chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore injection site; sore right arm; sore right arm/joint/neck/jaw/back; sore right arm/joint/neck/jaw/back; sore right arm/joint/neck/jaw/back; sore right arm/joint/neck/jaw/back; headache; upset stomach; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Nov2021 14:30 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "owrens" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "IBS" (unspecified if ongoing), notes: Irritable bowel syndrome; "Hypoglycemia" (unspecified if ongoing); "migraines" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 22Apr2021, when the patient was 40 years old, for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 30Mar2021, when the patient was 40 years old, for Covid-19 Immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Dec2021 06:00, outcome "not recovered", described as "Sore injection site"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021 06:00, outcome "not recovered", described as "sore right arm"; ARTHRALGIA (non-serious), NECK PAIN (non-serious), PAIN IN JAW (non-serious), BACK PAIN (non-serious) all with onset 01Dec2021 06:00, outcome "not recovered" and all described as "sore right arm/joint/neck/jaw/back"; HEADACHE (non-serious) with onset 01Dec2021 06:00, outcome "not recovered", described as "headache"; ABDOMINAL DISCOMFORT (non-serious) with onset 01Dec2021 06:00, outcome "not recovered", described as "upset stomach". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, arthralgia, neck pain, pain in jaw, back pain, headache, abdominal discomfort.  Additional information: The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient received several other medications within 2 weeks of vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Monovalent Pfizer 12+ was given instead of Bivalent pfizer vaccine 12+ (correct age group but was supposed to be bivalent booster )
Within one hour developed golf ball size lump on side of face that continued to grow slowly. After second dose the next day lump grew to the size of a baseball and extended from mid-cheek to below jaw and ear. Work up is concerning for a vac stimulated, rapidly progressive malignancy
Patient experienced a pierced vein or capillary; Had a large bruise/bruise is still visible on 2DEC2021; Lot of soreness; This spontaneous case was reported by a consumer and describes the occurrence of VEIN RUPTURE (Patient experienced a pierced vein or capillary), CONTUSION (Had a large bruise/bruise is still visible on 2DEC2021) and PAIN IN EXTREMITY (Lot of soreness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 041L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Cancer.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced VEIN RUPTURE (Patient experienced a pierced vein or capillary), CONTUSION (Had a large bruise/bruise is still visible on 2DEC2021) and PAIN IN EXTREMITY (Lot of soreness). At the time of the report, VEIN RUPTURE (Patient experienced a pierced vein or capillary) and PAIN IN EXTREMITY (Lot of soreness) outcome was unknown and CONTUSION (Had a large bruise/bruise is still visible on 2DEC2021) had not resolved.            No Concomitant medications were reported. No Treatment details were reported. Patient received the vaccine in his left arm shoulder deltoid muscle. The patient feels that the events was caused by administration technique. The patient stated that the he received the received the correct dosage of a 3rd dose for immunocompromised patients.   This case was linked to MOD-2021-404030, MOD-2021-403976 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Follow up received. Event related information was updated that the patient received correct dosage.
I started with pain at the injection site (on the day of the vaccine) and that wasn't resolving. I was having a lot of pain bringing laptop into its bag, on July 13th is when I noticed that my whole arm was hurting. I saw Doctor and was in excruciating pain with it. I saw her on September 9th. Before that, I had spoken with a HCF NP around 19th of August, and she prescribed Meloxicam and gave me the referral to doctor. The doctor diagnosed me with a frozen shoulder. She prescribed more meloxicam at that time. My pain was so bad I couldn't get dressed; I couldn't sleep. It was getting progressively worse. Initially the Meloxicam helped a little bit but after a while it became less effective to help with the pain. I had run out of Meloxicam the week before I saw the doctor. September 10th, I got an appointment for Physical Therapy and started those 3 days a week (started 13th of September) until just recently (November 1st) I'm down to 2 days a week. I'm still going 2 times a week. That is helping me. Note: The day after my vaccine I got sick with achiness and fever. I couldn't function, was exhausted. About a day and 1/2, I was pretty sick. But then it got better.
Information was received from a nurse via a company representative. No medical history or concomitant medications were reported. The nurse reported that an expired dose of GARDASIL (lot number: 0420AE, expires 01-DEC-2014) was inadvertently administered to a female patient (age not reported) on 02-DEC-2014 (dose and location not specified). No adverse effects reported. No other information was provided. Additional information is not expected.
Didn't have a good night; Vision was not good; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision was not good) and INSOMNIA (Didn't have a good night) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     Concurrent medical conditions included Back disorder NOS (Back problems). Concomitant products included METFORMIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and LEAD for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VISUAL IMPAIRMENT (Vision was not good). On an unknown date, the patient experienced INSOMNIA (Didn't have a good night). The patient was treated with NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Vision abnormal, at an unspecified dose and frequency. At the time of the report, VISUAL IMPAIRMENT (Vision was not good) had not resolved and INSOMNIA (Didn't have a good night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Eye drops.
Sneezing and itching; Sneezing and itching; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 08:00 (Lot Number: El9265, at the age of 67-years-old) as single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus, ongoing hypertension, non connective tissue disease from an unknown date and unknown if ongoing, allergies from an unknown date and unknown if ongoing. The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination, and did not tested positive post vaccination. The patient experienced sneezing and itching on 29Jan2021 14:00. It was unknown if treatment was received for adverse events. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a mother concerning her 19 year old daughter (patient). The patients concurrent condition included TYLENOL III allergy and had no pertinent medical history. The patients concomitant medication included oral birth control tablets (manufacturer not specified). On an unknown date the patient was vaccinated with GARDASIL. On 30-DEC-2013 the patient was mistakenly administered the 4th dose of GARDASIL instead of hepatitis A injection during her physician visit by the physicians nurse. The patient received her first dose of GARDASIL sometime during her Senior year of high school and had completed the dosing schedule (dates not specified). On 31-DEC-2013 the patient returned to the physician's office the next morning and received the HEPATITIS A vaccine. The consumer called the physician and hence was considered as sought medical attention. On 13-JAN-2014 the patient experienced flu like symptoms (high fever, hot and cold sweats, body aches) after receiving the 4th dose. The patient was administered with TAMIFLU as treatment. The outcome of flu like symptoms was recovering. Additional information has been requested.
Large local reaction with pustules, erythema, and swelling or entire anterior thigh. Treated with diphenlydramine
Severe vertigo- not able to walk or stand due to ongoing spinning. Injection date 4/9- first dose- regular symptoms of sore arm and fatigue for first 48 hours. Vertigo began 4/12 and is ongoing.; Injection date 4/9- first dose- regular symptoms of sore arm and fatigue for first 48 hours; Injection date 4/9- first dose- regular symptoms of sore arm and fatigue for first 48 hours; This is a spontaneous report from a non-contactable other healthcare professional. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the right arm on 09Apr2021 at 00:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy (reported as Shrimp allergy). Concomitant medications taken within two weeks of vaccination included collagen (MANUFACTURER UNKNOWN) (reported as collagen peptides) from unknown date for unknown indication. Prior to the 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 any other vaccines within four weeks prior to the vaccination. On 09Apr2021, on the  injection date of first dose, patient experienced regular symptoms of sore arm and fatigue for first 48 hours. The patient experienced severe vertigo- not able to walk or stand due to ongoing spinning. Vertigo began on 12Apr2021, and was ongoing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of vertigo and included treatment with over the counter (OTC) meclizine. The clinical outcome of the event regular symptoms of sore arm and fatigue for first 48 hours was resolved on 11Apr2021. The clinical outcome of the event severe vertigo- not able to walk or stand due to ongoing spinning was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
transferred to this hospital with COVID pneumonia and renal failure after being hospitalized elsewhere for 2 wks; hx of follicular lymphoma and on immunosuppressive therapy; pt has been sedated during the 2 wk hospital stay; pt on mechanical ventilation; complicated hospitalization related to shock and AKI; transferred to ICU; overall prognosis bleak at best; pt went into cardiac arrest; ACLS protocols followed but pt passed away in the ICU
This was patients first dose of pfizer had been given on 11/2/21 without adverse rxn today she received pfizer and within minutes she began to pass out. We got her sitting, put cold clothes on her neck, and got her a lemonade to drink. We took her blood pressure 3 times and all three readings were low. Patient after an hour and half was able to walk around the store and came back to be observed and for a final reading. At that time her blood pressure was still lower then normal but much higher then the first reading. Patient refused EMS services and stated she was feeling ok and stated she would go if anything changed. Her mother was with her the whole time and would be driving her home.
had a fever of 101; This non-serious case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylaxis and INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   On an unknown date, the patient received Arexvy, PREVNAR and FLU VACCINE (NAME UNKNOWN). On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: had a fever of 101).  The outcome of the fever was resolved (duration 2 days).   It was unknown if the reporter considered the fever to be related to Arexvy.     It was unknown if the company considered the fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-SEP-2023 The patient was given Arexvy, flu and Prevnar at the same time and had a fever of 101 for 2 days following vaccination. Information regarding formulation, dose, frequency, lot, start/stop date (duration if dates) were not known. The reporter denied the consent to follow up
TOOK THIRD DOSE ON DAY 4; A spontaneous case report was received from a consumer on 28-Jan-2019 for two consumers.  Based on the information obtained from the consumer, two individual case safety reports PVX201901-000066 (PVX2019-258; wife) and PVX201901-000067 (PVX2019-259, husband) were created and cross-linked in the database.  This case report described a female consumer who "took third dose on day 4". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003239) for typhoid fever prophylaxis.  It was reported that the consumer took two doses in a row. The doses were taken on 23-Jan-2019, 25-Jan-2019, and 26-Jan-2019, respectively.  The action taken with Vivotif with respect to the event "took third dose on day 4" was not applicable.  The clinical outcome of the event "took third dose on day 4" was unknown.  Company's Comment: The causality of the event "took third dose on day 4" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 4" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000067:
Information has been received from a medical assistant concerning a male patient who was vaccinated IM with a 0.5 ml dose of Pneumovax 23 (lot # 651374/0485F). Subsequently, the patient experienced a severe reaction after the vaccination. The patient's injection site was "red, hot, and swollen" similar to cellulitis. The patient also experienced a high fever and was "sick." Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. A lot check was requested by the reporter. No product quality complaint was involved. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of Standards of the Center for Evaluation and Research and was released. Additional information has been requested.
Vaccine exposure during pregnancy with no reported adverse event; Initial information received on 02-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 30 years old female patient who was exposed to vaccine influenza quadrival A-B vaccine [Fluzone QIV] in context of vaccine exposure during pregnancy with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Vaccine exposure during pregnancy with no reported adverse event occurred at 15 weeks of pregnancy and the patient was exposed to influenza quadrival A-B vaccine at 15 weeks of pregnancy, during second pregnancy trimester for influenza quadrival A-B vaccine.  The date of last menstrual period was reported as 14-May-2022. The estimated due date is 19-Feb-2023. The patient has Twin pregnancy. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 31-Aug-2022, the patient received a dose of suspect influenza quadrival A-B vaccine Suspension for injection (strength and dose not reported; lot uT7682KA, expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for prophylactic vaccination.  On 31-Aug-2022, (latency: same day) the patient had vaccine exposure during pregnancy with no reported adverse event (exposure during pregnancy) following the administration of influenza quadrival A-B vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event. Additionally, at time of reporting, the pregnancy is still ongoing.
Flumist given 11/2/08.  Developed HA 11/10.  Neck pain, nuchal rigidity 11/13.  Afebrile.  Head MRI negative.  HA resolved 11/14, neck pain resolved 11/16.  Abd pain 11/16, V x2.  No D.  Temperature 99.2.  No P.O., abd pain severe - ER.  P.E. sig. for afebrile, RUQ abd pain to palp, severe leg pain to palp.  CXR negative.  WBC = 19K with 90% polys.  U/A positive ketones only.  Pain resolved with NSO4 and IVF.  Today (11/17) without do.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (route, dose number, lot number and dosage were unknown) for prophylaxis.  The vaccines underwent a temperature excursion from  47°F to 77°F during two hours. There was no previous temperature excursion and it was due to a data logger issue.
11/17 9:30 pm - Increased swelling of pain to upper (R) arm; felt feverish with chills. 11/18 0900 am - took naproxen sodium - pain /other sx. improved.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA000819: US-009507513-2112USA000825: US-009507513-2112USA000821: US-009507513-2112USA000822: US-009507513-2112USA000823: US-009507513-2112USA000824: US-009507513-2112USA000818: US-009507513-2112USA000713: US-009507513-2112USA000820.
Vaccine that expired 15OCT2021 was given to some (16) patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that expired 15OCT2021 was given to some (16) patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     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 that expired 15OCT2021 was given to some (16) patients). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that expired 15OCT2021 was given to some (16) patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.
tested positive for COVID-19 after being fully vaccinated (experiencing  sx; fever, cough, sore throat, shortness of breath, fatigue, chills, headache, and runny nose).
A few days after the vaccine I developed low O2 saturation. SOB, wheezing, low HR. 8/14 I went to the Urgent Care because I had severe SOB. There I was prescribed prednisone and and Albuterol inhaler and a chest X-Ray was performed.  8/17 I say my PCP's nurse who prescribed an Advair Inhaler and an Epi Pen. I was referred to a Cardiologist and went to visit him on 8/18. A ECHO was scheduled and performed on 8/19 and a Holter monitor was worn from 8/18-8/21. My follow-up with cardiologist is scheduled 8/30 to determine if a Pacemaker is needed or what's the next steps from there. I've had 3 different COVID test all were negative.
I got the vaccine at 0930am on 01/11. At 0100 on 01/12 I had a headache that was relieved by Tylenol. At 0530am all of my upper body muscles were throbbing in pain. I went to sleep around 9am when I got home from work and all symptoms were relieved when I woke up.
I had my 1st shot on March 1 at 6:15 p.m at Pharmacy,. At 12:00 midnight I experience a significant muscle spamming mid of my back. In the morning when woke up, I felt a slit headache  on the left side of my head. Very localize. I could put my finger on the spot, which was just above my left ear. The headache intensify  thoughout the workday, on and off 8 to 10 times. The headache has continued daily  for over a month. I saw Dr to report the headache. I schedule a MRi of my head and blood test. I was referred to a Neurologist. Who give me two head injection. Which have not help. The headache continue and yest was very intense and vertigo effect.
Muscle pain soreness, fever, fatigue, redness/pain at injection site (started 6-8 hrs after injection).
shrill cry started 5PM & was loud & cont; seen by MD about 730PM-8PM; crying stopped approx 830PM; pt fell asleep; no fever; mom had used APAP;