chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection Site Redness; Injection Site Swelling; Injection Site Warmth; Injection Site Pain; Injection Site Itching; It was tender but then worsened; Couldn't sleep; Slight discomfort at injection site; Inappropriate Schedule of Vaccine; Fever; Chills; Headache; Knots in the muscle that moved throughout the muscle area; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number B4772, expiry date 20th November 2021) for prophylaxis.   Previously administered products included Zostavax and Shingrix (received 1st dose in May 2018).   On 13th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 13th September 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 14th September 2019, the patient experienced injection site erythema, extensive swelling of vaccinated limb, injection site warmth, injection site pain, injection site itching, tenderness, sleeplessness and injection site discomfort. In September 2019, the patient experienced fever, chills, headache and muscle mass. On an unknown date, the outcome of the injection site erythema, extensive swelling of vaccinated limb, injection site warmth, injection site pain, injection site itching, tenderness, sleeplessness, fever, chills, headache, muscle mass, injection site discomfort and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema, extensive swelling of vaccinated limb, injection site warmth, injection site pain, injection site itching, tenderness, sleeplessness, fever, chills, headache, muscle mass and injection site discomfort to be related to Shingrix.  Additional details were reported as follows: On 13th September 2019, the patient received the 2nd dose of Shingrix, which led to lengthening of vaccination schedule. The patient stated that had redness, swelling, warmth, pain and itching at the site. The area was about 4 x 6 and the whole upper arm. The patient stated that it was tender but then worsened , it was painful to lay on and she could not sleep. The patient also had fever, chills and headache. The patient also saw knots in the muscle that moved throughout the muscle area. On the time of reporting the patient still had slight discomfort, itching and warmth at the site. The patient has not reported the event to the physician because everything she read is her events were common. The patient wondered if the events to the second dose had anything to do with the fact that she was so late receiving the second dose.
it was the patient's one year old visit; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were provided as follows: The reporter stated that, it was the patient's one year old visit, who received dose of Kinrix vaccine, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case was linked with case US2021AMR166793, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166793:same reporter
Patient reported chest pain and shortness of breath 2-3 days following her vaccination. She did not present until one month later.
This incident occurred on 1/22/2022 at 12:30pm. An 11 year and 9 month old patient received the 12+ dose of Pfizer.  This was her 1st COVID vaccine.  Due to the nature of the clinic, we have our vaccinators check each screening form to assure that the proper vaccine is given.  We also screen and turn away kids 11 and under once patients meet the data team at the first checkpoint.  This patient however, somehow received paperwork and entered the clinic.  Our vaccinator did not notice the age 11 that was written on her screening form and proceeded to vaccinate her.  The patient responded normally to the injection, waited 15 minutes for observation and left the clinic.  The issue was later brought to the site manager?s attention by a data entry personnel during checkout.
Patient recieved their Bivalent booster in the wrong site. The patient was supposed to recievethe vaccine in the deltoid muscle or vastus lateralus muscle, instead patient was injected in the Left Upper gluteal. Per nurse pt had no adverse reaction.
A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 15-Jan-2013. The reporter stated that expires FLUMIST was administered. The outcome of the event of ADMINISTERED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
3RD MODERNA COVID VACCINE DOSE GIVEN 10/26/21, LOT # NOT RECORDED; pt had a positive COVID test on 8/22/22 at a local healthcare clinic; was in the hospital until 10/30/22 and was treated with dexamethasone and ABX; admitted 9/5/22 to another local healthcare facility for worsening SOB and LE edema; given empirical ABX; pt was DNR; condition deteriorated and he transitioned to comfort measures, a Hospice program where he passed away.
mom reports pt lt arm & axillary became swollen & sore;arm was warm to touch;pt devel severe headache;APAP taken w/o results;mom reports missed 2 days of school d/t h/a pain;instructed to used cool compresses on arm & axillary area;
A case was received from a health care professional in the United States on 11 May 2007. A male patient with no known medical history had received a subcutaneous injection of YF-VAX (batch number UE951AA) on 04 MAY 2007 and 5 days later, on 09 May 2007, experienced pain, redness, and a hard nodule at the injection site. Additional vaccinations received on 04 May 2007 included oral Typhoid (batch number 3001160) and Hepatitis A (batch number not provided). The patient had received one prior dose of Hepatitis A vaccine, and no prior doses of YF-VAX or oral Typhoid. He was not suffering from any illnesses at the time of vaccination. The events had not yet resolved. The reporter stated that the patient's son had received the same vaccinations, and developed the same adverse events; the son's information is captured in case 2007-1745. This case pertains to the father.
23AUG93 mild fever (100); rash, described by mom as red blotches; white ring, on legs, arms, abdo face; 24AUg94 saw MD prescribed DPH; 25AUg94 fever some rash worse; returned to MD saw MD; MD felt it was coxsackie virus;
A report has been received from a Physician via Medical representative concerning an 7 years old, male patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient developed fever, cough. They tested positive for Influenza. Doctor did not know the date each patient developed the symptoms, but her said it was 3 months after receiving nasal FLUMIST QUAD in Oct-2013. Patient were treated with TAMIFLU and recovered. The reporter considered the event to be non-serious.
Bell's Palsy symptoms; facial paralysis right side of face; Loss of taste right side of tongue; This is a spontaneous report from a contactable consumer (the patient, reported for herself). A 26-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0168 and expiry dates was unknown), via unspecified route of administration, in the right arm on 16Jun2021 12:15 PM (at the age of 26-year-old) as single dose for COVID-19 immunization at school or student health clinic. Medical history included bell's palsy (before), known allergies to penicillin, nuts, avocados and bananas. Concomitant medications were not reported. On an 17Jun2021 at 10:15 PM, patient experienced bell's palsy symptoms, facial paralysis right side of face and loss of taste right side of tongue. All the events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient was received treatment in response to the adverse events (Medication for the symptoms). Patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Patient has not been tested for COVID-19, post vaccination. Outcome for all the events was not recovered.   Follow-up attempts are needed. Further information is requested.
Systemic reaction. Full body rash, congestion, itchy throat, full body itching
Patient c/o feeling tired and running out of breath on 12/31/20.  Condition exacerbated on 1/2/20 and she thinks it may be due to anxiety.  Patient will go to urgent care today for an evaluation (1/3/21)
lt arm dec inj site redness & warm to touch;Keflex & DPH given;
This spontaneous report as received from a pharmacy technician concerning a currently 4 year old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 08-APR-2014, the patient was vaccinated with VARIVAX lot#J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
little bit of skin sensitivity; burning; itching; really bad stinging on face; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning), PRURITUS (itching), PAIN (really bad stinging on face) and SENSITIVE SKIN (little bit of skin sensitivity) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced BURNING SENSATION (burning), PRURITUS (itching) and PAIN (really bad stinging on face). On 10-Mar-2021, the patient experienced SENSITIVE SKIN (little bit of skin sensitivity). On 10-Mar-2021, BURNING SENSATION (burning), PRURITUS (itching) and PAIN (really bad stinging on face) had resolved. At the time of the report, SENSITIVE SKIN (little bit of skin sensitivity) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.   Patient used cold pack as treatment for the symptoms.  Events started 17 minutes after receiving vaccine and they lasted nearly two hours.
Swollen lips; Swollen face; Can hardly talk; Mouth was hurting/still hurts a lot; Feeling bad last night; Previously received the J and J vaccine and received Moderna Booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Mouth was hurting/still hurts a lot), APHASIA (Can hardly talk), LIP SWELLING (Swollen lips), SWELLING FACE (Swollen face) and FEELING ABNORMAL (Feeling bad last night) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE JANSSEN.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Previously received the J and J vaccine and received Moderna Booster dose). On 04-Nov-2021, the patient experienced ORAL PAIN (Mouth was hurting/still hurts a lot) and FEELING ABNORMAL (Feeling bad last night). On 05-Nov-2021, the patient experienced APHASIA (Can hardly talk). On an unknown date, the patient experienced LIP SWELLING (Swollen lips) and SWELLING FACE (Swollen face). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1/2 benadryl. On 01-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Previously received the J and J vaccine and received Moderna Booster dose) had resolved. At the time of the report, ORAL PAIN (Mouth was hurting/still hurts a lot), APHASIA (Can hardly talk), LIP SWELLING (Swollen lips) and SWELLING FACE (Swollen face) had not resolved and FEELING ABNORMAL (Feeling bad last night) outcome was unknown.            No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received on 10-NOV-2021, contain new events (swollen lips, swollen face) and contact details of reporter are added.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender.  The patients medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date(s), the patients were vaccinated with improperly stored doses of M-M-R II from lot #s L039613 with expiry: 08-OCT-2017; L036851 with expiry: 23-SEP-2017 and L026553 with expiry: 16-JUL-2017, for prophylaxis (dose, route and anatomical location not reported). The vaccine lots had a temperature excursions of -1.7 degree Celsius for 1 hour and 10.8 degree Celsius for 2 hours. No adverse effects were reported. The vaccines had no previous temperature excursion. The temperature excursion was identified by data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided. No concomitant medication was reported. It was reported that, dose of vaccine was administered after 9 days from first puncture.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant follow-up
After receiving the booster (7 months after the second vaccine), I began having chills, high fever, muscle aches, stiff neck, sore arm and headache. These side effects were similar to the side effects I experienced after the second dose, however , they were more severe and lasted a lot longer. 36 hours post booster, these symptoms subsided, but I started having frightening episodes with my heart (I had a cardiac ablation for SVTs a few years prior and I thought my SVTs were returning). BUT!! The heart symptoms were different than SVTs. I was having extreme pounding, especially at bed time. The heavy, erratic pounding would be so bad that I would  get an instant headache. Additionally, 4 days after receiving the booster, I tested positive for Covid - with Covid symptoms!!!! Therefore, when I contacted my physician with the concerning cardiac symptoms, they couldn't administer an EKG until my quarantine was over. By the time the quarantine was over the cardiac symptoms had subsided. I am convinced they were a result of the booster.
The same day of the vax, the pt experienced a fever of 104. The following morning the fever had dropped to 100.4. The pt also experienced lethargy.
pain on swallowing in the throat; throat started feeling itchy; pins and needles feeling; throat was swollen; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL0140, expiry date unknown), via an unspecified route of administration on the left arm on 12Jan2021, 9:00AM at a single dose for COVID-19 immunization. The patient's medical history included asthma and allergies to Amoxicillin, Quinolones, and Sulfa drugs, all from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B 12); patient received these medications with two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 12Jan2021, 19:00, just after evening, patient's throat started feeling itchy and had pins and needles feeling. Gradually the symptoms increased in intensity and in the night of 12Jan2021 (time unspecified), he felt like his throat was swollen. It was also reported that patient woke up today, 13Jan2021 with the same feeling and there is pain on swallowing in the throat. No therapeutic measures were taken in response to the events. Outcome of the events was reported as recovering.; Sender's Comments: Based on a chronological association, causality between events odynophagia, pharyngeal swelling and throat irritation and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
full body rash (pruritic, maculopapular) starting 24h after administration of vaccine, improved on its own over next few days, nearly resolved by day 5 post-administration. no SOB, GI sx, other s/s anaphylaxis
Information has been received from a physician concerning a 4 year old female who on 29-JAN-2008 was vaccinated with a dose of PROQUAD (03480 invalid lot#). On 29-JAN-2008 the patient experienced pain, redness, swelling and hot to the touch at the injection site. Subsequently, the patient recovered on an unknown date. Unknown if medical attention was sought. No product quality complaint. Additional information has been requested.
Got shot, got shingles/suspected vaccination failure; Shingles; Hurts; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot, got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Hurts). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that the Shingles vaccine did not stop the shingles. The reporter stated that his or her friend received the Shingles vaccine and experienced shingles. The reporter reported that it only hurt for a week or so but the shingles would stay for years. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR046164 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR046164:Same reporter- Daughter case
15 minutes after vaccination, profuse projectiile vomiting and lethargy. Admitted for observation and IV fluids. No medications needed. Resolved all symptoms in 3 hours. Patient was treated at ER after reaction began. Medical record states dehydration. It was noted that pt had an "adverse reaction to immunizations." Pt was in hospital 7-8 hrs only.
Patient came into the pharmacy friday around 3 pm to pick up prescriptions written by cnp in mdo for hydroxyzine hcl 25 mg and medrol dosepack for injection site reaction of left arm following covid omnicron booster on mon 11-21-22. Arm was swollen, red and  warm to the touch. Pt reported that she started feeling chills, feverish, shaky,achy joints, and sweating into the second night,  swelling started that night as well but gradually got worse to cover a swollen area which included elbow to shoulder.
Within four hours of first dose MASSIVE amounts of chest pressure and pain as well as heart palpitations. Continued indefinitely.
CHILLY; ACHES; This spontaneous report received from a patient concerned a female 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 03:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced chilly. On 10-MAR-2021, the subject experienced aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches, and the outcome of chilly was not reported. This report was non-serious.
Initial solicited report received on 08 June 2016 from a consumer participating in the below-mentioned study. This case involves a 22-year-old male, who received a dose of FLUZONE Intradermal (site of administration and batch number not reported). On an unknown date after receiving a dose of FLUZONE Intradermal (site of administration and batch number not reported), idk didn't really help. The outcome of event idk didn't really help was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.