chrisvoncsefalvay/vaers-outcomes huggingface dataset:
syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; body pain; headache; felt uneasy; nausea/Felt like throwing up; dizzy/lightheaded; Profuse sweating; EKG showed low heart rate, blood pressure; EKG showed low heart rate, blood pressure; feeling weak; could not stand; Feeling worse; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Cholesterol (blood cholesterol abnormal) from an unknown date. There were no concomitant medications. The patient previously received first dose of BNT162B2 for covid-19 immunisation on 24Mar2021. The patient also previously received naproxen and experienced allergies. The patient experienced syncope, soreness overnight in left arm, expanding pain to left shoulder, strong fever/low fever, body pain, headache, felt uneasy, nausea/felt like throwing up, dizzy/lightheaded, profuse sweating, ekg showed low heart rate, blood pressure, feeling weak, could not stand and feeling worse all on 15Apr2021 at 13:00. All the reported events caused hospitalization for 1 day. It was reported that After receiving Pfizer vaccine at 4pm developed Soreness overnight in left arm, expanding pain to left shoulder. Strong Fever and body pain in morning. Feeling worse throughout morning after breakfast of tea and fruits. While having lunch at 1.30 pm felt uneasy and nausea and could not complete lunch. Felt like throwing up and got up feeling dizzy and lightheaded. Experienced syncope and had to lie down on kitchen floor. Tried to get up with help from family members but could not stand and had to lie down again on floor. Profuse sweating. Wife called 911 and ambulance who arrived and checked pulse, EKG showed low heart rate, blood pressure. Taken by ambulance and paramedics to hospital Emergency where IV fluids were given to stabilize and discharged after 4 hours of observation. Still feeling weak, headache, low fever. Taking Tylenol and fluids while recovering. Adverse event start date: 15Apr2021. Adverse event start time: 01:00 PM. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): low on 15Apr2021, EKG (electrocardiogram): showed low heart rate, blood pressure on 15Apr2021 and pulse/heart rate (heart rate): low on 15Apr2021. Therapeutic measures were taken as a result of all the events which includes IV fluids and Tylenol. Outcome of all the events was recovering  Information on batch/lot number was requested.
Improper administration due to expired vaccine on July 13, 2022. Patient didn't report of any side effects or other outcomes.  Health Center was notified that once vaccine is received it can be kept in the freezer for 6 months. To prevent it from happening again, we will use the vaccine expiration tool to know the exact expiration date.
Initially after the first shot, no sickness or fever.  Soreness experienced in left arm (arm injected).  Didn't think much of the soreness until a few weeks later when I noticed that the soreness did not go away.  It was getting close to having to get the 2nd dose, which I did consult my primary care physician.  We agreed that I would receive the 2nd dose in the same arm, to prevent injuring both arms.  Same symptoms happened with soreness,  but I also had some chest pain and pain in the trapezoid area by my neck.  It got to a point where it was painful for me to move my arm to brush my hair.  I was unable to dress or undress without extra assistance due to the pan in my arm.  I could not even bathe myself properly.   Given the option to do physical therapy.  After four weeks of physical therapy, the therapist noticed that I was not improving, and the pain was being exacerbated.  It was getting worse.  She requested for a consult with Physical Medicine.  I am currently waiting on appointment with them.
Went 2 days without the medication and had a migraine; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Went 2 days without the medication and had a migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ATOGEPANT tablet for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In October 2021, the patient started ATOGEPANT (unknown route) 1 dosage form. In 2021, the patient experienced MIGRAINE (Went 2 days without the medication and had a migraine). At the time of the report, MIGRAINE (Went 2 days without the medication and had a migraine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter. No treatment information provided by the reporter. It was reported that patient was taking the Qulipta for 12 days, and then she  started in mid October, she went 2 days without the medication and had a migraine. She had been back on it for 1 week.
Vaccine was given to pt as patient has 2 vaccine cards. No adverse reactions were noted during the 15 min observation. Pt was also called to inform of incident @ 3:58PM. Pt stated he was stable.
Numbness, tingliness in right arm/hand -area.; ~5-7 minutes after administration; No treatment needed; Patient had been sitting after receiving shot, on her phone. Patient counseled to follow up with her doctor/primary care physician, or the pharmacy, if she continued experiencing symptoms.
This spontaneous report as received from a medical assistant (M.A) refers to multiple unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot# and expiration date were not specified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
compromised lung function; Diagnosed with breast CA; patient's low oxygen stores; a week later she had shortness of breath; felt bad for a day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST CANCER (Diagnosed with breast CA) and HYPOXIA (patient's low oxygen stores) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (felt bad for a day). On 17-Mar-2021, the patient experienced HYPOXIA (patient's low oxygen stores) (seriousness criterion medically significant) and DYSPNOEA (a week later she had shortness of breath). On 05-Apr-2021, the patient experienced BREAST CANCER  (Diagnosed with breast CA) (seriousness criterion medically significant). On 08-Apr-2021, the patient experienced LUNG DISORDER (compromised lung function). The patient was treated with Surgery for Breast cancer female. On 11-Mar-2021, FEELING ABNORMAL (felt bad for a day) outcome was unknown. At the time of the report, BREAST CANCER FEMALE (Diagnosed with breast CA), HYPOXIA (patient's low oxygen stores), DYSPNOEA (a week later she had shortness of breath) and LUNG DISORDER (compromised lung function) outcome was unknown.            Treatment for the events included oxygen therapy.  Company Comment: Based on current available information and the temporal association between drug use and the start date of the events a causal relationship cannot be excluded except for the event of Breast cancer as this causality is unlikely.   This case was linked to MOD-2021-031179; Sender's Comments: Based on current available information and the temporal association between drug use and the start date of the events a causal relationship cannot be excluded except for the event of Breast cancer as this causality is unlikely.
SENSITIVE HANDS; BODY ACHED; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sensitive hands, body ache, chills, and body ached. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensitive hands, body ache, chills, and body ached. This report was non-serious.
Rash, UrticariaPruritus, NauseaVomiting, Diffuse rash covering torso Narrative:
arm got warm; This is a spontaneous report from a contactable consumer(patient) via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced First shot arm got warm. Second shot arm got warm. Had no other AE. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 29-Apr-2021 at 4:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 4:12 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (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.   The age of the patient was reported as 20.32.  No concomitant medications were reported.  On 29-Apr-2021, 5 vials were moved to clinic.   The vial was initially moved to the fridge on 19-Apr-2021 and proposed beyond use date was 19-May -2021.   On the date of administration, at 10:00 A.M., the temperature recorded was 33 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.  The occupation of reporter was reported as clinic manager.  This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a registered nurse concerning a 55 year old Caucasian male with no known allergies who on 27DEC2003 between 8:00-9:00 am was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant medication included metoprolol succinate 25 mg QD. It was noted that on 13DEC2003, the pt was recovering from sinusitis. On 27DEC2003, (also reported as that evening or next day), the pt developed fever, chills and swelling of the right arm which was red and hot to touch. It was noted that although the temperature was not actually checked the pt's wife told the nurse "it probably went higher than 101." There were no diagnostic lab tests performed.  On 28DEC2003 , the next day the client slept most of the day and his arm continued red, swollen and warm. It was also noted that the pt felt okay and that he was almost back to normal. His arm continued to be a little red + swollen, however it was also noted that he had recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned that the pt's son was vaccinated with dose of pneumococcal 23v polysaccharide vaccine and experienced a similar reaction. Additional info has been requested.
Left forearm swelled with crepitus.  Swelling from left elbow to wrist.  Pain with palpation and flextion of wrist.
Child developed urticaria 4+ days after received IPV #3 and DTaP, age 3. Now 36+ hours out, new diffuse hives. Believed fine.
Fever of 103, muscle aches, extreme pain in arm of administration, headache, eyes burning
She got the shot and has not had a period since. She's in a lot of pain. Her periods were normal for the past two years til she got this shot.
Patient was observed post Covid-19 immunization for 30 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  Chills .   Assessment : Time of assessment. Alert and oriented.   Actions taken:  Vitals sign taken  VAERS form completed   Bp 120/79 Medications administered: No medication administered.   Disposition:Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.
Pain in groin  on 10/13/13 then death on 10/14/21 days later.
Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 09Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 03Feb2022 at 17:00 as dose 3 (booster), single (Lot number: FW0698) at the age of 16 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Patient did not received any other vaccine in four weeks and not received any other medications in two weeks. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant) with onset 05Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 05Apr2022, outcome "recovering" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Patient did not received any other vaccine in four weeks and not received any other medications in two weeks. AE resulted was in none of the above. She did not experienced Covid prior vaccination. She was tested Covid post vaccination.   No follow-up attempts are possible. No further information is expected.
I got my second booster May 31,2022 and the hives came back like immediately and a sudden eruption on my arms and mostly on my back. My husband noticed my back first and I had someone to take a picture and show it to me.  I see a massage therapist at least once a month and she said it was dramatically different from the last visit. This gave me major concern so I went back to see my doctor It caused me to see a dermatologist June 24,2022 which diagnosed me with seborrheic keratosis and hives as well as  Lesra Treale. The hives itch and were very uncomfortable. Hydroxyzine was prescribed and it dose help at night with the itching. Still currently dealing with this and I do have a follow up schedule.
This spontaneous report as received from a consumer (patients mother) via an unspecified person from an Immunization Coalition and company representative refers to a female patient of unknown age. No information regarding the patients medical history was provided. On an unknown date the patient was vaccinated with GARDASIL injection. Dose and route of administration were not provided. No concomitant medication was reported. In the email from the Immunization Coalition was stated that an unspecified mother claimed that her daughter died in 2008 as a result of GARDASIL. Additional information has been requested.
Headache, Myalgia, injection site pain Narrative:   Other Relevant History:
Moderna vial was punctured at 12pm 11/17/21  left out overnight in the refrigerator. Staff member drew and administered dose from punctured vial at around 10am on 11/18/21
rash @ site of inject; blotchy rash on torso, face buttocks; DPH administered by mom;
Pt is still experiencing muscle aches/weakness and dizziness upon standing shortly after and at least 5 days after vaccines. Going to doctors.
Shingles; first dose approximately 4 years, has not received second; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's comment: The RPH(registered pharmacist) called on behalf of patient. The patient received first dose of Shingrix approximately 4 years ago(from the date of reporting) and had not received the second dose.  The reporter reported that the patient was currently experiencing active case of Shingles.  The reporter also reported that the patient was experiencing an adverse reaction to the first dose of Shingrix, but did not provide any details regarding the adverse reaction.  The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as single dose (dose 2) for COVID-19 immunization. The patient's medical history wand concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in Mar2021 for COVID-19 immunization. The patient got her first dose in Mar2021 and had mild side effects then 3 weeks later on 01Apr2021 she got the 2nd dose. She has not been normal since then, she stated that it does not work. She signed a paper that showed all the side effects with the vaccine and the side effects she had were not on that paper. The patient thinks they were negligent. She passed out two times, it knocked her down but she didn't call the ambulance, her heart stopped for 2 minutes and came back it's been several days since she got the vaccine. She was weak, she has no energy, felt like she was going to die any moment, she can't eat food and she didn't digest for 12 to 16hours. These side effects were not mentioned on paper. The patient mentioned that she has no health issues. She was extremely healthy, she was a former athlete and mentioned that all this was because of the vaccine. It's not normal that she can't eat. She was dizzy and very weak and she felt like her heart can stop anytime. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Within minutes of receiving vaccine, became pale with faint feeling, and elevated BP.  Experienced this feeling in waves for an hour after the event.
No additional AEs; expired vaccine, PROQUAD, (lot# S02 l 73 2, expiration 10-JAN-2021) given to a patient; This spontaneous report was received from a nurse and refers to a patient of unknow age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 01-FEB-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), lot number S021732 with expiration date 10-JAN-2021 (dose, route and anatomical location were not reported) for prophylaxis. It was confirmed that there was no pervious temperature excursion. No additional adverse events were reported.
Pressure in middle of chest, comes and goes, noticed if individual is active the pain is constant, pain level 3/10,
Swollen arm at site, redness. Headache, malaise, upset stomach, fatigue, mild fever.
First Moderna dose fine during 15 minute wait on 3/3/2021. Upon arriving for second dose 28 days later, patient states that 30 minutes after the  first shot, she felt that her throat had a little tightening. Patient states she went to a restaurant to have something to eat, at which time she felt better and experienced no further issues . Second shot was declined , advised to receive in a medical setting.