chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm started itching, with a raised red bump where needle went in; raised red bump where needle went in; raised red bump where needle went in; arm feels warm to touch; burning; soreness mid upper arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 11:00 as dose number unknown (booster), single (Lot number: GJ2524) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "High BP" (unspecified if ongoing), notes: High BP; "Known allergies: Sulphur" (unspecified if ongoing), notes: Known allergies: Sulphur. Concomitant medication(s) included: LEVOTHYROXINE; LOSARTAN; METOPROLOL; METFORMIN. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunization. The following information was reported: FEELING HOT (non-serious) with onset Sep2022, outcome "not recovered", described as "arm feels warm to touch"; BURNING SENSATION (non-serious) with onset Sep2022, outcome "not recovered", described as "burning"; PAIN IN EXTREMITY (non-serious) with onset Sep2022, outcome "not recovered", described as "soreness mid upper arm"; VACCINATION SITE PRURITUS (non-serious) with onset 17Sep2022, outcome "not recovered", described as "arm started itching, with a raised red bump where needle went in"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE MASS (non-serious) all with onset 17Sep2022, outcome "not recovered" and all described as "raised red bump where needle went in". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site erythema, vaccination site mass, feeling hot, burning sensation, pain in extremity.  Additional information: Patient was not pregnant at time of vaccination. One week after the injection, arm started itching, with a raised red bump where needle went in. This week, 2 weeks after injection, arm feels warm to touch, burning, and a lump and soreness mid upper arm. If other vaccine in four weeks reported as No. AE resulted in none of the above. If covid prior vaccination and if covid tested post vaccination reported as No.  Follow-up attempts are completed. No further information is expected.
expired Moderna vaccine administered to patient; Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator on 05-APR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator on 05-APR-2022) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator on 05-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator on 05-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported.  Reporter reported that the administration of vaccine occurred from 6-Apr-2022 to 9-Apr-2022. Patients have not reported any adverse reaction after the vaccination. The manufacturing date of the vial was 1-Dec-2021. Vial was initially placed in refrigerator on 5-Apr-2022. The product didn't undergo any temperature excursion issue.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-537580, MOD-2022-538672, MOD-2022-538673, MOD-2022-538676, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538691, MOD-2022-538692, MOD-2022-538696, MOD-2022-538701, MOD-2022-538702, MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538701, MOD-2022-538672, MOD-2022-538676.
PT EXP TINGLING AT SOI FOLLOWING ADMIN OF THE 1ST DOSE OF ENGERIX-B.
Big red swollen mark at injection site on my left upper arm for 10 days. Applied cortisone cream for 3 days - 2 x's a day. Redness went away - left a blackish mark on my arm.
Patient developed pain and difficulty raising arm, numbness, and heavy sensation. Started to develop burning sensation and cough, sore throat, and felt cold.  At 11:30 PM, she got up and vomited one time. The next day (8/31/12), she was very tired and spent the day laying on the couch. Patient felt OK on Saturday (9/1/12) and could return to usual daily activities.
she came down with an autoimmune disease; had a lot of joint discomfort; ended up being a form of vasculitis; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (BNT162B2), first dose via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she called on the suggestion of her rheumatologist to see if we can help whether or not she should get a second Pfizer shot. The patient stated she received the first Pfizer vaccine on 02Feb2021, and then on 04Feb2021 she came down with an autoimmune disease that had a lot of joint discomfort and ended up being a form of vasculitis. The patient stated she was on steroids and immune suppressing drugs to deal with the damage the disease causes. The patient stated she has been seeing two of the top Rheumatologists and they said Pfizer would be the best to find information about getting the second shot because the Rheumatologists don't have enough information. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Rash spread from head down to trunk and then to extremities. Rash was very red and all over body.
After receiving the vaccine the client fell to the floor backwards, striking his head on the ceramic tile floor.He was assessed immediately and found to be unconscious for approximately 30 seconds and was incontinent of urine. When he regained consciousness he was "dizzy and nauseated", very pale and diaphoretic but oriented to person, place and time. He continued lying down with an ice pack to his head for 30 minutes after which time his father took him to the emergency room.
I received the vaccine on 3/3/21. The injection site was swollen, red and warm. This went away after 3 days. Then on 3/10/21 the injection site started to swell again. It is red and warm to the touch.
Pt. did not die from COVID vaccine.  He was diagnosed with COVID19 on 06/04/2021.  He had an extensive past medical history with several preexisting conditions which COVID exacerbated.
Frequent urination; lower back pain; body aches; loss of appetite; Chills; Fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination), BACK PAIN (lower back pain), PAIN (body aches), DECREASED APPETITE (loss of appetite) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for Adverse event.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 04-Mar-2021, the patient experienced POLLAKIURIA (Frequent urination), BACK PAIN (lower back pain), PAIN (body aches), DECREASED APPETITE (loss of appetite), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (fatigue). At the time of the report, POLLAKIURIA (Frequent urination), BACK PAIN (lower back pain), PAIN (body aches), DECREASED APPETITE (loss of appetite), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she recorded her fever 100F which went down to 99 F next morning and rose again to 101.2 F at 3:20 pm. Patient reported that she was drinking enough fluids.  No concomitant medications were reported.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A 58-year-old patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; estrogens conjugated (PREMARIN). The patient's relevant medical history included: "heart condition" (unspecified if ongoing), notes: So I have, and a heart, condition, so I have no immune system virtually; "so I have no immune system virtually" (unspecified if ongoing), notes: So I have, and a heart, condition, so I have no immune system virtually. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), for COVID-19 immunization, reaction(s): "I have long COVID even though I am vaccinated 3 times", "I have long COVID even though I am vaccinated 3 times"; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown), for COVID-19 immunization, reaction(s): "I have long COVID even though I am vaccinated 3 times", "I have long COVID even though I am vaccinated 3 times"; Bnt162b2 (Dose Number: 3, Batch/Lot No: Unknown), for COVID-19 immunization, reaction(s): "I have long COVID even though I am vaccinated 3 times", "I have long COVID even though I am vaccinated 3 times". The following information was reported: SYMPTOM RECURRENCE (non-serious), outcome "unknown", described as "I had a flare up again". The action taken for estrogens conjugated was unknown. Additional information: During the call, the patient stated, I am sick today. I became disabled. I was literally shocked when I went there yesterday to pick it up. It was 66 dollars. Do not get COVID. I got it and I have long COVID even though I am vaccinated 3 times. I was supposed to get vaccinated, get my fourth shot yesterday for my second booster and I had a flare up again. So, it gives all kinds of weird symptoms when you have long COVID. I am petrified of it that I have long COVID because just a couple of days ago on the news they were talking about long COVID and they gave another slew of symptoms that are associated with, uh, long COVID. If I needed another thing to make me scared to death about dementia. As I needed anything else to tell me I could potentially get dementia. The fear is real and then they said the long COVID is showing dementia, brain (inaudible). Those kinds of things. If I had not been vaccinated 3 times I would have died from it I am sure because I have (inaudible) that are auto-immune related. So I have, and a heart condition, so I have no immune system virtually. I got it in the hospital. I still got it. (COVID) Note: The patient/reporter did not specify which vaccination they received. Pfizer-BioNTech COVID-19 Vaccine is being reported out of an abundance of caution. 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) : PFIZER INC-PV202200051652 master case, Dose 1;
No SEs reported after 15 min observation. Administered vaccine to under 18 years old.
3 hours after receiving the vaccine the patient developed a rash on both sides of his face.  He also developed numbness on both cheek.  He also endorces hives and rashs on his neck.  His symptoms do not extend beyond his neck. He has equal 5/5 strength in lower and upper extremities with clear normal speech and reactive pupils.  He denies changes to his visions or fever.  He endorses a 6/10 headache.  He took benadryl 3 doses in the last 1.5 days.
Localized hives on arm of injection site; This is a spontaneous report from a contactable Physician. A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), second dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single dose for immunisation. The patient medical history was not reported.     The patient's concomitant medications were not reported. The patient previously took the first dose of meningococcal group b rlp2086 (TRUMENBA) for immunisation and had no problems. The patient experienced localized hives on arm of injection site after 2nd dose on an unspecified date. The outcome of the event was recovered. Patient is fine now but physician wanted to report the incident.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother called office 30min-1 hour after having vaccines stated his eye was huge and about to pop out of head. She brought him back he had severe swelling to (R) eye. ORAPRED and BENADRYL was given by FNP in office and he was sent to ER where he was watched for a few hours.
my chest started hurting me at 3:50 a.m. this morning; stomach hurts; felt squeezed, I could not breath; had the feeling of being squeezed; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiry date unknown), via an unspecified route of administration on 15Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 25Jan2021 and experienced AFib, diabetic, COPD, stomach issues, chest pains and fever. About 20 minutes after the first dose, I had chest pains, from one side clear across the other side. She took a nitro, and had fever over a 100°F for 24 hours on Jan2021. She received second dose on 15Feb2021 and experienced they had her get an EKG. Patient felt squeezed, she could not breath on Feb2021. Her oxygen level and blood pressure were both fine on Feb2021. She had the feeling of being squeezed on Feb2021. Her chest started hurting at 3:50 a.m. (16Feb2021) this morning, stomach hurts like doing flip flops inside her. She did not have anything that would aggravate it. The outcome of the events was unknown. The events was reported as non-serious.  Information on the batch/lot number has been requested.
Nursing daughter developed hair loss 8 days after mother's vaccination. Saw pediatrician and received referral to pediatric dermatologist the following day. Diagnosed with Alopecia Areata by Dr.  04/07/2021 without obvious triggers than Mother's vaccination.  Otherwise, health of child is normal. Progression of loss continues at about 50% loss in the past 3 weeks.
About 12 hours after the vaccine had a violent vertigo attack with vomiting which lasted for about 6 hours.  This is the second time this has happened to me in the past 3 years after receiving a flu vaccine.
Vomiting after second vaccine,; Headache; Soreness of arm starting day of second vaccine approximately 8 hours after injection; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 10May2021 at 09:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs (sulfonamide allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 19Apr2021 at 09:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 11May2021 at 23:00 approximately 38 hours after second vaccine the patient had vomiting and as well as headache. On 10May2021 at 17:30, starting day of second vaccine approximately 8 hours after injection, the patient had soreness of arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vomiting as well as headache and soreness of arm, was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Wrong patient received vaccine . This patient did not present to the pharmacy for the vaccine, but received it in error.
Patient had neck pain and fever. She went to urgent care. I have not received a return phone call or any information on treatment.
pt recv vax 7JUL98 & same day devel h/a, nausea, fever & gen malaise;
On 01/08/2001 the patient developed 20 to 30 "insect bite like" raised lesions on his face, arms and abdomen. Also noted, the patient's mother had chicken pox 12/22/2000 or 12/26/2000. The patient sought unspecified medical attention. On an unspecified  date the patient recovered. No further information is expected.
fatigue; headache; Neckache; Slight nausea; shoulder sorenes; This is a spontaneous report from a contactable consumer reported for herself that. A 40-year-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was 5318) via unspecified route of administration on 17Feb2021 at 8:30 (age at the time of vaccination was 40-year-old) in right arm, as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. Previously the patient received first dose of bnt162b2 (COMITNATY, Solution for injection, Batch/Lot number was 5318) via intramuscular route in left arm on 27Jan2021 (age at the time of vaccination was 40-year-old) as single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not have any other vaccine in 4 weeks and no other medication in 2 weeks. Starting within about 5 hours of the 2nd vaccine. On 17Feb2021 at 13:30, the patient experienced fatigue, Headache, Neckache, Slight nausea and shoulder soreness. The patient did not receive any treatment for the adverse events. Outcome of all the events was recovered in 2021.  Follow-up (07Jul2021): Follow-up attempts completed. No further information expected.
A report has been received from a Physician concerning an 8 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 09-Nov-2012. The patient experienced Mild RUNNY NOSE. The patient recovered from the event of RUNNY NOSE on an unspecified date. The report was considered to be non-serious. The reported physician causality between the event runny nose with the FLUMIST to be yes. Summary of follow-up information received on 30-Nov-2012 from Physician: Reported causality added. Outcome of event runny nose changed from unknown to Recovered and intensity added for the same event. Vaccination history added. Corrected report on 07-Dec-2012: New reporter added. Patient initial added.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 2:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 2:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 22.37 for dose administered on 22-Jun-2021.  Batch number 008C21A underwent temperature excursion on 22-Jun-2021 with temperature 35 degrees Fahrenheit at 08:00 AM. This vial was moved to fridge on 27-May-2021 and beyond use date for the vial was reported as 26-Jun-2021. Product moved to clinic on 22-Jun-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degrees Fahrenheit. Temperature recordings were taken using a brand traceable temperature monitor at every hour.  No concomitant and treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
About 2 days after vaccine, right arm was numb, tingling, and burning for 1-2 hours. About 2 days later, left wrist and part of hand was numb for a couple of hours. Symptoms went away without treatment.
The patient stated that she felt weak/ fatigued. The clinical staff attended to her. They took her vitals. She stated that she felt better. She was cleared by the staff. (SP02 ? 99, Pulse ? 91 , Resp 18 B/P 123/89 mmhg).