chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from the patient's mother and refers to her daughter, a female patient of unknown age. There was no information about patient's pertinent medical history, concomitant and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). Additional information is not expected, as no contact details were provided.
Pt exp temp elevation 99.2, h/a, nausea, vomiting & diarrhea p/recvd flu vax; pt hospitalized x 2 days due to persistent severe h/a; an MRI & LP were performed; Results are awaited;
Patient was seen in the office on 12/29/2021 following a two day history of cough productive of increasing amounts of blood.  He also noted L-sided pleuritic-type chest pain.   On exam, his vitals were:  BMI 28.2, BP 110/70, P 116, T 97.2m O2 sat 95%.  His primary symptom was the chest pain, he was not short of breath but was noted to be diaphoretic.  Blood work and CT angiogram of chest were ordered.  The CT was positive for segmental pulmonary emboli within the lingula and RLL with associated pulmonary infarct.  He was admitted to the hospital due to risk of hemorrage because of active hemoptysis. He was treated with anticoagulants, the hemoptysis resolved and he was discharged home on Xarelto 15 mg po bid.
I felt feverish but had no fever; I couldn't sleep; I couldn't sleep, and had really bad brain fog for a day or two\ Felt rush up neck; The second, too salty/I felt it rush up my neck to my head and had a metallic taste in my mouth.; Things tasted more sour after 2nd dose\Food tasted saltier; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 42 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Apr2021 (Lot number: EW0158) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: Feb2020 (unspecified if ongoing), notes: When I had COVID, I lost my sense of taste for 5 months before it came back, Lost sense of taste for 5 months. Very mild case, No fever; "I felt low on oxygen", start date: 13Feb2020 (unspecified if ongoing), notes: I felt low on oxygen; "Dry cough", start date: 21Jan2020 (unspecified if ongoing); "I had brain fog", start date: 13Feb2020 (unspecified if ongoing); "felt a little sick to my stomach", start date: 13Feb2020 (unspecified if ongoing); "Lost my sense of taste", start date: 14Feb2020 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8727, With the first shot, food was more sour), administration date: 19Mar2021, for COVID-19 immunization, reaction(s): "food was more sour/Food also tasted sour for a few weeks"; Bnt162b2 (Dose Number:01, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8727), administration date: 19Mar2021, for Covid-19 Immunization, reaction(s): "Felt a little brain fog for the first day", "tired", "couldn't sleep for a few nights"; Bnt162b2 (Dose Number:01, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8727), administration date: 19Mar2021, for covid-19 immunization, reaction(s): "felt feverish". The following information was reported: DYSGEUSIA (non-serious) with onset 10Apr2021, outcome "unknown", described as "The second, too salty/I felt it rush up my neck to my head and had a metallic taste in my mouth."; PYREXIA (non-serious) with onset 11Apr2021, outcome "unknown", described as "I felt feverish but had no fever"; SLEEP DISORDER (non-serious) with onset 11Apr2021, outcome "unknown", described as "I couldn't sleep"; FEELING ABNORMAL (non-serious) with onset 11Apr2021, outcome "unknown", described as "I couldn't sleep, and had really bad brain fog for a day or two\ Felt rush up neck"; TASTE DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "Things tasted more sour after 2nd dose\Food tasted saltier". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
10/05/21  1. Suspected COVID-19 virus infection   2. SOB (shortness of breath)   3. Hypoxemia    10/05/2021 ED to Hosp-Admission  Current  10/5/2021 - present (10 days) Hospital  Pneumonia due to COVID-19 virus  Principal problem  Plan:  Admit patient -Continue supplemental oxygen, high flow oxygen to keep the sats to 92%.   If patient shows any deterioration, will plan for BIPAP. - Will Follow-up respiratory viral panel, COVID-19, blood cultures.  Covid with respiratory failure, will give remdesivir.    If patient improves, will plan for out of bed and activity as tolerated. Strict intake output Daily weights Inhalers as per protocol DVT prophylaxis with heparin  personally reviewed imaging
Since havi by the vaccinations I have had 2 week monthly cycles instead of my normal of 28 days. These cycles have been heavier than normal as well.
Injection was painless.   Within 5 minutes of vaccine felt dizzy and had heart rate into the 120's.  Duration approximately 5 minutes then tachycardia and dizziness resolved.  Also had a tremor.  No angioedema, urticaria or other skin/mucosal findings.  Was not anxious.  Arrived home and wife and children told me I looked flushed and noticed my pupils were significantly dilated.  The flushing and dilated pupils resolved over the next hour.  No shortness of breath or hoarse voice of any kind however my mouth felt extremely dry.  I did not do anything for treatment.  Spontaneous resolution.
Whelps developed. Got in waiting area she began to break out with a pruritic rash and had difficulty breathing. 62.5 Solumedrol IM given, 0.2 Epinephrine SQ given, 25mg Benadryl IM given. After 10 minutes, VS remained stable and pt reported relief. Was followed up 3/13/09.
This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age and race received  PREVNAR 13, via an unspecified route of administration in Sep2016 at single dose for immunisation.  The patient medical history and the patient's concomitant medications were not reported.  The patient experienced arm discomfort, she cannot use her right arm properly. The outcome was reported as unknown.  She went to doctor and he gave her muscle relaxant.
right hand became cyanotic about 45 minutes after admin- left hand later became cyanotic
I received the vaccine at 1:30pm on April 10, 2021. The next morning at 10am, I fainted.
Rash on forehead; temple to temple Rash on face; cheek to cheek and across the nose Rash around the lips Headache
There was no actual adverse event reported, the immunization was administered during a recall of a lot number that had a shorted expiration date.  It was later stated by the mfg that the vaccine was still safe to use, the patient did not need to repeat series and we did not need to notify the patient....but we are submitting this for record purposes only.
12yo receives COVID vaccine on 8/19/2021 w/in 12 hours starten t hoarse voice, body aches, fever SXS. worsening over 1 week, tested to COVID negative. RequireD Prednisone for laryngitis sxs. persisted x 2 weeks seen in ER 9/2/2021
COVID 19 Treatment/Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FP8891) and on 25Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic asthma" (unspecified if ongoing). Concomitant medication(s) included: AZITHROMYCIN, start date: 29Jun2022, stop date: 03Jul2022; ALEMBIC TELMISARTAN, start date: 29Jun2022, stop date: 03Jul2022. Past drug history included: Codeine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID 19 Treatment/Drug ineffective"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive, notes: COVID symptoms returned worse than before treatment with fever on 8Jul22. Therapeutic measures were taken as a result of drug ineffective, covid-19. The vaccine received reported as yes. Other medication in 2weeks reported as yes. Anti viral details was Product reported as COVID 19 Treatment as Paxlovid. Treatment start date was 29Jun2022. Treatment stop date was 04Jul2022. Indication was treatment of COVID-19. Other medication in 2weeks product was Azithromycin. Other medication in 2weeks brand was Alembic. Other medication in 2weeks start date was 29Jun2022. Other medication in 2weeks stop date was 03Jul2022. Adverse event start date was 08Jul2022. Adverse event start time was 12:00 AM. Patient recovered was not recovered. Treatment ae was no.
This spontaneous case reported by a consumer, describes the occurrence of out of specification product use (patient could have been provided a dose 6.5 hours after the vial was punctured) and pain in extremity (left arm sore after vaccination in the same arm) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown) for COVID-19 immunization. The patient's past medical history included no adverse event. No medical history reported. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Mar 25, 2021, patient experienced out of specification product use (patient could have been provided a dose 6.5 hours after the vial was punctured) and pain in extremity (left arm sore after vaccination in the same arm). On Mar 25, 2021, out of specification product use (patient could have been provided a dose 6.5 hours after the vial was punctured) resolved. At the time of the report, pain in extremity (left arm sore after vaccination in the same arm) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided. Reporter did not allow further contact.
Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 14-SEP-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose and frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a consumer concerning a female who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent and "experienced an adverse reaction" also described as "experienced side effects". It was unknown if medical attention was sought. There was no product quality complaint involved. No additional information was provided. No further information is expected.
Information has been received from a health professional concerning a 11 yr old female with no known medical history who on 11Sep95 was vaccinated SC with a 0.5ml first dose of varicella virus vaccine live. There was no concomitant medication. On 03Dec05 the pt presented with 60-75 vesicular lesions in varying stages over her whole body, a 102F fever and itching. The pt was treated with ibuprofen (Motrin) and diphenhydramine hydrochloride (Benadryl). At the time of the report the pt was recovering. There was no product quality complaint involved. Follow up information indicated that the pt had chickenpox. On 05Dec05 the physician's office received a phone call from the parent, symptoms and treatment were reviewed; isolated for duration of vesicles. It was noted that the pt's brother (WAES0511USA04538) had chickenpox the previous week. Subsequently the pt recovered on 15Dec05. No further information is available.
Had only two imminizations today. Prevnar in Left thigh about 1 hour later red hot and swelling down to Left knee. Very fussy and crying, screaming if touched at site.  Mother gave a bath and swelling decreased but stayed larger than a 50 cent piece. Came back to office for exam Tylenol given, cool washcloth and will Not give Prevnar in future. Documented in chart.
On 1/16/21 I went to my 10:40 vaccine appointment at the Stadium. By the time I received the vaccine it was 1:15pm and by 2:30 I had a throbbing headache (I had a slight headache already before the vaccine). When I got home I took 2 extra strength Tylenol's and felt fine. At 3:30am that night I had pain and bruising on my left arm which I rolled on in my sleep and the pain woke up me. When I went to turn on my right side I heard a popping noise in my neck and was no longer able to move my neck to my right. I got up scared and started to experience chills, nausea, and dizziness. I went back to bed to try to calm down. I was not able to move my neck at this point or pick up my head off the bed. I called my sist
Pt received vaccines at 0740am and at 0743am she developed SOB, nausea, tingling/swelling of lips, throat swelling, and redness of the face and upper extremities. She received EpiPen 0.3 IM, Benadryl 25mgPO, and alb neb. Within a few minutes of received the epi, patient BBS CTA, color of lips and skin returned to normal, denied SOB, denied tingling and swelling with none noted on assessment either. She was monitored in the office for approx. 1 more hour at which time she was discharged with instructions to call 911 if any allergic symptoms reoccurred.
Cold sores on lower lip.  Painful blisters and cracking; Cold sores on lower lip.  Painful blisters and cracking; Cold sores on lower lip. Painful blisters and cracking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 at 14:45 as dose 4 (booster), single (Lot number: 9943) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "High BP, Cholesteral" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN; LOVASTATIN. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Booster, unknown manufacturer), for Covid-19 Immunization. The following information was reported: CHAPPED LIPS (non-serious), LIP PAIN (non-serious) all with onset 20Apr2022 at 13:00, outcome "not recovered" and all described as "Cold sores on lower lip. Painful blisters and cracking"; LIP BLISTER (non-serious) with onset 20Apr2022 at 13:00, outcome "not recovered", described as "Cold sores on lower lip. Painful blisters and cracking". Therapeutic measures were not taken as a result of chapped lips, lip pain, lip blister.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine received in four weeks. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Olmesartin, lovastatin. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. COVID was not prior vaccination. COVID was not tested post vaccination. No Known allergies. Other medical history included High BP and Cholesterol.
On 9/17/2020 the patient called and said she was having swelling and Rt shoulder pain down to her wrist after her shot was given on 9/16/2020.. the Clinical manager spoke with her after speaking with the doctor and told her to use heat or ice for the swelling and tylenol or advil for the pain. Patient called back 9/22/2020  and said she was fine and the pain and swelling where gone.
no additional AE's reported/no symptoms were reported; Proquad administered since the excursion occured on 22-JUL-2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # T037955, expiration date 09-MAY-2022, dose 1 (unit not provided) (injection site and route of administration were not provided) for prophylaxis.   On 22-JUL-2021, the administered dose experienced a temperature excursion of 13.02 degrees Fahrenheit for 1 hours and 30 minutes The digital data logger was involved in recording the temperature excursion details. Previously the dose experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (14 degrees Fahrenheit) for 6 hours, 14 degrees Fahrenheit to 46 degrees Fahrenheit (46 degrees Fahrenheit) for 14 hours and 47 degrees Fahrenheit to 77 degrees Fahrenheit (48.9 degrees Fahrenheit) for 30 minutes. The vaccine was given a new expiry date of unknown date in September 2021. No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000958: US-009507513-2108USA000973:
Chills, mind foggy-ness, very tired all day 4/12/22, the day after the injection. Resolved by 4/13/22 so 1 day duration.
Information regarding PREVNAR 13 was received from a healthcare professional regarding an 86 year old patient who received PREVNAR 13 instead of PNEUMOVAX. The patient received a dose of an unspecified date. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced received PREVNAR 13 instead of PNEUMOVAX. No adverse event was reported. No additional information was available at the time of this report.
Dizziness, light headed, fever, nausea, vomiting, joint pain, headache.
On July 5th my watch started to alert me of a high resting HR (around 110). I got these alerts five times that day.I noticed a pressure feeling in my chest area as well as shortness of breath.  On July 8th, my watch alerted me again of a high resting HR (130 bpm resting after no physical activity). I tried deep breathing to calm myself, but this did not work. I waited 2 hours for it to subside, but it didn't. I felt a weird tingly sensation in my lower calf area, and again pressure in my chest area. Due to this, I decided to go to the ER to have my symptoms evaluated in case of a blood clot.
Information has been received from a physician concerning a 13 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 17-MAR-2007 the patient developed a full blown case of chicken pox. On 19-MAR-2007 the patient presented to the doctors office. The patient's mother indicated that the child was previously vaccinated with varicella virus vaccine live (Oka/Merck) on an unspecified date but there was no written documentation of the vaccination dates. The patient was treated with "acyclovir(ZOVIRAX). At the time of the report the patient was not recovered. There was no product quality complaint involved. Additional information has been requested.
1st dose administered to 17 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 17 year old). On 21-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 17 year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided  Treatment medication was not provided   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Initial additional. Reporter reported no adverse reaction.
Flu like symptoms, soreness at site. Lymph node pain. Lasted over a 24 hr period. Dx was unable to work.
Patient reports pain, redness, swollen bruising at injection site. Injection site is lower than the deltoid muscle
Initial case was received on 26 October 2009 from a physician. This was reported as one of a cluster of two patients who experienced adverse events following vaccination with H1N1 2009 Monovalent Vaccine - Preservative (lot number UP001AA). The other patient experienced a non-serious event, which is captured in case number 2009-04481. A three-year-old male patient, with no reported medical history, experienced dystonia after receiving an intramuscular left deltoid first injection of H1N1 2009 Monovalent Vaccine - Preservative (lot number UP001AA) on 14 October 2009. Approximately four days post-vaccination, on 17 or 18 October 2009, the patient's mother noted right eye twitching, jerking of the right arm, and occasional jerking of the right leg. The symptoms occurred daily, particularly when the child was attempting to fall asleep. He was seen by his physician on 21 October 2009 and an exam was normal at that time; however, the physician noted that the patient's mother had videotaped the events and that the videotape was "impressive". He was subsequently seen in the emergency room, and was diagnosed with dystonia. An MRI and EEG were normal. At the time of the report, the event had not recovered. The patient had not received any other vaccines within four weeks of vaccination. Per the reporter, he did receive annual seasonal influenza vaccines. Documents held by sender: None. 11/3/2009 ED records from 10/21/2009. Patient with c/o's eye, mouth and arm twitching, jerky movement of lt arm and rt leg. Neuro exam norm, TX: close observation, no meds. DC DX Dystonia versus focal seizures. 11/9/09 Vaccination record received and updated.    11/3/09 DC summary received for dates 10/21/09 to 10/22/09. DX:Dystonia vs focal seizures. Pt. presented with sudden onset of twitching eyes, mouth, arms muscles lasting a few seconds x4 days prior to admission. 4 days prior to onset of sx, pt had H1N1 vax.
pt recvd vax & had 4cmx4cm area of induration on Lt Leg at site of inject; no fever or erythema; non pruritic;
Painful Tracking bruise about 2 inches in length. Bilateral reddened rash to the left and right of the vaccine site.   Rash subsided in 2 days and tracking bruise remains one week post-vaccine.