chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tired; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and HEADACHE (Headache) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired) and HEADACHE (Headache). At the time of the report, FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.            No concomitant drugs provided. No treatment information provided.  Action taken with respect to product mRNA-1273 was not applicable.
Patient was accompanied by their parent to the vaccine clinic. On the consent form they wrote that they were 16 years old however their date of birth (5/4/2021) indicates that they were 7 days shy of their 16th birthday at the time of receiving the vaccine and the discrepancy was not noticed until after the patient had been vaccinated. When the patient was asked about their age they verbalized that they were 16 years old. The patient was observed for 15 minutes post vaccination and did not experience any adverse reaction.
Breakthrough case admission after 3 vaccines Moderna 1/15/21 lot# 011J20A;  Moderna 2/12/21 lot# 013M20A;  Moderna 11/3/21 lot# 077C21B
Covid-19; Covid-19; Pfizer Dose 1,2,3; Moderna Dose: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 12Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 01Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Lot number: 033K21-2A), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 23Sep2022 as dose 5 (booster), single (Lot number: AS7146B), in left arm and on 05May2023 as dose 6 (booster), single (Lot number: AS7173B), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "unknown", described as "Pfizer Dose 1,2,3; Moderna Dose: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment (Paxlovid). Treatment stop date 28Sep2023. Known allergies: No.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316477 Same patient, different drug and event;
HYPOTENSION 1/4/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 11-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX dose and route unspecified (lot # J001697) that expired on 08-MAY-2014. No adverse effects reported. Additional information has been requested.
Major bruising occurred at site of injection one day after vaccination with a "tough knot" that formed beneath the skin. Patient applied ice for a day on Sunday. Slight pain but nothing major for the patient. Also developed the more typical reaction referred to as "covid arm" with the red stripe a few inches below site of injection, warm to the touch. More concerned about redness which I let her know is relatively normal and will go away but to keep an eye on the bruising as it was significant. If no better (or worse) over the next two days schedule a doctor's appt and follow up with us
Patient  had received the pfizer covid vaccine, and approximately 10 minutes after dose, she felt light headed, headache, and nauseous. 12.5mg benadryl was given in the idea that she had an allergic reaction. over the next few minutes she had begun to talk about itchy, hot throat and immediately administered epinephrine and called 911. paramedics showed up briefly after, informed about her heart condition, afterwards paramedics took her out and under her care at this time. Epi administered into left
Extreme lethargy and headache within ~2 hours  Rash appeared almost six days to the hour at the injection site
inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient said whenever she goes to the hospital she gets hives. Counseled patient to take diphenhydramine and get allergy testing.
Received vaccine and got up and stood on line-"everyhting got fuzzy" and fell to floor. States eased self down and did not hit head. Remained responsive. BP 100/90 9:50 110/50 P 90.
17 year old male patient was given Hep A ADULT instead of Hep A PEDIATRIC
Injection site became swollen, red and hot. Patient was questioned about reactions to injections before.  Patient discussed being treated for hives related to allergic reaction when having infections.  Patient then said they felt faint.  I retrieved Epi-Pen and 0.3mg was administered. Patient then bucked back and her eyes rolled back in head.  Patient then started to speak, but had no recollection of the possible seizure. She was very relaxed but speaking when the EMS arrived.  They took her vitals, that were low but normal.  She was referred to go to the emergency room by the EMS.
Itchy sensation but no visible rash . 1 dose of oral benadryl 25mg given. Pt report improvement after 15 minutes.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.46.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
The day after vaccination, patient developed fever and pain with walking.  Admitted to the hospital 02/03/2020 to 02/05/2020 with an abscess, cellulitis and leukocytosis.   Taken to OR for drainage on 02/04/2020.  Clinical improvement and discharged home on oral abx.  Readmitted on 02/06/2020 to 02/14/2020.  A drain loops were placed.  Wound vac placement and 2 more surgical procedures.  IV antibiots until discharge on oral antibiotics.  Sterile abscess felt to be a reaction to components of vaccine
Slight sore shoulder at injection site; Dose 3; 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 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Nov2021 09:15 (Lot number: FF8839) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM, Route of Administration: Intramuscular), administration date: 01Mar2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM, Route of Administration: Intramuscular), administration date: 23Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 09:15, outcome "unknown", described as "Dose 3"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021 22:00, outcome "recovered" (2021), described as "Slight sore shoulder at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination  No follow-up attempts are possible. No further information is expected.
One day post vax pt developed an injection site reaction characterized by redness, swelling and tenderness.
URTICARIA Treatment: Prednisone, antihistamines, Coconut oil Signs and Symptoms: red welts on skin with intense itching Time Course: 7 days
I received my first dose in April 2021, 2nd dose in May 2021. I received a third shot in May 2021 because the pharmacy incorrectly diluted the vaccine with sterile water and not saline. Since May, I have been experiencing changes in my menstrual cycles. They have increased in duration. My symptoms such as cramping and heavy bleeding are prolonged. My cycles were 28 days. They are now ranging 35-38.
Vomiting; Fever; Chills; Can't stand and weak; No appetite; Headache; Body aches; Chest hurting; Hard to breath; A spontaneous report  was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vomiting, pyrexia, chills, asthenia, decreased appetite, headache, pain , chest pain and dyspnea.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the events, vomiting. fever, chills, can't stand and weak, no appetite, headache, body aches, chest hurting, hard to breath.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, vomiting, fever,chills,can't stand and weak, no appetite, headache, body aches,chest hurting,hard to breath was unknown.
Headache, Palpitations, HYPERtension, Tachycardia, Left hand finger tingling Narrative: employee is believed to have received 2 doses of the Moderna vaccine at the same visit. It was supposed to be her dose #2 but an error was made during administration.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY HYPOTENSION
Patient complained of itchiness around the injection site. Observation nurse pulled aside patient and conducted vitals and performed is back, assessment of patients skin. Assessment found some redness around the patients upper arm and on his back.  Patient recieved 25mg IM of benedryl will good effects. Patient was monitored for 45 minutes, rash did not spread and benedryl relieved itchiing.
Severe digestive issues; Nausea; Vomiting; Diarrhea; Upper back pain; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's son explained he has gotten a call from his mother who was 77 years old and received her first vaccine this past Thursday at a Hospital. She was now experiencing vomiting, diarrhea, and upper back pain. He wasn't sure if him and his brother should take her to the emergency room because of her age and her condition. He was not sure if this was a reaction to the vaccine since the vaccine was given so many days ago. He explained he and his mother had the vaccine basically at the same time and he has had no reactions. However, his mother was experiencing digestive issues and lots of diarrhea, vomiting, and nausea. He was trying to determine the best course of action and determine if she should go to the emergency room based on her age and condition. The outcome of the events was unknown.
21OCT felt bad that not p/shot but does not name anything specific;22OCt had fever, chills & stayed in bed all day;small sl raised red area @ inj site;area < size of dime;hurting in both shoulders & arms;23OCt dizziness & faint;
swelling rt arm mid upper arm to mid forearm;given 3 days of IV ATB as outpatient;
3/14, 1 AM--awoke with fever, could not sleep for more than an hour or more at a time. Got up at 7 AM and took a Tylenol and drank water. Extreme weakness for the rest of the day with chills, some body aches, a little nausea. 3/15, 7 AM--woke up after 9+ hours of sleep and felt great. Drank water, took the dog for a walk (about an hour). Returned to my house and was talking to a neighbor when I was overwhelmed with lightheadedness and nausea, told her I needed to sit down and suddenly passed out. Came to in about a minute, had a cut in my head from hitting the concrete and could not stand without feeling dizzy. An ambulance was called and I was transported to the local hospital. Was given fluids and anti-nausea medication in the ambulance.
heartburn; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER8731) via an unspecified route of administration in the left arm on 13Apr2021 at 18:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, temporomandibular joint syndrome, sulfonamide allergy, allergy nos(allergy to   various topical chemical) and heartburn. Concomitant medications included levocetirizine dihydrochloride (XYZALL), rosuvastatin calcium (CRESTOR), melatonin (MANUFACTURER UNKNOWN), doxepin hydrochloride (SILENOR), desogestrel, ethinylestradiol (VIORELE), d and vitamin b complex; all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EN6208) via an unspecified route of administration in the right arm on 22Mar2021 at 18:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 03:00, the patient experienced heartburn starting 9-10 hours post injection. She had heartburn before, so this could be unrelated to the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures taken for the reported events were unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heartburn was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/administer expired vaccine to patients, after the manufacture date of expiration) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses.  The vial did not undergo any temperature excursions.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains, additional reporter was added.
Visual disturbance, nausea, cold chills, dizzy. He took Benadryl and Tylenol later that evening.
Rash occurred on the stomach, chest and left forearm the morning after receiving the vaccine. It appeared red, inflammed, and itches. Later that afternoon, it appeared to begin clearing up and has not spread any further.
Whooping cough vaccine given 9/15/15 and about 1 week later customer had reaction left arm with hard lump.
48 hours following 2nd Pfizer Vaccination, experienced a pungent burning smell that overrode being able to smell anything else.  Symptoms lasted about 15 hours and then returned to normal.  Other than this, no side effects noted for either dose.
I started with sore throat,feeling like it was swelling and no difficulty breathing around 5pm. At 7 pm started exp chills, fever 101.9, the highest it got over next 2 days 100.5. The pain in my legs cause me to not be able to walk and severe headache. Due to the pain in my legs exp bruises in both legs of calf muscles. I felt as if I had Covid therefore I went to the doctor 4 days.
PT was in waiting area for his 15 min wait. about 10 minutes after receiving vaccine, pt complained of chest pain. Pt had a pacemaker and had a cardiology appointment previously where provider instructed pt to receive covid vaccine. EMS assist was initiated and ER staff responded within 3 minutes of notification. Pt has been admitted to inpatient unit for observation
Menstrual changes - late and very heavy period. About 1 tampon and hour.
arm pain started maybe a couple of days after the first dose; shoulder pain in the arm of injection which is his left arm for both doses/ shoulder still hurts; 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 81 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 09Feb2021 09:45 (Lot number: EL3247) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Myeloma" (ongoing), notes: He has Myeloma, blood cancer. He was diagnosed with both of those 10 years ago; "Melanoma" (ongoing), notes: He has Melanoma, skin cancer. He was diagnosed with both of those 10 years ago. There were no concomitant medications.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm pain started maybe a couple of days after the first dose"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "shoulder pain in the arm of injection which is his left arm for both doses/shoulder still hurts".  Additional information: Vaccine was not Administered at Facility. There was no History of all previous immunization with the Pfizer vaccine considered as suspect. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was no prior Vaccinations (within 4 weeks). Patient has been having shoulder pain in the arm of injection which was his left arm for both doses. He was wondering if someone could tell him why his shoulder still hurted him where he got the injections. Like was there something to do for the pain? It wasn't painful, but it hurted. The arm pain started maybe a couple of days after the first dose. He does have two types of cancer. He has Myeloma, blood cancer, and Melanoma, skin cancer. He was diagnosed with both of those 10 years ago. AE(s) did not require a visit to Emergency Room and Physician Office.  No follow-up attempts are possible. No further information is expected.
Headache BODY ACHES, FATIGUE, CHILLS, SORE THROAT Narrative:  Other Relevant History: