTHESIA (pins and needles sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided by reporter. No treatment information was provided.  Very limited information regarding the events has been provided at this time.; Sender's Comments: Very limited information regarding the events has been provided at this time.
patient received pneumococcal vaccine before discharged from hospital 11/20/2010, patient went home, now returns later same day to ED 18:07 (ie 6:07 PM) with chief complaint: left upper arm now red, edematous, tender, painful, c/o tingling left fingers. ED MD decided this was a localized allergic reaction secondary to pneumococcal vaccine, discharged with Pepcid, Claritin, use Benadryl if needed, Vicodin for pain, to f/u later with her own MD who is not on hospital staff
Just over 24 hours of injection symptoms began. Nausea  Diarrhea  Dizziness  Difficulty focusing Forgetfulness  Arm pain at injection site, difficulty moving arm Lethargic  As of the date and time of this report symptoms are persisting, but arm pain has decreased and arm movements are almost normal
Hospitalized with COVID  cough, shortness of breath, chest pain, sore throat, rhinorrhea, congestion.  No treatment for COVID
diarrhea; weird pain in certain joints like the left knee and right ankle and left shoulder/weird pain in certain joints like her knee, her right shoulder; she like had a tenderness under her parotid gland on the right side of her cheek.; Some swelling; very chills; This is a spontaneous report from a contactable other hcp (nurse). An elderly (Age:65, Units: Unknown) female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on 03Mar2021 (Lot Number: EN6203, Expiry date was not reported) as dose 1, single for COVID-19 immunisation. Medical history reported COVID-19 from Nov2020. she had really weird pain in certain joints like the left knee and right ankle and left shoulder and that is kind of what she has again. The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced diarrhea, She had specific joint pain, She like had a tenderness under her parotid gland on the right side of her cheek, Swelling and chills. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unspecified date in Nov2020, she had covid back in November. The patient was due for her second dose on 24th of March. The kind of all the symptoms that she had than she had with the shot. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient received vaccine and fainted. He was dizzy, felt hot, was groggy, and side of his neck hurt. He had no previous reactions to any vaccines. We provided water, cool cloth, and called ambulance.
Fever up to 104 degrees.  Onset 1 week after MMR and DTAP were given.  Fever continued apx. 4 days.  Childrens Motrin was used to keep fever within normal range during this 4 day period.  Child was cranky/irritable and lacked energy during this period.
Child was napping, when mom heard her cry.  Went into room and child was having a seizure.  EMS was activated after 4-5 mins of seizure activity.  Child was sent to ER via Air Med.  While in ER child had 2 prolonged tonic-clonic seizures.  Was admitted to PICU x 2 days while awaiting septic workup, then was placed on Pediatric Floor until 3/29/2011.  Neurology was consulted on child.
HIVES AFTER ADMINISTRATION OF NASAL FLUMIST; A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided).    No medical history was reported.     No concomitant products were reported.    On an unknown date, the patient received Flumist (influenza vaccine) once/single administration, via nasal route. The patient started treatment with Covid Vaccine (covid-19 vaccine) on an unknown date.     A Unknown administered FLUMIST. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced hives after administration of nasal flumist (preferred term: Urticaria).     It was unknown if any action was taken with Flumist and Covid Vaccine.     The outcome of the event hives after administration of nasal flumist was unknown.    The event was considered non-serious.     The reporter assessed the event hives after administration of nasal flumist as non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray   Product Role: Suspect
04/03/21 Redness and swelling in upper left arm.  On or about 04/09/21 very bad cough and great difficulty in breathing.  On advice of Dr. went to Emergency Room.  After chest X-ray, EKG, and blood panels was diagnosed with congestive heart failure and furosemide was prescribed.  On 04/27/21, 05/05/21 and 05/12/21 had previously scheduled with Dr. Echocardiogram, Stress Test, and Carotid Svan, respectively.  As a result, it was found that there was abnormal perfusion scan with severe evidence of infarct in the apex apical inferior, mid inferior apical anterior and mid anterior segment(s).   Abnormal left ventricular size with abnormal systolic thickening and systolic function..
gave a 0.25 ml of the Moderna Covid-19 vaccine to a patient who was supposed to get a full dose for his 3rd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (gave a 0.25 ml of the Moderna Covid-19 vaccine to a patient who was supposed to get a full dose for his 3rd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 16-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (gave a 0.25 ml of the Moderna Covid-19 vaccine to a patient who was supposed to get a full dose for his 3rd dose). On 16-Dec-2021, ACCIDENTAL UNDERDOSE (gave a 0.25 ml of the Moderna Covid-19 vaccine to a patient who was supposed to get a full dose for his 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Expiration date was reported as 06Ap22021.
Fever - 101.8 x 12 hrs Chills Weak x 2 days - couldn't stand for more than 2-4 min
Client came in to receive a booster dose of Moderna after a Janssen vaccine. Client received a 0.5 ML dose when she should have received a 0.25 ML dose.  No symptoms at this time.
Body Aches Chills Fever Nausea Abdominal Pain  Poor appetite  Migraines  Change in vision Fatigue
Pain and swelling in the left elbow. Subsequent infection - Staph infection. Treatment: ER - diagnosed it initially (Bursitis) and drained some fluid from the elbow. Prescribed an antibiotic which was Cephalexin - 10 days. Bandaged it up and sent me home. About a week later, I saw my primary care doctor. She did a mini-operation on elbow - cut it and drained it and cleaned the area thoroughly and put an ACE bandage on it - and a week after that she said it was healing and to keep it clean and to continue to let it heal. She prescribed five more days of the same antibiotic. I kept the band-aid on and it healed.
Patient had severe nausea/vertigo episode upon awakening on 1/8/21. Patient fainted and collapsed onto bathroom floor. He hit his head on the wall during the fall. Patient was found barely conscious by his wife right after the fall. Patient temperature, O2 sat and BP all within normal limits measured within 5 minutes of fall.  Patient does have history of Meniere's disease x 5 years, but is well-controlled with medication and middle ear steroid injections. Patient has not had severe vertigo episode in 2+ years.
Patient returned to office on 11/13/2023. Patient reported painful rash on left upper arm at injection site. Patient reports symptoms began on 11/09/2023, 2 days after injection administration, and that they have been worsening since then.  Physician  examined patient and advised on treatment.  Treatment plan was advised for pat to take Benadryl and use Ice for rash. A steroid pack was offered and declined at this time. Pt was advised to call office if symptoms are not improving.
plaque psoriasis flare ups on back and leg; droopy problem with both eyes lids top and bottom; Sick; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (plaque psoriasis flare ups on back and leg), EYELID PTOSIS (droopy problem with both eyes lids top and bottom), ILLNESS (Sick) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (plaque psoriasis flare ups on back and leg), EYELID PTOSIS (droopy problem with both eyes lids top and bottom), ILLNESS (Sick) and PYREXIA (Fever). At the time of the report, PSORIASIS (plaque psoriasis flare ups on back and leg) had not resolved and EYELID PTOSIS (droopy problem with both eyes lids top and bottom), ILLNESS (Sick) and PYREXIA (Fever) outcome was unknown.            Concomitant medication was not reported.  The patient had a droopy problem with both eyes lids top and bottom. She tried to get plastic surgery on both her eyes to correct the droopy problem, but her eye specialist was worried about her taking SKYRIZI and infection. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Myoclonic-like seizure began approximately 48 hrs after vaccine. Seizures occurred over 1-2 hrs periods, with up to 400 seizures in one hour. Seizures peaked for about 2 weeks, then tapered off. Seizures have continued for 8+months, with no benefits seen from medication. Developmental delays have also appeared. 60 day follow up states patient has continued daily seizures, poor sleeping patterns, and developmental delays (gross and fine motor, speech). The annual follow up received on 12/10/03 states continued neurological symptoms (tests pending). Continued developmental delays (gross motor, fine motor, social, academic, and self help). Continued severe language and speech delays. Seizure activity appears to have diminished. However, the onset clearly began two days after the above vaccination and seizures continued daily for 18 months to follow.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 29-year-old male. Neither medical history nor concomitant medications were reported. On 26-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Hives from head to toe including palms of her hands; Bruises; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955), via an unspecified route of administration in left arm on 27Mar2021 (also reported as 06Mar2021) (at the age of 49 years), as dose 2, single, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously received the first dose of BNT162B2 (Lot Number: EP6199) on 06Mar2021 at 10:00 AM (at the age of 49 years) for COVID-19 immunization (left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not administered with other vaccine in four weeks. The most recent COVID-19 vaccine was administered in a pharmacy or drug store facility. On 29Mar2021 at 09:30 AM (about 48 hours after second vaccination), the patient broke out in hives from head to toe including palms of her hands. Hives lasted 8 days. Hives erupted so violently they left bruises behind (2021). The patient received a steroid shot, took oral steroids, cetirizine hydrochloride (ZYRTEC), and diphenhydramine hydrochloride (BENADRYL) but nothing helped. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient considered the events as non-serious. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Hives from head to toe including palms of her hands" on 07Apr2021; and from the other event in 2021.  Follow-up attempts are completed. No further information is expected.