chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a literature report for the following literature source(s):  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19 infection" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: PYODERMA GANGRENOSUM (medically significant), 14 days after the suspect product(s) administration, outcome "unknown". The location of lesions was left pretibial region. Therapeutic measures were taken as a result of pyoderma gangrenosum included infliximab injection, oral prednisone, cyclosporine, biweekly adalimumab injections. The clinical outcome was injection reaction to infliximab, unresponsive to all other treatments.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: Pt given booster first and then flu shot into other arm. While getting up she got nervous, fainted, LOC for 4 seconds, woke up confused but was okay afew a few seconds. Juice, water, ice pack given, pt ok after 5 mins
2 expired PENTACEL vaccines used,no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number-00536990) and transmitted to Sanofi on 26-Mar-2021.  This case involves a 4 month old female patient who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ146AAA, expiry date: 14-Feb-2021) via unknown route in unknown administration site for prophylactic vaccination on unknown date (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to expired vaccine used (latency same day).  Nurse states that 2 expired PENTACEL vaccines were administered. Patient received an expired Pentacel.  At the time of reporting, patient had no adverse event.  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.
Large red blotch has developed on arm where shot was given, appearing about a week after the shot, itchy and about 2.5" in diameter. Has looked this way for 4 days now.
Systemic: Fainting / Unresponsive-Mild, Additional Details: called 911.  fire and EMT/rescue checked patient.  patient declined to go to hospital.  Brother was nearby and drove her home.
Information has been received via the Merck Pregnancy registry, from a registered nurse, a 24 year old female with a drug hypersensitivity to morphine, who was unknowingly pregnant (LMP date of 24-JUN-2007) when on 24-JUL-2007 she was vaccinated with the first dose of Gardasil (lot # not provided). On 17-SEP-2007 the nurse reported that she "started to miscarry," and consequently underwent an outpatient dilation & curettage (D & C) procedure. The fetus was at 8 weeks gestation at the time of the miscarriage. At the time of this report, the patient had recovered (duration not specified). The nurse considered miscarriage to be serious as an other important medical event. Additional information has been requested.
diagnosed with covid; diagnosed with covid; This is a spontaneous report from a contactable nurse.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient was diagnosed with covid on an unspecified date after the first dose was administered. This was described as diagnosed 18 days out.  The patient underwent lab tests and procedures which included positive Covid-19 on  an unspecified date.  The outcome of diagnosed with covid was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I received my second Pfizer COVID-19 booster on 5/4/2022. On 10/14/2022, I felt like I had a very bad cold, I had fever, a headache, fatigue, and general malaise. I took a home antigen test, but I got a negative result. The symptoms continued on 10/15/2022 and 10/16/2022, and I developed a cough that was particularly pronounced in the evening. On 10/17/2022, I took another home antigen test and got a positive result. I called my doctor and informed her of the situation. She prescribed me Paxlovid and advised me to stay home from work for the week. After a few days of taking Paxlovid, my symptoms began to subside, but I still didn't feel totally well. On 10/24/2022 or 10/25/2022, I took another home antigen test, which yielded a negative result. Despite the negative result, I continued having a cough and didn't feel well. I don't remember the date, but I went to the doctor, and I was diagnosed with bronchitis. I was prescribed an albuterol nebulizer, which I was to use 3 times a day. After I began using the nebulizer, I felt better and was able to breathe better. On 11/4/2022, I went to the doctor for a follow-up. From then on, I no longer had to do the albuterol treatments. I was able to return to work on 11/7/2022.
Site of injection is swelling; Swelling of lymph nodes in both arms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Site of injection is swelling) and LYMPHADENOPATHY (Swelling of lymph nodes in both arms) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Site of injection is swelling) and LYMPHADENOPATHY (Swelling of lymph nodes in both arms). At the time of the report, VACCINATION SITE SWELLING (Site of injection is swelling) and LYMPHADENOPATHY (Swelling of lymph nodes in both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
My arm swelled up and was red and hot and itched, and had a huge lump where the shot was given. I took Benadryl and rubbed some cream on it, to stop the itching and burning.
patient received only one dose of GARDASIL 9; no adverse effect; This spontaneous report was received from a pharmacist and refers to a 24 year old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On an unknown date (reported as about a year to 1 and 1/2 years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, strength, frequency, route of administration, lot# and expiration date were not reported).         The patient received only one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No adverse effects were reported.
she was in a lot of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program support. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "chrons disease" (unspecified if ongoing), notes: for several years now and is disabled, prior to getting any shot; "bad back" (unspecified if ongoing), notes: for several years now and is disabled, prior to getting any shot. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "she was in a lot of pain". Therapeutic measures were taken as a result of pain.  Additional information: Patient second shot was scheduled for 09Apr2021. She had a steroid shot pre-scheduled for two weeks after her first dosage and has already taken that steroid shot now for the reported event. Patient was asking will this affect the efficacy of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Syncope episode Pt. remained ATO x4 Pt. seen by EMT on site and transferred to hospital 12 Lead EKG (-) result Ice pack given to patient for posterior head
Felt like fainting, did not faint; Felt like it was anxiety; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt like fainting, did not faint) and ANXIETY (Felt like it was anxiety) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (Felt like fainting, did not faint) and ANXIETY (Felt like it was anxiety). At the time of the report, DIZZINESS (Felt like fainting, did not faint) and ANXIETY (Felt like it was anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
7/5/06 Within 1 hour after receiving vaccine ate and then vomited x4-broke out in a sweat-c/o dizziness and light headed. Came back to see MD at 3pm will come back again in a.m. for re-evaluation of sx.  7/6/06 feel fine no symptoms of vomiting or dizziness.
The next day and since the vaccine on and off I keep smelling a burning smell. I didn't have this issue until after I recieved the vaccine
Severe joint and muscle pain; Severe joint and muscle pain; Fingers becoming deformed very rapidly; Bones deteriorating rapidly; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3246) via an unspecified route of administration administered in left arm on 19Jan2021 at 11:00 (at 65 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. The patient medical history was not reported. Concomitant medications included hctz, bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium, esomeprazole magnesium (NEXIUM), and alprazolam (XANAX) modified-release tablet; all from unspecified date for unspecified indication. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced severe joint and muscle pain, fingers becoming deformed very rapidly, and bones deteriorating rapidly on 22Jan2021. All events resulted to physician office visit. Treatment received for the adverse events included prednisone. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL9265) via an unspecified route of administration administered in left arm on 09Feb2021 at 11:00 as single dose for COVID-19 immunization. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 52 years old female patient. The patient was vaccinated with ZOSTAVAX (lot#, dose/frequency, route unspecified). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced injection site reaction and a severe headache soon after receiving the ZOSTAVAX injection, injection site reaction and the headache subsided after 5 days without any specified treatment. It was reported that the patient sought to medical attention. The outcome of severe headache and injection site reaction was reported as recovered/resolved(date not provided). Additional information is not expected.
vaccines were store the wrong way; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vaccines were store the wrong way) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were store the wrong way) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (vaccines were store the wrong way) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (vaccines were store the wrong way).    No concomitant medications was provided. No treatment medications was provided.
Arm hurt; A spontaneous report was received from a consumer concerning a female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm hurt.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter   On 31-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (batch unknown), Intramuscular for prophylaxis of COVID-19 infection.   On 31-DEC-2020, after vaccination, the patient's arm had hurt.  As a treatment the patient had taken a pain reliever.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event her arm hurt was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Headache; Mild fever; Lack of energy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248; Expiration date was not reported) on 19Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included Celiac disease and gluten allergy. Concomitant medication included fexofenadine hydrochloride (ALLEGRA). On 20Jan2021, the patient had headache, mild fever and lack of energy. The patient did not receive any treatment for the reported events. The outcome of the events, headache, mild fever and lack of energy, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Mother states child had shaking spells following the injection. (See previous report filed by our office.) Mother did not notify us of this until recently. Mother thought he was having a seizure.
I woke up on Saturday AM, the night after receiving the vaccine, and I passed out while walking back to bed.
January 5, I had some pain in my left collarbone and the pain continued into the evening. 9 pm, I noticed a lump above my collarbone - above it - the size of a quarter. On Jan 6 at 3:00 pm I noticed  - on top of my shoulder to neck area - swollen on both sides - I went to a urgent care at 5:00 pm. They said it was a cyst and gave me doxycycline for 10 days. On January 9, I experiencing a sore throat and body aches and I went to URGENT Care again for COVID test - negative result. The doctor looked and it wasn't a didn't think it was a cyst - they said to continue to take antibiotic as a precautionary though and so I did stay on it but it didn't do anything . January 13, upper thoracic CT with contrast  - 11 mm inflamed lymph node - and they referred me to an EMT doctor and I got the second January 26th.  The swollen lymph nodes were not resolved at the time of the second dose.
Pt was given 4 vaccines including Dtap, Hep A, Hib, and PCV vaccines that was intended for another pt. PNP explained to mom that the error was made and apologized. Explained that pt needs Hep A, MCV4, Tdap, and Varicella vaccines. Mom was understanding and wanted to move forward with the vaccines pt does need. PNP explained since pt received Dtap today, we do not want to give Tdap. Pt received MCV4 and Varicella. Will come back another day for Tdap.
7-9-03 - 4cm red warm swelling. Dtap injection site - 7-10-03 12 cm inflammation left lower anterior thigh red-hot-denies pain.
Fever began 5 hrs after immunizations, next morning had large local are swelling and redness. Four days later presented with periorbital cellulitis and continued fevers.
covid vaccine breakthrough case  dose 1 Moderna  4/22/21  017B21A dose 2 Moderna 5/20/21  017B21A dose 3 Moderna 11/19/21  027H21B
experienced painful joints after the 1st dose and it was even worse with the 2nd one; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (experienced painful joints after the 1st dose and it was even worse with the 2nd one) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ARTHRALGIA (experienced painful joints after the 1st dose and it was even worse with the 2nd one). At the time of the report, ARTHRALGIA (experienced painful joints after the 1st dose and it was even worse with the 2nd one) had not resolved.            No concomitant medications were reported. It was reported that the painful joints was so bad that the patient looked like a crippled person and was not like that before. The patient went to the doctor, and they felt that it was the vaccine. The doctor also said that was the Moderna vaccine. No treatment medications were reported.
I am reporting these reactions only as associations and possible adverse events, most certainly definative. The event I'm reporting are in response to the booster - third, partial dose, of Moderna. (I responded to second Moderna dose with chills and unwell feeling duration one day) Possible Association with booster: 1.  First time appearance or red, painless, flat pin prick-like mark on forearms dorsal side or wrists. These by internet search look something like senile purpuras.  First appearance 1 week following vaccine. Next occurance today. 2. Pain in upper right quadrant in area of liver or gall bladder, sensitive to touch.  Ultrasound and blood work showed no abnormalities. 3. Vaccinated arm remains very sore.  (Person administering shot appeared unskilled.) Upper R quadrant pain has resolved.  Lasted weeks. I also developed a uti, and antibiotics eased symptoms of both. Pin prick rash ( senile purpura?) appeared again today - second time.  Upper arm pain persists.
Based upon the follow-up information received on 27-Jan-2016, influenza vaccine was added as a company suspect drug. Initial information regarding this clinically sponsored solicited case was received on 13-Jan-2016 from the patient via the Patient Support Program. This case concerns an approximately 64 year old adult male patient who had mild flu symptoms few days after and was feeling tired and felt funny, unspecified time after receiving Praluent and influenza vaccine. No past drugs or concurrent conditions were reported. On 30-Dec-2015, the patient commenced therapy with subcutaneous alirocumab injection at the dose of 75 mg every other week (lot/batch number and expiry date unspecified) for Hyperlipidemia, unspecified delivered via alirocumab prefilled pen. On an unknown date, the patient started treatment with influenza vaccine (dose, form, route, frequency, lot/batch number and expiry date: unknown). On an unknown date, the patient reported having mild flu symptoms that started a few days after last injection. An unspecified time later, since an unknown date, the patient has been feeling tired lately. Reportedly, today was the first day he was starting to feel a little bit better. He has had sinus trouble for over 20 years and it was not unusual for him to have flu symptoms. Upon follow-up it was reported the patient felt funny after the 1st injection. He did develop flu-like symptoms. Symptoms were not severe. Patient not sure if it was the alirocumab or the flu shot that he received 2 weeks before. No information on any corrective treatment received was provided, and alirocumab was continued as planned. At time of reporting, the outcome of was unknown for feeling abnormal and recovering for other events. Reporter causality: Unknown for alirocumab and not reported for influenza vaccine. Company causality: Not associated for alirocumab and associated for influenza vaccine. Additional information was received on 27-Jan-2016 from the patient via patient support program: Influenza vaccine was added as a company suspect drug, new event of feeling abnormal was added and narrative was amended.