chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MACROCYTOSIS; WEARING OFF EFFECT; COVID-19; GENERAL BODY PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate posterior and panuveitis, and moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced macrocytosis, wearing off effect, covid-19, and general body pain. Laboratory data (dates unspecified) included: Lab test Red blood cells enlarged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from covid-19, was recovering from wearing off effect, and general body pain, and had not recovered from macrocytosis. This report was non-serious.
Had smell in nose of "Rotten eggs" for about 4 hours then started hoarse, raspy voice which has gone on now for three days. No throat pain reported.
Day2: Sudden depression, severe tiredness, body aches. Day3: Ear pain, throat pain.  All the symptoms are gone except for ear pain it's still there, pain increases at night, feels like ear pressure or blockage in the right ear. I did not yet see a doctor.
Myalgia, ErythemaMultiform, pain reness swelliing itching at vaccination site Narrative:   Other Relevant History:
EPILEPSY, GENERALIZED IDIOPATHIC 12/21/2022 GOUT OF LEFT FOOT ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/21/2022 GOUT OF LEFT FOOT EPILEPSY, GENERALIZED IDIOPATHIC 12/21/2022 AORTIC VALVE REGURGITATION ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/21/2022 AORTIC VALVE REGURGITATION
Initial unsolicited report received from pharmacist on 08-Nov-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date (reported as last year). The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient's arm was swollen and red. Lab data and corrective treatment were not reported. On an unspecified date, the patient recovered from events. List of documents held by sender: none.
suspected vaccination failure; got shingles a while ago and am still numb in my left eye; numb in my left eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and eye numbness. On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown and the outcome of the eye numbness was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and eye numbness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingles vaccination and still got shingles a while ago and was still numb in the left eye. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Fever (99.80), Nausea, Headache, Low back pain, Intestinal cramping x 36 hours; left arm pain around site of injection x 5 days.
Raised, swollen bump under skin at injection site, painful and tender to touch and movement. Approx quarter size. Still present as of 12/29/2015.
24 hours after Varivax administration, patient noticed tenderness, erythema, warmth and swelling at injection site. Sx slightly worse at 48 hours after injection. Recommended Motrin TID and Xyzal 5mg QD.
Experienced, numbness and tingling in left arm that progressed into general pain in Joints. After 2 weeks pain occurred in left chest area and was diagnosed on 4/27/2021 as Pluerisy. Treatment with Methylprednisolone and rest.
constant sneezing; nose stuffy; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (constant sneezing) and NASAL CONGESTION (nose stuffy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified (Heart issues), Lung disease (Lung issues), Diabetes, Blood pressure high and Nervous system disorder NOS (Nervous system problems).    On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced SNEEZING (constant sneezing) and NASAL CONGESTION (nose stuffy). At the time of the report, SNEEZING (constant sneezing) and NASAL CONGESTION (nose stuffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Pharmacist reported receiving a shipment of Flublok Quadrivalent that was deemed unsuitable due to a delay in the shipment. However, by the time he was informed by the company, he had already administered a dose to a patient/no adverse event; Pharmacist reported receiving a shipment of Flublok Quadrivalent that was deemed unsuitable due to a delay in the shipment. However, by the time he was informed by the company, he had already administered a dose to a patient/no adverse event; Initial information received on 17-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist via call.  This case involved a patient with unknown demographic who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number and expiry date unknown) via unknown route in unknown administration site (Product storage error and Product distribution issue) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, past vaccination(s),concomitant medication(s) and family history were not provided.  It was an actual medication error case due to Improper storage of product in use and Product shipment delay (latency: unknown).  At the time of reporting, 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.  There will be no information available on the batch number for this case.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for Covid-19 immunisation; Covid-19 vaccine (COVID-19 VACCINE), on 25Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation; Covid-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Interchange of vaccine" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; DIVIGEL; PROMETRIUM [PROGESTERONE]; LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", Suspected COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (Apr2022) and all described as "tested negative 7 days after I initiated Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Negative. Therapeutic measures were taken as a result of Covid-19. Clinical Information: The patient was taking other medications within 2 weeks of starting COVID-19 treatment. She received COVID-19 vaccine. She received treatment with Paxlovid for COVID from 11-Apr-2022 to 15-Apr-2022. She tested negative for COVID-19, 7 days after she initiated Paxlovid. She completed all five days and was adherent to the package insert instructions. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2 days after immunization started to have itching all over her legs, chest, arms and back.  No visible rash no other signs/symptoms.
Pt had Adacel and Menactra vaccines on 1-30-06. Father called 1-31-06 to report chills, headache, stiff neck, no fever. Lt arm sore and swollen but not red. Spoke with father 2-1-06. Feeling a little better but now pain into middle of back and still stiff neck and slight headache. Able to touch chin to chest but painful to do it.
Initial hospitalization was on 1/5 at different hospital. Came in with pneumonia and altered mental status diagnosed with COVID at that visit.  1/12 visit patient had seizure, lethargic confusion, generalized fatigue not acting like himself.
At check out pt c/o sore throat and feeling closing/tightness to throat. Provider called to eval pt. BP 136/89, P-82, SPo2 98%. @13:53 Solumedrol 125 mg single dose given IM to L buttock. Epi pen 0.3mg to L thigh, Benadryl 50mg/ml IM given to R deltoid- all orders from NP received. EMS called,
Pt. states that after receiving the 3rd dose of Moderna 12/03/2021, started experiencing symptoms 12/04/2021 of Neuropathy (Feet), fever (100.7), and extreme fatigue. Symptoms lasting 48hrs, no noted Primary visit/communications.
This case was reported by a physician via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX (batch number 5737X, expiry date 23rd January 2021) for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 21 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was reported as follows: The patient received the vaccine in the left deltoid. The patient experienced shingles rash on the right side of her face after vaccination with SHINGRIX. Since 15th September 2018, the rash had worsened. As of the reporting date, the doctor had started the patient on VALTREX. No further details were provided.
Covid Arm  developed 10 days after shot ?swelling , redness where the shit was given ? mild headache - tired
Not showing immunity; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4ZH95, expiry date 30th October 2020) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 4CH95, expiry date 30th October 2020) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 4TG43, expiry date 18th September 2020) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th January 2019, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 29th November 2018, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 19th September 2018, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023AMR032485   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The registered nurse (RN) reported that patient received the 3 doses of Pediarix vaccine and did not show any immunity. The patient also received 1 dose of Infanrix and 2 doses of Havrix. The nurse consented to follow up Additional supportive information: The patient received 3 doses of Pediarix and showed no immunity, which led to therapy non-responder. This case is linked with US2023AMR032485, reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR032485:same reporter
Day 1: injection site soreness, headache, fever, chills, body aches, air hunger, O2sat = 91. Day 2: extreme fatigue, headache, fever, chills, body aches, unable to eat (food revulsion), unable to concentrate, word loss, blurry vision, eye pain, moderate air hunger, O2 sat = 94.  Day 3: fever, headache, eye pain, swollen lymph glands left side, dizzy, chills, body aches, loss of appetite, fatigue, mild sob, O2 sat = 97. Day 4: fatigue, body aches, eye pain, left side lymph gland swelling., O2 sat 97.
left foot swollen; Slight numbness in left shin area; right foot swollen and puffy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 17:15 (Batch/Lot number: unknown) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 25Mar2021, outcome "recovered" (2021), described as "left foot swollen"; HYPOAESTHESIA (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Slight numbness in left shin area"; PERIPHERAL SWELLING (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "right foot swollen and puffy". The action taken for bnt162b2 was unknown.  Additional information: Patient reported out of everyone she had talked to, some people didn't had any symptoms and some had more flu like symptoms. Her symptoms were different. Her left foot swollen was started after the first dose, the next day, about 24 hours later. It was not swollen anymore. It might had lasted around 4 days. She reported above the area, in the shin, noticed a little bit of a slight numbness feeling. It was the next day after the foot was swollen. It lasted about the same time, 4 or 5 days. Her right foot swollen and puffy was not really in any pain, just swollen and puffy. It was started the day after the left foot and went down 2 days later. No visit to emergency room or physician office was required. Patient called her physician after the first dose when the foot was swollen. They hadn't heard anything and didn't give any suggestions. Her sister is a nurse and said that it may be lymph nodes and drainage. That might be why her foot had swollen up. No prior vaccinations (within 4 weeks). No family medical history relevant to adverse events reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortly after my initial 1st dose I ended up with a serious infection and abscess in my right arm need almost 2 weeks of iv antibiotic therapy as well as surgical intervention. Never in my life have I had issues with medication however this even I did not respond to any oral antibiotics causing my infection to worsen. My doctor said this may be a result of the vaccination.
Sx. Started with extreme fatigue. At around 16:00. Near 18:00 I had developed a fever, concurrent with aches and chills. Near 22:00 I had developed a headache, one of a dull nature, with Sharp throbs. Between 22:00 and 00:00 01/11/:12 I had developed tinnitus. Near 01:00 01/12/2021 I had developed swelling of the injection sight with contralateral numbness on the left arm and leg. Near 02:00 01/12I had loss sensation In my left arm and developed numbness in the face. From 20:00 01/11 to 22:00 01/12 I had developed episodes of tachycardia with a peak resting heart rate of 143bpm measured via Watch. Between 15:00 01/12 and 22:00 01/12 I had experienced terrible non radiating angina proximal to the sternum. I had developed pain while urinating at around 21:00 01/11 my last urination was at 23:00 01/12, I did not go again until 16:00 01/13. I had experienced lower back concurrent with that. From 22:00 01/11 to 23:00 01/12 I had terrible SOB, and chest pain upon exhalation. Fever and body aches did not subside until through the night of 01/12:13. I had not experienced any symptoms as the night of 01/12. I had developed a rash across my chest near 18:00 01/11 though it has subsided it is still present.
his arm hurt 2 days after having been vaccinated; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in arm in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 2 days after receiving Arexvy, the patient experienced pain in arm (Verbatim: his arm hurt 2 days after having been vaccinated). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK receipt date 31 Oct 2023: The patient stated that his arm hurt 2 days after having been vaccinated. The reporter did not consented to follow up.
big fat lip; light bloody nose; bad dizziness; muscle ache; fatigue; pain and sore over the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle ache), FATIGUE (fatigue), LIP SWELLING (big fat lip), EPISTAXIS (light bloody nose) and DIZZINESS (bad dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021 at 5:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE PAIN (pain and sore over the injection site). On 06-Jan-2021, the patient experienced MYALGIA (muscle ache) and FATIGUE (fatigue). On 07-Jan-2021, the patient experienced LIP SWELLING (big fat lip), EPISTAXIS (light bloody nose) and DIZZINESS (bad dizziness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Jan-2021 for Lip swelling, at an unspecified dose and frequency. On 07-Jan-2021, MYALGIA (muscle ache) had resolved. On 08-Jan-2021, EPISTAXIS (light bloody nose) and DIZZINESS (bad dizziness) had resolved. At the time of the report, FATIGUE (fatigue), LIP SWELLING (big fat lip) and INJECTION SITE PAIN (pain and sore over the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medication was provided.
Onset of symptoms occurred approximately 2 hours after receiving vaccine and last for approximately 48 hours. Symptoms included: muscle aches, fever, chills, headache, and rapid resting heart rate.
My daughter fainted 15 minutes after the vaccination as we were checking out at the doctors office.  We had difficulty getting her to become conscious, it took over 30 minutes before I could even get her to the car and then the nurse used a wheelchair.  My daughter slept for hours after that incident and felt foggy.  She did not act the same for months after and began having panic attacks within 48 hrs of the vaccine, which we had never experienced before.  She would experience shortness of breath, severe crying, nausea, headaches, and said she just felt foggy for months.  We began therapy after as she could not walk into or talk about going to a doctors office without having a panic attack.  She still, over a year later, experiences anxiety and panic attacks.
This spontaneous report as received from a physician via company representative refers to a 64 year old female patient. Patients medical history, drug reactions and allergies were unspecified. On 18-DEC-2006, the patient was vaccinated with ZOSTAVAX Subcutaneous Injection, (dose, frequency, route of administration, lot number and expiry date were unspecified) for vaccination. Concomitant medications were unspecified. On 13-JAN-2014, the patient was evaluated in the reporters office and was diagnosed with shingles. The patient was referred to an unspecified ophthalmologist and was prescribed steroid (unspecified) eye drops. No intervention required to prevent any serious criteria. There was no disability or incapacity to the patient due to the event. No hospitalization required to treat the event. The event was not life threatening. No product quality complaint was involved. The outcome of the event was unknown. The reporters causality for the event with the therapy with ZOSTAVAX was not reported. Additional information has been requested.
5 hours after receiving the vaccine ( 3pm) I began to have some mild abdominal pain.   At 7 pm the abdominal pain had intensified to where it was painful to ambulate.  At that time I went to bed.  The pain continued to intensify and within another hour I was in a fetal position and could barely move.  My whole abdomen was painful.  If I moved at all it radiated throughout my entire torso.  I would rate this pain a 9 -10 out of 10!  I did not have an upset stomach, this pain was nerve pain and excruciating.  Around midnight I considered having my husband take me to the ER but realized I couldn't move enough to even get out of bed.  Around 2:30 am the pain subsided and by 3 am it was basically gone.  Twelve hours after onset. Later that morning I noted that my entire upper arm where I had received the vaccine was red and I was unable to even touch it as it was so painful.  The abdominal pain was basically gone with just some residual pain here and there.  By 3 days after the vaccine my arm was back to normal and I no longer had any residual abdominal pain.