chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 months after receiving the second dose of Shingrix, patient developed Shingles; Shingles; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and 6 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. On an unknown date the patient received 1st and 2nd dose of vaccine. About 6 months after receiving the second dose of Shingrix, patient developed Shingles. The reporter consented to follow up.
Rash on neck; This is a spontaneous case, initially received from other health professional via e-mail on 26-Sep-2019 and follow up received on the same day (being processed together), concerning a 46-year-old, female patient.   The patient's relevant medical history, drug reactions or allergies and concomitant medications were not reported.  On 25-Sep-2019, the patient was administered with Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: intramuscular, anatomical location: right upper arm, dose, batch number and expiration date: not reported] for an unknown indication.   On the same day, six hours later, the patient developed a mild rash on neck.  The outcome for the event of neck rash' was recovered.  The reporter did not provide seriousness and causality assessment to Flucelvax.  Company Comment: Event's causality was assessed as related to the suspect product per company.  Follow up was received from other non health professional on 04-Oct-2019: Patient age, route of administration and anatomical location for the vaccine, as well as outcome for the event of neck rash' was provided.  Non-significant case correction performed on 26-Nov-2019: Severity removed from the verbatim of the event and added to structure field. Medically confirmed by healthcare professional (HCP) ticked as 'yes' in general and event tab.  Significant case correction performed on 30-Apr-2020: Suspect vaccine recoded from Flucelvax TIV to Flucelvax QIV. No changes in narrative.; Sender's Comments: Event's causality was assessed as related to the suspect product per company.
supraclavicular lymphadenopathy on left side. same side as injection site which was administered in the left deltoid. The lymph node is sore to the touch and entire shoulder aches.
Swelling, heat, and redness at injection site, 9cm x 7cm swelling.
Employee rec'd H1N1 vaccine 11-12-09 (multi dose vial) woke up 11-13-09 with hives.  generalized entire body. No SOB. No wheezing. No arthralgia. No myalgia. No HA. No fever. Went to her PMD tx with BENADRYL, taper PREDNISONE. We will see her on 11-16-09 as F.U. had reg flu (multi dose vial) - 1 month ago.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 78 year old female. 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: 1805029 expiry: UNKNOWN) 1 total, administered on left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient had no problems at all. The patient had the test last week and got antibody blood test and it showed no antibodies left. The test came back with word Equivocal.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20211103729-Covid-19 vaccine ad26.cov2.-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
CHILLS SOMETIMES COME WITH NIGHT SWEATS; OCCASIONALLY CHILLS; OCCASIONALLY HEADACHE; FEVER; ABDOMINAL PAIN (STOMACH ACHE); This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced abdominal pain (stomach ache). On an unspecified date, the subject experienced chills sometimes come with night sweats, occasionally chills, occasionally headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from abdominal pain (stomach ache), occasionally headache, occasionally chills, and chills sometimes come with night sweats. This report was non-serious.
Even though I got the vaccine in my left arm, my right shoulder and upper arm became very painful and throbbing the night of the booster shot.  The pain was intense for 2 days, then was persistent but less intense for another week.  I then developed frozen shoulder which became noticeably worse in the following week.  I needed a steroid injection in my R shoulder on 12/22/21.  Now I'm in PT and accupuncture with about 50% improvement of the frozen shoulder.   I also developed a breakthrough Covid infection on 1/6/22 (fever, chills, generalized myalgias for 2 days) but oddly enough when i had Covid, my R shoulder pain came back intensely similar to when i had the vaccine side effect but it was also short lived for about 2 days.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 17-JUL-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # J007954 and expiry date: 27-JUN-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Case number PHEH2012US018500 is an initial spontaneous report received from a healthcare professional on 05 Sep 2012: This case refers to an unspecified age and gender patient. The patient was received only Men A component of MENVEO (batch number: unknown) reconstituted with sterile water on an unspecified date. The patient was not re-vaccinated. No adverse reaction reported following this administration error.
tested positive for Covid after receiving 2 shots and a booster; tested positive for Covid after receiving 2 shots and a booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL3247), on 09Feb2021 as dose 2, single (Lot number: EL9269) and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid after receiving 2 shots and a booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: a self test and it was positive; Weight: 181-182 lbs. Therapeutic measures were taken as a result of covid-19.
COMPLAINED HEAD HURT, VERY TIRED. NEXT MORNING WOKE WITH 102 TEMPERATURE THAT LASTED FOR 3 DAYS.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Ulcer (Open ulcer) and Prostate cancer. Concurrent medical conditions included Penicillin allergy. Concomitant products included OMEPRAZOLE for an unknown indication.    On 11-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 PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.   This case was linked to MOD-2022-565257, MOD-2022-565270 (Patient Link).
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 01-FEB-2016, the patient was vaccinated with improperly stored dose of ZOSTAVAX (temperature: 43 F, time frame: 44 days) (lot # L034736, exp. 01-FEB-2016, dose and route was not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter link. Additional information has been requested.
Administration error:  Pfizer administered to a 15 year old patient.  Patient was registered with a birthday of date(showing an age of 16 years upon vaccine clinic check-in).  ID was not checked to confirm birthdate prior to vaccination.  Following vaccination, ID confirmed actual birthdate was date (making the patient 15 years old).  No adverse effects noted following administration.
Patient came to pharmacy 7.3.18 and had 3 imz. HAVRIX and ADACEL in left arm (HAVRIX upper, ADACEL lower) and SHINGRIX in right arm. Daughter called 7.4.18 around 3:30 stating patient's right arm is swollen, red, warm, and raised. Pharmacist asked whether she was taking anything for this--she said no. He also asked if there was swelling of lips/mouth or difficulty breathing--she said no. Pharmacist suggested she take tylenol and benadryl to help symptoms. and that symptoms should resolve in a couple of days--if it gets worse or if swelling of lips, mouth or difficult breathing occurs see PCP.
Headache , Dizziness, unsteadiness, diploplia, blurry vision started 1 week after second dose
The patient experienced constant crying, red blotches on her chest, is not eating and is fussy.
This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE EVENT (couple of adverse events) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (couple of adverse events). At the time of the report, ADVERSE EVENT (couple of adverse events) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up received on 6-JULY-2021 and does not contain any new information.
They gave the Moderna vaccine to a 12-year-old girl. That is not suitable for his age. I didn't know it wasn't for 12 year old kids. And they didn't say anything and put it on.
Noticed some redness around the site of this injection on the right thigh on 12/8. The patient did not have a fever but was fussy. The area of redness increased over a 2-day period and the patient was seen in clinic on 12/10. The physician who saw the patient (which was not the patient's PCP) felt that the redness was a cellulitis related to the vaccine injection. Patient was treated with amoxicillin and is doing well.
this is happening only on my left arm/something is there in my underarm; side effects; acid reflux; hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow), LIMB DISCOMFORT (this is happening only on my left arm/something is there in my underarm), ADVERSE REACTION (side effects) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0251214 and 0251321A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced PERIPHERAL SWELLING (hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow). On an unknown date, the patient experienced LIMB DISCOMFORT (this is happening only on my left arm/something is there in my underarm), ADVERSE REACTION (side effects) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow) had not resolved, LIMB DISCOMFORT (this is happening only on my left arm/something is there in my underarm) had resolved and ADVERSE REACTION (side effects) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PERIPHERAL SWELLING (hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow), LIMB DISCOMFORT (this is happening only on my left arm/something is there in my underarm) and ADVERSE REACTION (side effects) to be related. No further causality assessment was provided for GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux).    No concomitant medication was reported. No treatment medication was reported however, patient had taken Motrin for 2 days post the first dose at the time.   This case was linked to MOD-2021-311729 (Patient Link).
Throwing up, fever 104 for a day, crying, has to be held all the time, very light color stools.
The first shot was March 23, 2021 and I woke up with extreme pain down my right leg that early morning after the shot.  It eventually didn't ache as much until I received my second shot April 13 th and then both my legs started to ache badly mostly during the night.  I now remember that my first shot was in my right arm and my second shot was in my left arm.  I had my mammogram done April 15th and they recognized enlarge lymph nodes under my right arm.  They immediately scheduled a biopsy because this was never in my medical history.  I had to first get an ultra sounds and then a biopsy.  My legs continued giving me pain so, my Dr. prescribed meds for the inflammation and recommended I get a doppler done on my legs. During the doppler the first part of June, they saw two other swollen lymph nodes on the left and right of my groin area. The right side was larger.  So, I went back to my doctor and then he ordered a CT scan to be done to make sure the lymph nodes were not cancerous.  I got the CT scan in July 26th and by that time the lymph nodes were no longer swollen.  My scan was considered normal.
Vaccine was expired on 09-Nov-2021 and was administered to the patient on 10-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and was administered to the patient on 10-Nov-2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and was administered to the patient on 10-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and was administered to the patient on 10-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 09-Nov-2021. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter address updated.
COPD exacerbation with pneumonia was treated with ceftiaxone and doxycycline as well as nebs and steroid.  UTI was also treated and pt was noted with sepsis and lactic acidosis. Discharged to home. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Abscess. Required surgical drainage. Abscess at site of Pediarix injections. Similar reaction to PCV 8/11/06.
Severe nose bleed after both doses; approximately 12-15 hours after injection.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 3-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 3 years, in left leg for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EPISTAXIS (non-serious) with onset 2022, outcome "unknown", described as "Severe nose bleed after both doses; approximately 12-15 hours after injection.". Therapeutic measures were taken as a result of epistaxis.  Additional information: Patient did not receive other vaccine in four weeks. Patient doesn't have Covid-19 prior to vaccination and not been tested for Covid post vaccination. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Cold symptoms; This spontaneous case was reported by another health care professional and describes the occurrence of NASOPHARYNGITIS (Cold symptoms) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold symptoms). At the time of the report, NASOPHARYNGITIS (Cold symptoms) 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 reported. The patient had concerned that if could get a booster vaccine if they had cold symptoms. No Treatment medication reported.
Ear ringing and pulsating  Dizziness  Vertigo  Some hearing damage to right ear Inflamed ears Jumping eyes or twich
heavy chills; shakes; fever; sweating; horrible headache; Arm was hot and sore; Arm was hot and sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EPT533), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 13:00 (at the age of 72-years-old) as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included CLL (chronic lymphositic lukemia) and covid prior to vaccination. Concomitant medications (other medications in two weeks) included atorvastatin (ATORVASTATIN), fluoxetine (FLUOXETINE), alprazolam (ALPRAZOLAM) taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. Known allergies was reported as no. Patient had covid prior to vaccination and patient was not tested with covid after vaccination. On 15Apr2021 01:00 after 12 hours after first vaccination patient experienced very heavy chills and shakes along with fever and sweating profusily along with a horrible headache all symptoms lasted for 12 to 14 hours and arm was hot and sore for about 12 hours or so. The patient did not receive treatment for events. The outcome of events was recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Sore body; Fever of 101 degrees; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore body) and PYREXIA (Fever of 101 degrees) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (Sore body) and PYREXIA (Fever of 101 degrees). At the time of the report, MYALGIA (Sore body) and PYREXIA (Fever of 101 degrees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was given. No laboratory details was given. No treatment information was given.   This case was linked to MOD-2021-065271, MOD-2021-065300 (Patient Link).
Anaphylaxis; Angioedema of lips, tongue, eyelids. Stridor. Nausea + emesis. weakness in all extremities.  Not a robust reaction to Epi Pen, eventual resolution of sxs after Epi gtt. Also gave IV Steroid, and 2 anti histamine. No breathing Tx, given no wheezing. Pt not on beta blocker. No hypotension.  Unknown length of hospitalization, pt transferred to higher level of care from my ER.
Arm pain @ injection site, able to sleep on right side; relieved with Ibuprofen. Headache, mild, next afternoon, relieved with Ibuprofen.
Heavy drainage. Inflamed throat severe  burning  In chest area behind brests to back. I thought I had bronchial pneumonia. Chest hurt do bad for 24 days
Large warm mass at site of injection; red and itchy. No red streak marks, no fever and no irritability; ambulates well.