chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe headaches; dizziness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 12:00 (Lot number: EL3247) at the age of 53 years as dose 2, single and administered in arm right, administration date 23Feb2021 (Lot number: EL3247) for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Batch/Lot no: EL3247 , Anatomical Location: Arm Right), administration date: 23Feb2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 16Mar2021, outcome "recovering", described as "Severe headaches"; DIZZINESS (non-serious) with onset 16Mar2021, outcome "recovering", described as "dizziness"; FATIGUE (non-serious) with onset 16Mar2021, outcome "recovering", described as "fatigue".  Follow up(22Mar2021): This is a follow up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included:  The Pfizer unit recently received the attached report submitted by you via Pfizer. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.  No follow-up attempts are needed. No further information is expected.
The injection site is hot, rock hard, painful, swollen and red.  Patient did get PREVNAR in the same arm, albeit lower on the arm.  That immunization is not causing a reaction.
Varicella disease (breakthrough) -day 1 today 6/16/15-41 spots, widespread papules vesicula discrete lesions. Afebrile, no exanthema.
Information has been received from a RN concerning a patient who was vaccinated with a first and second dose of varicella virus vaccine live on 04/21/2000 and 05/18/2000, respectively. The serum varicella zoster virus antibody test was done on 08/09/2000 and it indicated that the patient was "non-immune" to varicella zoster. The patient sought unspecified medical attention. No further information is expected.
got my period for the first time since Sep2020 and it was much heavier than I ever had it before with a lot of clotting; got my period for the first time since Sep2020 and it was much heavier than I ever had it before with a lot of clotting; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: ER8727) via an unspecified route of administration on 29Mar2021 at 08:00 (at the age of 54-years-old) as a single dose in the left arm. Medical history included high risk lesions in breast, stop menstruating (I am taking Tamoxifen 200mg daily, which has made me stop menstruating) and COVID-19 (prior to vaccination), all from unspecified dates and unspecified if ongoing. The patient had no known allergies and no relevant past drug history. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included tamoxifen taken for an unspecified indication from Sep2020 and ongoing at 200mg, daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021 at 23:30, the patient experienced got my period for the first time since Sep2020 and it was much heavier than I ever had it before with a lot of clotting. The events were reported as non-serious. The events resulted in a doctor or other healthcare professional office/clinic visit. The course of events was reported as follows: "I am taking Tamoxifen 200mg daily, which has made me stop menstruating since I started taking it in Sep2020. I received the first dose of the COVID Vaccine at 8am on 29Mar2021.That night while sleeping I got my period for the first time since Sep2020 and it was much heavier than I ever had it before with a lot of clotting. I received the second dose of the vaccine on 19Apr2021 and within 3 days, the same thing happened. I had a phone consultation with my oncologist to inform him of both incidents." Treatment was not received for the events. The clinical outcomes of the events got my period for the first time since Sep2020 and it was much heavier than I ever had it before with a lot of clotting were recovered/resolved on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.
Fever, sore throat, malaise  EXTREME Weakness and fatigue from onset until present time...
I tested positive for Covid on 02/04/2022. I had a sore throat, headache and mild nasal congestion. My symptoms only lasted for 3 days.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2021 at 12:00 as dose 1, single (Lot number: EK9231), in left arm, on 26Jan2021 at 14:30 as dose 2, single (Lot number: EL3248), in left arm and on 25Oct2021 at 14:30 as dose 3 (booster), single (Lot number: FF2593) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Sep2015, stop date: 09May2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course:  No Seriousness criteria-results in death, life threatening, prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Report about COVID treatment. Vaccine was received.  There was other medication in 2 weeks. She began feeling better 12 hrs after 2nd Paxlovid dose. Felt normal by day 7 and returned to work. 3 days after finishing Paxlovid the symptoms came back as an-other bad sinus head cold. No treatment for AE. No Known allergies.; Sender's Comments: Based on the available information in the case, the causal association between the events Vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
On the day of administration, vaccine was past its 30 days of refrigeration. We reached out to the manufacturer and they responded with the following, "Thank you for your patience. Analysis of the vials associated with your storage excursion is complete. The vaccine administered on February 14, 2022, February 15, 2022, February 16, 2022, February 18, 2022 and February 21, 2022 from lot number 042J21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
With in 2 minutes of shot felt: 1. Medicine being diffused out of heart with burning sensation that lasted about 30sec that followed by 2. Irregular heartbeat (that lasted about 5 minutes) 3.Need to get fresh air (felt like lowering mask) 4. Low blood pressure that caused little sweaty and cold hands All the symptoms in total lasted for 5 minutes and then I felt back to normal
Injection site pain, headache, muscle pain, chills, fever, nausea, swollen lymph nodes
Fever & soreness/swelling at injection site a few hours post vaccination swelling lasted a few days.
Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received its 30-days Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 2:27 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Patient  complained of Nausea, scant emesis. She asked for water and was given a 16 oz bottle of water. She drank about a third of the bottle, said she felt better and asked to leave around 3:14 PM
PT'S MOTHER CALLED 6/23/21 TO REPORT PT HAD RED, SPLOTCHY AREA WHERE SHOT WAS GIVEN ON THE NEXT DAY.. THE DAY AFTER THAT, THE AREA HAD BECOME LARGER AND HAD ALSO BECOME WARM TO THE TOUCH. MOTHER USED HYDROCORTIZONE CREAM TO TREAT THE AREA. MOTHER DENIES FEVER, N/V, HA
Patient states he was called a few minutes prior to 1000 today to remind him about his vaccine appointment; he relays he didn't know about his appointment and therefore he did not eat breakfast. Patient states he was observed for 15 minutes following the vaccine administration and was advised he could then go home. He states while driving home, he began to feel dyspneic, nauseous, and lightheaded. Patient also states he felt as if his voice changed. He states he then started to drive back to the hospital. When he arrived back to clinic, he was unable to park properly as he felt he was going to vomit.
Stated that after shot received, she started feeling soreness to site on (R) deltoid. Also felt a lump at site, and noticed bruising. States bruising got bigger by the next day.
20 minutes after the shot, Friday 7/23: tingling in left arm, numbness in lip on left side moving up towards my eye over my left cheek Day 6, Wednesday 7/28: numbness in left side of face is stronger and reached my left eye, numbness in left ear going down into my neck Day 7, Thursday 7/29: tingling around my left lip and chin, numbness all around my left eye, numbness on the outside of my left cheek and my entire ear.
Fatigue, fever, headache, chills, and muscle aches for about 24 hours
Mild red rash - raised.  (Like hives)  about 2 inches in diameter.   Located within a  1/2 inch of the injection site.   Not itchy.   First noticed on 1/30. Could very possibly been there before prior to that time. But I am not sure.    I applied hydrocortisone cream 1%. Upon discovery.  Raised appearance  went away, but redness and very mild itching is present on 1/31.
flu shot gave the flu worse than patient ever had it.; Initial information received on 10-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.   This case involves a patient with unknown demographics who experienced flu worse than patient ever had it (Influenza), while he/she received Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, it was reported that the flu shot gave patient the flu worse than patient ever had it (Influenza) (Unknown latency) following the administration of Influenza Vaccine. Never got another one, the nurse giving the shots told us a certain percentage of you will contract the flu from this.   Laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was Unknown.  There will be no information available on the batch number for this case.
Severe, dehabilitating headache for someone who has less than 5 headaches; This is a spontaneous report from a contactable consumer (patient herself). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were unknown), via an unspecified route of administration in the left arm on 09Mar2021 14:45 as a single dose for COVID-19 immunisation. Medical history included colitis and H1N1 influenza. Allergies to medications, food, or other products was unknown. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. She was not pregnant at the time of vaccination. On 11Mar2021 08:00, the patient experienced severe, dehabilitating headache for someone who has less than 5 headaches ever, the last of which was during H1N1. No treatment was received for the adverse event. The outcome of the event was not recovered. Event was reported as non-serious. The patient had not been tested for COVID-19 since the vaccination.  No further follow-up needed. Batch/Lot number cannot be obtained.
Adverse reaction to tetanus, diphtheria and acellular pertussis vaccine possible injection reaction. Allergy list updated. Review treatment options. Patient and family defer steroids for treatment. They were agreeable to below treatment. Review medications with patient and family. Instructed to go to the ER if develops new symptoms or symptoms worsen which patient and family understood this. Monitor blood sugar readings and report them to this office. Check lab work order at previous visit. Start hydroxyzine HCl 10 mg tablet 1 mg every 8 hours. Start loratadine 10 mg tablet 1 tablet every day.
Patient has non-immunity after 2 series; 2nd series, 3rd dose was given on 9th May 2022; 1st series: 1st 8/9/02, 2nd 2/14/03, 3rd 5/21/03; 1st series: 1st 8/9/02, 2nd 2/14/03, 3rd 5/21/03; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 6-month-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis, HBV (Engerix B pediatric) for prophylaxis and HBV (Engerix B pediatric) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B PEDIATRIC) and HEPATITIS B VACCINE (ENGERIX B PEDIATRIC).   On 9th August 2002, the patient received the 1st dose of Engerix B pediatric. On 14th February 2003, the patient received the 2nd dose of Engerix B pediatric. On 21st May 2003, the patient received the 3rd dose of Engerix B pediatric. On 9th May 2022, the patient received the 6th dose of Engerix B pediatric. On 14th February 2003, not applicable after receiving Engerix B pediatric, Engerix B pediatric and Engerix B pediatric, unknown after receiving Engerix B pediatric and not applicable after receiving Engerix B pediatric, Engerix B pediatric and Engerix B pediatric, the patient experienced drug dose administration interval too long. On 21st May 2003, the patient experienced drug dose administration interval too long. On 9th May 2022, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long, drug dose administration interval too long and drug dose administration interval too short were unknown.   Additional Information: GSK Receipt Date: 9-May-2022 Reporter's comments: After 1st completed series, the immunity test was carried out and it showed, the patient had no-immunity. The 2nd series was started on 22nd December 2021, 2nd dose was given on 21st January 2022 and 3rd dose was administered on the reporting day. This was all of the reported information by the healthcare provider at this time. The patient's immunity was tested for higher education. The reporter consented to follow up. Additional Supportive Information: The patient had no  immunity for Hepatitis after complete primary series, which led to therapy non-responder. Also, the 2nd and 3rd doses of primary series were received late than the recommended interval, which led to lengthening of vaccination schedule. The patient started second series but the 3rd dose was received too early, which led to shortening of vaccination schedule.
Sore arm first 3 days, reported on V-Safe. That was only reaction.  The after 1 week, Fri. arm started to hurt again, then itch and turned red around injection area for several days.  Took Photo if needed.
4/8 migraine, severe lower back pain, debilitating fatigue 4/11 &12 violent diarrhea 4/12 (eve) severe back pain returned, painful urination at times passing blood lower abdominal pain, pelvic pain back, pelvic pain, fatigue ongoing
On June 14th, 2021, I got my first Covid-19 Moderna Vaccination. Within a few hours of receiving the vaccination, I developed a significant itch on my left hand. The itching continued on into the night with no relief. Upon arising the next morning I developed a severe outbreak of the hives. I called the doctor and he prescribed Benadryl which gave me some relief. The severity of the hives continued over the next two weeks without significant change. It took me a month before I was completely free of the outbreaks. On August 12th I had another outbreak in three locations, but it lasted only one day without treatment.  In addition, I experienced numbness in my feet following the shot, but I was so focused on ridding myself of the hives the numbness did not concern me until it became so prominent that my feet began to feel like they were weighted down and felt very heavy. I consulted with three doctors over the next three months to determine if there could be any other explanation other than the Moderna Vaccine. Unfortunately, none of the doctors could give me an alternative explanation for the numbness. Although the numbness continues as I complete this report, I have sensed that there has been a slight improvement over the past week.
Pain Swelling of injection site very tired and sleep, plus weak. Low grade fever 100.1 -? Kept a constant Headache (Regular) for 4 .straight days. these symptoms started the evening of the vaccination. By the first full day after my Shingrix shot I incurred swollen under arm pit on the right side and an inability to have any normal range of motion with the right arm none of these symptoms abate for 7 whole days after the original vaccine was given to me.  I didn't go to the E.R. or my regular Dr. Because I couldn't get an appointment (regular Dr.) Instead I call the C.D.C. and the pharmacy that gave me the vaccine and waited for it to get better.
Elevated heart rate over 110 for 48 hours constant post vaccine.  Body aches but mostly tachycardia was issue. Continues randomly post vaccine and has never neen a problem prior to vaccine.
My period would be a week long with two days of light spotting. Clotting through out the week. Heavy cramping.
2" x 3" red, warm, slightly raised welt from day 2 to day 9 (ongoing)
Blanchable rash at injection site 1?x 1.5? - the next day circular rash 2?x2? and painful/swollen lymph node in armpit of same arm as injection.
Patient was being vaccinated with Fluarix on right arm when patient moved. PHN removed needle from patient's arm to prevent any injury.  No fluid was injected from syringe.  PHN did not note any bleeding on arm when needle was removed. RN, PHN reviewed with patient's mother the importance stabilizing patient's extremity for safe injection of vaccine.  Mother verbalized understanding.   PHN replaced needle tip with a new needle and upon return to vaccine table, patient's mother Mother stated that patient was bleeding at injection site.  PHN observed slight bleeding at injection site, and noted that bleeding stopped after a few seconds.  Bleeding ceased from injection site and no redness or swelling was observed by , PHN.   Patient was vaccinated with Fluarix  on right deltoid, one inch below the first injection attempt, per CDC guidelines to separate injection sites by one inch. Mother and patient waited in post-vaccination observation area and no adverse symptoms were noted or reported by mother. Mother was educated by PHN on emergency precautions and when to seek emergency care for patient.  Mother verbalized understanding
Developed macular-papular rash (lesions 3-7 mm diameter) some with pinpoint whitish center (2 to 3) but overall negative vesicles. Positive pruritus. Rash developed approximately 22 days after receiving Varicella vaccine. Negative fever, only mild nasal congestion. As of March 26, 2014 - patient still with rash and more spots appearing.
Multiple vesicular lesions over arms, neck, face & back starting day 9 of initial vaccinia immunization. Mild FLS. BP 102/70 P 56 T 97.8. CDC does not feel that vaccinia IgG indicated. But lesions progressing to hands & wrist 8/22/11. Last Td 1/1/09.
LOWER HEART RATE; LITTLE HEADACHE; SORE ARM; POTENTIALLY HELPED SYMPTOMS OF POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME/LESS ADRENALINE RUSH/ LESS NEUROPATHY; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included postural orthostatic tachycardia syndrome, neuropathy, hepatitis c, and adrenaline rush, and other pre-existing medical conditions included patient wore a heart monitor and normally heart rate was in 150 - 160s when play ball. patient can not take certain medications because liver enzymes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a71a, and expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the subject experienced potentially helped symptoms of postural orthostatic tachycardia syndrome/less adrenaline rush/ less neuropathy. Laboratory data included: Heart rate (NR: not provided) 10 beats lower per minute, 140s, 130s, Low 140s, 156. On 02-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced little headache. On 05-JUN-2021, the subject experienced lower heart rate. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 150s. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little headache, sore arm, lower heart rate and potentially helped symptoms of postural orthostatic tachycardia syndrome/less adrenaline rush/ less neuropathy was not reported. This report was non-serious.