chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sprain in leg; thinking I am deaf; had covid; had covid; had little chills; Tired; throat was painful; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Apr2021 16:45 (Lot Number: EW0169) as single dose for covid-19 immunization. Medical history included Knee arthroplasty. The patient's concomitant medications were not reported. Patient received the dose1 (lot: EP7533) for Covid-19 immunisation. The patient felt a little bit tired like the symptom when had covid and throat was painful and had little chills on 20Apr2021. had a sprain in leg but patient guessed that because had a knee replacement on unknown date. Patient stated, "Sorry, I am thinking I am deaf. I am sorry, I cannot understand". The outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Around 5 pm the day of getting the flu vaccine began to feel wheezing and SOB.  These symptoms did progress somewhat.  Normal peak flow is 400 at 7pm that evening my peak flow was 250.  Used Albaterol inhaler and steam bath to help symptoms which elected to pass about 9pm.
This is in follow-up to report (s) previously submitted on 7/16/2007. Information has been received from a 30 year old female with no medical history or allergies, who on 14-JUN-2007 was vaccinated with 0.5 mL first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, the patient became very dizzy and stated that she almost fainted. The consumer also stated that the "nurse did not shake the liquid in the syringe before administering the vaccine." In addition to the dizziness felt after teh injection, and which carried on for a few days, the patient had a general felling of irritability and anxiety, as well as recurrent tachycardia. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Patient presented to the pharmacy 12/1/18 indicating that her left upper arm had started hurting within the past week. She states that her arm is sore to sleep on within the past week and hurt when reaching to grab an item in her home.
Extremely sore about six inches from injection site with red, warm rash. One place has a "knot" under the rash.
LUMP SIZE OF QUARTER AT INJECTION SITE.  NO PAIN OR FEVER.
Pt called on 10/16/15 regarding red, swollen, warm 2-3" diameter at injection site (L) upper arm. Flu admin left deltoid 10/13/15 site itchy. Stated 16th area decreased in size from day prior. Phone call 4/14/16 pt reported saw private provider 10/16/15 started on ciprofloxacin 500mg q 12 hours x 28 days. Inflammation resolved, no further problems. Medical director notified.
He had his 3rd Moderna COVID-19 vaccine on 23 Sep 2021; Flushed face and upper abdomen after 3rd shot; Red face and upper abdomen after 3rd shot; Sinuses hurting  after 3rd shot; Chills after 3rd shot; Fever 102 F after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed face and upper abdomen after 3rd shot), ERYTHEMA (Red face and upper abdomen after 3rd shot), SINUS PAIN (Sinuses hurting  after 3rd shot), CHILLS (Chills after 3rd shot) and PYREXIA (Fever 102 F after 3rd shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A, 004M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced FLUSHING (Flushed face and upper abdomen after 3rd shot), ERYTHEMA (Red face and upper abdomen after 3rd shot), SINUS PAIN (Sinuses hurting  after 3rd shot), CHILLS (Chills after 3rd shot) and PYREXIA (Fever 102 F after 3rd shot). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (He had his 3rd Moderna COVID-19 vaccine on 23 Sep 2021). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, FLUSHING (Flushed face and upper abdomen after 3rd shot), ERYTHEMA (Red face and upper abdomen after 3rd shot), SINUS PAIN (Sinuses hurting  after 3rd shot), CHILLS (Chills after 3rd shot), PYREXIA (Fever 102 F after 3rd shot) and EXTRA DOSE ADMINISTERED (He had his 3rd Moderna COVID-19 vaccine on 23 Sep 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, Body temperature: 102. f (High) 102.F.         No Concomitant medication was provided. Wife had stated that Flushed face and upper abdomen, and Red face and upper abdomen. She stated that it was not a rash that the flushing is happening as a result of the fever. Wife stated, her husband's sinus was hurting but thinks it was because of the AC. we both get that from the AC sometimes. She had stated that she has been alternating between Advil & Tylenol but the fever keeps coming back.and it comes back at 102 F. Wife stated that she tested positive for COVID-19 disease (Case# MOD21-147408 Cross-linked), in AUG2021 and her husband did not test positive and he was fine. Husband was supposed to have surgery in two weeks so we got him a third shot so he would not catch COVID in the hospital.
Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. The reporter did not know which dosage it was, if it was 0.5 or 0.25ML or 50 or 100mcg, and it was stated as  one from the booster dose.
Patient presented to clinic on 2/7/2020 with right arm vaccination site redness, swelling, redness.  States redness started one day after the vaccination and spread.  She was treated with 10-day course of doxycycline.  She followed up with pcm on 2/13/2020 and redness had resolved.
Information has been received from a health professional concerning a 6-year-old white male who on 18-JUL-2001 at 3:55 pm was vaccinated in the deltoid with a first dose of Varivax (Lot # 637371/1609K). ON 22-MAY-2006 at 2:00 pm the patient developed chickenpox on the trunk of the body, and on the bottom and axillary areas. The patient's chickenpox persisted. Additional information has been requested.
2-12 Dr said to put cold pacs on red, swollen, hot arm. Picture enclosed. 2-13 Dr. prescribed clindamycin 150 mg 3 times a day and BENADRYL 3 times a day. I had a rash on both arms. 2-15 Dr. for spots below right knee. He added ZYRTEC 1 time a day. He felt it may be a reaction to clindamycin and shingles shot. 2-20 Dr. spots on right leg have increased and are red, legs and arms are blotchy. There is a coating on tongue and it feels like I drank hot tea on the end of tongue. He prescribed Triamcinolone 0.1% cream 30 gm to apply on leg and LISTERINE 2 tmes a day for tongue. Picture of leg enclosed. I've received pneumonia and flu shots at pharmacy and never had a problem with any reaction.
arm was sore; Feeling unwell; Nausea; headaches; chills; diarrhea; shortness of breath; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 09Apr2021 at single dose for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. Consumer reported that her arm was sore and she started feeling unwell; the patient also experienced nausea, headaches, chills, diarrhea and shortness of breath; all on an unspecified date in Apr2021. The consumer doesn't know if it's connected to the vaccine and she wants more insight on this. She still felt unwell at the time of this report. The outcome of the remaining events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications details were reported.  Patient received vaccine at Pharmacy.  Beyond use date of the vaccine was 17-Feb-2022.  No treatment medications details were reported.  NDC number was reported as 80777-273-10.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received wherein patient and vaccination details added; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Sore arm; chills; headache; fatigue; body aches; This is a spontaneous report from non-contactable consumer (patient's wife) via Pfizer Sales Representative. A 31-year-old male patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for covid-19 immunization. None medical history. The patient with no known underlying health conditions. The patient's concomitant medications were not reported. The patient experienced Sore arm, chills, headache, fatigue and body aches within 24 hours after first vaccine injection on 31Dec2020. It was reported patient experienced stated symptoms yesterday 31Dec2020, after receiving Pfizer Covid 19 vaccine. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a Pfizer sales representative who reported on behalf of a contactable nurse for three patients. This report is second of the three patients. An elderly female patient of an unspecified ethnicity started to receive PREVNAR 13, on an unspecified date to an unspecified date at single dose. Two of the patients received vaccines were of Lot# J20343 and expiration date 31May2016 and the other dose was of Lot# L13519 and expiration date 01Jun2016. The patient medical history and concomitant medications were not reported. The patient experienced cellulitis, injection site was hot to the touch and swollen on an unspecified date with outcome of unknown.
Both legs and feet swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Both legs and feet swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Cholesterol medicines causes shortness of breath) and Allergy NOS (Allergic to a lot of things).    On 26-Jul-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 PERIPHERAL SWELLING (Both legs and feet swollen). At the time of the report, PERIPHERAL SWELLING (Both legs and feet swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  The patient was prescribed with hydrocortisone (thrice weekly) but the patient was yet to start the medications.  The patient received first dose of vaccine, lot number was 0a1B21A or 091B21A. The patient had so side effects until a few days later when both legs and feet started to swell. The patient's blood pressure was also raising, so the patient consulted with the physician as the patient thought about having some kind of reaction to the vaccine. The physician suspected that it was probably not related to the vaccine and prescribed hydrocortisone to take three times a week.  The patient was scheduled for second dose on 23-Aug-2021.
Severe migraine 24 hours after, worsening migraines since. Moderate-severe fatigue since 24-36 hours after that has not changed after 6 weeks. Shortness of breath 24 hours after for 5 hours (same time as migraine), SPO2 93 when checked with personal pulse oximeter.
My eyes began swelling roughly 36 hours post injection and the edema went down into my right cheek.  It resolved with Zyrtec two tablets bid x 1 day.
Patient started having a couple of symptoms on this date--diarrhea, falling, blackouts, leg weakness and was unable to walk.  He did not go to the hospital until 11/29.  They sent him home and he went back on 11/30 when they called in a neurologist.  He was then diagonsed with Guillain Barre syndrome at that time.  This was not reported to the pharmacy until today, 12/15/15.  The patient is now recovering in a rehabilitation facility.
Information has been received from a consumer concerning her 70 year old husband with no pertinent medical history who on 11-JUN-2007 was vaccinated SC with one 0.65 ml dose of ZOSTAVAX (no lot number available). There was no concomitant medication. On approximately 11-JUN-2007 "shortly after vaccination," the patient experienced sneezing and post nasal drip. Unspecified medical attention was sought. An "A test for allergies" was performed. The patient was not recovered. There was no product quality complaint. Additional information has been requested.
a month later she had thrombotic event- she had a central artery embolism to her right eye and multiple small ischemic strokes in multiple areas of her brain. she lost vision in her eye,
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 21-Dec-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with MOLNUPIRAVIR (LAGEVRIO) at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) outcome was unknown.            No concomitant medication was reported.  Patient reported that she had Covid a couple days after her Skyrizi injection. She took COVID antiviral medication lagevrio. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Primary reporter contact for lot number information was unsuccessful.  Company comment: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 that occurred in the context of booster dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had covid a couple of days after her co suspect Skyrizi injection (for her medical condition chronic palque psoriasis). She took covid antiviral medication lagevrio.  No further information on risk factors, detailed clinical course, investigations and details pertaining to the previous doses was available in the report. Outcome of the event was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 that occurred in the context of booster dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had covid a couple of days after her co suspect Skyrizi injection (for her medical condition chronic palque psoriasis). She took covid antiviral medication lagevrio.  No further information on risk factors, detailed clinical course, investigations and details pertaining to the previous doses was available in the report. Outcome of the event was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Lot number: ER8731), in left arm and on 11May2021 as dose 2, single (Lot number: EW0179) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Nov2021 as dose 3 (booster), single (Lot number: 012H21B), in left arm and on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anemia" (unspecified if ongoing); "ED" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: TADALAFIL, start date: 01Sep2022, stop date: 24Oct2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Sep2022, stop date: 06Nov2022; VITAMIN D [VITAMIN D NOS], start date: 01Sep2022, stop date: 06Nov2022; VITAMIN C [ASCORBIC ACID], start date: 01Sep2022, stop date: 06Nov2022; IRON, start date: 01Sep2022, stop date: 06Nov2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: New positive antigen test after Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8731 and EW0179 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 ER8731, fill lot EP8683, and the formulated drug product lot EP8570, and lot EW0179, fill lot EP8730, and the formulated drug product lot EP8611. 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.
Crying non stop 1 1/2 hour, anytime mom moves child he screams louder temp 102.
unusual inflammation in the mouth(throat and gums); unusual inflammation in the mouth(throat and gums); This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced unusual inflammation in the mouth (throat and gums) in Jan2021, he did not went to see a doctor. He also indicated that he is scheduled to take the second dose but wanted to know if it is safe to proceed. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Patient called to report local itching and swollen arm at site of injection two days after receiving flu shot. Patient received Fluarix two years ago with no complaints. Pt report this has been her first reaction to flu shot.
Schedule and mom said child needed Hep B vaccine. Internet down therefore I couldn't verify shot record. When internet up I verified child needed Hep A not Hep B.
Sore arm; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number, unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  No follow-up attempts are possible. No further information is expected.
Developed a moderate sized area of intense erythema and mild induration near site of MMR injection.  Also had a few erythematous macules scattered over body.
Initial report received from healthcare professional on 09 June 2014. This case is invalid as no patient identifiers available. Numerous patients, whose gender, date of birth, age at the time of event, medical history and concomitant medications were not reported, had received ad ose of FLUZONE HD (batch number, route and anatomical site of administration were unknown and dose number was not reported) on an unspecified date (last 2 Flu seasons). It was reported that on an unspecified date (last 2 Flu seasons), after receiving FLUZONE HD vaccine, the patient experienced redness, swelling and warmth at the injection site. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Red, swollen, warm to touch at injection site, 3-4 inches in circ. Advised Motrin-cool compress.