chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; Little bit of redness; Swelling; Warmth; This case was reported by a nurse via call center representative and described the occurrence of hives in a 7-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 55GY9, expiry date 30th June 2020) for prophylaxis.   On 15th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 16th October 2019, 1 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced hives, erythema, swelling and skin warm. On 17th October 2019, the outcome of the hives, erythema, swelling and skin warm were recovered/resolved.   It was unknown if the reporter considered the hives, erythema, swelling and skin warm to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The patient received FluLaval Quadrivalent 2019-2020 season on unknown deltoid. In the evening the patient's parents noticed a line of hives going down the arm from the injection site. The hives were in a line. There was a little bit of redness, swelling and warmth to to the touch but not much. The patient was put to bed with no treatment and in the morning the hives had resolved.
pt had fever the first night after taking the vax but is normal now however, she feels like she has a fever.  Today she had a red and blue rash all over her arms and legs.  She has a fire engine red rash that goes around her neck.  She continues to be fatigued, she is weak and sleeps all the time.  Pt will contact PCP.
Pt began having itching, rash, hives on 1/1.  He saw his PCP and a dermatologist. He was treated over the next week with steroid shot and pack. claritin, zyrtec, and Allegra.
Patient had low grade fever 6/19/19, 100. Systemic macular red scattered rash started 6/22/19 and has waxed/waned with heat until visit 6/24/19.
SWEATING OVERNIGHT; BODY ACHES; CHILLS; HEADACHE; SUDDEN SUPER NAUSEOUS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced sweating overnight, body aches, chills, headache, and sudden super nauseous. The action taken with covid-19 vaccinewas not applicable. The patient recovered from sweating overnight, body aches, chills, headache, and sudden super nauseous. This report was non-serious.
On 1/7/2022, patient noted a lump where the collarbone and neck meet at left side.  She had booster shot in her left arm.  The area was sore to touch. on 1/6/2022 she was sick with a temp of 99.1, congestion, headache and nasal cough.  She had been taking Ibuprofen 200mg x 2 daily with some relief noted.  She was advised to apply a cool compress to the area of the lump and contact her physician.  On 1/10/2022, the lump had decreased in size.  She spoke with her physician and continue to apply the cool compress to area and take Ibuprofen medicine as needed.  On 1/22/2022 the area had cleared and improved.
Itching and red rash at injection site. Approximately3? dia. Itching extending down arm towards elbow
THE INDIVIDUAL RECEIVED VACCINE THAT WAS FROZEN  TWICE; THE PHARMACIST AND THE STAFF KEPT THE VACCINE  IN THE FREEZER; This spontaneous report received from a health care professional concerned a 31 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced the pharmacist and the staff kept the vaccine in the freezer. On 18-NOV-2021, the patient experienced the individual received vaccine that was frozen twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received vaccine that was frozen twice and the pharmacist and the staff kept the vaccine in the freezer was not reported. This report was non-serious. This case, from the same reporter is linked to 20211150068.
Patient came to pharmacy morning of 10-24-15 and said she had rash on her arm where flu shot was given. She then went to facility and was diagosed as having cellulitis. She was given prescription for clindamycin 300mg every 8 hours for 10 days.
This spontaneous report was received from a licensed practical nurse concerning to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 15-SEP-2014, the patient inadvertently was vaccinated with ZOSTAVAX, vial, subcutaneous route (dose and lot number not reported) that expired on 14-SEP-2014. Supported. No adverse effects reported. Additional information has been requested.
Presented for cough, increased sputum production, increased shortness of breath, was found to be Covid-19 positive on 11/3/2021, required supplemental oxygen and was admitted. Was seen by Pulmonology and infectious disease and treated with Decadron, Lovenox, Remdesivir. Also received Lasix. Her COPD was managed with triple therapy (ICS, LABA, LAMA). Once her oxygen requirements stabilized, patient was able to be discharged home with oral Decadron therapy.
High fever; chills; shaking; headache; muscle aches; sweating; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 (Lot number: FE3594) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, brand=Pfizer), administration date: 09Mar2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, brand=Pfizer), administration date: 30Mar2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 20Dec2021, outcome unknown, described as dose received 3; PYREXIA (non-serious) with onset 21Dec2021, outcome recovered (2021); CHILLS (non-serious) with onset 21Dec2021, outcome recovered (2021); TREMOR (non-serious) with onset 21Dec2021, outcome recovered (2021); HEADACHE (non-serious) with onset 21Dec2021, outcome recovered (2021); MYALGIA (non-serious) with onset 21Dec2021, outcome recovered (2021); HYPERHIDROSIS (non-serious) with onset 21Dec2021, outcome recovered (2021). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, tremor, headache, myalgia, and hyperhidrosis.  The patient did not receive any other vaccines in four weeks. Covid prior vaccination and covid tested post vaccination was reported as no.  No follow-up attempts are possible. No further information is expected.
Loss of hearing in my right ear - Sudden Sensorineural Hearing Loss and now constant Tinnitus  10 days after 1st Phizer Covid vaccine I woke up with a plugged ear.  A week  later I went to an Urgent Care to have my ear checked out.  I was put on antibiotics.  After that not clearing up my ear, I visited an ENT doctor who diagnosed me with Sudden Sensorineural Hearing Loss.  I also now have constant Tinnitus in my right ear.  Dr did 2 injections into my eardrum with steroids and I was also put on Prednisone pills for 2 weeks.  After these course of treatments I had no improvement in the hearing loss.
This is a spontaneous report from a contactable consumer (patient's husband). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) (at the age of 66-years-old) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that he and his wife (patient) received first dose of vaccine on 08Feb2021. The consumer reported that patient test positive for COVID-19 on 17Feb2021 and has not had a fever for 48 hours. The consumer reported he and his wife are scheduled for second dose on 01Mar2021 and would like to know if it is safe for her to get the second dose. The consumer reported that he never did test positive for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Feb2021. The outcome of the event was unknown. Information about lot/batch number has been requested.
Headache, severe fatigue, arm pain, loss of appetite, GI upset, low grade fever, light headacheness,  back pain,
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 09-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 216 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion". The storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
spasms/twitching of muscles above and below lips (more frequently above upper lip -- both sides)
17 year old was given prime dose of Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old was given prime dose of Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old was given prime dose of Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old was given prime dose of Moderna vaccine) outcome was unknown.        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 concomitant medication was provided. No treatment medication was provided.
Patient is describing a "nerve-like" pain that begin a few days after the vaccination. At rest there is no pain but if she brings her arm abover her head, behind her body or crosses her body she feels the radiating pain from about shoulder level to elbow. She has used ice packs and Alieve starting shortly before 10/19/18 and states she has had some relief from this treatment. She has not seen a physician. She is planning to wait to see if the ice pack and pain relievers help any.
Ague Fever, muscle ache, headache, chills which lasted for about 30 hours. Fever went down after taking ibuprofen. Currently (48 hours after vaccination)  still tired, similar to recovering from a have fever and flu.
arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurts). At the time of the report, PAIN IN EXTREMITY (arm hurts) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 07-MAY-2021 and contains non significant information. Updated address and email address of the reporter.
1st dose 4 years later, 2nd not received; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient asked that the 1st dose of Shingrix was still valid 4 years later. The patient asked that he/she could get the 2nd vaccine. 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. The follow-up could not be possible as no contact details were available.
Sensitive to the touch at the time I am writing this (60 hours after vaccine).; 36 hours after the shot it was visibly swollen and painful; Left armpit started swelling 24 hours after shot; 36 hours after the shot it was visibly swollen and painful. No visible lymph nodes, just general swelling. Swelling went down after ~48 hours but still somewhat painful and sensitive to the touch; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 17:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified birth control medications from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 17:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 17Mar2021 at 17:00, 24 hours after shot the patient's left armpit started swelling; 36 hours after the shot on 18Mar2021 at 05:00, it was visibly swollen and painful. No visible lymph nodes, just general swelling. Swelling went down after 48 hours but still somewhat painful. Swelling was sensitive to the touch on 20Apr2021 at 08:47 the time, the patient was writing this report (also reported as 60 hours after vaccine). The events were reported because the patient read that swollen gland were only found in 0.3 percentage of Pfizer vaccine patients, but it may be more common. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, left armpit started swelling 24 hours after shot; 36 hours after the shot it was visibly swollen and painful, swelling went down after 48 hours but still somewhat painful and sensitive to the touch were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient was shopping after shot with family and as described by family passed out and fell to floor. Family came running back to pharmacy with child in arms awake and not seizing. 911 was called. Pt remained alert. Pt was examined and returned to shopping with parents.
Vaccines went into 2-8 C thaw state on or about 20-Dec-2021; Received vaccine past  its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past  its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 4:56 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past  its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past  its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Severe body aches and chills. Nausea and vomiting. Sore arm. Took Tylenol
I have a 24/7 constant chest pain; Intense heart pounding sensation; This is a spontaneous report from a contactable consumer (patient). A (age:39; unit: unknown) non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administrated in Left arm on 06Apr2021, as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included Ritual prenatal vitamins (Prenatal Vitamins [Minerals Nos; Vitamins Nos]). No other vaccine in four weeks. Patient had no known allergies. On 08Apr2021, the patient experienced I have a 24/7 constant chest pain, and Intense heart pounding sensation. On an unspecified date, the patient underwent lab tests and procedures which included laboratory Blood pressure measurement: Normal; Blood test: Normal; Body temperature: Normal; Echocardiogram: Unknown result, Waiting on Echo results; Electrocardiogram: Normal; Heart rate: Normal; and Oxygen saturation: Normal. Patient did not received treatment for adverse events. Patient visited to physician office. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse practitioner via a company representative and refers to a currently 11 years old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient received his first dose of GARDASIL 9 injection via intramuscular route in the left deltoid, lot # M037770 with expiration date 01-JUN-2019 (strength and dose were not reported). On an unknown date, when the patient received the vaccine, he fainted off the table and hit his head. The patient was given an ice pack for treatment, and he remained under medical supervision until he was known to be stable. There was no product quality complaint involved in this case. The outcome of the events and the relatedness between the events and GARDASIL 9 were not reported. Additional information is not expected as the reporter did not wish to be contacted.
Baby was found unresponsive by mom at 8A 1/14/03 (per state police).
Vial underwent temperature excursions/ Patient's received vaccine after BUD; No adverse event; Erroneously vaccinated  clients with expired vaccine/ Patient's received vaccine after BUD/ Vaccine underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Patient's received vaccine after BUD/ Vaccine underwent temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Vial underwent temperature excursions/ Patient's received vaccine after BUD) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Patient's received vaccine after BUD/ Vaccine underwent temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial underwent temperature excursions/ Patient's received vaccine after BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Patient's received vaccine after BUD/ Vaccine underwent temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Vial underwent temperature excursions/ Patient's received vaccine after BUD) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Patient's received vaccine after BUD/ Vaccine underwent temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vial underwent temperature excursions/ Patient's received vaccine after BUD).    No concomitant medications were reported.  It was reported that the patient was administered a vaccine dose after 30 day use by which was 9 days past expiry date. The size of the vial was 2.5 ml. The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022. Beyond use date was reported as 02-Nov-2022. The vial had also undergone a temperature excursion.    No treatment information was reported.   This case was linked to MOD-2022-513828 (Patient Link).