chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ED Discharged  7/28/2021 (3 hours) Emergency Department  DO Last attending ? Treatment team COVID-19 Clinical impression Shortness of Breath Chief complaint Review of Systems  Constitutional: Positive for activity change, appetite change, fatigue and fever.  HENT:       Positive for loss of sense of taste and smell  Respiratory: Positive for cough and shortness of breath.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Positive for abdominal pain and diarrhea.  Neurological: Positive for weakness and headaches.  All other systems reviewed and are negative.   Physical Exam Vitals and nursing note reviewed.  Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is ill-appearing.     Comments: Patient appears tired  HENT:     Head: Normocephalic and atraumatic.     Nose: Nose normal.  Eyes:     Extraocular Movements: Extraocular movements intact.     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Decreased breath sounds present.     Comments: Patient has a wet cough. Abdominal:     General: Abdomen is flat. There is no distension.     Tenderness: There is no abdominal tenderness. There is no guarding or rebound.  Musculoskeletal:        General: Normal range of motion.     Cervical back: Normal range of motion and neck supple.     Right lower leg: No edema.     Left lower leg: No edema.  Skin:    General: Skin is warm and dry.  Neurological:     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.      ED Triage Vitals [07/28/21 1611] Temperature: 37.2 °C (99 °F) Heart Rate: 83 Resp: 19 BP: 127/74 SpO2: 96 % Temp src: n/a Heart Rate Source: n/a Patient Position: n/a BP Location: n/a FiO2 (%): n/a
Arm pain in right upper area where shot was received developed in late afternoon of day of shot (3/16).  Upper muscular(right) arm pain increased and persisted for following 48 hrs after  initial injection. Injection site was red hot and swollen (swelling approx size of my palm). Upper right arm injection site stayed red hot with mild swelling for next three days then begun to itch  (3/22). It is now 3/27 upper right arm still mildly red hot and itchy.  some mild muscular pain - all pain localized to upper right arm  where injection received.
Onset of extreme chills, body aches, feeling very cold/chilled, shaking, malaise, for just that night.  Better the next day.  Took Advil/Tylenol, rested.
Received 3rd dose of GARDASIL 7/29/08.  Contacted office 8/19/08 with c/o dime sized "knot" that had increased in size within past 2 days.  Area slightly tender to touch, skin slightly discolored - pinkish red.  Very slight warm to touch.  Stated has had "knot" since date of injection.
His reaction really made him feel bad; He did not feel well for a day; This non-serious case was reported by a physician via sales rep and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: He did not feel well for a day) and feeling bad (Verbatim: His reaction really made him feel bad). The outcome of the feeling unwell was resolved (duration 1 day) and the outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling unwell and feeling bad to be related to Shingrix.     It was unknown if the company considered the feeling unwell and feeling bad to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR056717   Additional Information: GSK Receipt Date: 06-APR-2023 The patient self-reported this case (over age 50). The patient took preventative Shingrix vaccine. The patient reported that after his vaccine he did not felt well for a day and that his reaction really made him feel bad. The sales representative did not know if the reaction was to both shot 1 and 2 or one or the other. This case was linked with case US2023AMR056717, reported by same reporter.
AE identified; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (AE identified) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Sep-2022,  after starting , the patient experienced IMMUNISATION REACTION (AE identified). At the time of the report, IMMUNISATION REACTION (AE identified) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) 0.65 ml SQ. The patient developed Shingles within 2 weeks of receiving the vaccination. The patient sought unspecified medical attention. Additional information has been requested.
Rash itchy and urticarial. Scattered wheals. ORAPRED 15mg/5mg, 1/2 tsp BID.
L-back upper arm with 4.5cm x 3 cm erythematous, warm, and indurated area.  No lymphadenopathy.  Fever of 37.8 C.  Area burning ans hard to the touch.
After the second shot I was told I would get pain at the vaccination site headaches etc. Here I am 3 months later and my elbow and wrist are in chronic pain. It feels like I have tennis elbow in both of them that has prevented me from doing many physical activities I used to be able to. In general I try to stay physically fit with cardio and weight lifting. I have been unable to do any kind of heavy lifting with my right arm since my second dose without pain. Even small amounts of light movement will cause pain over time.
Diagnosed with with Pityriasis rubra pilaris (PRP) . Symptoms started days after vaccine.  Started with skin issues and firm diagnosis of Pityriasis rubra pilaris (PRP) . He has been in and out of hospital, he is extremely ill and will be for years. He is unable to walk or use his hands.
Information has been received from a registered pharmacist concerning a 60 year old female with "being sensitive to things" but no allergy to gelatin or NEOSPORIN who on 30-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Her concomitant medications and past drug history were unknown. On 01-APR-2009 the patient experienced redness the size of an orange, and a golf ball size of lump/also reported as swelling over injection site. It was unknown if any relevant laboratory testing was performed. The outcome was not reported. Follow up information was received from the registered pharmacist who reported the female patient had rash after receiving the ZOSTAVAX vaccine (Merck). The patient informed the pharmacist the rash was the size of and orange and inside the rash there was brighter area that was the size of a golf ball. The rash was in the pattern of a maple leaf. The reporter was not sure if the rash had blisters as she stated the patient would be coming in the afternoon on 02-APR-2009. Additional information has been requested
Itchy, red rash covering stomach, neck and arms. The rash stayed one day.
Pt received  second Bivalent booster vaccine by mistake. Pt. parents informed, possible side effects explained. Pt was feeling ok when leaving clinic.
Infant received 2nd dose of rotateq on 6/7/07.  Mom called on 6/8/07 at 4:00 PM to report "streaks of blood" in soft stool X 1. No apparent discomfort.  Mom instructed to observe.  Instructed to go to ER if symptoms of pain or further bleeding ocurred.  F/U phone call to mom on 6/11/07--she states no further symptoms ocurred over weekend.
On 9/8/21 patient presented to ER, and was admitted to the hospital. For the last couple days she felt  slight uneasy feeling or a pressure in the chest.  When she came to the ER,  she was found to have problem with AFib with rapid ventricular rate at times  going up to 150-200.  She had no specific symptoms related to that of  palpitations, syncope or near syncope.  Case was discussed with cardiologist.   She is started on Cardizem drip.    She has a previous history of peptic ulcer disease.  Not too long ago she also  had significant nosebleed.  She had a recent hip surgery done due to infected  hip and has a spacer and ongoing antibiotics.  The patient's potassium was  also low.    She also has been having problem with this watery diarrhea, not foul smelling  for last 4 or 5 days.  Frequent BM.  Every time she eats she has to go and  sometimes it starts before she can even control it.  When she came to the ER,  her potassium was low also.  Due to that, she is being admitted for further  management. On 9/18/21, was positive for COVID. She was incidentally found ot have RLL nodule on admission concerning for low grade adenocarcinoma . Fine needle aspiration 09/10/21 was complicated by  pleural bleed which caused hemorrhagic shock s/p multiple units of PRBC and platelets , septic shock was also suspected , required pressor support ,  s/p chest tube that was removed 09/17/21 , s/p IR angiography selective right intercostal artery T 6 - T11 but no active bleeding or aneurysm noted  . The pathology from the aspiration was negative for malignancy .    Diagnosed with COVID 19 pneumonia positive 09/18/21 , though vaccinated with Pfizer 06/16/21 . This is likely due to immunocompromised status . Completed Remdesivir ,     Required mechanical ventilation due to COVID 19 pneumonia  , initially extubated 09/11/21, but subsequently re intubated 09/19/21. She is s/p trach and PEG 10/06/21. Respiratory culture 10/30/21 did grow serratia marcecens. Respiratory culture prior to this was positive for candida albicans 10/07/21.Patient was managed with Ertapenem.     Foley catheter associated UTI - Klebsiella oxytoca. Urine culture positive 10/29/21.    GI bleed also reported , but remained unstable for invasive GI interventions.    She had AKI requiring CCRT .     Also CT head  10/10/21 noted intracranial bleed , neurosurgery evaluated , conservative treatment for now.    IVC filter was placed 09/24/21 for non occlusive DVT right common femoral vein  Non occlusive thrombus right proximal superficial femoral vein. Discharged on 11/10/21
Initial information received on 19-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves patient (with unknown demographic) who experienced rash, while received vaccines DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and PREVNAR 13. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and PREVNAR 13 (lot number and Expiry date unknown) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious rash (Unknown latency) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and PREVNAR 13. (Other relevant tests included No lab data.) Final diagnosis was rash. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown. List of documents held by sender: none.
Unwell feeling; Nausea; painful Rash; Fatigue but restlessness; Fatigue but restlessness; short of breath; muscle pain; joint pain; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 11:45 (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "Unwell feeling"; NAUSEA (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "Nausea"; RASH (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "painful Rash"; FATIGUE (non-serious), RESTLESSNESS (non-serious) all with onset 30Nov2021 23:45, outcome "not recovered" and all described as "Fatigue but restlessness"; DYSPNOEA (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "short of breath"; MYALGIA (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "muscle pain"; ARTHRALGIA (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "joint pain"; CHILLS (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "Chills". Therapeutic measures were not taken as a result of malaise, nausea, rash, fatigue, restlessness, dyspnoea, myalgia, arthralgia, chills.  Additional Information: The patient did not have covid prior to vaccination. The patient did not have covid tested post vaccination. The patient did have known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Developed a fever, chills and felt achy all over.  Had a fever for close to 10 hours.  At the injection site, my muscle begain twitching/spasming at around noon. This continued for the next 48 hours.  The muscle in the shoulder where the shot was administered became swollen and painful.
90 x 80cm of redness around injection site. Warm to touch. Patient states painful and stiff.
One week after patient's first dose Moderna vaccine,  she developed severe headache, body ache, and "heart discomfort ".  She went to see a doctor and she was told she had a high risk developing heat attack in the next few weeks.  Patient is back to work now, but she suspect this has something to do with her Moderna vaccine.
Much better than shot #1 . No pain with this shot at time of shot 6:00 pm 4/23/2021 . At 11:00pm slight local pain at injection site . Today at 2:54pm have  local pain at injection site .
PATIENT HAD PREVIOUSLY RECEIVED A JANSSEN COVID-19 VACCINE ON 07/02/2021
Pt. was given a ZOSTAVAX at 10:26 a.m. and began C/O bad taste in her mouth and throat tight. C/O internal jittery and chest tightness.
Almost 2 months later my left arm still hurt and I have limited motion. If I get it raised, it's painful and more painful to lower it. I have weaknesses and difficulty doing everyday task. I have trouble sleeping due to the pain.
BODY ACHES; CHILLS; This spontaneous report received from a patient 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 was not reported, administered on 30-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 30-OCT-2021, the patient experienced body aches. On 30-OCT-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and body aches. This report was non-serious.
Short term irritation and soreness at the injection site. About 5 or 6 days after the injection, I developed severe hives on my head, neck and body on both left and right sides of my front and back.  I made an early morning visit to the clinic and received prescription for a regimen of steroid tablets.  The hives nearly cleared and the prescription was changed to Claritin and Pepcid in the morning and Benydril in the evening. The symptoms have become less severe. The prescription was then change to Cetrizine HCL tablets and Pepcid AC in the morning and Montelukast in the evenings. The symptoms remained the same. After a couple weeks I saw an allergist who prescribed Centrizine HCL and Pepic AC twice daily and Montelukast in the evening. Symptoms persist.
Fully vaccinated and boosted on 12/10/21.  COVID infection breakthrough with inpatient hospital stay.
Red, circular rash itchy. Pt came in to be seen by provider and was put on BENADRYL.
I put vaccine in baskets this day when they came in from company and we had one in freezer and put the wrong vaccine in basket that was age 6-11 booster dose and not the bivalent that was bivalent. This was found in charting dose and was reported
No additional AE reported.; Customer called and reported that PROQUAD was inadvertently administered to a 16 year old consumer rather than MMR and VARICELLA.; Customer called and reported that PROQUAD was inadvertently administered to a 16 year old consumer rather than MMR and VARICELLA.; This spontaneous report was received from a medical assistant regarding 16-year-old patient of an unspecified gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-AUG-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W012743, expiration date: 16-OCT-2023 (strength, and route of administration were not provided) as prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/merck) (manufacturer unknown) (Wrong product administered and Product administered to patient of inappropriate age). No additional adverse event (AE) reported.
Dose 1 given on 2/4/2021. Injection area pain for about 48 hours, after that ok.  Then  8 days later, injection site redness, about nickel size. That redness area grew to about 4 1/2 " over the next 11 days, each day color changed from darker red spots to pink. Area was kind of tender.  The last few days area was itching, but not bad.
Pain at time of injection, which increased over time. It became so bad, I could not move shoulder. I went to my Dr. 5 wks after injection because pain was not getting better.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax & contracted atypical varicella like rash w/greater than 50 lesions which was pruritic soon p/vax;
No addittional adverse events reported; Gardasil 9 expired 11/30/2020; This spontaneous report has been received from a medical assistant, concerning a 19 year old patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 25-JAN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter,  lot # R009614 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 30-NOV-2020 (frequency, route and anatomical location were not provided) for prophylaxis with no temperature excursions. No additional adverse events reported.
2 1/2 inch X 1 1/2 inch red, hot. Subcutaneous reaction.
Fell several times; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell several times) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FALL (Fell several times). At the time of the report, FALL (Fell several times) outcome was unknown. Not Provided          No treatment was reported. No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-117899 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-117899:Himself
Starting 02/02, extreme dizziness, nausea, diarrhea , vomiting , muscle ache. 02/04 symptoms subsided. 02/06 redness, itching and swelling at site of injection continuing 02/07. Treatment: Ginger ale, broth, topical over the counter cortisone at injection site.o
No adverse event occurred or reported. Patient will be revaccinated approx. 1 month from incident date (2/9/15).
muscle pain; cough; fever/have high fever above 102; injection site pain; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular on right arm on 28Dec2020 17:00 at a single dose for COVID-19 immunization. Medical history was reported as none. Patient was not pregnant. Patient has no known allergies. The patient's concomitant medications were not reported. The patient reported she experienced symptoms like fever, injection site pain on 28Dec2020 (also reported as 09Dec2020, for clarification), muscle pain on an unknown date, and cough in Jan2021. She had high fever above 102 on 29Dec2020, one day after the vaccination and on the 5th day she started to cough. Patient did not receive any treatment for the events. Outcome of the events was not recovered.  Information on the Lot/batch number has been requested.