chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tickle in throat/hot brain Narrative:  LOCAL TITLE: Addendum STANDARD TITLE: ADDENDUM DATE OF NOTE: APR 05, 2021@10:32:53 ENTRY DATE: APR 05, 2021@10:32:54 AUTHOR: PROVIDER EXP COSIGNER: URGENCY: STATUS COMPLETED patient with s/e tickle in the throat not brain provided with apple juice and water drank all of the juice no additional tickle in throat at 1006am, discussed with lead who cleared for release at 1008am vvs 0950 62 pulse, 96/65 b/p and rr17 vvc 1003 67 pulse, 103/69 b/p and rr 16 02 sat 98% on room air /es/ Provider Nursing Specialty  Clinic Signed 04/05/2021 10:36 ================================================================== --- Original Document --- 04/05/21 VAERS NSG COVID VACCINE ADMINISTRATION: The patient was given the EUA fact sheet for this vaccine which list the benefits and side effects of the vaccine and which reviews the risks of the vaccine. The fact sheet was reviewed with the patient and they were given an opportunity to ask questions. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. The patient gave verbal consent to receive the vaccine. Dose #2 The patient received Pfizer COVID-19 Vaccine 0.3 ml IM. MVX (Manuf); Lot#; Exp Date: PFR; ER8732; 07/31/2021 Administration Anatomic site: Left Deltoid Vaccine administered without complications. The patient was advised to remain in the facility for 15 minutes post vaccination. The patient was given a completed COVID-19 vaccination record card, a copy of the facility side effects and adverse events reporting fact sheet and instructed on how to report any adverse reactions. Vaccine administered by protocol without complications. The patient was advised to remain in the facility for 15 minutes post vaccination. /es/ Provider Nursing Coordinator Specialty  Clinic Signed: 04/05/2021 09:37
Information has been received from a physician concerning an 18 year old female patient who on 07-SEP-2007, was vaccinated with a first 0.5 ml dose of GARDASIL. Within 24 hours, the patient developed a high fever of 103F and vomiting. Unspecified medical attention was sought. The patient was instructed to take MOTRIN as needed. Subsequently, the patient's symptoms resolved and "is fine now." No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007.  Information has been received from a physician concerning an 18 year old female patient who on 07-SEP-2007 at 16:00 was vaccinated with a first 0.5ml dose of GARDASIL (Lot reported as "01984").  Within 24 hours, the patient developed a high fever of 104F and vomiting.  Unspecified medical attention was sought.  The patient was instructed to take MOTRIN as needed.  On 12-SEP-2007, the patient's symptoms received and "is fine now".  No product quality complaint was involved.  Additional information is not expected.
Symptoms: Severe headache, nausea, muscle aches, very tired, left arm pain, dizziness, weakness - began some time in early morning of March 21 Called Emergency Room. Spoke to ER doctor who recommended: 2 Tylenol, 1/2 Benadryl, plenty of fluids, eating light, light activity level  I followed these except used only 1 extra strength Tylenol which I repeated twice during the day. Spent most of day sleeping. Improvement by morning of March 22. March 22 - tiredness continued so limited activity.
Pt recvd vax on 2SEP92 & on 8SEP92 lab eval revealed inc serum bilirubin; repeat lab eval was not performed; No further details were provided;
Blood pressure was 130/70; Pulse rate was 133; 48 hours later injection site swelled up to peach size; Fast heart rate, a dozen times a day; Fluctuating heart rate from 20-30 points, difference from 80-120, not steady; Adverse reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE REACTION (Adverse reaction to the vaccine), TACHYCARDIA (Fast heart rate, a dozen times a day), HEART RATE ABNORMAL (Fluctuating heart rate from 20-30 points, difference from 80-120, not steady), BLOOD PRESSURE INCREASED (Blood pressure was 130/70) and HEART RATE INCREASED (Pulse rate was 133) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction and Epilepsy, unspecified. Concurrent medical conditions included Peanut allergy and Migraine, unspecified. Concomitant products included AMITRIPTYLINE and ORAL CONTRACEPTIVE NOS for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ADVERSE REACTION (Adverse reaction to the vaccine). On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (Fast heart rate, a dozen times a day), HEART RATE ABNORMAL (Fluctuating heart rate from 20-30 points, difference from 80-120, not steady) and INJECTION SITE SWELLING (48 hours later injection site swelled up to peach size). On 05-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was 130/70) and HEART RATE INCREASED (Pulse rate was 133). At the time of the report, ADVERSE REACTION (Adverse reaction to the vaccine), TACHYCARDIA (Fast heart rate, a dozen times a day), HEART RATE ABNORMAL (Fluctuating heart rate from 20-30 points, difference from 80-120, not steady), BLOOD PRESSURE INCREASED (Blood pressure was 130/70) and HEART RATE INCREASED (Pulse rate was 133) had not resolved and INJECTION SITE SWELLING (48 hours later injection site swelled up to peach size) outcome was unknown.            Treatment for the events included lab work, EKG and chest x-ray. No results provided. Patient was advised to follow-up with Cardiology.   This case was linked toMOD-2021-068409 (E2B Linked Report).; Sender's Comments:  MOD-2021-068409:CROSSLINKED WITH DOSE 1
Onset of chest pain a couple of days after receiving Pfizer Covid-19 vaccine. Sharp pain over left chest - some days it is persistent and other days it is intermittent. No meds taken, pain eventually subsides. Vaccine was given at local discount store.
10-15 min after administration of her 2nd booster, she came up to me and told me that within 5 min of giving her the shot she felt a pinching feeling in her chest. She said that at that point it had started to subside. She took her BP on the HIGI machine and it was 126/62. I asked her if she wanted me to call anyone for her. she declined. I asked her to stay a little longer for further observation. at this point she said that the pinching feeling had almost completely subsided. She continued to sit in the waiting area until she came up to me and told me she was leaving and that she felt fine. I told her to call 911 if it came back or if there was an emergency. *I did ask her prior to immunization whether she had reacted to any of the previous 3 doses and she said no*
Information has been received from a registered nurse (R.N.) referring to a 31 year old male patient. No relevant medical history or concurrent conditions were reported. The patient was vaccinated with two pediatric doses of RECOMBIVAX HB (dose not reported), on 28-MAY-2015 (lot #010535, expiration date not reported) and 28-JUN-2015 (lot# K020216, expiration date not reported) respectively, intramuscularly in the left deltoid. On an unknown date in 2015, the patient experienced muscle twitching in the left deltoid. The patient sought medical attention by reporting the event to the reporter's department. The outcome of muscle twitching was unknown. Causality between muscle twitching and RECOMBIVAX HB was not reported. Additional information has been requested.
Recurring periods of increased chest pain and fluttering; Recurring periods of increased chest pain and fluttering/Sustained dull ache in chest; Chest discomfort increases at night and in morning; Experiencing some shortness of breath when chest discomfort peaks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Nov2021 (Lot number: FF8839) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, product=COVID 19, brand=Pfizer - COVID 19 - Sanford (SNF-PFIZER-COVID19), lot number=FF8839, administrator route=Intramuscular, vaccine location=Left arm), administration date: 20Oct2021, when the patient was 28 years old, for COVID-19 Immunization. Sustained dull ache in chest starting a few days after second dose; recurring periods of increased chest pain and fluttering. Chest discomfort increases at night and in morning, wanes during the day. Experiencing some shortness of breath when chest discomfort peaks. As of 22Nov2021 symptoms continue. Have waited to see if symptoms subside before seeking medical treatment. The following information was reported: CARDIAC FLUTTER (medically significant) with onset 16Nov2021 06:00, outcome "not recovered", described as "Recurring periods of increased chest pain and fluttering"; CHEST PAIN (non-serious) with onset 16Nov2021 06:00, outcome "not recovered", described as "Recurring periods of increased chest pain and fluttering/Sustained dull ache in chest"; CHEST DISCOMFORT (non-serious) with onset 16Nov2021 06:00, outcome "not recovered", described as "Chest discomfort increases at night and in morning"; DYSPNOEA (non-serious) with onset 16Nov2021 06:00, outcome "not recovered", described as "Experiencing some shortness of breath when chest discomfort peaks". Therapeutic measures were not taken as a result of cardiac flutter, chest pain, chest discomfort, dyspnoea.
HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 is unable to perform follow up to request batch number No concomitant medications were reported. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Started with chest pain and nausea 6/16/21 morning. Transported to Emergency Department due to recent news of possible vaccine side effects. Troponins found 11.47. Transported to Pediatric ICU for monitoring. Stable and resolved chest pain. Was monitored with peak troponin 44.96 on 2nd day of admission. Found to have myopericarditis, ECHO initially 56% ejection fraction on 6/16->55% on 67->62% on 6/22. Troponins downtrended after intravenous immune globulin given twice. Troponin 0.54 6/22 (repeat one pending) prior to discharge.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/13/2021 and 2/3/2021. Patient presented to ED on 9/16/2021 for hypoxia. Patient was hospitalized, became delirious, and aspirated. Patient received dexamethasone, remdesivir, ceftriaxone, and zosyn. Patient continued to decline throughout hospitalization. Family decided to transition to comfort care and patient expired at 1212 on 9/21/2021.
Approximately one hour after receiving the vaccine, I noticed slight heart palpitations, very occasional and mild.  I had not experienced these before.  No very worrisome, but noticeable.  They occurred approximately four times a day.  They occurred while I was sitting.  I did not have any issues with exercise.  They increased one week later.  On 12/30/20 I was seen at urgent care for an EKG, bloodwork, etc.  Although the EKG was normal, the physician and nurse were able to detect preventricular contractions on the heart monitor.  My blood pressure was very elevated.
Doctor had sent script for Shingles vaccine to pharmacy but then received it in the office. The pharmacist didn't check the data base and gave another shingles vaccine. Where error took place: Retail Pharmacy How prescription filled: Electronic prescription sent directly to the pharmacy (by computer) from my doctor's office Type of pharmacy: Chain Pharmacy
Pt. called the health unit on 08/31/2012 stating that she woke up the morning after receiving Hep A and meningococal shots with face swollen, rash on face and back and itching. Denied any problems with breathing.
RN sitting with patient talking to her. At 10:25 she received her first dose of Pfizer. At 10:27 patient reporting filling her heart racing ,feeling woozy feeling like she was going to faint. Patient went limp in the chair with her eyes rolled in the back top of her head unresponsive for 20 to 30 seconds. Patient came to and said she was nervous about the vaccine since all of her family reacts this way. Assisted transfer to wheelchair then transferred to gurney. At 10:32 AM BP 105/66 heart rate 63. At 10:37 BP 120/80 heart rate 62 respirations 20 oxygen saturation 98% temperature 98.0. Because of history with seizures and not taking seizure medication EMT was called. 1042 EMT arrived and did their assessment. At that time patient was sitting up and ambulating without dizziness. Patient called friend to pick her up in private auto at 11:17 to take her home and reported he could stay with her for the next couple of hours for observation.
Headaches/migraines lasting 20 hours, feeling unwell, tiredness, nausea, vomiting, sore arm
The patient had a previous reaction to a flu vaccine.  She was treated for Bell's Palsy related to the flu vaccine 3 years ago.  The patient with the moderna vaccine started feeling left arm weakness and the arm felt heavy.  She was unable to lift arm.  She had a lump in her throat but minimal difficulty breathing and swallowing.  She then reported right arm weakness and being unable to move either arm.  She was having episodic type reactions. Every few minutes she would lose color and appear to be having difficulty breathing and swallowing but would come back to normal within a minute or two.  After the 4th episode in which she stated she was going to pass out and could not move her legs, we had EMS called to come monitor the patient.  EMS took vitals and monitored for and additional 20-30 minutes.  The patient refused to leave with EMS and I continued to monitor for a short time longer for the duration of about 1.5 hours.
6 May - TWINRIX administered (R) deltoid. Dizziness; global HA; localized redness & soreness. 6.1 cm x 4 cm (wxh) tx - 9 May- Prednisone 10 mg po 2d for 5d; TYLENOL 325 mg two every 4-6 H PRN.
Headache, Myalgia & NauseaVomiting Narrative:  Headache, myalgia, nausea
Chills; severe headache; nausea; 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 CHILLS (Chills), HEADACHE (severe headache) and NAUSEA (nausea) 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 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (severe headache) and NAUSEA (nausea). At the time of the report, CHILLS (Chills), HEADACHE (severe headache) and NAUSEA (nausea) outcome was unknown. Not Provided          No concomitant medication information was provided. No treatment medication information was provided.   Reporter did not allow further contact
Patient complains of bilateral neck swelling and tenderness to touch in addition to soreness to injection site (right arm).
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was vaccinated with the first dose of RECOMBIVAX HB (Lot # 1742A2) on 15-JAN-1995, second dose of RECOMBIVAX HB (Lot # 1742A2) on 10-JUL-1995 and third dose of RECOMBIVAX HB (Lot # not reported) on 18-MAR-1996. This is one of several reports received from the same source. Additional information is not expected.
Patient developed red splotchy areas to face and noted itching to those areas within 10 minutes of vaccine administration. Patient was observed for 30 minutes after vaccine administration and symptoms (redness and itching) significantly improved. Patient noted no other associated symptoms. No medications were given to relieve symptoms and provider plan is to have patient evaluated by allergist before future vaccines are given.
Rash Severe arm pain that radiated down arm with tingling and numbness. Radiated up to left jaw. Narrative:
Sick day after shot, Rash in arm 3 days after shot, shingles 1 week after shot (
Caller states her son had all of the Pfizer Covid vaccines, 2 series, and 2 boosters, and subsequently tested positive for Covid; Caller states her son had all of the Pfizer Covid vaccines, 2 series, and 2 boosters, and subsequently tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the parent.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6198), in right arm, on 30Mar2021 as dose 2, single (Lot number: EP6955), in right arm, on 12Jan2022 as dose 3 (booster), single (Lot number: FJ5683, Expiration Date: 31Jan2022), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9896, Expiration Date: 30Jun2022) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seizures" (ongoing), notes: From: 6 months old.seizures happened after a Pertussis vaccine. , . There were no concomitant medications. Vaccination history included: Pertussis vaccine (AE(s) following prior vaccinations: Seizure: Caller probed : Pertussis vaccine: Caller cannot provide an NDC, Lot number, expiration date, when probed, as it was years ago.), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Caller states her son had all of the Pfizer Covid vaccines, 2 series, and 2 boosters, and subsequently tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: Patient had all of the Pfizer COVID vaccines, 2 series, and 2 boosters, and subsequently tested positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course:Patient had no prior vaccinations(within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Immunization DTaP/IPV given on 07/18/2003.  DTaP done on right arm.  Called on 07/19/2003.  Size of lemon redness, with swelling around shot area on right arm.  Warm to touch, no temperature.
Aches/ body aches; Lymph node is swollen; Fever of 101.5; Chills; Headaches; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Aches/ body aches), LYMPHADENOPATHY (Lymph node is swollen), PYREXIA (Fever of 101.5), CHILLS (Chills) and HEADACHE (Headaches) in a 59-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 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Aches/ body aches), LYMPHADENOPATHY (Lymph node is swollen), PYREXIA (Fever of 101.5), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, MYALGIA (Aches/ body aches), LYMPHADENOPATHY (Lymph node is swollen), PYREXIA (Fever of 101.5), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided by the reporter.
Subjective reporting of fever after 1 day.  Subjective reporting of right arm pain and decrease ROM.
Febrile for 9d starting the day after vaccine and rash (diffuse confluent erythema, maculopapular rash on trunk, back, ext, palms, soles) X 2 days.
High fevers 102+, Nausea, Dizzy, lethargic, weak & tired
1/22/2021 - Extreme Fatigue, Headache, Nausea, Dizziness 1/23/2021 - Headache, Pain at Injection Site 1/23/2021 - Present - Blurred Vision in Left Eye
while giving the injections to the patient, the second injection the medicine shot ran down in my lap; while injecting Typhim vi syringes came apart; Initial information received on 29-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA120316 (patient's case).  This case involves a patient of unknown demographic who experienced occupational exposure to product, while giving the injection of vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (lot number N1K81and Exp. Date 19-Oct-2019) to patient on 25-Apr-2019.  The patient's past medical history not reported.   This was a case of occupational exposure to product and Syringe issue as while giving the injections to the patient, the second injection the medicine shot ran down in pharmacist lap as syringe came apart from the syringe.  It was not reported whether patient experienced any adverse event.  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 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.  List of documents held by sender: none.
Information has been received from a registered nurse concerning a 14 year old female patient with no medical history or allergies who on 18-MAY-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 655324/0089U). Concomitant therapy included vitamins (unspecified). On 18-JUL-2007, the patient was vaccinated with a second dose of Gardasil (Lot# 654535/0960F). On 18-JUL-2007, the patient had experienced generalized achiness with joint pains. Unspecified medical attention was sought. It was reported that the patient was to be seen in the office on 21-AUG-2007. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
pt recvd measles vax on 6DEC91 & on 14DEC91 shook all over; 15DEC91 became febrile & restless; sx persisted on 16DEC91; no further details were provided;
Vaccine administered was at room temp for 4 hours 10 minutes at time of vaccination.  Manufacturer states vaccine should be discarded at 2 hours.
Erythematous plaque presented 24 hrs after administering Tdap and MCV at Right Deltoid.
Fatigue; muscle pain at injection site; joint pain; headache; low grade fever; chills.
Extramural tires joint and muscle pain still to this day doctor suggested Benadryl joins feel swollen and hard to move muscles hurt all over