chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Can't swallow; Face blow up again; Chest feels heavy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Can't swallow), SWELLING FACE (Face blow up again) and CHEST DISCOMFORT (Chest feels heavy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced DYSPHAGIA (Can't swallow), SWELLING FACE (Face blow up again) and CHEST DISCOMFORT (Chest feels heavy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (Can't swallow), SWELLING FACE (Face blow up again) and CHEST DISCOMFORT (Chest feels heavy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   This case was linked.
My said that she found an enlarged lump in her breast before the shot . After the shot the lump enlarged ? took  off.?By May her breast was oozing so much she needed breast pads to control the serosanguineous discharge. She died Sept 11, 2021 . She never had treatment and only described it to a Dr . It was probably Inflamatory Breast Cancer
Fever and body aches/joint pain began while sleeping (around midnight on 1/17/21) and persisted through the day 1/17/21 until evening. Was unable to do most daily activities. Extreme fatigue and slept almost all day, also due to fever and pain from body aches/joint pain. Took Tylenol (700mg at 7:30am and 2:30pm) but fevers continued to register between 100.2 and 100.8. Fever was definitely higher at night but temperature unknown. Took Tylenol again at 7:30pm and at this point did not have fever, mostly did not have body aches/joint pain at this time. No symptoms besides tiredness the next morning (1/18/21)  Large red welt appeared at injection site, about 4 inches by 3 inches. Hot to touch, itchy at times, very sore. Still has welt as of 1/19/21.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 62-year-old female patient who received SHINGRIX (batch number 33745 ?, expiry date 22nd November 2020 GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. On 8th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th August 2018, 1 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right ram. On 9th August 2018, the patient woke up with a chest rash. However, the latency for chest rash was reported several hours. Clarification has been raised for batch number.
12 hours later woke to feeling as cold as I have ever been in my life.  Felt "fluish" for next day.   Following day felt strange and began having palpitations of the heart.  I have never had palpitations before.   Bought a blood pressure cuff and blood pressure 160/92.  I have never had hypertension. Palpitations worsened over next several days.  Palpitations made me feel awful.  Palpitations persisted on and off for days.  Elevated blood pressure on and off over next week also. Weather wad bad, I was out of town and I was unable to get to the doctor right away.  Saw cardiologist 2/18/21.
Information has been received from a physician concerning a 55 year old male with cardiac failure, hyperlipidaemia, obesity, apnoea, arthritis, a penicillin allergy and drug hypersensitivites to diphenhydramine hydrochloride (BENADRYL), Lisinopril and atenolol.  On 17-Oct-2006, the patient was vaccinated intramuscularly with 0.5 ml of pneumococcal 23v polysaccharide vaccine (Lot#654593/0358F).  Concomitant therapy included 22 unspecified therapies.  On 17-Oct-2006, later in the evening, the patient developed an injection site reaction which was painful, red and tender.  At that time, the patient did not have a fever noted.  Later the next day, the patient developed a temperature of 102.5 F and went to the emergency room (ER).  On 18-Oct-2006, the patient had developed a warm, red shoulder with 5-6 cm erythema.  The patient was admitted to the hospital from 19-Oct-2006 to 22-Oct-2006.  It was reported that the patient had a biopsy conducted but the results were unknown by the physician.  At the time of this report, the patient had recovered from the events (date unknown).  The reporter considered the events to be serious as immediately life-threatening and disabling.  A lot check of concern has been requested.  Additional information has been requested.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On 09-OCT-2018, there was an storage temperature excursion and on 29-OCT-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N035958 with expiration date on 18-DEC-2019 (strength, dose, anatomical location or route of administration were not provided), for prophylaxis; which was administered concomitantly with a sterile diluent (MERCK) that was not reported as improperly stored. The storage temperature of the vaccine was reported as 47 to 77 degrees Fahrenheit (°F) (58.5 °F) for a time frame of 13 hours and 20 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were being reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA012810.
Swollen eyelids that droop. Itching around the ears. Rash about 2 inches above my belly button that is itchy.
PATIENT HAD SHOT ON FRIDAY MORNING. REPORTED ARM AND LEG TINGLING AND ARM FEELING HEAVY. WENT TO EMERGENCY ROOM ON SUNDAY (2 DAYS LATER). THEY TOLD HER SHE HAD AN ALLERGIC REACTION TO FLU SHOT.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The patient received the first dose of GARDASIL intramuscular injection, 0.5 ml, on 25-MAR-2014, the second dose on 13-OCT-2014 and third dose on 13-DEC-2014 (which was slightly out of the recommended schedule). No adverse effects were reported. No concomitant therapies were reported. Additional information has been requested.
On the day after first dose of the vaccine, I started to have nerve pain going down both legs in the front, from the groin area down. I also started to have a headache, and my left eye started to twitch and turned into Bell Palsy. This lasted for 3 weeks. After the second shot on 5/26/21. Lot #EW0187 I had a lot of pain on the area of vaccine on the left arm, and really bad pain under arm pit. Also, the night of the 2nd shot I developed a light rash under my breast area/upper stomach. By June 4th I had more allergic reaction around my mouth and by June 5th a had hives and rash all over my face, neck, and my scalp. By June 6th I had severe itching, rash, hives, and started swelling of my head. By June 7th I was at urgent care as the back of my head and left side was swollen, I felt like my ear was clogged and my i was in pain and itching. The Urgent Care gave me a steroid  shot due to severity and prescribed pepcid, and methylprednisolone; on June 8th it spread to my check are on top, under breast, hips area, upper butt area; under stomach area. On June 14th went to see PCP, still bad rash, got more steroid pills and cream for specific areas; On June 16th had bruises all under my stomach from one side to the next. This rash and bruises lasted until July 22. On July 22nd started needles and pins on my thumbs, and fingers which i still have today that come and go. Also, on June 25th my heart started racing or skipping a beat, that comes/goes.
he got the Pfizer booster shot, and after getting vaccinated, he got the COVID-19 virus again; he got the Pfizer booster shot, and after getting vaccinated, he got the COVID-19 virus again; he got the Pfizer booster shot, and after getting vaccinated, he got the COVID-19 virus again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "he got the Pfizer booster shot, and after getting vaccinated, he got the COVID-19 virus again". The patient mentioned that he bought Pfizer products like ibuprofen (ADVIL) and esomeprazole (NEXIUM) . The caller mentioned that he had his own personal policy. If the company where he bought the products did something political, he would stop buying them. He also stated that he posted his comment on social media six months ago. It was not that horrible and , and he wasn't being hateful; he was suspended from social media. The caller also mentioned that he got the Pfizer booster shot, and after getting vaccinated, he got the COVID-9 virus again. Since the patient mentioned that he had the Virus after getting the Pfizer Booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache for 8+ hours morning after vaccine then developed painful swollen axillary lymph nodes on same side as vaccine, moderate pain for 24 hours then continuing mild pain
Pfizer booster dose given to 12 year old was 0.2ml, and not the proper 0.3ml dose.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 1st March 2023, the patient received Havrix. On 1st March 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comment: The reporter declined to provide patient's date of birth.  The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Selective IgA deficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 07Aug2023 to 11Aug2023. Patient did not have known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE, COVID-19 and the suspected drug cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300278919 Same patient, different drug/AE;
second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes; no adverse event; second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes), PRODUCT STORAGE ERROR (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes) and NO ADVERSE EVENT (no adverse event) in a 47-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-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 29-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes), PRODUCT STORAGE ERROR (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes) and PRODUCT STORAGE ERROR (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes).    No Concomitant medications were provided. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-694391, US-MODERNATX, INC.-MOD-2023-694859 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2023: Follow-up received no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694391:Same reporter US-MODERNATX, INC.-MOD-2023-694859:Same reporter
This spontaneous report was received from a nurse via a company representative and refers to a 17 month old female patient. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On the same day, in an unknown date, the patient was vaccinated with Oka-Merck PROQUAD and (wistar ra 27-3) M-M-R II for prophylaxis (inappropriate schedule of drug administration). Strength, dose, frequency, route of administration, lot#, and expiration date were unknown. No adverse effects were noted.
Reported 11/30/07. Sore swollen arm (L) site increased in size - hot and red - Pt describes decrease in use - told to see doctor or go to Urgent Care - went to clinic 11/30/07. Given Indocin - Lortab/Zithromax.
Information has been received from a physician concerning a 15 year old female patient, with no medical history reported, who on 15-MAY-2008 was vaccinated with the first dose of GARDASIL (Lot #660387/1967U).   Concomitant therapy included a dose of MENACTRA and a dose of ADACEL.  On 15-MAY-2008 approximately three to four minutes after receiving the vaccine, the patient fell head first to the ground.  She was taken to the emergency room but it was unknown if the patient was admitted.  Diagnostic testing performed included a computed axial tomography and a cervical spine series, no results reported.  At the time of this report the events had improved and the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
her arm complete sore and puffy, just a little swollenness; her arm complete sore and puffy, just a little swollenness; The arm she was given the injection is really sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 11Mar2021, outcome "recovering" and all described as "her arm complete sore and puffy, just a little swollenness"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "unknown", described as "The arm she was given the injection is really sore".  Additional information: patient mentions that she has Tramadol and wanted to know if that medication she could take for the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The child presented with vesicular rash on face and extremities on 12/11/01. Mom stated that the rash had appeared the day before and was not itching. The pt was not in any distress and was afebrile. He had no respiratory signs or symptoms upon exam.
Received a 3rd Monovalent Booster instead of a Bivalent Booster dose; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a 3rd Monovalent Booster instead of a Bivalent Booster dose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Received a 3rd Monovalent Booster instead of a Bivalent Booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a 3rd Monovalent Booster instead of a Bivalent Booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown. No concomitant medications were reported.  Patient went to the pharmacy to receive the new Bivalent Booster, but the pharmacist gave him the Monovalent Booster instead. Patient received primary series and 3rd monovalent booster vaccines and experienced no side effects.  No treatment medications were reported.
sores in his mouth; diagnosed with Covid-19 via a PCR test with symptom (fever); This is a spontaneous report received from contactable reporter (Consumer) from medical information team. The reporter is the parent. An 8-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly administered in the left arm on 11Nov2021 19:30 (Batch/Lot number: unknown) at the age of 8 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. The patient has no relevant family history. The patient had no predisposing factors. There were no concomitant medications. There are no other vaccines administered on same date with the Pfizer vaccine considered as suspect. The parent reported that her 8-year-old son who received the first dose of the orange cap Pfizer Covid-19 vaccine on 11Nov2021 and was diagnosed with Covid-19 via a PCR test on 21Nov2021. The parent stated that her son is scheduled to receive his second dose of the orange cap Pfizer Covid-19 vaccine on 02Dec2021 and inquired if her son receives the second dose of the orange cap Pfizer Covid-19 vaccine, will it overwhelm his system with antibodies. She also inquired if myocarditis be more likely or any other issues with having too many antibodies after receiving the Pfizer Covid-19 vaccine and diagnosis of Covid-19 after receiving the vaccine and if it is not recommended for him to get the second dose of the orange cap Pfizer Covid-19 vaccine while being symptomatic with Covid-19. The reporter added that the patient had onset of COVID on 18Nov2021, with COVID PCR Test performed on 21Nov2021 which verified diagnosis as positive for COVID. She further described symptoms to include onset of fever on 18Nov2021 and he got sores in his mouth today (23Nov2021). She thinks the event is getting worse, symptoms getting worse. She has not heard of sores in the mouth being a symptom of COVID but does not know what else that would be related to. The patient underwent the following laboratory tests and procedures was sars-cov-2 test: (21Nov2021) positive with notes of no other testing or investigations performed other than COVID PCR Test which was performed as throat swab. The adverse events did not require emergency room visit or physician office visit. The patient was not hospitalized. The outcome of the events was not recovered.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age, race and gender received TRUMENBA on an unspecified date at 0.5 ml single for immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever, vomiting, diarrhoea and headache, all on an unspecified date with unknown outcome. The reporting physician considered the events related to the suspect vaccine.