chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was incorrectly given the pediatric formulation rather than the adult formulation of Pfizer Covid vaccine by our nurse, despite the fact that she is already 12 years old.  This was discovered upon entry in the statewide vaccine database.  Two voice messages have been placed to notify the parent but she has not returned the call as of 12/23/21.  We will notify her of the error, and instruct her to schedule the second dose for 21 days after the first dose, using the adult fomulation  Guidelines for this case instruct NOT to repeat the incorrect dose in a 12 year old.
Service member complained of 'sleep problems and fatigue approximately 1 month post 1st anthrax injection that he received on 30 Jul 05. He received no other vaccines on this date. He also complained of migratory myalgias and arthralgias, chronic headache, nausea, bloating, alternating constipation and diarrhea, difficulty concentrating and with short term memory generalized pruritus and new onset bilateral swelling of his lower legs and feet.
8:00 pm on the day of vaccine I started getting the chills and having some body aches and queasy stomach. During the night my arms started hurting a lot with pain all the way up into the side of my neck. Took 1 tablet ALEVE during the night. The following day I had chills, body aches, no appetite and very sore arm. Stayed in bed and slept all day. Took ALEVE during the day, but it didn't really seem to help. The next day I felt better, less chills, fatigue and body aches.  Continued to take ALEVE twice a day. My arm continued to be very sore, itchy and felt like it had pins and needles in it. Continued to experience fatigue for up to a week after the vaccine. Four days after the vaccine, my arm continued to be red, swollen down to the elbow, and warm to the touch.  Made an appt to see the doctor. Saw the doctor not he 5th day after vaccine. Doctor suggested I take prescription strength of ALEVE..2 in am and pm. I also took some BENADRYL. This seemed to help. More then 1 week after shot my arm is not red or swollen, but it is tender to the touch in certain spots.
on the 18th sore arm both days; 2nd dose received around noon the 16th by midnight had a 102-103 fever lasted till around 7pm them occasionally 99-100+ fever; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) in the left arm on 16Apr2021 at 11:45 (at the age of 34-year-old) as a dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications included paracetamol, chlorphenamine maleate, pseudoephedrine hydrochloride (TYLENOL SINUS) was taken occasionally for unspecified indication and unknown if ongoing. The patient previously received BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:ER8733) in the left arm on 26Mar2021 at 13:00 (at the age of 34-year-old) as a 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.  On 16Apr2021 at 00:00 the patient experienced, the second dose received around noon the 16th by midnight had a 102-103 fever lasted till around 19:00 then occasionally 99-100+ fever. On the 18Apr2021 sore arm for both days. The patient did not receive any treatment for the event. The clinical outcome of the event fever and sore was recovering at this time of report.  No follow-up attempts are possible. No further information is expected.
indigestion; SENSITIVE TUMMY AREA; Couldn't sleep well because all my body hurt; bone started hurting a lot from my neck down to my feet; really tired all weekend; didn't do anything; the day of the vaccine, arm started to hurt; muscle started hurting a lot from my neck down to my feet; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (SENSITIVE TUMMY AREA), SLEEP DEFICIT (Couldn't sleep well because all my body hurt), DYSPEPSIA (indigestion), BONE PAIN (bone started hurting a lot from my neck down to my feet) and FATIGUE (really tired all weekend; didn't do anything) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergy. Concomitant products included PANTOPRAZOLE (Protonix), MULTIVITAMIN (Centrum silver vitamin), CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE 600 + D), ACETYLSALICYLIC ACID (ASPIRIN) and ASCORBIC ACID (VITAMIN C).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced SLEEP DEFICIT (Couldn't sleep well because all my body hurt), BONE PAIN (bone started hurting a lot from my neck down to my feet), FATIGUE (really tired all weekend; didn't do anything), INJECTION SITE PAIN (the day of the vaccine, arm started to hurt) and MYALGIA (muscle started hurting a lot from my neck down to my feet). On 18-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (SENSITIVE TUMMY AREA) and DYSPEPSIA (indigestion). On 18-Jan-2021, BONE PAIN (bone started hurting a lot from my neck down to my feet) and MYALGIA (muscle started hurting a lot from my neck down to my feet) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (SENSITIVE TUMMY AREA), SLEEP DEFICIT (Couldn't sleep well because all my body hurt), DYSPEPSIA (indigestion) and FATIGUE (really tired all weekend; didn't do anything) outcome was unknown and INJECTION SITE PAIN (the day of the vaccine, arm started to hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
9/27/16 Received phone message that she was itching and had hives. Stated her DR. thought reaction to Flu shot. 9/28/16 Received another message stating she was getting worse and having difficulty walking. 10/10/16 Left message for patient to call us so we can follow up. 10/10/16 Weakness, pain in muscles, tingling hands and feet. Pain in back.
Vitiligo on both of hands and face; This is a spontaneous report from a contactable physician. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via intramuscular route of administration in the left arm on 19Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via intramuscular route of administration in the left arm on 13Apr2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any concomitant medication within 2 weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient had vitiligo on both of his hands and his face. It was reported that he did not have this problem prior to vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included an unspecified treatment. The clinical outcome of the event vitiligo on both of hands and face was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (doses, route of administration, anatomical location, lot# and expiration date were not reported). Administered doses of GARDASIL 9 experienced temperature excursion of 35 degree Fahrenheit for 6 days, on an unknown date. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Additional information has been requested. This is one of several reports from the same reporter.
rash around torso/ under arms/ upper arms/ thighs; This case was reported by a physician via call center representative and described the occurrence of generalized rash in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number T73K2, expiry date 9th June 2021) for prophylaxis.   On 22nd March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The caller was the patient and physician himself. The patient experienced rash around torso, under arms, upper arms, and thighs. The patient still had the rash that was present. The patient went to his internist and was then referred to dermatologist. The reporter did not give consent to follow up. No further details were provided.
Headache; I am just kind of my achy feeling this morning; today I got achy bones; muscle achy feeling; I am just kind of my achy feeling this morning; today I got achy bones; muscle achy feeling; I am just kind of my achy feeling this morning; today I got achy bones; muscle achy feeling; I am like discomfort right now; I had a restless night.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown, Expiration Date: 28Jul2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE: MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE: MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE: MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown"; BONE PAIN (non-serious), MYALGIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "I am just kind of my achy feeling this morning; today I got achy bones; muscle achy feeling"; DISCOMFORT (non-serious), outcome "unknown", described as "I am like discomfort right now"; RESTLESSNESS (non-serious), outcome "unknown", described as "I had a restless night."  Additional Information: Consumer stated I had my booster, second booster (Clarified as Pfizer Covid 19 vaccine) yesterday and during the night I had a restless night and I am just kind of, I am achy feeling this morning and I got a headache. Can I take Aleve or something like that. Is that okay to take something. Consumer stated Yes I want to know because I had a headache and kind of achy feeling, you know muscle achy feeling. Okay, Well I am not. I need to know is that okay to take something for the headache. Can I take Just the Aleve, you know an aspirin is not aspirin but its something like Ibuprofen or something that kind of medication (Further clarification unknown hence captured as Unspecified medications). Can I take that for my headache and my discomfort today, I have got achy bones. .Consumer further stated Okay, Alright. I just, okay. I can be alright. I am like discomfort right now but anyways. Okay. I will let it go with that and hopefully I just go and take one if she can help." (Further not clarified). But they are closed right now, they are closed. If it is there. I will calling the pharmacist who gave me the shot before that I am thrilled, anyways thank you for trying. Will this be HT347 I mean that's something written over here.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A few hours following vaccination, developed cough, congestion, sore throat and diarrhea. Symptoms have persisted for two days
congestion in her chest,heaviness and tightness in her chest but no fever or muscle/ joint pains.; pains in her head and congestion but these symptoms are not as severe as before; shooting head pain all over different parts of her head (similar to the first dose); shooting head pain all over different parts of her head (similar to the first dose); congested cough; continued to feel fatigue from her previous shot.; diarrhea; arm also felt sore for about 4 days.; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (congested cough), CHEST DISCOMFORT (congestion in her chest,heaviness and tightness in her chest but no fever or muscle/ joint pains.), HEAD DISCOMFORT (pains in her head and congestion but these symptoms are not as severe as before), DIARRHOEA (diarrhea) and PAIN IN EXTREMITY (arm also felt sore for about 4 days.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced DIARRHOEA (diarrhea), PAIN IN EXTREMITY (arm also felt sore for about 4 days.) and FATIGUE (continued to feel fatigue from her previous shot.). On 08-May-2021, the patient experienced COUGH (congested cough), PAIN (shooting head pain all over different parts of her head (similar to the first dose)) and HEADACHE (shooting head pain all over different parts of her head (similar to the first dose)). On 10-May-2021, the patient experienced CHEST DISCOMFORT (congestion in her chest,heaviness and tightness in her chest but no fever or muscle/ joint pains.) and HEAD DISCOMFORT (pains in her head and congestion but these symptoms are not as severe as before). On 25-Apr-2021, PAIN IN EXTREMITY (arm also felt sore for about 4 days.) had resolved. At the time of the report, COUGH (congested cough), CHEST DISCOMFORT (congestion in her chest,heaviness and tightness in her chest but no fever or muscle/ joint pains.), HEAD DISCOMFORT (pains in her head and congestion but these symptoms are not as severe as before), DIARRHOEA (diarrhea), PAIN (shooting head pain all over different parts of her head (similar to the first dose)), HEADACHE (shooting head pain all over different parts of her head (similar to the first dose)) and FATIGUE (continued to feel fatigue from her previous shot.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-116713 (Patient Link).
Walking away from vaccination table offender became dizzy. Sat down. BG checked and 107, normal for patient. Maintained consciousness but became increasingly unsteady. VS checked, P 34, unable to obtain BP, R 20 and shallow, O2 94%. LCTAB. Patient became pale and lips became cyanotic. Unable to obtain P and O2 at this time. Epinephrin 0.3cc administered, P increased to 54, O2 93, transferred to trauma room and IV fluids administered. Patient fully recovered within an hour.
2 days after receiving FLUZONE High Dose and ZOSTAVAX immunizations patient had DVT in (L) upper leg.
she is miserable; she is totally depressed because of this; has gotten very little sleep because she is up all night scratching; itchy all over, on her legs, arms, trunk, neck, front side, you got it; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The caller said that she has had a miserable month and she keeps thinking that it was going to get better. She had her second Pfizer COVID vaccine, and the first dose did not give her any complications at all, it was smooth and easy. The same night that she got her second dose she started with itchy all over, on her legs, arms, trunk, neck, front side, you got it. She cannot live with it anymore. She wakes up every day thinking that it will be better. She just wants someone to know that she was miserable. She wants Pfizer to reach out to her on if they can help her or anyone else going through this miserable experience. Caller asked, how can she make it go away. So basically, she was stuck in limbo. Basically, live with it and be done. Sorry, she does not mean to sound condescending but until someone was able to walk in her shoes they would not understand. She has had this since 02Apr2021. Every day she wakes up and prays it goes away, but it has just intensified. She was sorry that she ever took this drug. She thinks she would have had a better time with COVID than with this. She said she was thankful of this agent's time, but she was totally depressed because of this and it was not this agent's fault but until you can walk in her shoes and feel what she has felt then you might would understand. She has stuck it out and stuck it out and has hoped for it to go away. She has gotten very little sleep because she was up all-night scratching. It was such a bad thing; she would not wish this on anyone. The outcome of itchy was not resolved and sleep deprivation, depressed mood, feeling miserable was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine, on or about 07-NOV-2013, at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and subsequently the patient contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2017, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Less than 5 minutes after receiving vaccination pt reported feeling lightheaded. During observation patient lost conciousness for <1min. Patient awoke with chills, sweating, and continued lightheadedness. These symptoms abated during observation and after 30 minutes patient was sent home for rest in a quiet dark room.
two weeks after the vaccine patient developed dry, cracked lips, dry mouth, and burning in the mouth and tongue. Sense of taste changed to acidic.
Patient had a Pfizer vaccine back on March 9, 2021 and after receiving the vaccine had chest palpitations and never received the second dose. His doctor advised him that he should get the Jansen Covid vaccine and not to complete the Pfizer series based on the adverse reaction he had with the first dose. So patient received two different vaccines 5 months apart, 1 pfizer and 1 jansen.
Pt. called on 5/12 reporting baseball size redness at immunization site welts x 2 & burning. Recommended evaluation. Pt. has done this as of 5/13 at 1pm.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 24, 34 and R; 144, 31 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
severe shooting nerve pain; muscle pain around my neck area, upper back, shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing), notes: anxiety just around the, same time I got vaccine. No previous, health problems. Concomitant medication(s) included: BUPROPION; CITALOPRAM. Past drug history included: Azithromycine, reaction(s): "known allergies: Azithromycine", notes: known allergies: Azithromycine.The following information was reported: MYALGIA (disability) with onset 01Jun2021, outcome "recovered", described as "muscle pain around my neck area, upper back, shoulder"; NEURALGIA (disability) with onset 01Jun2021, outcome "recovered", described as "severe shooting nerve pain". The events "severe shooting nerve pain" and "muscle pain around my neck area, upper back, shoulder" required physician office visit. Therapeutic measures were taken as a result of neuralgia, myalgia.Clinical information: Ae treatment: Prednisone, Advil, physiotherapy for 5 months.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1 hour after COVID vax dose # 2 administration, individual reported onset of upper body itching, neck swelling and skin was blotchy red.  Neck swelling more on left than right.  Short term feeling of altered breathing  -- > "real or panic" per individual -- > self resolved.   Left deltoid area Injection site redness, hot to touch and swollen developed as well.  "general un-well" feeling all day  2/21/21.  She reports sxs improvement today.  She was given Claritin (as can not function after taking Benadryl) by  Medical Personnel (Detention Ctr employee) -- > itching sensation lessened.
This spontaneous report as received from a nurse refers to a 23 week old patient of unknown gender. The patient's pertinent medical history and concomitant medications were not reported. On 28-JAN-2016, at the age of 23 weeks, the patient was administered the first dose of ROTATEQ (lot # L020859, expiry date 19-JAN-2017, orally). No adverse effects were reported. Additional information has been requested.