chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jun-2021 and was forwarded to Moderna on 19-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant Information was Reported. No Treatment Information was Reported.
Injection site soreness, foggy headed, tiredness and headaches. Narrative: Injection site soreness/tenderness lasting 2 weeks-Day 2 Felt foggy headed Day 3 & 4 Tiredness and headache.
Red raised fluid filled itchy burning rash to bilateral chest, upper abdomen, right neck area and rightmedial shoulder.
Patient presents following administration of the second dose of Moderna COVID19 vaccine in the left deltoid.  Patient stated that 20 minutes following administration of the vaccine, the patient started to experience an itching sensation in her left shoulder, neck, and right shoulder.  She denies decrease in muscle strength or difficulty swallowing.  She relates that a similar experience also happened following administration of the first dose of Moderna vaccine.  She related that it lasted for about 2 hours and went away without intervention.  She did not seek medical attention.  She denies allergies to medication, vaccines, and food.  She denies a past medical history.  She does not take medication on a regular basis.  She denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting.     Exam (update as needed): GEN: Alert and oriented x 4, NAD. HEAD: NCAT EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD.  CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: No rashes, skin warm and dry.  No erythema or edema of the injection site. MSK: FROM, MS 5/5 NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no ataxia, gait steady   Clinical Impression/Field Tx: Paresthesias related to vaccination.  No acute skin manifestations or anaphylactic manifestations that require emergent intervention.  Vitals signs stable.  Symptoms are stable.  Patient was driven to the site by significant other and stated they would take PO Benadryl once they arrive at home. They do not intend to operate heavy machinery for the remainder of the day.  Further instructed patient about what vaccine side effects to expect following second dose administration and appropriate interventions/at home care.   Instructed patient to consult their PCP regarding the post-vaccination reaction.  Patient instructed to go to emergency department should they develop chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting, as these are signs of possible anaphylaxis that requires immediate intervention.     Medications administered: None   Disposition:  Home
Boils on right butt, cheek, under nipples and on legs; Hand burns; Neck pain; Throat pain; spine pain; stiffness behind head, neck, throat and spine; Left arm tingles down to the hand; Head pain; This spontaneous case was reported by a patient and describes the occurrence of FURUNCLE (Boils on right butt, cheek, under nipples and on legs), SKIN BURNING SENSATION (Hand burns), NECK PAIN (Neck pain), OROPHARYNGEAL PAIN (Throat pain) and SPINAL PAIN (spine pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced FURUNCLE (Boils on right butt, cheek, under nipples and on legs), SKIN BURNING SENSATION (Hand burns), NECK PAIN (Neck pain), OROPHARYNGEAL PAIN (Throat pain), SPINAL PAIN (spine pain), MUSCULOSKELETAL STIFFNESS (stiffness behind head, neck, throat and spine), PARAESTHESIA (Left arm tingles down to the hand) and HEADACHE (Head pain). At the time of the report, FURUNCLE (Boils on right butt, cheek, under nipples and on legs), SKIN BURNING SENSATION (Hand burns), NECK PAIN (Neck pain), OROPHARYNGEAL PAIN (Throat pain), SPINAL PAIN (spine pain), MUSCULOSKELETAL STIFFNESS (stiffness behind head, neck, throat and spine), PARAESTHESIA (Left arm tingles down to the hand) and HEADACHE (Head pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  The reporter's causality for the events of head pain, left arm tingles down to the hand, boils on right butt cheek, under nipples and on legs, hand burns, neck pain, throat pain, spine pain and stiffness behind head, neck, throat and spine was not provided with HUMIRA(ADALIMUMAB).  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.   This case was linked to MOD-2022-630553 (Patient Link).
Seizure less than 1 hour long with fever. Needed intubation for respiratory depression after numerous doses of anticonvulsants. Transported via helicopter from out of state to local hospital.  Nurse follow up on 09/03/04 states: "Complete."
Patient had his 1 yr shots on 10/29/10/. Pt developed red rash on (R) upper thigh. Mom became alarmed over rash became raised, swollen, painful. She went to ED 11/2/10 was diagnosed & cultured with Staph > abscess. We saw ED on 11/8/2010.
heart pain when waking up in the morning and sporadically during the day. Doctor had me use Aleve--pain went away.
Patient started to develop itchiness on head, chest, and arms -diphenhydramine 25 mg PO (10 mL) x2
signs/symptoms, not sure if true adverse event:  had a taste in my mouth immediately after receiving first dose. Two days after first dose:  heart rate increased to 130's resting, systolic blood pressure increased to 140's resting, (usual heart rate 70's-90's,  usual systolic blood pressure 110's-120's), dizziness, headaches, very weak,  temperature up to 99F. Symptoms lasted about two days.   One day after 2nd dose: temperature up to 99F, heart rate increased to 130's resting (lasted about an hour),  systolic blood pressure to 140's resting (lasted about an hour), felt flushed in the face, headaches, weak, temperature up to 99F, no dizziness.  Symptoms lasted about one day.
BRIEF OVERVIEW: Admission Date: 8/30/2023 Discharge Date: Sep 2, 2023 Discharge Disposition:  home health care svc  ?  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE: 86-year-old female with a past medical history significant for chronic kidney disease stage IIIB as well as known atrial tachycardia and hypertension who presents due to complaints of bilateral lower extremity weakness.   Patient also notably had some complaints suspected related to upper respiratory infection.  Patient is mildly hypoxic on admission with a 90% oxygen saturation on room air.  Labs were remarkable for a creatinine of 1.35.  COVID-19 testing came back positive.  Chest x-ray showed no acute infiltrate.  Patient was admitted to the hospital for further evaluation and treatment.   Patient was initially placed on supplemental oxygen with 2 liters/minute and started on oral Decadron.  Respiratory symptoms improve and patient was weaned off oxygen.  Patient was discharged to complete 6 days total of oral Decadron.  Patient was seen by PT and OT recommended home with home care.  Patient was subsequent discharged home in medically stable condition.
Patient stated their shoulder was sore and they were unable to raise their arm (decreased mobility in arm).
accidentally administered expired ActHIB (expiry date 11Aug2023) to patient with no reported adverse event; Initial information received on 22-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 13 months old male patient for whom accidentally expired HIB (PRP/T) vaccine [ACT-HIB] (expiry date 11-Aug-2023) was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Aug-2023, the patient received accidentally an expired dose of 0.5 ml 1x (frequency: once) suspect of standard strength HIB (PRP/T) vaccine suspension for injection (lot:  UJ787AAA, Expiry date: 11-Aug-2023) via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Received TDaP and PNEUMOVAX L deltoid 3/31/09. Reaction of swelling, redness and immobility began within 24 hours of injection. Slow resolution of immobility and swelling with ongoing immobility.
Sudden palpitations, skipped heart beat, weakness in arms, sweating, nauseous. Had to go to for ECG and it came back abnormal and was rushed to hospital for further tests. These symptoms are currently ongoing and have been seeing a cardiologist since and have to take medication to control symptoms.
Allergies: Pneumococcal Vaccines Swelling; Pneumococcal Vaccines Swelling; This spontaneous report was received from a nurse practitioner via Pfizer and refers to a female patient of unknown age.  The patient's medical history and concomitant therapies were not reported. Her concurrent conditions included allergy to amlodipine (swelling), enalapril (nausea and vomiting), hydrochlorothiazide (cramps), lisinopril and to statins.  On an unknown date, the patient was vacinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (dose, frequency, strength, lot #, expiration date, anatomical injection site and route of administration were not provided).  On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (allergy to vaccine) as swelling. The outcome of the events was not reported.  The events were considered to be related to the suspect vaccine.  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2305USA004158:
Within 5 minutes of receipt of vaccine, reddened ears and reddened blotches on chest appeared.  No worsening after 10-15 minutes, but after 20 minutes appeared to worsen, and transport to ED via wheelchair initiated.  Pt treated in ED with epinephrine, solumedrol, Benadryl, famotidine and 1 liter of 0.9% Normal Saline IV on arrival time to ED.
pt recv vax;subsequently devel neck pain,hip pain & flu like sx;recovered w/in 2 days;
MILD HEADACHE; FEVERISH; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced mild headache, feverish, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild headache, feverish and fatigue was not reported. This report was non-serious.
Night of shot got body ache and tense feelings. Couldn't walk. Went to ER next day. Diagnosed with Guillain Barre virus. Hospitalized for 1 month. Double vision. Muscle weakness.
Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: nausea and vommiting
On 01/01/21 the whole shoulder showed erythema from the acromion area to the neckline down to the chest area. Itching and redness developed late on 01/07/21 around injection site continues to grow into hardening red patch of about 5 inches wide today.
Patient complained of worsening of a headache she experienced since 2/8/2021 after receiving the vaccine. Reported the headache was 8/10 on pain scale. She also reported she has hx of migraine headaches 2-3 times weekly. Was taken to ER via ambulance. She was given medications to control B/P and pain, then discharged to home after six hours.
Patient called the pharmacy and stated that she began experiencing arm pain shortly after recieving the injection. The pain intensified over the next couple of days but subsided before emerging again.  She noted that she thinks she received the shot a bit high. Patient states that she has begun taking OTC anti-inflamatory medication and is at this time having difficulty moving the arm or grabbing a cup of coffee from a table.  Patient was asked to seek medical attention if pain and immobility continue.
Arm is a little sore; A spontaneous report was received from a male consumer of unknown age who received Moderna's COVID-19 vaccine and experienced sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On Unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   After receiving the vaccine, he experienced sore arm. Treatment for the event was unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event was Unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I have a constant ache and limited range of motion in my left arm, sometimes throbbing and interrupting sleep. Sometimes I feel dull, sharp pains down the left arm to fingers of my left hand.
The evening  I received the vaccine I started to feel a spasm in my upper right side lip. Over night it moved up into my full cheek. It was a constant spasm that lasted through Monday. When I woke on the 19th my symptoms were gone.
Diarrhea; Stomach issues; Wasn't feeling well; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach issues) and MALAISE (Wasn't feeling well) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 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 DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach issues) and MALAISE (Wasn't feeling well). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach issues) and MALAISE (Wasn't feeling well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Patient presented to the ED with complaints of mild diarrhea that started the day she received her vaccine.  Doctor prescribed Lomotil and probiotic with instructions to follow up if diarrhea still present after 1 week.
About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and feeling tingling and maybe swollen, also, all of my regular pains in my body, ie. various mouth pains and said pains, certain things that act up in my body, were intensified and more bothersome, and I had a headache that wouldn't go away.  I felt "off" that night and the next day.  Probably like I was mildly sick and fatigued with body feeling sore all over and headachey.  About 36 hours after getting the initial dose, I was feeling regular again.
64 Y female with h/o HLD, DM2, cigarette smoker, vaccinated for COVID in March 2021, initially admitted 8/5 for AHRF in setting of COVID PNA (s/p toci x 2 and iNO) requiring escalation to ICU for bradycardia to the 20s, transferred to floor 8/10, then transferred back to the ICU 8/14 for increasing O2 req on HFNC 60L 100% with chest pain and trop elevation (0.37). Found to have acute MI on EKG 8/15 with ongoing chest pain, scheduled for intubation and PCI. In ICU, CP has resolved, amio and dobutamine drips were started, pt is extubated, and proning to improve oxygenation. On 8/22, had increasing oxygen requirement with CXR showing worsening infiltrates c/f PNA so decadron was increased to 20 mg daily and Zosyn was restarted out of c/f secondary bacterial/fungal/opportunistic PNA. Continuing to have increasing oxygen needs 8/23-25 with elevated inflammatory markers and increase in BNP c/f COVID inflammation and ?CHF so pulse dosing methylprednisolone, increasing respiratory support to CPAP, and continuing to diurese.  Note pt is till in the ICU on 8/26/21
pt recvd vax on 17jan90; on 15feb90, recvd 2nd dose of HEP B;at time of report no problems noted;
Case number PHEH2044US003824 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 and a follow up report from the pharmacist received on 18 MAR 2014. This report refers to a 15-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 004011A, expiry date: 30 JUN 2014) at a dose of 0.5 ml intramuscularly in the left arm on 13 DEC 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration).    Follow up report from the pharmacist received on 18 MAR 2014: FLUCELVAX vaccination date, batch number, expiry date, dose and vaccination site were updated.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 18 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Information has been received from a physician concerning a 2-3 year old patient who was vaccinated with ROTATEQ (lot number not reported) oral. Subsequently the patient was hospitalized with rotavirus. It was unknown that the patient received how many 2ml doses of ROTATEQ. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient. A female patient of an unspecified age received the second dose of the BNT162B2 (Pfizer COVID-19 vaccine, Lot/Batch number: EL9266, expiry: 31May2021) intramuscularly in deltoid right as dose 2, single for Covid-19 immunization on 22Feb2021 at 08:40 (2 hours prior to this report). Medical history and concomitant medications were not reported. The patient received the first dose of the BNT162B2 (Pfizer COVID-19 vaccine, Lot/Batch number: EN5318, expiry: 31May2021) intramuscularly in deltoid right (shoulder joint) on 01Feb2021 at 1:20PM as dose 1 single for Covid-19 immunization. It was reported that the second dose was inadvertently administered at her shoulder joint and not to her deltoid muscle on 22Feb2021 at 08:40 (instant). It was clarified upon follow-up that  reported medication error affected the patient with clinical consequences as the patient had shoulder pain requiring steroid treatment in an instant on 22Feb2021 08:40. Therapeutic measures were taken as a result of arthralgia: steroid treatment. It was reported that the events were evaluated at the physician office visit. The outcome of the event arthralgia was recovering. The reporter/pharmacist did not consider the Pfizer product to have had a causal effect to the events. Information on the Lot/Batch number has been requested. Follow-up (29Mar2021): This is spontaneous report received from a contactable Pharmacist. Updated information: suspect drug lot and expiration added. historical vaccine information updated (lot, expiry, route, vaccination date and time), event details (shoulder pain requiring steroid treatment added as event and coded "dose was inadvertently administered at her shoulder joint and not to her deltoid muscle" to inappropriate route of vaccine). This case is upgraded to serious IME. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Sender's Comments: Based on the information in the case report the causal relationship between the event Inappropriate route of vaccination, Shoulder pain, and suspect drug BNT162B2 can be excluded.
was observed post Covid-19 immunization for 15 minutes .  During the observation period, he experienced an adverse reaction with the following symptoms:  Tired feeling, eyes burning, flushed feeling.   Assessment : Time of assessment 0912.   Actions taken:  BP 162/79, P 82, 97% O2 saturation. He was placed in a wheelchair and taken out to the triage area by RC-EMS. Blood sugar 122. 12 Lead EKG done, patient monitored additional 15 minutes and reported feeling better. Last BP 165/82, P 83. He was able to get off the stretcher and ambulate to the door to go home with his wife. Instructed to call 911 if symptoms reappear, she verbalized understanding.
Within 24 hrs developed clusters of blisters on posterior area of tongue. Blisters surrounded by layer of white film.  Moderate pain in location of blisters, also accompanied by fever, fatigue, pain at injection site. Tongue blisters & white film reduced significantly by 24 hrs after presentation. Improvement continued for all symptoms. 72 hrs after presentation, blisters & white film no longer visible. No fever, fatigue, no pain at injection site.