chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 13-JAN-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022; Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022) and PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022) and PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022) 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.  The vials were initially stored in refrigerator on 04-Apr-2022. The vial has not undergone any temperature excursion. 155 patients where vaccinated with expired doses.
Pt received vaccine on 12/3/18 at 1:30pm. Itchiness and swelling developed on left arm and hand on 12/4/18 at 6 pm. Pt went to ER doctor on 12/5/18 in the afternoon and doctor suggested antihistamine (allegra) for patient. Pt is doing well today (12/6/18) and swelling has gone down just a little and itchiness as well.
Bruising at or near injection site. Muscle area below was discolored, yellowish, as if there had been bleeding in the muscle.  No pain or discomfort during or after injection.  Site was not examined until discoloration was observed by wife about 5 days after the injection (2/13/2021) when he came out of shower.  The discoloration covers a circular area of about 1.5" diameter.  The red area at the top of the circle has not subsided.  Observed by a physician during routine office visit for another purpose on 2/16.
Patient became very sleepy shortly after receiving the vaccine and subsequently went home to rest.  Patient woke up shortly thereafter, with severe wheezing, shortness of breath, red, puffy eyes and a complaint of general itchiness.
Mom report t101-104 1 wk p/vax; Seen in ER 4JUN92; afebrile, no cough, vomiting, diarrhea; alert & playful in ER; MD dx delayed shot rxn;
Information has been received from a registered nurse concerning a patient who was vaccinated with a first dose of Rotateq. Subsequently the patient developed fever and diarrhea. Unspecified medical attention was sought. The patients outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a nurse refers to patients of unknown age. Since July 2014, unspecified patients were vaccinated with improperly stored VAQTA (lot #, expiration date, route, dose not reported). No adverse effects were reported.This is one of the several report from the same source. Additional information has been requested.
Indurated nodule underneath vaccination site within deltoid muscle; 2"x2" with warmth, erythema and localized swelling of his entire upper arm. Fever of 103 3-4 days after vaccination for 8 hours. Nodule remains and is still palpable after nearly one month, however it is improved and is now 1/2" x 1" in size.
covid vaccine breakthrough case  dose 1 Pfizer 1/12/21 EL3248 dose 2 Pfizer 2/4/21 EL9265  delivered baby on 5/4/22
15 hrs later woke up in the middle of the night with severe total body itching, facial, eye and lip edema
Information has been received from a medical assistant in a physician's office concerning a male toddler who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced breakthrough chickenpox. the case was reported to be mild. Unspecified medical attention was sought. A product quality complaint was not involved. No further information was available. The medical assistant also reported a 6 year old male who had a similar experience after therapy with varicella virus vaccine live (WAES0404USA00013).
painful raised red patch at the injection site, it hurt; painful raised red patch at the injection site, it hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Feb2021 13:55 (Lot number: EN6202) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer", start date: 2016 (unspecified if ongoing), notes: Verbatim: Cancer; "a-fib", start date: 2020 (unspecified if ongoing), notes: Verbatim: a-fib. There were no concomitant medications. The following information was reported: PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 01Mar2021, outcome "not recovered" and all described as "painful raised red patch at the injection site, it hurt". Therapeutic measures were not taken as a result of pain, vaccination site erythema.  Additional Information: Patient is 80 years old, she got the first dose of Pfizer's COVID-19 vaccine on 28Feb, two days later she had a painful raised red big patch at the injection site, it hurt and she still has it. Caller says they have not had any other recent vaccinations or started any new medications.  No follow up attempts are possible. No further information is expected.
After injection - experienced lightheadedness/dizziness/blurry vision.   Patient was hypotensive -and once supine for a few minutes and his blood pressure returned to normal levels.
After receiving vaccine, pt walked into the post vaccine observation room located outside the door of the vaccination room.  Pt. sat down in chair, went to put his head down towards his knees, then patient slid out of chair and onto the floor.  This RN was immediately at the patients side, and pt. immediately responded to his name.  Pt. insisted on standing up against this RN's advice, and got back into the chair.  Pt stated he didn't know what happened, so I explained to him that he had fainted.  His mother and father were present.  Pt stated he ate no breakfast today.  Pt. states he has no health concerns, allergies, or issues.  Pt.s stated that he is very afraid of needles and thinks he was just nervous.     BP readings:  09:45 90/75 HR 60, 09:50  90/75 HR 60 10:00 BP 113/72 HR 65.  Pt stated he was feeling fine. Pt. released to go home w/Parents at 10:30.  This RN called this pt. to f/u at noon today, and patient stated he was feeling good and thinks he was just really nervous.  Pt. thanked this RN for the phone call and call was ended.
On Tuesday, January 26, 2021, I had chills nausea and headache at 2:00AM. Then the night of the 27th, Jan, 2021, I started to coughing and my bronchial tubes were tight. Then I started on my inhaler for my asthma. Inhalers: Advair and Ventolin.  I wrote these symptoms in my health file portal to my doctor and she later prescribe me  prednisone 20 mg. I took 2 tablets starting on January 29, 2021.
This is a non-serious spontaneous case, initially received from other non-health professional on 21-Nov-2018, concerning a female patient of unspecified age. On an unspecified date (30 years ago as reported), the patient was administered influenza vaccine [dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported]. On an unspecified date, after vaccination, the patient developed unspecified eye condition which was reported as a reaction to thiomersal. The Ophthalmologist confirmed that the reaction was due to thiomersal. The outcome of the event was not reported. The reporter assessed the causality of the event as related to suspect vaccine.
Initial report received on 15 January 2007 from a health care professional. A 50-year-old male patient, with no illness at the time of vaccination, had received an intramuscular, left deltoid injection of Adacel, lot number C2455AA, on 09 January 2007. Three days later, the patient developed pain and swelling of the left axilla that continues. At the time of this report, the patient had not recovered.
The vaccine refrigerator went out which caused a temperature excursion affecting the MMR and IPV vaccines. No adverse effects were reported due to this.
This spontaneous report as received from a physician refers to a 17 years old female patient with acne. The patient was vaccinated with dose 1 GARDASIL (Lot # 0313AE expiration date 26-OCT-2014). Concomitant medications included: minocycline. The physician reported that on 30-JUN-2012, the patient developed fever blisters. The patient was seen in the office and was treated with ZOVIRAX. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
c/o knot (R) side were injection was given of DTaP and IPV, red swollen and fever present at site x 2 days.
I had SOB, weakness, loss of appetite, and severe diarrhea for about 6 days.  I had a fever for about 5 days.  Everything that I ate tasted like salt.  I was off work for about 3 weeks.  On Sept 7th, I tested positive for COVID-19. I went to the doctor about this.  They did chest x-ray because I developed COVID-19 pneumonia.
The location of my arm started to itch profusely 4 days after I had the vaccine. By the end of day 4 there was a big, hard, painful knot where the vaccine was given, which was also covered by a 4" area of red skin.  NO RASH, just red.  Finally, 4 days later approximately 10pm,(which is 8 days post vaccine) the symptoms were gone.
SORENESS IN LEFT ARM AT INJECTION SITE; FEELING TIRED; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, anxiety, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies.  there were no drug abuse or illicit drug usage. the patient was on anxiety medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-APR-2021, the subject experienced soreness in left arm at injection site. On 16-APR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in left arm at injection site on 19-APR-2021, and was recovering from feeling tired. This report was non-serious.
Patient reported redness in a 4 inch line on her arm. She stated it is slightly warm to the touch.
Stomach ache; Leg pain; Pain in extremity; Fatigue; Nausea; Headache; Feeling bad / aching; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Leg pain), PAIN IN EXTREMITY (Pain in extremity), FATIGUE (Fatigue) and NAUSEA (Nausea) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03AX20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Allergy (allergies to Sulfur and Kflex) and Hypertension.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Leg pain), PAIN IN EXTREMITY (Pain in extremity), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Feeling bad / aching). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Leg pain), PAIN IN EXTREMITY (Pain in extremity), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Feeling bad / aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
slight headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that patient asked could she take aspirin 30 minutes after getting vaccinated? Mentioned she was considering taking it due to a slight headache. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
Pt. showed up with rash outbreak, appears to be shingles but she states she has never had a shingles outbreak before, all along the L side of her body, vesicular rash along dermatomes.
EXTRACTION OF MODERNA VACCINE FROM THE VIAL WAS NOT CONSISTENT WITH MODERNA TECHNIQUE I.E. MORE THAN 20 DOSES WERE DRAWN FROM THE VIAL.
Faulty syringe; the top of the syringe popped off as i went to adminsister the vaccine. I had to readminister.
Suspected vaccination failure; I had them twice within a year / Same place both times... / left back under arm to shoulder blade to spine; Hurt; Itched; Mild cases but left nerve damage; This case was reported by a consumer via 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, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, pruritus and nerve damage. On an unknown date, the outcome of the vaccination failure, shingles, pain, pruritus and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus and nerve damage to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported. The patient had shingles twice within a year after the patient had the shot a year before. Both times, shingles were on left back under arm to shoulder blade to spine. Shingles hurt and itched but the patient did not experience blister. The patient had mild cases but left nerve damage. The patient used dermoplast antiseptic and pain relieving spray. It was the only thing that worked. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR121438:Same reporter
Patient received first dose of Moderna vaccine on 1.8.21. Reported to urgent care on 1.10.21 and was diagnosed with shingles. Prescribed antivirals at that time. Today (1/11), bad headache, burning from shingles, and more joint pain than usual.
lt arm itchy & swollen/red around site-streaking down arm (like an S) about 4"; throat is itchy; took only Nuprin;  reaction began on Thursday 6MAY inject given 5MAY;
Influenza- unsure which. Developed urticaria day after administration. No dyspnea/stridor/N/V.
Severe Vertigo; nausea; dizziness; This is a spontaneous report received from a contactable healthcare professional, the patient. A 62-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the left arm on 27Mar2021 at 08:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included osteogenesis imperfecta and osteoporosis. Concomitant medication included diclofenac (VOLTAREN) via topical route for an unspecified indication from unknown date. The patient previously took VIOXX for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 04:00, the patient experienced severe vertigo, nausea, and dizziness onset while sleeping. The events did not result in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the severe vertigo, nausea, and dizziness was recovering (also reported as the events lasted for approximately 8 hours and now 48 hours after injection nearly completely resolved).  No follow-up attempts are needed. No further information is expected.
Right deltoid swelling, heat, pain.  Large palpable nodule in right axilla.  Rx:  Augmentin E S 600mg 1 1/2 tsp po BID x 10d.   Warm compresses to affected area.
This is a spontaneous report from a contactable other HCP (reported for himself). A 74-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot#: EL9267), at the vaccination age of 74, via an unspecified route of administration, left arm, on Feb 27, 2021, single dose, for COVID-19 immunization. The patient's medical not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccination. No allergies reported. The patient received other medications in two weeks. On Mar 3, 2021, at 04:00, patient experienced shortness of breath, tiredness, racing heart, headache and had hard time going to bathroom to defecate; with outcome of recovered Mar 2021. No follow-up attempts possible. No further information expected.
Site of injection of right thigh was red, swollen, warm to touch and tender to touch X 48 hours.
Patient was vaccinated as part of a mobile vaccination clinic at an assisted living facility. A copy of the COVID-19 Vaccine Card was provided to the pharmacist, showing the patient received her primary series and 2 monovalent boosters. The patient was given a Bivalent Moderna COVID-19 vaccination. Upon returning to the office, it was discovered upon entering into the system, the patient had actually received a Bivalent Booster on 10/14/2022 as well from another provider. The clinic coordinator at the facility was notified to keep an eye on the patient and to let us know of any side effects or concerns.
With 24 hours  pain at site of injection that traveled through shoulders and neck.   Severe neck pain/swollen glands/- 2 days later pain traveled to mouth and throat- on day 5 in the evening starting run a fever with severe night sweats/Chills/no appetite/fatigue .  I have never experienced this feeling before --- the amount of sweat coming out of my body was like a demon was being released.  I felt these severe symptoms for about 4 days .   One week later from onset of night sweats/c hills/ fatigue I still have these symptoms but not as severe.
Pt inadvertently vax w/ MMR twice on same day same at same site.  Exp local soreness.
p/vax pt exp reiter's synd;the illness began w/a sudden onset of widespread arthritis involving primarily hips, shoulders & knees;seen by rheumatologist who said illness resembled lupus, however did not have lupus;exp dull pain;60 day follow-up dated 10/25/00 provided no additional data.
Initial unsolicited report received from a nurse on 14-Jan-2016. This case involves a female patient (age was not reported) who was vaccinated with a first dose of Fluzone ID (batch number- UT5354BA, expiry date and route were not reported) in the arm on 19-Oct-2015 (her first time with the intradermal). Medical history and concomitant medications were not reported. On an unspecified date, after vaccination patient had experienced palpable lump that patient can feel under the area of redness and she stated that it was not painful and just mildly burned when she rubbed it. Laboratory investigations and corrective treatments were not reported. On an unspecified date, patient recovered from the events (reaction lasted for long (almost 3 months). Documents held by sender: none.
19Mar91 pt vax; 3 hrs later devel diffuse urticaria w/ swelling of hands, feet, & face, bronchospasm.  20MAr90 pt vomiting.  Tx w/ meds.  Pt remained under tx.
MALAGIA; 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced malagia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from malagia. This report was non-serious.
Information has been received from a male physician patient with lymphoma who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). After vaccination patient experienced a case of shingles. No lot number provided. The patient sought unspecified medical attention. The patient was hospitalized on an unspecified date. At the time of report the patient's status was unknown. Additional information has been requested.
Site injection reaction: light swelling with raised bump to injection site arm, with tenderness to light touch.  Hurt to move arm.
Deep Venous Thrombosis, 5 days of calf/leg swelling,  diagnosed 8 days later, treated with Xarelto. Currently being treated.
Site reaction with significant swelling, redness and hives. Lasted x 3-4 days with BENADRYL and ice.
Mom reported patient had a 4" x 3" area on her upper bicep which was warm to touch & firm x 3-4 days. Soreness only to touch. No fever & did not favor arm.