chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist, via a company representative, and refers to a 64 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were unknown by the reporter. Approximately in 2003, the patient was vaccinated with PNEUMOVAX 23 (dose, route, frequency, lot number and expiration date were not reported) for prophylaxis. On an unknown date, after vaccination, the patient was diagnosed with breast cancer. It was unknown by the reporter whether the patient received treatment, sought medical attention or if any laboratory tests were carried out. The outcome of breast cancer was reported as recovered on an unknown date. The reporter did not provide a causality assessment between the event and PNEUMOVAX 23. Upon internal review, breast cancer was considered to be a medically significant event.
Chills, high fever, full body ache. Flu like symptoms. Rash on left arm remains today
INJECTION SITE PAIN; Radiating pain; pain in arm / Feet pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, radiating pain and pain in arm. On an unknown date, the outcome of the injection site pain, radiating pain and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain, radiating pain and pain in arm to be related to Shingrix.  Additioanl details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The pharmacist reported that, there were number of patients(over 10) experienced injection site pain after vaccination with dose of Shingrix. The reporter stated that, some of the patients reported that, the pain radiates over the arm and feet. No additional information provided. The reporter consented to follow up.
At 11:45, MCV and Hep A vaccine were administered to pt. At 11:50, pt had severe headache, dizziness, nausea, sweating, and skin edema in bilateral hands. Blood pressure was 78/39 P 60 O2 97% or RA. Pt placed supine. EMS called and arrived to treat pt. Pt was discharged to ER with mom and EMS at 12:15. At discharge, BP 107/62, symptoms improving.
pfizer vaccine was in fridge beyond 30 days at time of administration. pharmacist did not know of this until after administration. discussed with pt. pt stated no adverse reactions to vaccination
The pt states she experienced hives on the legs, arms, face with shortness of breath approximately 4 hours post vax. The pt was treated with Benadryl in the ER.
A 41-year-old female patient, with not concurrent illnesses pre-existing medical conditions, or use of other medications, had received an intramuscular left deltoid injection of MENACTRA (Lot # U2342AA); a subcutaneous left arm injection of YF VAX (lot # UF301AA); and an oral dose of "TYPHOID" vaccine (manufacturer Burna, Lot # 16930A). Seven days post-vaccination, the patient called the physicians office to report that she had experienced a headache and vertigo that lasted just one day, and that she currently had a low grade temperature of 100.0 degrees Fahrenheit (patient's temperature normally runs between 97.4 to 97.8 degrees Fahrenheit), and felt like she had a hangover, and her head felt "weird." The patient did not report the exact start dates of the symptoms. At the time of this report, the symptoms were still ongoing with little improvement.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. It was reported that the patient had a severe allergic reaction to ADACEL. The reporter did not know if the patient was ever vaccinated with M-M-R II for prophylaxis. On an unknown date, the patient just after the patient gave birth, she had a low titer for rubella.
Raised hives one inch down from injection site to elbow.  The hives were an irregular shape about the size of a dime. They reminded me of a topographical map of South America.  Soreness in arm that lasted approx 24 hours.  Pain and soreness radiated from injection site to wrist.  Arm warm to touch.  Our dentist offered a homeopathic remedy that made symptoms lessen on 8/10/11 at 4p.  I think the remedy was hypericum.
As per narrative patient took 2 Bivalent booster doses; A single additional age appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine;; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (As per narrative patient took 2 Bivalent booster doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A single additional age appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine;) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 059F22A and AS7145B) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis.   On 12-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Dec-2022, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (As per narrative patient took 2 Bivalent booster doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A single additional age appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine;). At the time of the report, EXTRA DOSE ADMINISTERED (As per narrative patient took 2 Bivalent booster doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A single additional age appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine;) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   This case was created for female patient involved in this report.  Concomitant medication was not provided. Treatment information was not reported.   This case was linked to MOD-2023-730066 (Patient Link).
Since the 1st vaccine, I have experienced intermittent tingling of my fingers; This is a spontaneous report received from a contactable nurse (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), intramuscular in left arm on 03Jan2021 (at the age of 56-year-old) as 1st dose, single for COVID-19 immunisation. The patient was not pregnant. Facility vaccine type was reported as hospital. The patient's medical history included hypothyroidism, psoriasis, hyperlipidaemia (HLD), all from unspecified date. No COVID prior vaccination was reported. The patient's concomitant medications included levothyroxine sodium (SYNTHROID), from unspecified date. No other vaccines were received within 4 weeks from vaccination. The patient previously took propylthiouracil (PTU) and tapazole, both reported as known allergies. It was reported that since first vaccine, she had experienced intermittent tingling of her fingers on 10Jan2021. No treatment was received for the event. It was also reported that patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), administered in right arm on 24Jan2021. The patient had not been tested for COVID post vaccination. The outcome of the event was not resolved.  Follow-up (12MAY2021): Follow-up attempts are completed. No further information is expected.
7pm-Dizziness, weakness, tiredness, chills. 1/26-530am - Chills, body aches, slight fever -101.0, headaches, dizziness,
Pt admitted to hospital 9/10/21 with COVID+ pna. Pt had received 2 doses of Pfizer (1/29/21 & 2/19/21). Pt is immunocompromised on chronic prednisone.   Hospitalized 9/10-9/14, then re-admitted 9/20 & passed 9/21
Child healthy. Family denied any known allergies. Pre-kindergarten physical and MMRII, DTAP, Varivax, and IPV given. Approx. 10 minutes, post vax, child became red, eyes and lips swollen, wheezing and coughing. PO Benadryl was given. BP-108/66, R-16. 911 called and EMTS took child to ER, awake, alert and able to speak.
Information has been received from a physician referring to patients of unknown age and gender. Concurrent or historical condition was not provided. On an unknown date the unspecified number of unspecified patients were administered improperly stored doses of M-M-R II (rHA, lot # L009213 with expired dose of 17-MAR-2017, strength, dose, frequency and route unknown). Concomitant therapy was not provided. The temperature excursion included 73F for 1 hour 29 minutes and other temperature time frame was also reported as 33.4F for 41 minutes, 34.1F for 2 hours 3 minutes and 34.3 for 1 hour 29 minutes. Data logger was involved. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient described reddness at injection site about 3 inches across. No pain, tingling, or swelling.
improperly stored one dose of VARIVAX was administered; This spontaneous report was received from a medical assistant referring to a 12 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 29-APR-2020, the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S028918 with expiration date on 16-SEP-2021, by subcutaneous route for varicella immunisation (strength, dose, anatomical location, and route of administration were not reported), which was reconstitued with properly stored sterile diluent (MERCK STERILE DILUENT).    The administered dose of tvaricella virus vaccine live (oka/merck)(VARIVAX) experienced a temperature excursion of 12.2°F (degrees Fahrenheit) for 26 minutes, as recorded by a data logger. No previous temperature excursion was reported. Furthermore, no product quality complaint was involved.
Arm/shoulder/neck pain noted about 1 week following flu vaccine. Persistent pain with decreased range of motion and weakness despite use of heat, nsaids, and Physical therapy.
Patient received pfizer bivalent in a dose of 0.5ml instead of 0.3ml.  As of 9/19/22, patient has had no adverse effect.
Within 15 minutes of INJ, numbness, tingling, and changes in color to my left hand were noted. My palm;  pointer, index, and ring finger turned white followed by purple. This resolved within 5 minutes. However, preceded to happen for two additional days all lasting less than five minutes from occurrence till resolution.
Flublok Quadrivalent was administered to a 16 year old, NO AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Office Staff).  This case is linked to case 2019SA269553 (same reporter).  This case involves a 16 years old female patient who was vaccinated with Flublok quadrivalent (INFLUENZA QUADRIVALENT RECOMBINANT VACCINE) [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1913, Exp 6/29/2020 via intramuscular route in the right deltoid.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of the report, no adverse event was 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 the sender: none
On day 8 after my vaccination, a large raised red rash appeared at the site of my injection.  It is itchy and swollen.
Varicella vaccine had an expiration date of 4/16/23 and administered on 4/26/23. Per patient no adverse reaction was reported.
16 hours after injection, I was stung by a bumble bee.  24 - 48 hours after receiving injection I developed a red "sunburn" like reaction around waist and on stomach.  8 days after injection I developed red sores on chest and back.  Sent picture to Dr.   She confirmed it is a reaction, but not shingles and prescribed prednisone.
This spontaneous case was reported by a physician and describes the occurrence of PSYCHOTIC DISORDER (patient had new onset of psychosis within a month of receiving the 2nd dose), FEELING ABNORMAL (patient felt like someone was breaking into her home) and IMPAIRED WORK ABILITY (she quit her job at the grocery store) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high, Diabetes and Thyroid disorder NOS. Concomitant products included LOSARTAN POTASSIUM (COZAAR) and HYDROCHLOROTHIAZIDE for Blood pressure management, METFORMIN for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PSYCHOTIC DISORDER (patient had new onset of psychosis within a month of receiving the 2nd dose), FEELING ABNORMAL (patient felt like someone was breaking into her home) and IMPAIRED WORK ABILITY (she quit her job at the grocery store). The patient was treated with QUETIAPINE FUMARATE (SEROQUEL) at a dose of 1 dosage form and RISPERIDONE (RISPERDAL) at a dose of 1 dosage form. At the time of the report, PSYCHOTIC DISORDER (patient had new onset of psychosis within a month of receiving the 2nd dose), FEELING ABNORMAL (patient felt like someone was breaking into her home) and IMPAIRED WORK ABILITY (she quit her job at the grocery store) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, Anti-NMDA antibody: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 23-AUG-2021 she was taken to Emergency room by her family. She was not suicidal and did not have a family history of any psychosis related issues or trauma. She had never been on any anti psychotics before this.
Vasculitis. Started with pain in legs, progressed to swelling in legs and hands, and pinpoint bleeding in legs. No blood clots; diagnosis is vasculitis.
Fever 101-102 degrees intermittently for 48 hours after vaccination. Diffuse myalgia, headache, stiff neck. Resolved spontaneously.
Reoccurance of sinus swelling; Headache; Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS INFLAMMATION (Reoccurance of sinus swelling), HEADACHE (Headache) and PYREXIA (Mild fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient had no known allergy.    On 31-Mar-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 27-May-2022, the patient experienced PARANASAL SINUS INFLAMMATION (Reoccurance of sinus swelling), HEADACHE (Headache) and PYREXIA (Mild fever). At the time of the report, PARANASAL SINUS INFLAMMATION (Reoccurance of sinus swelling), HEADACHE (Headache) and PYREXIA (Mild fever) was resolving.            No concomitant medication were reported. Device Date : 31May2022
pt recv vax 3FEB97 & w/in 1wk pt sx recurred chest pain, inc heart rate, diff breathing, dizziness, a shingles type severe painful to touch & itchy rash;
Patient received the high dose flu shot but he is only 63 years old. There weren't any adverse events related to him getting the incorrect vaccine.
In February on night, I went to bed and when I woke up, I could not walk. It was the burning pain from my back all the way down my left leg to my foot. My foot was numb and stayed numb for about a week. I felt it mostly numb in my outside 3 toes. It was sharp pain and burning in my back and leg and buttock. It did not improve over time. I consulted with my doctor and received a steroid and TYLENOL. My pain got a little better but did not go away completely. As of today, I am not longer feeling pain from the sciatic nerve.
Approx 8 PM 10/16/03 right arm (RD) area began itching, some redness and swelling noticed. 9 PM took Advil. Reports sleepless night due to pain. Repeated Advil 8 AM 10/17/03. 10/17/03 4:30 PM called HD to request swelling now down to 1 1/2" above elbow joint with swelling to medial site of arm as well. Hot to touch. Plans to call PMD yet today. 10/20/03 TC to pt - seems better, swelling down, used ice packs and Advil.
Optic Neuritis Rt. Has seen opthomologist Neurology. Seen at clinic. IV Steroids. The 60 day follow up states optic neuritis in my right eye. My vision has not improved in 6 months. I still have optic neuritis in my right eye "optic nerve." It doesn't look like the vision will come back. My night vision is very poor. Always blurry and cloudy. I received a letter from VAERS that mentioned possible compensation. I had almost $8, 000 in medical bills because of that flu shot. Do I qualify for that? Please let me know. Thanks
Patient initially noticed one hive and pain in left arm, which progressed to hives on arms and head. Advised patient to contact family doctor and seek medical treatment if any difficulty breathing or swelling on head or face. Patient saw company doctor on 10/13/2010 who diagnosed allergic hives and prescribed Benadryl and Claritin as needed. Doctor believes allergy to vaccine received on 10/12/2010. Patient received other vaccines at company doctor on 9/14/2010.
Vaccine stored in refrigerator on 11/04/2021 and vaccine expired 10/03/2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/04/2021 and vaccine expired 10/03/2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/04/2021 and vaccine expired 10/03/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/04/2021 and vaccine expired 10/03/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 04-NOV-2021.Vial did not undergo any temperature excursion. No adverse event was reported.  No treatment medications were reported.
Initial misuse report received from a healthcare professional on 14 January 2014. A patient had received a dose of PENTACEL which was administered dtap/ipv part without the hib. It's an underdose. This is invalid case as the individual patient identifiers missing. No adverse event was reported. List of documents held by sender: none
Pt c/o palpitations that began 20 mins s/p vaccination @12:25pm. Denies SOB/CP/ wheezing/ lip swelling/ nausea/ extremity swelling. No PMH of heart diease/lung disease. Pt state 3 years ago had full cardiac work up for unknown reason. States work up was normal. Pt states recently underwent a colposcopy on Thursday 4/1, in which local lidocaine was administered and had similar palpitations after procedure to what she is experiencing now. States was told that day that "palpations are normal" and would wear off in a couple hours. Reports palpitations resolved same day and has not had any episodes until now. Pt states "may just be my anxiety". Pt requesting water and states would prefer to stay in medical bay to see if symptoms improves before being sent to outside facility for medical care. Therefore pt given water and montered for 10 mins. At 12:35pm pt reports persistent palpitations, therefore rec EMS transport to ER for ekg and further evaluation. Pt very hesitant for ER evaluation due to fear of "contracting covid." Reviewed more serious risk of potential diff dx including but not limited to dysrhythmias/ACS/PE loss of life. Pt states will go to ER however only by private vehicle. Float RN present during AMA. Informed pt due to risk of worsening condition during transport do not recommend private vehicle. Pt still refused EMS transport despite risks listed above. Outcome of the adverse event (if paramedic please list hospital taken to): Pt refused EMS transport ro ER for evaluation, aware of risks listed above. Upon leaving facility VSS, pt in NAD. States driving directly to ER .
It was reported that an 18 month old female pt received her 1st Tripedia vaccination on 12/3/99. Reportedly, the pt develope "severe" swelling at the injection site. "Her leg was very red and hot, and she would also scream for more than 3 hours at a time. When she got her 2nd dose on 2/3/00, the same thing happened." The reporter switched physicians and the "3rd dose was administered in 2 half doses with Benadryl on 8/23/00 and 9/23/00 and no problems occurred."
I've been in bed for 2 and a half days feeling awful, like I have the flu; I've been in bed for 2 and a half days feeling awful, like I have the flu; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "I've been in bed for 2 and a half days feeling awful, like I have the flu".  Additional information: The patient had two Pfizer and two Moderna COVID-19 vaccines and it's always the same reaction no matter which one she gets.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.