chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough positive COVID test after full vaccination; Breakthrough positive COVID test after full vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough positive COVID test after full vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
SURGICAL PATHOLOGY REPORT Order#: Collected: 8/22/2022 10:48 AM Received: 8/22/2022 10:48 AM SPECIMENS: A. Cervix, Uterus CLINICAL HISTORY: Menorrhagia; fibroids, submucosal and intramural; endometrial hyperplasia, unspecified FINAL DIAGNOSIS: Cervix and uterus, hysterectomy: Benign cervix, no dysplasia Secretory endometrium with endometrial polyp, no hyperplasia or malignancy Myometrium with multiple intramural and submucosal leiomyomas, largest up to 3.3 cm in greatest dimension (Specimen weight: 172 grams)
Face is swelled up/eyes feels closed/eyes shut; Patient got sick everytime like she had COVID; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (Face is swelled up/eyes feels closed/eyes shut) and ILLNESS (Patient got sick everytime like she had COVID) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058f21a and 058f21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergic to cats.   On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022, the patient experienced SWELLING FACE (Face is swelled up/eyes feels closed/eyes shut) and ILLNESS (Patient got sick everytime like she had COVID). At the time of the report, SWELLING FACE (Face is swelled up/eyes feels closed/eyes shut) and ILLNESS (Patient got sick everytime like she had COVID) had not resolved.      The concomitant and treatment medication was not reported. Patient stated that since receiving the 1st dose on Sep 8 2021 he had adverse effects and from that date still has the same symptoms. Patient's face was swelled up, her eyes feels closed, her eyes shut and this happens twice a month. Patient got sick every time like she had COVID and it affected her life, currently she had been 8 days absent to her work as a teacher. Patient never had COVID positive test. No vaccines were given within one month prior to Moderna COVID-19 vaccine. AE had caused patient to seek medical care (office visit, Urgent care, ER, hospitalized) Yes, office visits, her doctor told her to go yesterday to the ER if it got worse but she had not gone. The patient had no experienced a similar event in the past.   This case was linked to MOD-2022-652193 (Patient Link).
fatigue; chills; muscle pain; nausea; vomiting; soreness in arm at injection site; glands by throat swollen; received Pfizer as 1st dose instead of Moderna COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR ( received Pfizer as 1st dose instead of Moderna COVID19 vaccine), FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscle pain) and NAUSEA (nausea) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025E21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR ( received Pfizer as 1st dose instead of Moderna COVID19 vaccine). On 29-Apr-2021, the patient experienced FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscle pain), NAUSEA (nausea), VOMITING (vomiting), VACCINATION SITE PAIN (soreness in arm at injection site) and LYMPHADENOPATHY (glands by throat swollen). At the time of the report, PRODUCT ADMINISTRATION ERROR  received Pfizer as 1st dose instead of Moderna COVID19 vaccine) had resolved and FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscle pain), NAUSEA (nausea), VOMITING (vomiting), VACCINATION SITE PAIN (soreness in arm at injection site) and LYMPHADENOPATHY (glands by throat swollen) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported No treatment medications were reported
Redness at site, soreness, red streaking down to armpit and sore lymph nodes.
On examine for Insurance Coverage PSA (below) level elevated and testicale swollen (9/11)  Neither previous issues
This is a spontaneous report from a contactable consumer reported for herself. This 18-year-old female patient of an unspecified ethnicity started to receive TRUMENBA, via an unspecified route of administration at single dose in Sep2017 for immunization. The patient medical history and concomitant medications were not reported. The next day after vaccination (Sep2017), the patient experienced arm was in so much pain, back was in so much pain, can't sleep, can't really move arm that much. The outcome of the events was unknown.
Headache, body aches, dizzy, weak. Site of injection is sore, has a knot and red with fever in it.
Pt recv vax on 10/1/98; on same day pt exp achy feeling, sore arm, backache, headache, not sleeping well; tx=Tylenol
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA274329 (same reporter). This case involves a female patient (age was not reported) who received a 0.5 mL dose of FLUBLOK QIV (lot number, expiry date, dose in series and site of administration was not reported) via intramuscular route. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that vaccine had been over a total of 24 hours out of range, too warm. No known adverse reaction, symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
right thigh adjacent to injection site with 10 cm x 5 cm red, warm, indurated area, noticed this am by mom, vaccines yesterday, no fever, no pain
runny nose, sore throat, rash on back (blotchy);pt was treated w/DPH;c/o rash under lt arm pit;
pt recv vax 2NOV95 & on 21FEB97 pt exp a breakthrough case of varicella;
following vax pt had sz dx as hypsarrythmia by EEG; pt recvd course of ACTH; pt had mild development delay; father states child had these "movements" prior to vax;
The underage patient inadvertently received a Moderna Covid-19 booster (0.25mL) vaccine on 01/15/2022 after completing her initial Pfizer  Covid-19 vaccine series on 05/18/2021.
Face redness; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination.  The patient's concomitant medications were not reported.  The patient experienced face redness on an unspecified date. The outcome of the event was unknown.    Information on batch number has been requested.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Blood pressure raised; Felt dizzy; Eyes could not focus; Speaking with a lot difficulty; Body felt very heavy, could not move my body much; Feeling of tiredness; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 19Mar2021 at 16:30 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient medical history included hypertension, allergic to silicone and mix nuts. The patient had anaphylactic to flu vaccine, flu and cold medicines and epinephrine. The patient relevant past drug reactions included slight high blood pressure, dizziness and shaking when treated with cortisone shot and hepatitis B vaccine. Concomitant medications reported as propranolol (MANUFACTURER UNKNOWN), alodipine (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN) and tyneol (MANUFACTURER UNKNOWN) taken for unspecified indication from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other vaccines within four weeks of the vaccination. On 19Mar2021 at 04: 30 PM, the patient blood pressure raised and felt dizzy. Moments after patient felt spaced-out, disoriented, eyes could not focus, speaking with a lot difficulty and body felt very heavy, could not move body much. After 15-30 min, BP went down slightly but the patient body was still not reacting normal. The doctor said feeling of tiredness was normal and sent to home for rest. Around 2 hours after the patient blood pressure was still off at 140/60, while normal is 110/70 with BP meds. For almost 3 hours after vaccination, the patient still felt body heaviness, completely unfocused, not move my body well and could speak lightly with difficulty, but all the while, her mind was sharp and thinking clearly and drank gatorade and felt better and body reacted more normal. The next day the patient still felt body was off and was quieter. The patient did not receive treatment for the event. The events result in emergency room/department or urgent care. On 19Mar2021, the patient was tested negative for SARS-CoV-2.  The clinical outcome of blood pressure raised, body felt very heavy, could not move my body much, dizzy, eyes could not focus, speaking with a lot difficulty and feeling of tiredness was resolving at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained.
Left shoulder (arm where vaccine was administered) pain started on Monday morning, two days after vaccine administration.  Today is just more than four weeks since onset of pain.  I have lost range of motion in my shoulder and cannot zip/unzip my clothes, put on coats, or make a full circle with my arm.
Anaphylaxis / anaphylactic shock, hot feeling in throat (a few minutes after receiving second dose), tightness in throat, difficulty breathing, hyperventilation, shallow breathing, wheezing
Left arm sore the next day to the point where patient had difficulty raising left arm. Pain has persisted now for 1 month per patient. Confirmed with patient how vaccine administrator puts the injection in the thickest part of the deltoid to reduce risk of vaccination injury, but that unintentionally damage to nerve tissue in deltoid muscle is an  inherent risk with IM administration.  Patient encouraged to utilize cold compression to decrease any residual swelling and to follow up with doctor.
Cold; Loss of Appetite; Soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), DECREASED APPETITE (Loss of Appetite), PAIN (Soreness) and FATIGUE (Fatigue) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), DECREASED APPETITE (Loss of Appetite), PAIN (Soreness) and FATIGUE (Fatigue). At the time of the report, NASOPHARYNGITIS (Cold), DECREASED APPETITE (Loss of Appetite), PAIN (Soreness) and FATIGUE (Fatigue) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On 03-AUG-2016, the patient was treated at a family practice for a blistering vesicular outbreak, which was diagnosed as herpes zoster.The patient was prescribed VALTREX for management of his painful symptoms and "chronic." As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
10 hours after vaccination I got very tired. Went to bed at 9:30. Had chills. and slight head ache. Woke up around 12:30  with  rapid heart beat. My normal resting heart rate is 61(per activity tracker) It was 98 ish.  and somewhat eractic. (but not a lot). Also had nausea and diarrhea. Finally got some sleep. Woke up at 7:00am and took 2 aspirin. Today I'm feeling fine.  Maybe a little tired.
This spontaneous report was received from a physician via company representative, who saw an article by another physician. This report refers to 44 female patients of unknown age, whose concurrent conditions, medical history and concomitant medications were not known. On an unknown date, the patients were vaccinated with GARDASIL (details not known). As per the article the 44 patients died as a result of receiving GARDASIL and hence causality of death was considered to be related to the vaccine. The reporter considered the event serious (death). Upon internal review, death was considered to be medically significant. Additional information is not expected as the physician does not want to be contacted.
Pt received vaccine in left deltoid. Reported the next day that her arm was very tender, warm and swollen with difficulty moving arm x 2 days.
Began experiencing left-sided chest pain on June 7, 2021. Pain got progressively worse over several hours, and resulted in difficulty with inspiration. Exam at ER June 8, 2021 revealed multiple lower left Pulmonary Emboli with co-existing pneumonia.
Patient received ZOSTAVAX 2/14/10, and by 2/16/10 had pain and slight rash along left - side T -5 back/ pain/ chest in a Zosteriform fashion. By 2/18/10, this rash was a classic presentation of H zoster with vesicles only watery base in T-5 dermatome with pain.
after the shots i've had complete sinus pressure in ears in which i've never had before. its been going on 4months of complete misery. my immune system is going crazy. I've had blood tests and all kinds of test and there's no problems accept severe allergies and ear drum with holes in both. i need help bad. this has never happen even close to what i'm experiencing now.
Sore Arm for a couple days then the pain went away then after a couple days the pain came back so bad she couldn't move her arm. Patient is going to speak with md as well.
Patient receieved Gardasil and FluMist vaccines in offices.  Patient fainted approx. 15 mins. afterwards. Regained consciousness within a few seconds.
Massive red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Massive red rash) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Massive red rash). At the time of the report, RASH ERYTHEMATOUS (Massive red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's friend after reporting ADR continued as "I will be bringing her to her dr. I will be sending you the bill. Now this is everyone I know. You very well knew there were severe reactions. You knew and lied. Thanks a bunch"
Red, warm, rash, painful. Red area measures 5 cm x 3 cm. Mother applied hydrocortizone cream and gave MOTRIN which didn't improve symptoms.
six pts exp tenderness & swelling @ DTP inject site; inject site area was hot to the touch; tx included APAP & ice packs;
chest was killing me, from the upper half to my neck; chest was killing me, from the upper half to my neck; A spontaneous report was received from a (Reporter Consumer) concerning a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list  is  1.chest discomfort 2.Myalgia  The patient's medical history was not provided. No relevant concomitant medications were reported.   On Date of  23-jan-2021, the patient received  first of two planned doses of mRNA-1273 (lot/batch: is  unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On date of 24-jan-2021 The patient experienced the events list (verbatims)  Her chest discomfort whole day from upper half of neck. and myalgia.    No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The events, chest discomfort from upper half of neck and Myalgia were considered  NOT RESLOVED on 24-jan-2021; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
After first injection I experienced fatigue for 3 days, injection site soreness, and feeling run down. After my second injection I experienced the same symptoms plus swollen lymph nodes too. I have had unexplained blindness in my right eye starting on July 12, 2021. I'm just wanting to see if this is a possible vaccine side effect. The eye doctor says that my optic never is elevated (swollen), but doesn't know why and that is after examining an MRI of my head.
Aches, chills,  fever 101 and fatigue . So far, has lasted 16 hours.
eyelids were flaky; severe rash on body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYELID SKIN DRYNESS (eyelids were flaky) and RASH (severe rash on body) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016M20A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced EYELID SKIN DRYNESS (eyelids were flaky) and RASH (severe rash on body). At the time of the report, EYELID SKIN DRYNESS (eyelids were flaky) and RASH (severe rash on body) was resolving.            Treatment medication given for patient include steroids and topical steroid cream.  Action taken with mRNA-1273 in response to the event was not applicable.
This is in follow-up to report(s) previously submitted on 8/14/2008. Initial and followup information has been received from a nurse practitioner concerning a 23 year old female with an allergy to CECLOR and no illness at the time of vaccination who on 26-JUN-2008 was vaccinated IM in the left deltoid with a first dose of GARDASIL vaccine (yeast) (lot# 660393/0067X). On 28-JUN-2008 the patient experienced restlessness, tiredness, shortness of breath, migraines, wrist soreness, teeth grinding, hot face, ankle soreness and knee soreness, edgyness, skin breakouts, and body hurts. The patient was treated with ibuprofen and referred to her physician. The outcome was not reported. Additional information has been requested.
Stomach cramps/upset stomach day vaccine was given and typical soreness at injection site, followed by numbness/tingling of area surrounding injection site and entire (L) arm. Numbness/tingling occurred approx. 3 days after vaccine was administered.
This spontaneous report as received from a pharmacist refers to four patients of unknown demographics. The concurrent condition and medical history was not reported. On 14-APR-2016 the patient was vaccinated with PNEUMOVAX 23 (dose, route, frequency and lot details were unknown) at a vaccine clinic. The concomitant medication was not reported. On the same day, all the patient's arms were swollen twice the size at the injection site and their arms were painful and discolored from the injection site down to their hands. The patients sought medical attention by contacting the pharmacist and no treatment was rendered for the event. The action taken with the vaccine was not applicable. The outcome of the events was reported as not resolved. No product quality complaint was filed. Additional information has been requested.
I95.9 HYPOTENSION 9/1/2022 ANEMIA I95.9 HYPOTENSION 9/1/2022 HYPONATREMIA
Patient came to ED with complaints of worsening abdominal pain, nausea and vomiting. Patient admitted for gallbladder and COVID-19 positive.