chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer; No adverse event; Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-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 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer).    No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not reported any adverse event.  No treatment medications were provided. No adverse events were reported.    This case was linked to US-MODERNATX, INC.-MOD-2022-676622 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-676622:Same Reporter
redness at injection site; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that unknown number of patients aged 75 years old or older that had received the Shingrix and developed redness at the injection site which spread down the arm. The reporter consented to follow up.
28Sep90 pt (/p 2nd dose in series) developed heaviness in ankles in both feet (1st rt then lt) 10 min /p vax, couple days later developed pain in legs, then felt warm, Next day pain all over body lethargic, pt now "feels better".
Pt stated that she was vaccinated with Pfizer x2 in march 2021. Received booster in Nov 2021. Admitted to hospital with dyspnea caused by COVID 19
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6198), on 18Mar2021 as dose 2, single (Lot number: EN6204) and on 27Sep2021 as dose 3 (booster), single (Lot number: FC3181), in left arm for covid-19 immunisation. The patient relevant medical history included: "ADHD" (unspecified if ongoing), "depression" (unspecified if ongoing), "anxiety" (unspecified if ongoing), "migraines" (unspecified if ongoing), "chronic constipation" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE, MOTEGRITY, TROKENDI XR, TIZANIDINE, MAGNESIUM GLYCINATE, VITAMIN D3, B-COMPLEX [VITAMIN B COMPLEX], ZINC, NAPROXEN SODIUM, FLUOXETINE. Past drug history included: N/a, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive (Day 1) via rapid antigen test (RAT), Negative, notes: Symptoms were reduced, began testing negative on Day 6 via RAT. Tested negative via RAT from day 6-9, Positive, notes: bright red positive on RAT on Day 10, Positive, notes: I ended up testing positive via RAT from day 10 - 17, during which time I became symptomatic again with intense sinusitis like congestion. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical Course: Product was COVID 19 Treatment and brand was Paxlovid. Treatment was started 09May2022 and stopped 14May2022. Indication was Treatment of COVID-19.  Conclusion: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6198, EN6204, FC3181 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6198, fill lot EN5330, EN6204, fill lot EN5335, FC3181, fill lot EY0567 and the formulated drug product lot EN5319, EN5325, FE3195. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.   SUSPECT PRODUCT is under agreement with SOCIETA PRODOTTI ANTIBIOTICI SPA.
Hives; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had hives after taking the first dose of the covid-19 vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
He did not get a 2nd dose of vaccine; Burning symptoms; Light rash; Head, face, back, hands and feet tingling and stinging; Head, face, back, hands and feet tingling and stinging; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He did not get a 2nd dose of vaccine), PARAESTHESIA (Head, face, back, hands and feet tingling and stinging), PAIN (Head, face, back, hands and feet tingling and stinging), BURNING SENSATION (Burning symptoms) and RASH (Light rash) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bipolar disorder and Hypertension.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PARAESTHESIA (Head, face, back, hands and feet tingling and stinging), PAIN (Head, face, back, hands and feet tingling and stinging) and RASH (Light rash). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He did not get a 2nd dose of vaccine) and BURNING SENSATION (Burning symptoms). At the time of the report, PRODUCT DOSE OMISSION ISSUE (He did not get a 2nd dose of vaccine) had resolved and PARAESTHESIA (Head, face, back, hands and feet tingling and stinging), PAIN (Head, face, back, hands and feet tingling and stinging), BURNING SENSATION (Burning symptoms) and RASH (Light rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the concomitant medications included: Bipolar and blood pressure medications  I t was reported that the treatment information included Antihistamine and  topical cream for burning symptoms, tingling and stinging.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Additional Information received included no new information On 23-Jul-2021: Additional Information received included no new information On 27-Jul-2021: Additional Information received included patient's age.
On 03/03/23 I noticed a red rash with blister. I was away from home and talked a doctor at the health care facility there. He examined me and determined that I had a shingles outbreak. He prescribed an antibiotic, antiviral, and topical cream to help deal with the itching. Although the first night was hard to sleep, it is getting better.
Extreme pain and difficulty in mobility. Took BENADRYL and TYLENOL to no avail. Condition worsened to date... Nov 19.
Rotateq given on 2/6/07, patient was 4 mos old 48 hrs later, mom noted immobility and huge amounts bright red blood mixed in with stool in sheet and also mucousy, no fever. 2 weeks later, had long smelly large amounts of mucous and mixed with bright red blood. Pt was fussy and stomach was "rumbling", no fever, no vomiting. Rotateq given 12/5/06 24-48 hrs later had stool with very small amount of blood, fussiness, didn't inform MD
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 via PCR test 09/02/2022. I contacted my allergist and he prescribed PAXLOVID.
Starting the morning after receiving the vaccine, the injection site was painful, red, sore, and very swollen. Every single day since (It is now 03/10 - 5 days after), the injection site welt has grown in size and redness, as well as painful to touch, warm to touch, and soreness extending down left arm. It is very similar to the "COVID Arm" hypersensitivity effects seen with the Moderna vaccine.
day p/recv vax pt devel a fever, lethargy, and decreased appetite; pt mom rpt decreased appetite lasted 5 days;
The patient's arm is swollen and itchy.  It started about 2 days after her vaccine administration.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/4/2023 Discharge Date: 2/8/2023  PRESENTING PROBLEM: Encephalopathy COVID-19   HOSPITAL COURSE: Patient is a 71 y.o. female with PMHx of vascular dementia (axO x1 at baseline), essential hypertension, GERD from a memory care facility who presented 2/4/23 with encephalopathy. Patient more lethargic at baseline. In the ED found to be COVID positive. Vitals stable and imaging negative. She was admitted for encephalopathy likely 2/2 COVID. She was symptomatically treated for COVID. Neurology consulted for further potential workup and stated to treat underlying infection and added aspirin to regimen. Patient with oropharyngeal phase dysphagia did improve and was able to tolerate a diet. Patient started to return to baseline cognitive function and was discharged back to memory care unit on 2/8/2023.
Rash, swelling, and itching at the injection site (left arm). Got better slowly over a week, but still itches.
the person reported that she had inflammation in her arm after vaccination.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (BOOSTER); Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 (BOOSTER); Manufacturer unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset Oct2023, outcome "recovered", described as "the person reported that she had inflammation in her arm after vaccination.". It was unknown if therapeutic measures were taken as a result of vaccination site inflammation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever of 102, body aches, muscle twitching and shaking, extreme sweating, started approx. 10pm, fever broke approx 7am, still having muscle twitching and body aches
Swollen, red, inflamed area around right eye. Quarter to sand dollar sized rash patches on stomach, breasts, back and legs. Extremely itchy. Hands are extremely itchy, but no rash visible.
Swelling of arm about 4 inches below injection site. Followed by joint and muscle aches. Fatigue, nausea lasting about 12 hours, then only the swelling and tender to touch lasting for 3 or more days.
Patient received second booster dose of Moderna COVID19 vaccine. Patient did not present with any symptoms or adverse events post vaccination.
They received their Moderna booster dose 2 months after the JJ booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They received their Moderna booster dose 2 months after the JJ booster dose) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (booster dose) in October 2021 and JANSSEN COVID-19 VACCINE (Initial dose). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE and JANSSEN COVID-19 VACCINE.    In December 2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They received their Moderna booster dose 2 months after the JJ booster dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They received their Moderna booster dose 2 months after the JJ booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. HCP  told the patient is over the age of 50 years old.
58 F with complicated medical history including urostomy, frequent UTI, fibromyalgia, seizures, presenting to the ED for presyncope/seizure following a COVID vaccination today. She reports that after getting the vaccine she felt dizzy. she is able to recount the events, no tongue biting. She was given diazepam via EMS en route. Has not missed any doses of medications. No other complaints. Symptoms started following the COVID vaccination and no other symptoms today.
The pt experienced a 2 cm tender nodule at the injection site approximately 24 hours post vax with increased irritability, no fever, no itching, was noted. The pt also experienced erythema to the right upper leg. Treated with cephalexin.
Pale, (droggy, fainted) (per mom). Pulse 64, 10:15 am, fell hit head, red line, respires 28, head-hurting.
Rash on waistline began to develop within hours after shot. Over the next few days blisters appeared on rash and continued growing in size for 7 days following. On day 5, I went to urgent care and was diagnosed with shingles.
heart discomfort, heavy breath after about 4 hours chilling, low fever, and fatigue after about 12hours
In May, I had stopped up ears. My NP 50mg  (6pak). Then a month later  I experienced some vertigo/dizziness and returned to see Dr. At that time some of the fluid was reduced, but I now had inflammation in the right ear. She prescribed Cefdinir 300mg (qty 20).   I did not return to Dr, but in July I saw my audiologist who said it looked like a few bubbles, but no redness of the eardrum. This person is not an MD. I was feeling okay but my ears feel like they have fluid still. Sometimes it feels stopped up, and I can pop them (release the eustachian tube).   Also: on July 29th I saw my ENT surgeon for a followup to a surgery from Feb 2020. He stated that I had no infection of the ears, but that I had dysfunction of the eustachian tubes. I have yet to make another doctor appointment, but plan to in September.   I do not usually suffer much from seasonal allergies, but this spring and summer I have been taking Loratadine 10mg daily, along with Sudaphed 120mg (extended release) intermittently. If I do not take the decongestant, I frequently have some dizziness upon waking in the morning. It does not last.
Vax given 13JUN91 presented to MD 21JUN91 t101 @ home, body aches, h/a, chills & sweats; No sore throat, cough, rhinorrhea; 23JUN91 devel rash on face, neck, back, itching; Still out work 25JUN91, myalgias resolved but rash not 25JUN91;
At. 10:25am during observation, patient verbalized dizziness and lightheadedness. Vital signs noted: blood pressure 185/99, pulse 80, respiratory 18 02 Sat. 99%. Patient shared medical history of hypertension and migraine headaches. Patient provided information to follow up with primary care physician as soon as possible to treat hypertension. Patient stated husband would transport her to urgent care. Patient was being assisted from chair to wheelchair to exit clinic.  She became weak and lethargic. Vital signs were taken again, noted at: blood pressure 204/179, pulse 136,  02 98% , respiratory 22. EMS was called and patient was transported to Medical Center.
pt recv vax; that eve T of 101; on 22aug pt lethargic & pale; slept all day, some nasal congestion;
Patient was given ZOSTAVAX on 4/13/12, she called 4/15 that injection site was red, swollen, hot to touch and worse then day before. Instructed patient to seek medical attention.
nausea, vomiting, dizziness, palpitations, sweating, weakness, light headness, aches and pains, inability to focus, weakness
fever, chills, fatigue, blurry vision (onset evening of vaccine), L arm/hand numbness
Reaction at injection site; lump, hot, red, itchy. A day later diarrhea began for 2 days; also nausea. Took PEPTO BISMOL. Then fatigued, unsteady, started to develop insect bites on trunk of body. Ithced terribly. Only had a couple 2-3 that later blistered, oozed and scaled over. Next day a few more appeared. Could not sleep because of itchiness. They are not along nerves or nerve roots like if shingles. This morning checked packet insert and symptoms similar to what is noted which is chicken pox. Counted 30 spots located on back, chest, midriff, both arms to elbows only, on neck but not on face nor on lower extremities. Pt doesn't know if she ever had chicken pox in childhood.
Information has been received from a physician concerning a 16 year old female patient who in August 2009, was vaccinated with the second dose of GARDASIL. According to the physician, the patient developed headaches and fatigue after the second dose of GARDASIL. At the time of the report the patient had not recovered. The patient sought medical attention by an office visit.  Follow up information has been received from the physician who indicated that the patient was a female student with no known drug allergies/reactions and no pertinent medical history who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (LOT # 659054/0311Y) intramuscularly into her left arm at 14:10 pm and on 13-OCT-2009 was vaccinated with her second dose of GARDASIL (LOT # 659054/0311Y) intramuscularly into her left deltoid at 13:50 pm. No illnesses were reported at the time of vaccination. It was reported that on approximately 19-OCT-2009 the patient began experiencing headaches, daily nausea, loss of appetite, vomiting, lethargy and inability to concentrate. At the time of the report the patient had not recovered. Diagnostic laboratory tests were performed included a CT scan and the US of abdomen reportedly as normal limits, other diagnostic tests were within normal limits and other labs and hospital visits per other physician.  The reporting physician considered headaches, daily nausea, loss of appetite, vomiting, lethargy and inability to concentrate to be disabling/incapacitating events since the patient missed many days at school (additional information was not legible).  Additional information is not expected.
GBS - numbness, tingling, burning of feet, progressing to calves and near knees. 8 days hospitalization. Immunoglobulin - 5 days.   7/13/09 Hospital records received DOS 12/26/09 to 1/3/09. Assessment: Atypical Guillain Barre Syndrome. Following several days of diarrhea and nausea, the patient presented with bilateral lower extremity weakness and, preceded by numbness, burning sensation and tingling in legs. Several falls injuring knee and twisting ankles. Swelling of right lower extremity. Absent reflexes at ankles, diminished at knees. Intially tachycardic and hypoxic. Left lower lobe pulmonary emboli. Developed progressive weakness and was unable to walk. Septic from urinary tract infection. IVIG.  ICD-9 codes: 357.0, 415.19, 276.1, 401.9, 272.4, 300.00, V12.54, 733.90, 253.8   7/22/09 Received Neuro medical records of 12/2008- FINAL DX: idiopathic polyneuropathy, Guillain Barre syndrome Records reveal patient experienced fever w/thoracic rash, diarrhea, weakness, difficulty walking, several falls w/leg injuries & swelling, excessive sleepiness s/p cruise ship travel.  Initial exam revealed absent ankle reflexes, swollen ankles bilaterally, right calf swelling, ataxia, bilateral weak dorsiflexion & intermittent pain.  Follow up visits s/p hospitalization for AIDP tx w/IVIG reveal patient w/continued leg weakness, bilateral foot drop, s/p PE & on coumadin. Recent fall at home w/burn injury; continuing PT.
Day after second vaccine (4/10/21) experienced flu-like symptoms--body aches, chills, 101 temperature, extreme tiredness. Lasted about 24-36 hours. On 4/11/21 upper right arm where received vaccine swelled and was red and sore. That receded over the next few days. Had a low grade 99 degree temp off and on for the next week or so.   6/6/21: I have started seeing knotty bruises in my right arm two months later. I am not aware of any activity that would have caused them. Yesterday large I found a bruise on the back of my upper arm and this morning there is a bruise on the front in the muscle. Both had deep color and a knot in the center. I am not sure there is a correlation but wanted to report as these were in the arm where I received the vaccine. I sometimes bruise easily but do not have a history of severe bruising.