chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe heart palpitations; Break out in sweats; Freezing cold; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 at 15:00 (3:00 PM) (at the age of 67-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 12Mar2021 at 04:00 AM, the patient experienced severe heart palpitations, break out in sweats, freezing cold. 67-year-old female patient received Pfizer's COVID vaccine on 11Mar2021 at 3 pm. Patient stated, from 3 to midnight, I had no effects whatsoever, but from 12 am - 4 am, I was not well with heart palpitations. One minute I would break out in sweats and 5 minutes later I would be freezing cold. Since then, I've had no effects. My other shot is 01Apr2021. Patient is asking if it is safe for her to have the second dose. Patient also asking if there are any records of worse reactions after the second dose. The patient is calling about the covid vaccine. The patient had the first vaccine on 11Mar2021 and she had it at 3:00pm and was fine until midnight and then she started having severe heart palpitations, breaking out in sweats then to freezing and it lasted about 4 hours. This happened between midnight at 4:00 am. Since then she has been fine. The patient is scheduled for her second dose on 01Apr2021. Is it safe for her to get her second dose. Is this a reaction from the vaccine. Outcome of the events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I awoke in bed and had a seizure type effect that caused severe internal shaking of my brain. I?ve never had it before. It was severe and unmistakable. It terrified me. It happened just once that I know of.  I fell back asleep and didn?t awaken til 12 hours later. I?ve had blurred vision since and bad exhaustion.
Headache, Myalgia. Fatigue, Redness and swelling at injection site. Narrative:
Vaccine give 05-11-2017 at 1:51 pm. Patient started itching at first at site of injection after 2 hours, then arm started to swell, red, and warm. Patient when to hospital around 4-5 pm of the same day. 05-12-17 - patient went back to hospital. 05-13-17 patient went to pharmacy to fill Rx for antibiotics given for swelling or possible cellulitis.
Pt vaccinated with OPV/DTP developed possible local reaction. Seen by MD probable varicella, recommendation heat applications to inject site. Tavist syrup 1/2 tsp qid & Tempra.
The pt developed adult onset diabetes approx 6 weeks following one dose of anthrax vaccine and 100 day coures of post exposure antibiotics.
Approx 5-10 min after shot, patient's arm felt numb. She started feeling nauseas, her ears were ringing, and her vision started fading, eyes rolled backed in head, she lost consciousness and had seizure-like activity fro 5-10 seconds. She then regained consciousness but remained light headed, shaking and clammy.
Patient says she started with some redness around the injection site, but the next day the redness slowly moved down her arm and started moving down slowly. The site got swollen for a few days, small itching, but no fever. Patient went to see her Doctor after a few days and doctor told patient to examine the site for any further redness. Followed up with patient after a few days and patient says she feels better now and her redness and swelling has gone down.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 11:00 as dose 1, single (Lot number: HD9835) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interstitial lung disease" (unspecified if ongoing); "myositis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE], start date: 01Oct2012. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Patient was very irritable and "not himself" for a duration of 3 days after administration of the second dose of Hep A vaccine.
Breakthrough case admission after 5 vaccines mOderna 1/18/21 Lot# 026L20A;  MOderna 2/15/21 Lot# 038K20A;  Moderna 8/25/21 Lot# 088D21A;  Moderna 2/23/22 Lot# 046L21A;  Moderna 1/3/23 Lot# 011H22A
-Vaccine was given around 2:30pm -No symptoms until the following day around 1:00pm (Dizzyness, Fatigue, Shaking) -Symptoms continued into the  night and progressed (Fever, Headache, Body Aches -The next day around 10:00am (No Fever, No Body Aches, Still Fatigue, and Still Headache)
(1) Soreness @ injection site (immediate, lasting 4 days) (2) Body aches, weakness, chills, tired, sweaty. (Began Day 2, Lasting 3 days)
Tingly sensation and very flushed feeling. Heartbeat began to rise quickly.   Could?ve been a panic attack or adverse reaction. Not sure.
Elevated fever of 104.3 within 12 hours of vaccine administration-left arm swelling, warm to touch and pain-complained of abdominal pain, vomited x1, headache-was seen by MD 7/24/03-MD stated ?virus versus vaccine reaction.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.     On 15-Apr-2021 at 9:22 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:22 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 27.09~  Concomitant products were not provided.   On 15-Apr-2021, Excursion time was 9A temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
A patient received two doses of Fluzone HD Quad no AE; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via Agency (Reference number- 00878921) and transmitted to Sanofi on 30-Nov-2021.  This case involves a 88 year old male patient was received two doses INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 18-Nov-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ747AA, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (latency same day).  It was reported "The caller is asking for direction regarding administering a double dose of FLUZONE HD QUAD to a patient."  No other adverse event was reported.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a physician concerning a 12 month old female with no allergies or medical history who in approximately 2004 was vaccinated with a third dose of PedvaxHib (manufacturer unknown). Concomitant vaccination included a third dose of DTaP (unspecified) (+) tetanus toxoid. Subsequently, the patient developed a fever and abdominal pain and was hospitalized. Additional information has been requested. The patient subsequently experienced fever after vaccination with MMR II (WAES # 0612USA02888).
Patient rec'd 1st dose of SHINGRIX 8/8/18 at 14:45 pm. Remained in store at least 10 minutes (approx.) and appeared fine. His companion brought him back through drive thru around 1530 stating he had become cold, clammy and confused. She was also concerned that since patient is diabetic, these symptoms could have been caused by a drop in blood sugar, however they did not have a glucometer. I advised them to seek care at ER.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: She said she got red, swollen arm from elbow up that started a week after injection. It was hot and itchy to touch. She took benadryl and iced area and went to immediate care. If improved daily and she said that it is still a little red.
Child woke up in the morning of June 2nd with nausea and lethargic fatigue. Slept most of the morning. Went to bed then woke up screaming at 2:15 in the morning of June 4th. Could not talk, did not want to be held. Said few words, Brain rattle, loud noise, my head is noisy. After one hour he fell asleep again and when he woke up he remembered all what happen and was able to articulate better. Child reported that he wanted to talk but was not able to and it was like his head was shaking inside and a loud noise like a train.
sweats, fever, chills, severe headache, nausea, so tired, all I could do was sleep, I couldn't get out of bed for 2 days. I got up once for the bathroom and I felt like I was going to black out.  I have never been so sick in my life. This also happened on my first dose 2 months prior.  3 days and missed time from work. not fun
This spontaneous report was received from a Licensed Practical Nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L040178 and expiration date 31-AUG-2017, administered by an unspecified route reported as intramuscular/subcutaneous (unspecified strength and dose). The patient's concomitant medication was not provided. Additionally, no adverse effect were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
On May 25, 2018 while at Dialysis getting my treatment, I started with chills, vomiting, and fever of 101.3. Chills vomiting lasted until after treatment was over and fever lasted until about 6:00pm (started 7:30 AM).
large red painful rash on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (large red painful rash on the injection arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included METHOTREXATE for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE RASH (large red painful rash on the injection arm). At the time of the report, INJECTION SITE RASH (large red painful rash on the injection arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
About 12:30 AM on 2/14/21, I woke with extreme chills, muscle weakness, possible fever and sweats, joint pains. About 2:30 AM, I took two 325 MG aspirin.  About 9:30 AM, I woke again with the same extreme symptoms listed above. I took an additional two 325 MG aspirin. About 4 PM, my symptoms were not as severe, but I was still unable to engage in daily activities, and I took an additional two 325 MG aspirin. Symptoms continued, but lessened, and about 9 PM, I told an additional two 325 MG aspirin and a zolpedim CR to help me sleep throughout the night. I woke about 6:45 AM on 2/15/21, with mild muscle weakness, joint pain, and feeling slow and tired. As of this report at 11:15 AM on 2/15/21, I am functioning at about 80% capacity, some chills and muscle/joint pain.
4/2 ~4/3: No daily exercised (30 pushups in the morning) during these two days. 4/4/2021: Resumed daily exercise, and walked a few miles (usually 2-3 times weekly)? leg and butt pain April 5-7: stiff neck symptoms: back, right arm, shoulder, and neck pain,  April 8-11: stiff neck kind of symptoms: back, left shoulder, and neck pain April 10-11: stiff neck kind of symptoms (back, left shoulder, and neck pain) + injection site pain (left arm) April 11-13: continued left arm injection site pain. April 14: waked up with less left arm injection site pain. After daily pushups, continued left arm injection site pain. April 15:  waked up with less left arm injection site pain,
Pt said arms sore even after 3 weeks pt started having soreness in the right upper arm since the shot. And pt said still has pain while lifting arm and sleeping per pt.
Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.
still got covid; still got covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "still got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical details: Patient said she is a woman with covid and a prescription for Paxlovid. She asked what's the time interval between getting a recent Pfizer covid vaccine shot and starting Paxlovid. She stated that she had the bivalent Pfizer covid vaccine last month but still got covid now. She also mentioned that every after she got the Pfizer covid vaccine she experienced Guillain-Barre symptoms. Patient said she was taking immunoglobulin or IVIG (Gammagard) and would like to know if there is information for a possible drug interaction between Paxlovid and the IVIG. Patient said one of her doctors told her she could still take Paxlovid after the 5 day symptom onset but that it would not be as effective, and that her other doctors said that she should take it within the 5 day symptom onset. Patient asked what is Pfizer's recommendation on the matter since her doctors are giving contradictory information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient has an outbreak of hives/rash throughout entire body. Patient is being treated with topical and oral steroids.
Facial swelling on the left side of the face around the nose area that I had a facial filler.
came for her first 1st dose pfizer. unfortuantely she was vaccinated with a pediatric 5-11 year old dose even though she recently turned 12 year.
About 2 hours after vaccine administration, my entire body began shaking. There were no fever or chills present, just uncontrollable shaking. This lasted for about 4 hours and then ceased. After the shaking subsided I was extremely tired, but no other symptoms (other then injection site pain) were present.
Patient broke out in hives all over her body, which was highly pruritic.  Felt some throat swelling but not enough to constrict airway completely.  This occured approximately 6-8 hours after vaccination was administered.  Patient treated herself with 50 mg Benadryl and went to sleep.
2 days post vaccines - firm, indurated welt on left upper arm measuring 4.5" x 4"; warm, red. - present x 1 day - pruritic
Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine).    No concomitant medications were reported.  No other adverse events were reported.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-727280, US-MODERNATX, INC.-MOD-2023-727281.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727280:Master Case US-MODERNATX, INC.-MOD-2023-727281:Master Case
Angioedema.  Urticaria over entire body.  Daily allegra to control symptoms.  Tried stopping but can't as the symptoms return immediately.
This case meets vaccine breakthrough criteria review.  SXS INCLUDE FEVER, MALAISE, POOR APPETITE, FATIGUE, COUGH
In a few minute after vaccine, I felt shooting pains in right arm, and some discomfort and intermittent pain/soreness. Soon after my hand and arm was stiff and impossible to move/bend without discomfort and soreness. It felt arthritic and stiff. My left arm also had  a similar less pronounced reaction. I also became tired and a bit disoriented
This report was received from the investigator of a trial on 20 May 2010. A 26 year-old male subject received the following vaccines on 15 July 2009: ACAM2000 (lot number not reported); TYPHIM VI (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Fourteen days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject had a history of high blood pressure, elevated cholesterol, palpitations/pounding heart without exercise, and headaches. On Day 12 (27 July 2009), the subject had a Troponin I of 2.97 (abnormal) and electrocardiogram and echocardiogram which were both abnormal. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
No additional adverse event; Three doses of ROTATEQ were administered following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.       On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1694405, expiration date 06-DEC-2021, at a dose of 2 milliliter once, orally for prophylaxis. The vaccine experienced a temperature excursion, however, at the time of reporting, the reporter was waiting for multiple excursion form to be returned so no details were provided. Digital data logger was not involved. No adverse event was reported.; Sender's Comments:  US-009507513-2102USA008801: