chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight redness to injection site; slight pain when they pressed down in that area; there is a little bump; This is a spontaneous report from a contactable consumer. A 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: E18982), via an unspecified route of administration, in the right arm on 06Feb2021 08:40 AM (at the age of 82-years-old) as single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any concomitant medications. The patient did not receive any other recent vaccinations. The patient did not underwent any lab investigation. Consumer was calling about the BNT162B2 vaccine, to say congratulations and thanks for saving the nation. He said that he was 84 years old, and he had his first vaccination this past Saturday, as did his wife who is 82. He said that they only thing he would like to report was a slight concern that the only reactions they had were slight redness at the site and slight pain when they pressed down in that area, no other side effects. He says he was concerned whether the vaccines were effective in their bodies.Caller said that their vaccine cards were handwritten and they got the same LOT. Caller said NDC/EXP were not provided on their handwritten vaccine cards. He said they got their first dose at 08:40 AM 06Feb2021, and he got his in his left arm and his wife got hers in her right arm. AE slight pain at the site treatment: Caller said that they didnot do anything to treat this, and it went away, also the slight redness went away, there was a little bump. Caller said it was not bad, it was good that their side effects were small and not massive at all, and it was a little thing but they are concerned if their reaction could be considered unusual, like some people, or if should it could be a stronger dosage. He said at the time their vaccines were done in cars, so he has no knowledge of temperature or amount of dosage, though he was sure it was right and it was good they didnot have side effects from it, he wondered about the dosage could they be less effective in their bodies? Caller declines to be transferred to another unit for his question, and said that after they get their second dose on the 17th, if they donot feel anything they would call medical information with their questions. No treatment was received for the event vaccination site pain. Outcome of the events vaccination site pain and injection site redness were recovered on an unspecified date and unknown for other event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021195657 same reporter/drug/event, different patient
rash all over her upper body: her belly, some on her back, and mostly on her neck and shoulders; rash has worsened in redness/rash is red; a little bit of difficulty of breathing; feels shaky/nervousness/she is nervous; This is a spontaneous report from contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 at 15:00 (lot number: EW0162) on the left arm as single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medication included paracetamol (TYLENOL). The patient next dose was scheduled for 03May2021 at 11:40am. On 14Apr2021, patient reported to have a rash all over her upper body: her belly, some on her back, and mostly on her neck and shoulders. Patient mentioned she had a very severe rash all over her body and neck that it was pretty extreme and all over. It was the first time that something that extreme happened to her. Patient mentioned that she also had a little bit of difficulty of breathing and attributed it to her nervousness. She denied having a closing up throat. The rash all over body was reported as worsened and rash had worsened in redness. The patient's rash was red, patchy, and on her stomach it was more needle point looking. The patient wasn't feeling sick and didn't have any of the other symptoms. The patient felt shaky but it may be because she was nervous. The outcome of events "a little bit of difficulty of breathing" and "rash has worsened in redness/rash is red" was unknown, while the other events was not recovered.  No follow-up attempts are needed. No further information is expected.
pt devel an inj site rxn characterized by redness & induration p/vax;
Breakthrough case admission after 2 vaccines Pfizer 3/11/21 Lot# En6207;  Pfizer 4/1/21 lot# ER8732
stuffy nose; flu-like symptoms; headache; muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "headache", "flu-like symptoms", "muscle ache", "stuffy nose". The following information was reported: NASAL CONGESTION (non-serious), outcome "recovered", described as "stuffy nose"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu-like symptoms"; HEADACHE (non-serious), outcome "recovered"; MYALGIA (non-serious), outcome "recovered", described as "muscle ache".  Additional information:  The patient recently went to to get a COVID-19 booster. This would be patient's 4th shot in the last 2 years. With each of the previous vaccines, patient ended up showing flu-like symptoms (headache, muscle ache, stuffy nose, etc.) within 24 hours of receiving the vaccine. The symptoms went away within a day.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201363306 same patient/AE, different vaccine dose number;US-PFIZER INC-PV202200121275 same patient/AE, different vaccine dose number;
Information has been received from a physician concerning a child who was vaccinated with varicella virus vaccine live. It was reported that "yesterday"  on 10SEP2003, the pt presented with chickenpox. It was reported that , at the time of the visit, the child was just breaking out so the doctor was unsure how many lesions the child had. Unspecified medical attention was sought. This physician also reported another pt  who got chickenpox after vaccination with varicella virus vaccine live. Additional info has been requested.
Approx 10 minutes after receiving the Covid vaccine pt c/o itching in her throat, she was placed on cot supine and VS were obtained.  P76, R18, , 99%BP 176/5/89  Pt cont to c/o itching in her throat and stated she was SOB,   epi was given per protocol, and 911 called.  The pt stated she was starting to feel better post epi administration.  Pt observed throughout.  No hives or rash noted.  The ambulance arrived within 10 mins and pt was taken to the ED due to increased BP post epi BP 226/96
Headache, Myalgia, Arthralgia, Chills Narrative: Chills, body aches and headache lasting 12 hours.
Full body hives, severely itchy. Swelling of face, hands and feet. Throat got tight and was administered EpiPen in ER
Information not available.  Medical records not received from LTC facility.  Covid 19 listed as a cause of death on death certificate.
No Adverse Event; Moderna Covid-19 bivalent were administered BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 bivalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) in a 2-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 bivalent were administered BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 bivalent were administered BUD) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 bivalent were administered BUD).    Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up received and added patient details. On 28-Feb-2023: Follow-up received and added batch no. and ROA for suspect. On 28-Feb-2023: Follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 15
Information has been received from a physician concerning an 8 year old male who in 1997, at the age of 12 months, was vaccinated with one dose of varicella virus vaccine live. On 3/31/04, the patient presented to his practice with small, bite-like lesions all over his trunk and extremities. On 4/1/04 the patient presented to the physician with a fever and small vesicular like lesions all over the trunk, buttocks, thighs, face, and mouth. It was reported that the patient had not yet recovered. No product quality complaint was involved. It was also noted that 3 years ago according to the mother's recollection, the patient was diagnosed with a subclinical case of varicella. Additional information has been requested.
very high fever, tachycardia (HR 140), tachypnea, extreme muscle pain and weakness (unable to walk), dehydration, severe migraine, abdominal pain - symptoms took 3 days to improve.
Within 2 hours of administration, developed redness, swelling and itching to area above injection site. Instructed to ice. Lasted for 3-4 days.
67-year-old hypertensive, type 2 diabetic, not a known case of coronary artery disease, known case of chronic persistent or recurrent atrial fibrillation / flutter, status post multiple ablation and cardioversion, admitted from the office when he presented with worsening dyspnea and intractable cough.  Patient has been not feeling well since November when he was initially diagnosed in November 21, 2022 with COVID infection patient is fully vaccinated, he was treated with Paxlovid. Patient has been traveling, in March 2023 patient had bronchitis symptoms and was treated with Z-Pak with negative COVID-19 test, recurred with the symptoms and was treated with another dose of Z-Pak on May 1, 2023, he checked his COVID-19 testing at home and was negative. Before admission his COVID testing done to the hospital and reported to be positive.  Patient also have a history of sarcoidosis, suspicious of sarcoid exacerbation along with superimposed infection also discussed with the patient.  Started on IV Solu-Medrol, IV Zosyn, will consider remdesivir.  Placed on frequent nebulizer treatment and inhalers.  Patient also known case of obstructive sleep apnea, will continue on CPAP, will have a CT scan of the chest and ABG.  Patient is a known case of chronic persisting atrial fibrillation status post AV nodal ablation, with a pacemaker in place, continued on Eliquis.  Known case of type 2 diabetes mellitus, not on any medication, placed on insulin on low scale sliding scale.  The patient is not a smoker, occasional alcohol consumer, denies any drug use.
This case was reported by a pharmacist via call center representative and described the occurrence of blister in a female patient who received SHINGRIX. On 12th January 2018, the patient received SHINGRIX. In January 2018, 1 days after receiving SHINGRIX, the patient experienced blister and skin lesion. On an unknown date, the outcome of the blister and skin lesion were unknown. It was unknown if the reporter considered the blister and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. One or 2 days after being vaccinated with SHINGRIX, the patient developed lesions or blisters in her nostrils and under her ear. The pharmacist that called in was not the healthcare professional who vaccinated this patient, so he did not have any other details. No further information was provided.
tested positive for COVID-19; lost sense of smell; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), ANOSMIA (lost sense of smell), HEADACHE (headache) and PYREXIA (Fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K202A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 04-May-2021, the patient experienced COVID-19 (tested positive for COVID-19), ANOSMIA (lost sense of smell), HEADACHE (headache) and PYREXIA (Fever). At the time of the report, COVID-19 (tested positive for COVID-19), ANOSMIA (lost sense of smell), HEADACHE (headache) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-114621 (Parent-Child Link).   See case MOD-2021-114621 for details regarding the child case.
Local skin infection, warmth and redness at site of injection 3" x 1.5". Given antibiotic BACTRIM and MEDROL dose pak.
vaccine given around 915  around 1230pm was feeling faint, dizzy, color was off per mom (pale)  involuntary muscle twitching for approximately 2 hours from  1pm-3pm. Involuntary  twitching of all parts of body, including  both legs, both arms and abdomen. frequency of one muscle twitch every 5-10 minutes.   Resolved spontaneously with supportive care (time, ate a sandwich and drank fluids).
9:00 am got shot, 11:00 am arm was red, hot, swelled, itched, hurt touch. 5:00 pm arm from shoulder to elbow was red like 3 degree burn. Still hot very swelled hurt, called DR office at 11:00. She said put ice on 20 min and off 20 min. Didn't help. Lasted 3 days with decreasing symptoms. Today 11/16/06 arm still hurt at times.
approx 10min p/vax pt appeared to fain into closed door, as father picked pt up, pt went tonic (stiff) eyes rolled back, back arched, facial color pale;this lasted approx 30-45sec;pt was placed on floor no signs bleeding;appeared to have sz
injection area was itchy and slightly pain; hives on her non-injected arm, just above the elbow; airway started to constrict a little bit; injection area was itchy and slightly pain; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on her non-injected arm, just above the elbow), THROAT TIGHTNESS (airway started to constrict a little bit), VACCINATION SITE PRURITUS (injection area was itchy and slightly pain) and VACCINATION SITE PAIN (injection area was itchy and slightly pain) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced URTICARIA (hives on her non-injected arm, just above the elbow), THROAT TIGHTNESS (airway started to constrict a little bit) and VACCINATION SITE PRURITUS (injection area was itchy and slightly pain). On an unknown date, the patient experienced VACCINATION SITE PAIN (injection area was itchy and slightly pain). At the time of the report, URTICARIA (hives on her non-injected arm, just above the elbow), THROAT TIGHTNESS (airway started to constrict a little bit), VACCINATION SITE PRURITUS (injection area was itchy and slightly pain) and VACCINATION SITE PAIN (injection area was itchy and slightly pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Employee began to feel ill on 01/29/2010 at 6 pm. "Vomiting, dizziness, shaking, headache, extreme nausea, felt like a vise was squeezing my torso."
Pt reports pain after administration of Shingrix with Fluzone. Pt is still report pain scale of 8-9 upon waking 4 months after administration. Pain will subside as she starts to move around more.  Pt believes that it was the administration of the Shingrix not the Fluzone that has caused the residing pain.
Fever, Coughing, Body Ache, Headache.  Pt c/o burning sensation on top portion of body two days after vaccination.  Also, upper torso abdominal pain to LU quadrant for 1.5 days.  Headache, "all over" throbbing.
COVID 19 Treatment / Drug ineffective; COVID 19 Treatment / COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: AS7165B) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19 Treatment / COVID-19"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19 Treatment / Drug ineffective". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11Apr2023 to 15Apr2023.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300175647 same reporter/patient, different drug/AE;
he's sick from the vaccine (two doses); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunisation, reaction(s): "he's sick from the vaccine (two doses)". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "he's sick from the vaccine (two doses)".  Additional information: Caller mentioned that he was sick from the vaccine (two doses) and would never take the booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200083941 same patient/drug/event, different dose.
12/16/21 - Covid-19 Pfizer Booster shot 12/18/21 - I felt coolness in my thighs.  It is as if the heat turned off in my legs.  I typically have warm legs and sleep in shorts.  I now have to sleep in leggings.  I have been wearing lined running tights 24/7 to try to keep my legs warm.  When I sit at my desk, I have to drape a blanket over my lap.   They are cool to the touch and feel cold to me inside.  This symptom has continued to this day (2/9/22).   12/19/21 - My daughter tested positive for Covid.  I tested negative. 12/20/21 - I started to feel sick and felt pressure in my chest.  I scheduled an appointment with my primary care doctor, Dr. for the next day to discuss both the coolness in my legs and chest pressure.  Dr. is at a local medical office.    12/21/21 - Appointment with Dr. and shared that I was experiencing coolness in my thighs and the beginning of a respiratory illness starting with chest pressure. He prescribed antibiotics for possible respiratory infection. I had a 2nd negative PCR test for Covid on 12/22/21 and several negative at home tests throughout the week. I was sick for about 10 days and was better on 12/29/21. The coolness in my thighs persisted throughout these 2 weeks.  My mom experienced coolness in her legs after her initial Pfizer vaccine in January 2021.  She continues to experience her symptoms one year later.  She is 79 and in good health.  She has lupus and an essential tremor.  She has met with numerous doctors and has been unable to learn the cause of her symptoms or get any relief.   1/3/22 - The coolness moved to my buttocks which I would describe as icy. My thighs continue to feel cool.   1/5/22 - I got a sore throat and swollen glands 1/6/22 - I tested positive for Covid with an at home test.  I felt a strange tingling in my arm and was concerned about if the symptoms were moving to my arms or if I was having a problem with my heart 1/7/22 - Appointment with primary care doctor, Dr.  Did an EKG - normal.  I did a Heart Calcium Score and my score was 0 indicating no plaque in my arteries. He ran numerous blood tests all of which came back in the normal range.  He referred me to a neurologist. 1/24/22 - Appointment with neurologist.  He ran blood tests and ordered an MRI, skin biopsy and an EMG.  ANA test came back positive.  Referred me to a rheumatologist. 1/25/22 - Appointment with another primary care doctor, to get another perspective.   1/28/22 - Appointment with a fourth dr. from Arthritis and Rheumatology.   She ran additional blood and urine tests testing me for lupus (due to my mom's similar symptoms and lupus) and scleroderma.  These tests were negative.   2/1/22 - MRI on my neck and back.  Results were normal.  2/7/22 - Skin biopsy on small nerve fibers.  Awaiting results 2/8/22 - Follow up with Dr.   2/22/22 - EMG is scheduled.
Patient was administered 0.2 ml of undiluted pfizer covid-19. tris-sucrose 10 mcg (5-11 yr) vaccine.
TDAP and MMR administered 9/14/2007, that evening pt had a small rash on left upper arm where vaccine was administered.  On 9/17/2007,pt was in employee health and rash was noted by employee health nurse and thought to be a localized reaction to immunizations.  Rash was only on left upper arm at the time.  Rash is still remaining on left upper arm and has since spread to left elbow and right elbow and right cheek  Pt came in today with complaint of severe itching and burning.  Sent to occupational health MD.
Within 48 hours I was experiencing severe nausea, shortness of breath, and tachycardia. These symptoms became more severe over the next few months and I have now been diagnosed with POTS syndrome, gastroparesis, and general dysautonomia. At 6 months I have seen no improvement and am completely bedridden- unable to stand, walk, or eat solid foods.
Pt had Gardasil and Fluzone vaccines on 9/15/08. 9/22/08 presented to the office crying with delusions about family members with lethal disease. Pt sent to Hospital to the ER for Neuro consult.  EEG and labwork negative. 3 admits to Hospital and neuro work up. Inconclusive and unknown etiology. 11/14/08-records received for DOS 9/22-9/24/08-DC DX: Major deprssive disorder with psychotic features. Admitted due to changes in behavior and altered  mental status. Increased irritability, staring with right sided twitching.   Follow-up: Continues with psychiatric problems.