chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness and swelling of the right thigh anterior only. Treated with Benadryl, Motrin and Keflex.
they hurt a lot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles with an associated reaction of pain (received 1st dose on an unknown date and experienced pain, refer case US2023AMR129957).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: they hurt a lot). Rechallenge with Shingles vaccine was positive. The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR129957   Additional Information: GSK receipt date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient already took both doses and they hurt a lot. The follow-up could not be possible as no contact details were available.
Arm pain and fever of 100.5 began same day as vaccination.  Fever went away after several days, but return on 12/28 with fatigue.
Large red patch around injection site. Painful red patch on arm - not itchy but very sensitive to touch. Arm pain, headache, nasal congestion, lung pain when taking deep breath, nausea, exhaustion.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 07-SEP-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # N012492, expiration date 17-MAR-2018 subcutaneously (strength and dose number were not provided) for prophylaxis. The vaccine was diluted with an sterile diluent (MRK). On an unspecified date, the vaccine was exposed to temperature ranges between 6° Fahrenheit (F) to 14°F (9.2°F) during a time frame of 10 hours and 15°F to 46°F for 27 hours. There was not previous temperature excursion, the temperature excursion was called by a data logger. Adverse effects were not reported.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021 at 1:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:43 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 56.09 for dose administered on 03-APR-2021. No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 03-APR-2021 with temperature 34 Fahrenheit from 09:00 AM. This vial was moved to fridge on 30-MAR-2021 and beyond use date for the vial was reported as 29-APR-2021. Product moved to clinic on 03-APR-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-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
Not immunocompromised and was given a 3rd full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Not immunocompromised and was given a 3rd full dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 024MZ0A and 012A21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL and AMLODIPINE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Not immunocompromised and was given a 3rd full dose). On 22-Oct-2021, ACCIDENTAL OVERDOSE (Not immunocompromised and was given a 3rd full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-037205, MOD-2021-254142 (Patient Link).
Patients husband reported finding her unconscious/unresponsive, upon which she underwent respiratory arrest and was admitted into the hospital ICU from 5/11 - 5/16/13. She indicated there was a noticeable blistering rash on her face, along with some on her body/back which itched.
Booster; Long dizziness; weakness and I couldn't get out of bed without help and all because I was so weak; Injection site pain; Tiredness; Headache/ severe headache; Fever 100.4; feeling unwell; Disease appetite; All day I had muscle pain like you get when you have the flu / muscle pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FD0809) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal; POTASSIUM; BABY ASPIRIN; ROSUVASTATIN; VITAMIN D3. Vaccination history included: Bnt162b2 (Dose 1 (MANUFACTURER UNKNOWN)), for Covid-19 immunization; Bnt162b2 (Dose 2 (MANUFACTURER UNKNOWN)), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 11Nov2021, outcome "unknown", described as "Long dizziness"; ASTHENIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "weakness and I couldn't get out of bed without help and all because I was so weak"; VACCINATION SITE PAIN (non-serious) with onset 11Nov2021, outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Headache/ severe headache"; PYREXIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "Fever 100.4"; MALAISE (non-serious) with onset 11Nov2021, outcome "unknown", described as "feeling unwell"; APPETITE DISORDER (non-serious) with onset 11Nov2021, outcome "unknown", described as "Disease appetite"; MYALGIA (non-serious) with onset 11Nov2021, outcome "unknown", described as "All day I had muscle pain like you get when you have the flu / muscle pain"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, asthenia, vaccination site pain, fatigue, headache, pyrexia, malaise, appetite disorder, myalgia.  Additional information: Patient also took Multi-Vitamin as concomitant medication. When probed if administered with any other vaccine, patient stated, "No, I didn't."  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a registered nurse referring to unspecified number of patients. The patients medical histories and concurrent conditions were not reported. On unspecified dates starting on or after 06-JAN-2016, the patients were administered an unspecified number of improperly stored doses of VARIVAX (Merck) Temperature of 6.5 F in a time frame of 30 minutes (Lot # L010144; expiration date 24-MAR-2017) (dose and route of administration were not reported). Concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) in a 56-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 21-Feb-2022 at 4:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient had received booster dose. It was reported that patient had received lot 066H21A past its 30 days expiry date. No treatment drug information was provided.   This case was linked to MOD-2022-542869 (Patient Link).
about 5 minutes after administration, patient became unresponsive and was going in and out of consciousness. Her pupils became dilated and she would not respond to stimuli. Her respiratory status was unclear. No hives or rash could be observed. Patient became pale in the face. An allergic reaction could not be ruled out and the patient became less responsive so an EpiPen 0.3mg was administered in the left thigh. Patient was placed on her back on the ground. She became more alert and seemed to have normal breathing. EMS arrived and took vitals. Blood pressure was 138/77 with a heart rate of 88 bpm. Patient's father is taking her to her PCP for follow up this afternoon.
Migraine with aura a week after injection involving left side ear pain lasting now into 4th day. Not responding to my migraine medication Ubrelvy which normally works. Increase in tinnitus.
Intermittent hearing loss in both ears. Lasts for 3-4 days. Goes away. Comes back 2-3 weeks later. Everything sounds far away, muffled, and voices sound very tinny.  Initial onset of symptoms included two bouts of vertigo on two separate days.
Patient received influenza vaccination on 9/3/2009. On 9/4/2009 arm was red, warm to touch at site. No hardness felt itchy to patient took BENADRYL. No resp distress. Dr. stated hives.
Information has been received from a medical technologist concerning an approx. 40 year old female with no known drug allergies who "several months ago", in approx. 1/01, was vaccinated with varicella virus vaccine live. Subsequently, in approx. 4/01, titers were drawn that showed the pt did not sero-convert. Unspecified medical attention was sought. Additional information has been requested.
Pt reports GI sx nausea, vomiting, cramping; "nodules" on knees & elbows; devel some form of urinary tract problem; Seen by MD had 5 doses of vax;
heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 16 years old and unknown gender patient who had heart attack while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) 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.  On an unknown date the patient had serious heart attack (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) heart attack.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event (heart attack).  At time of reporting, the outcome was Fatal for the event heart attack. It is unknown if an autopsy was done. The cause of death was reported as Heart attack.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case involves a 16 years old and unknown gender patient who had heart attack while receiving vaccine INFLUENZA VACCINE. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, latency, medical history, concomitant medications, autopsy findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.; Reported Cause(s) of Death: NOT PROVIDED
Extreme tiredness, headache, chills, fever.  Lasted from 11:30pm until 7am the following day.  He?s feeling better now.
Patient received a vaccine with an extra component (Haemophilus I. type B) aside from DTaP and IPV (polio) vaccines on his annul visit on 1/13/2023. Mother reports patient didn't have fever or other concerns. Mother noticed he had diarrhea for 1 day that day. Mother asked to observe for any adverse reactions, but only expected within the next 24-48 hours after vaccine administration like uncontrollable fever, headache, injection site inflammation or redness, which mother denies noticing those. Mother verbalized understanding and will call back to notify if any concerns.
Experienced red rash, hot to touch next day. Went to urgent care, received abx thought to be possible infection.
4 yo male received .5cc AFLURIA H1N1 vaccine @ P.P. office. Parent notified, no adverse reactions reported. DR notified HD. Follow-up with CSL Biotherapies advised no further action to be taken.
Swelling, itching, hot to the touch at left delt (injection site.) Delayed onset 10 days.
An 82 year old male with past history of hypertension and diabetes but no prior cardiac history. He had no previous documented allergies. He had previously received flu vaccine in my office in 2001 and in 2002. He received the Fluvirin on 10/10/03. He was found at home expired with a presumed sudden cardiac death on 10/15/03. The death certificate received on 12/3/03 states cardiac arrhythmia and myocardial infarction.
Patient became nauseated shortly after receiving 2nd dose.  Onsite EMS was called vitals HR 16 BP 85/54 100% O2 BG 87. Adrenaline IM give a per the doctor. She did not have any adverse reaction to the 1st dose 3/4/21 Patient was transported to the hospital.
Deltoid swollen-red moved to area under arm and into rib area. MD seen/allergic reaction.
angioedema and chronic hives(total body) began April 30,2021 these symptoms are persistent as of this submission(11/28/2021) treatments have included H1 and H2 blockers daily at higher than usual doses-zyrtec and famotidine Also 4 courses of tapering steroids(prednisone10mg)-each treatment lasting 1 week have seen allergist/immunologist and have been offered Xolair  prior to this problem, the patient  had no history of any medical problems/hives/etc
Patient received 2mo immun 5/18/07. Fever of 101 started on 5/24/07. Fever continues daily, work up done, CBC, Bld cultures, urine culture WNL, Fever's run 100.3 - 100.4, R eye drainage, cranky.
Patient was called to come in for her second covid shot by her employer representative but was actually not supposed to get her second shot until the following week. Patient has cardiac history so when she got home after work, she figured out she was given the shot a week early, she notified her PCP and he told her to go to the ER. Patient felt like she was having some mild heart palpitations but decided to monitor her pulse at home and was able to return to work the next day with no further symptoms.
I started with a fast heart rate and palpitations. They lasted all day. That evening, I decided to check my blood pressure and my fancy meter let me know I was having an irregular heart rate. I called Dr.'s after hours doctor (10 pm) and asked if I should go to the emergency room and she said I did not need to go but could call in the morning for an appointment. I went to bed and when I woke this morning, my heart rate seemed to stabilize. I have checked my blood pressure with my monitor and it is not giving me the warning. I am feeling better. I do have occasions when I have palpitations but they have never lasted that long and I have not had them recently. I am going to continue to monitor my heart rate today.
High Fever, chills, fatigue, shortness of breath, rapid heart rate, pain at injection site,
patient received 2 doses of the rabies vaccine back in 1975, but he did not complete the 3 doses, with no adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from nurse.  This case involves an unknown age male patient who experienced patient received 2 doses of the rabies vaccine back in 1975, but he did not complete the 3 doses, with no adverse event while receiving vaccine rabies vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date in 1975, the patient received suspect rabies vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date, form, strength: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date the patient received 2 doses of the rabies vaccine back in 1975, but he did not complete the 3 doses, with no adverse event (inappropriate schedule of product administration) (unknown latency).  Nurse was inquiring if the patient can have a booster of IMOVAX or if the complete series needs to be administered. The patient was unsure of what rabies vaccine they received in 1979. The nurse indicated that the doses were already drawn up and she may give the booster as 47 years has passed.  Action taken: Not applicable.  Outcome: Unknown for the event patient received 2 doses of the rabies vaccine back in 1975, but he did not complete the 3 doses, with no adverse event.   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.
Woke up with them the day after 2nd shot. Not a bad case though.; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the shingles vaccine. The patient stated that, he/she woke up with them the day after 2nd shot of shingles vaccine but not a bad case though. Additional Supportive Information: The follow up would not possible as no contact details were available.
Received Menactra vaccine 5/16/07 PM. Arm became sore 6-8 hrs later. Woke 5/17/07 with temp 99.7, soreness in underarm. 5/18/07 soreness/swelling underarm worse. Developed body aches, back and hip pain. Slight headache. To HC provider 5/18/07 PM 5/21/07 recovered.
Pt. had a flu shot then complained of pressure in his throat, evaluated by EMT'S, BP 100/70, S/S resolved on their own quickly.