chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was asked to return to clinic for 2nd dose of influenza vaccine as mom related that this was first influenza vaccine she received. Patient was given #2 dose of flumist, when entering dose/date into immumization computer registry, it was noted that patient had had several other flu vaccines in past, so this 2nd dose was not needed.
Fever 105.6 12 hours after shot, persisting two days even with Tylenol, then fever 101-103  lasting 3 weeks,, racing resting heart rate, racing heart and dizziness at minimal activity.
Vaccine #1 5/9/2021 Pfizer EW0177  Pt currently has Covid 19 8/7/2021
Started with a Sinus/allergy infection for two months which lead to a  consistent cough . Cough never went away went back to a doctor for the 4th time to be diagnosed with asthma. I have never been to a doctor so much since I have had this covid vaccine.
Within 30 minutes of receiving vaccine I began having numbness in my chest and arms, within 45 minutes I developed hives. Headache developed at 1 hour. Hives continued to come and go (with Benadryl 50mg) for 3 to 4 days. Last date hives occurred 8-7-2021. Headache  from 8-4-21 thru 8-11-21. Fever of 101 oral started 8-5-21 around 10 am. Fever no higher than 101 lasted for 2 days. Dizziness began Friday 8-6-21, progressed to severe vertigo on Tuesday August 10th . I woke up at 5:15 to go to work and the entire room was spinning and I had to lay down. Wed August 11th the vertigo was improved as long as I moved slowly. I still have some vertigo if I turn my head to fast. Fatigue started on 8-5-21. Muscle weakness started 8-5-21. Muscle weakness is improving . I received my vaccine at place of employment that is a medical practice. I carry an epi pen due to environmental allergies.    I did not have any breathing difficulty . No treatment given other than rest and Benadryl.
Within 15 minutes of vaccine there was tingling sensation in the mouth.  Within 40 minutes of the vaccine there was tongue swelling, a metallic taste, and dry mouth. April 25, 2021 (10 a.m.) - Right half of face, right arm and right leg all went numb and tingly (Paresthesia). April 26, 2021 (evening) - slight shortness of breath, Dry mouth continued, sharp upper back pain  April 28, 2021 (evening) - Shortness of breath, throat swelling, Dry mouth continued, sharp upper back pain. April 29th - Prescribed 40 mg of prednisone for 5 days (I felt good while on the prednisone), advair and albuterol May 4th - Symptoms returned after the prednisone dose was complete - On and off tingling/numbness of arms and right leg (Paresthesia), sharp pain in left calve and foot, shortness of breath, sharp back pain (upper), stomach pain (sharp), heart palpitations, dizzy, light headed. - These symptoms continue until present day (June 10, 2021). 21 Day dose of prednisone has been prescribed and a referral to a pulmonary doctor.  June 10, 2021 - breath test came back abnormal indicating asthma -
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 12-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R018589, expiration date: 09-AUG-2019, strength, dose, frequency and route were unknown) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Pt vaccinated with HIB-TITER developed haemophilus influenza, sepsis, & meningitis admitted to hosp. First shot of series
Left sore arm at site 48 hours, dizzy, headaches, fast heart rate average 104-115 x 2 days, 3-5 days headaches and neck ache, neck stiffness, neck pain
Tech mistakenly mixed the undiluted pediatric vial with an undiluted adult vial and injected 0.2ml of the undiluted solutions into patient. Both vials were not diluted with normal saline
Swelling, redness of (L) upper arm. Applied ice packs every 4-6 hrs. OTC BENADRYL PRN, TYLENOL PRN.
I've had a sore throat, cough, wheezing, congestion, extreme fatigue, sob, sinus. I tested negative for COVID, strep, flu. They are calling it upper respiratory infection. They put me on doxycycline and prednisone.
Pt recvd Td vax on 8JUN92 & w/in 1/2 hr became nauseated, & sore in the area of inject; next 2 days exp nausea, vomiting & diarrhea; t101, arm was very sore w/swelling, numbness & tingling to the fingers;
48 hrs p/vax elevated temp of 104 x 5 days-genl malaise, around immun area very sore & almost a bruised appearance; temp dec p/5 days; genl malaise for 10 days APAP only treatment;
Weakness, nausea, headache, runny nose, sore throat, swollen lymph nodes in neck. Start of symptoms 9/10/06.
Did not receive the the 2nd dose between 25-35 days of the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive the the 2nd dose between 25-35 days of the 1st dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive the the 2nd dose between 25-35 days of the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive the the 2nd dose between 25-35 days of the 1st dose) had resolved.            Concomitant medications were not provided.  Treatment information was not provided by reporter.
Increased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Increased blood pressure) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Increased blood pressure). At the time of the report, BLOOD PRESSURE INCREASED (Increased blood pressure) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure management (120-80): 122/73 (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up information received on 20 Jul 2021 contains updated event outcome to recovering/resolving.
Patient starts complaining of heaviness and numbness to left side of face at 1317.  Patient taken to private tent to evaluate symptoms.  Patient has 2 red raised areas to left side of nose and cheek.  Benadryl 25 mg IM administered at 1320 in right upper arm.  Pulse rate of 100 in with oxygen saturation of 98% on room air.  As observation continues, patient complains of heaviness and discomfort to left arm, leg, and chest.  Patient?s oxygen saturation at 1325 is 100% on room air with pulse of 80.  Neuro examination at this time.  Equal facial movements and equal strength bilaterally. Patient with no deficits, but still complaints of weak and numb feeling, traveling down her left side.  1330 pulse of 84, oxygen saturation of 100% on room air and emergency services called at this time to further evaluate patient.  Continued patient monitoring until EMT arrival.  1335 patient?s oxygen saturation is 100% with pulse of 84 at this time.  Patient able to ambulated steadily without assistance with paramedics to truck.
On Saturday, January 20, 2018 I noticed that my left arm was sore from the flu shot, but not at the injection site. My whole entire arm was sore from the shot. On Sunday morning, I was not able to lift my arm above my head. I would have a sharp shooting pain in my arm and my fingers would go numb. I was not able to change clothes on my own due to the pain being so intense. I cannot sleep on the left side of my body due to my arm hurting. After a week and a half of pain, I went to  Clinic on Monday, January 29th. I was prescribed a dose of 500mg Naproxen and a muscle relaxer to help me sleep. I am going back to see her again on Friday, February 2nd. She believes that due to the swelling in my arm, I have a rotator cuff injury. Depending on my pain on Friday, she may refer me to physical therapy.
On 12/13/07 Mom brought patient to health department to obtain vaccinations but refused additional rotavirus. Mom reported patient received a dx of rotatvirus after vomiting dose given by a private physician on 09/12/07. Mom reported patient was "very ill" with diarrhea and fever. She also stated he had diarrhea one time in the month and was not allowed to return to daycare due to diarrhea. Dr office states patient was vaccinated at their office on 09/12/07. However, mother did not return until 09/24/07 and on that day complained of nasal cong. and cough. On 10/02/07 mother returned to doctor's office with complaints of diarrhea. Patient was seen on both visits. Dr office did not do any lab work; therefore did not give the patient a dx of rotavirus.
Pt received PCV-13 and Hep A on 2.20.15. On 2.22.15 he had an episode of altered consciousness w/eyes rolled back, limp, perioral cyanosis. No tonic/clonic movements, no choking, sudden onset of fever noted 102 degrees. Evaluated by EMT after 911 call not transported to ER.
Bodyaches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Bodyaches) and CHILLS (Chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (Bodyaches) and CHILLS (Chills). On 14-Feb-2021, MYALGIA (Bodyaches) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication included.  No treatment medication included.   This case was linked to MOD-2021-046146 (Patient Link).
incorrect pfizer covid 19 vaccine administered - should have been pfizer covid 19 bivalent
Nausea, extreme fatigue, excruciating leg pain,  leg and arm tingly and inflammation all over
reports a strong metallic taste in his mouth; This is a spontaneous report from a contactable consumer (patient's wife). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW0182; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in left arm bicep area on 17May2021 as 2nd dose, single dose for COVID-19 immunisation. The patient received the first dose BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW0170; Expiration Date: unknown) via an unspecified route of administration on 26Apr2021 for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On May2021, the patient experienced reports a strong metallic taste in his mouth. Patient inquired Pfizer heard about this and how long it will last. Caller stated that it was reported on the internet and saying it could last for several days. patient inquired several days was how long and if it is permanent. Its been a week or a week and a half now and nothing seemed to help. It was not changed and was pretty much the same. He did not take any medications. He had no HCP at this time. Patient wondered what Pfizer had heard and how long can they anticipate. Patient stated that it started on 17May2021 or 18May2021. Stated that it comes in waves that it comes and then subsides. Patient received treatment for the reported adverse event and stated that chewing gum was the only thing that helps, tried drinking extra water or fluids but that it did not help. The clinical outcome of the events was not resolved.   Follow up#1(PRD 25May2021): This is a Follow up spontaneous report from a contactable consumer. Batch number for both the doses was added.  Information on Lot/Batch number was available. Additional information has been requested.
Foggy; Very tired; Body Aches; Severe Chills; Severe Thirst; Shivers; Fever 101 F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), THIRST (Severe Thirst), CHILLS (Shivers), PYREXIA (Fever 101 F) and FATIGUE (Very tired) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (Fever 101 F). On 15-Apr-2021, the patient experienced THIRST (Severe Thirst), CHILLS (Shivers) and CHILLS (Severe Chills). On 16-Apr-2021, the patient experienced MYALGIA (Body Aches). On 17-Apr-2021, the patient experienced FEELING ABNORMAL (Foggy) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Apr-2021, THIRST (Severe Thirst), CHILLS (Shivers) and PYREXIA (Fever 101 F) outcome was unknown, CHILLS (Severe Chills) had resolved. On 16-Apr-2021, MYALGIA (Body Aches) had resolved. At the time of the report, FEELING ABNORMAL (Foggy) and FATIGUE (Very tired) outcome was unknown.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.
Initially started as shortness of breath followed by fevers, aches, muscle cramps.  Ultimately ended up in the hospital with hypoxemia, pleural effusions.  Laboratory values showed evidence of acute renal insufficiency, eosinophilia.  Physical exam consistent with pulmonary edema and lower extremity macular rash.  Entire presentation concerning for DRESS syndrome
Date the vial was initially stored in the refrigerator: 06/07/2023; No adverse event; Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 06/07/2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 06/07/2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 06/07/2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 06/07/2023).    Concomitant medication was not reported. Individual vials or intact cartons were 4 of vial size 2.5 ml. Date the vial was initially stored in the refrigerator was 07-Jun-2023. Vial did not under go temperature excursion. Treatment medication was not reported.  This case contains information for the 2nd of 5 doses described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728778 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728778:master case
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: pt had tunnel vison and lost his vision for a split second, he could not remmember me asking if he was okay. I gave his benadryl and checked bp that was 95/65, Encoraged pt to drink water and got a sucker for him. He was clammy and seemed worried. His bp started coming up within 5 minutes and was 105/80. His bp was 120/80 in 5min later, asked pt to get a ride and his wife came and got him. It had happened to him one time giving blood. pt had chills and ackes last night and is fatigued
about 3 1/2 months after the second shot i started to get alot of pins and needles feeling in my hands and feet. Also i have small muscle twitches all over body at random times. I have like a brain fog/dizziness in my head.
chills; fever 99.9; Symptoms began 8 hours after the shot including: intense fatigue, headache, body ache, and mild injection site pain. At 24 hours after injection, only fatigue; Symptoms began 8 hours after the shot including: chills, fever 99.9, intense fatigue, headache, body ache, and mild injection site pain. At 24 hours after injection, only fatigue and headache; Symptoms began 8 hours after the shot including: chills, fever 99.9, intense fatigue, headache, body ache, and mild injection site pain; mild injection site pain; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of 47-year-old received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 09Apr2021 at 09:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. No relevant medical history, she reported that she was healthy at the time of reporting. The patient did not receive any medication within two weeks of vaccination. The patient does not have any allergies to medications, food, or other products. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm right on 19Mar2021 at 09:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 17:15, the patient had symptoms began 8 hours after the shot including chills, fever 99.9, intense fatigue, headache, body ache, and mild injection site pain.  At 24 hours after injection, only fatigue and headache. At 34 hours after, the patient was feeling well again. On 09Apr2021, the patient checked Body temperature and the result was 99.9(unspecified units). No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, fever 99.9, body ache, and mild injection site pain were recovered on 10Apr2021. The clinical outcome of the events fatigue and headache were recovered on 10Apr2021 at 21:15.  No follow-up attempts are needed. No further information is expected.
hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th August 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hadn't received the 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-Aug-2023 A pharmacist called to inform that a patient had not received the 2nd dose yet. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
rash (red, fine) all over especially in ears, eyes, mouth, glands swollen underarms, neck;stiffness noted;had blood work r/o meningitis, eyes swollen red;has been in severe discomfort;seen in ER x2;? exacerbated MMR sx;
On the 5th, I couldn?t tell any difference, on the 6th I felt sluggish, 7th I had a lot of muscular pain, bone pain, blood pressure went up to 229/189 but this has happened before and I take Clonidine and it brought it down within an hour, the rest of the evening it was 94/46. My hands and feet were swelling and feet were in excorticating pain so I put them up and it went away. On the 8th it?s been the same thing, excorticating pain in hands and I must use a heat pad, my oxygen level dropped down and I was weak.  Today I?m still the same and extremely fatigued. My doctor wanted to me call because I?ve had to used oxygen and have some confusion.  The doctor?s office can tell that I?m not the same as before my shot.
Continued sorness at injection site, inability to lift my arm past a certain point, weakness when trying to lift arm or use it durimg exercise
Pt states "had a fever every day since received vaccine.  Not sure how high fever has been but some days over 100 degrees.  Sent home from school dur to fever and vomiting.  No other symptoms.