chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinated in the beginning but did not get the Boosters on time and came down with COVID; Vaccinated in the beginning but did not get the Boosters on time and came down with COVID; 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 patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hepatitis B" (unspecified if ongoing), notes: Hepatitis B. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Vaccinated in the beginning but did not get the Boosters on time and came down with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: because I took the Paxlovid and I am recovered and tested negative for the COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201212594 same reporter, same patient, different product, different event;US-PFIZER INC-202201212777 same reporter, same patient, different product, different event;
One day after receiving my first dose, I began to experience heavier than normal menstrual bleeding for a little over a week. I have been on birth control for the past year and my periods are normally shorter and lighter.
Patient is a lovely 74-year-old female with a long history of PACs and hypertension.  Her blood pressure has been getting a little bit worse over the past years.  She was admitted through the ER with 1st known episode of atrial fibrillation and hypertension. She reports that on 02/02 she received her 2nd COVID vaccine.  She had joint achiness and a low-grade temperature.  She rested the following day but then on 02/04 went for her usual hour long runs/hike.  She did not feel very well during exercise and started have a headache and some increasing palpitations.  Later that evening she was watching TV and started to have significant tachycardia that was irregular. Symptoms persisted and she presented to the ER which sound to be in AFib with rapid ventricular response with a blood pressure of 215/158. She was started on a diltiazem drip and has converted to sinus rhythm with PACs.  Blood pressure has improved significantly.  Troponin negative x2.   Her last evaluation at a Heart facility was  in 2017.  She had an echocardiogram in 2014 with normal EF, mild MR and mild TR with normal estimated PA systolic pressure.   She denies chest pain or dyspnea.  No history of syncope.  Sometimes with palpitation she does get lightheaded.  She gets occasional lower extremity edema that seems dependent in nature.  She is still having palpitations but recognizes that she is no longer in atrial fibrillation as that was more severe in terms of symptoms of tachycardia.
bruising close to hand; hot flash; sweating all over; blurry vision/white cloud on her eyes; hard time seeing; This is spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 12:15 (Batch/Lot number was not reported) (at the age of 75 years) as DOSE 1, SINGLE for covid-19 immunisation; ticagrelor (BRILINTA), oral from 28Apr2020 (Batch/Lot Number: MNO148; Expiration Date: Aug2023) and ongoing, at 90 mg, 2x/day for anticoagulant therapy. Medical history included glaucoma from 2016 to an unknown date, cataract from 2016 to an unknown date, blood pressure abnormal from an unknown date and unknown if ongoing, stent placement from 28Apr2020 to an unknown date. Patient previously took baby aspirin from unknown date and unknown indication and became anemic. Concomitant medication included losartan taken for blood pressure, start and stop date were not reported. The patient experienced blurry vision/ white cloud on her eyes, hard time seeing on 08Feb2021, bruising on an unspecified date, hot flash on 08Feb2021, sweating all over on 08Feb2021. Clinical course was as follows: On 08Feb2021, patient reported blurry vision, hard time seeing for three hours following dose. She woke up with bruising close to hand on side of administration, other bruising. Patient also stated that thirty minutes after she got the vaccine she ate, then an hour after she got the shot while she was going home her vision became very blurry, and she had a white cloud on her eyes, she had a hard time seeing. She says she also got sweaty and had a hot flash, she was sweating all over, this went away 3 minutes later. She says that the "blindness" or blurriness went away after two hours. She says she was also on Brilinta, a blood thinner, and has a big bruise on the arm where she got the vaccine, further down on her arm closer to her hand that is 4 inches, which they say was normal on Brilinta. She then clarified that the blurriness or white cloud got better two hours after she got home. She says she got the Pfizer COVID-19 vaccine shot at 12:15PM, by 04:30PM she could see clear again, she used eye drops and rested and could see clear. She said she has been on the same medications since she started the eye drops in 2016. She clarified that she was leery of getting the second dose and would like to know if she could be getting worse side effects or would be taking a chance for worse side effect than what she had, she doesn't want to go blind. The outcome of events bruise and hot flash was unknown, for events blurry vision/white cloud on her eyes, hard time seeing was recovered on 08Feb2021 16:30, for event sweating was recovered on 08Feb2021. The action taken in response to the events for bnt162b2 was not applicable, for ticagrelor was unknown. Therapeutic measures were taken as a result of blurry vision, white cloud on her eyes, hard time seeing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency# 778851) and refers to a 13-year-old female patient. It was reported that the patient had no health conditions before administration of GARDASIL 9. The patient was not on any concomitant medications. On 18-MAY-2007, the patient was vaccinated with GARDASIL 9 dose 1, batch/lot# 0389U, in the arm for prophylaxis (route: needle and syringe). Other suspect therapy included HAVRIX lot# AHAVB148AA, administered in the arm for prophylaxis (Route: Needle and syringe) on the same day. The vaccine was administered at a private facility. On 18-MAY-2007, after the first shot of GARDASIL 9, later that night the patient broke out in cold sweats and experienced heart palpitations and she became extremely fatigued. On 18-JUL-2007, the patient received the second dose of GARDASIL 9. After the 2nd dose, she passed out for the first time in her life in the doctor's office about 10 minutes after receiving vaccination. She began feeling even more fatigued and started seeing black upon standing. On 27-NOV-2007, the patient received third dose of GARDASIL 9. After the third dose, she was unable to hold her back up straight and started experiencing terrible gastrointestinal (G.I) symptoms. She started to miss numerous days of school and got sick all the time.  The patient went to numerous doctors with no answers until 2012 when she became diagnosed with postural orthostatic tachycardia syndrome (POTS). She was since been diagnosed with several other illnesses. The patient now had POTS, renal vein compression ("NCS"), Sjogren's syndrome, renal tubular acidosis and lymphocytic colitis. The outcome of cold sweat, visual impairment, Sjogren's syndrome, renal vein compression, renal tubular acidosis, posture abnormal, postural orthostatic tachycardia syndrome, palpitations, malaise, loss of personal independence in daily activities, loss of consciousness, gastrointestinal disorder, fatigue and colitis microscopic was reported as not recovered. The causality assessment was not reported. The health authority considered the events as serious due to hospitalization and disability. Follow up information was received on 15-FEB-2019. Lot Number 0389U was not valid for GARDASIL 9. However batch# 0389U with lot # 2118907 with expiry date of 06-FEB-2010 is valid for GARDASIL (Product lot number issue). Outcome and causality of product lot number issue was unknown.
Presents to the ED for shortness of breath, Tested positive for COVID,remdesivir, Decadron.Supplemental O2
Patient came into the pharmacy on 6-24 at approximately 8:50pm stating she had received a shingles vaccine. She said it was sore, red, and felt warm. I looked at the back of her arm and could see a red swollen area that was warm to the touch. She said it started to feel sore on Sunday and was not getting better. I recommended she contact her primary physician.
Extreme chills, fever but not taken, weakness, nauseous.  Took Prednisone and felt a little better.
Immediate arm pain at injection site and overall arm heaviness. Aches throughout body and exhaustion about 2 hours after. Headache and nausea about four hours after shot. Fever of 102.6 about 7 hours after shot accompanied by chills/shaking worse than any fever I?ve had. Tylenol was taken around time of headache which may have delayed the fever and chills. Tylenol and ibuprofen were taken simultaneously every 5 hours starting that evening and throughout the night and all the next day. Food consumption was minimal due to nausea but hydration  was maintained.
Pt.'s parents returned to Immunization clinc @ approximately 13:30. Pt had local reaction the Right thigh was red, swollen and warm and painful to touch.
Initial report received on 07 July 2009 from a health care professional. An 18 month old female patient received a fourth dose of DAPTACEL (lot number C3140AA) intramuscularly in the right thigh on 02 July 2009. On 03 July 2009 the patient developed full thigh swelling. The patient was treated with MOTRIN for pain. The reporter did not have further contact with the patient's parent, therefore the recovery status was unknown at the time of the report. Follow up report received on 27 July 2009 from a health care professional. The patient did not receive any other vaccines on 02 July 2009. The patient was not ill at the time of vaccination and no pre-existing physician-diagnosed allergies, birth defects or medical conditions. The patient recovered.
very significant aches in her legs; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very significant aches in her legs) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (very significant aches in her legs) and MYALGIA (Body aches). At the time of the report, PAIN IN EXTREMITY (very significant aches in her legs) and MYALGIA (Body aches) outcome was unknown.
Red rash from my top under my chin down to my chest; It has been itching and just making me crazy; deep itching; Penicillin allergy; I'm in a very uptight state of mind because my husband is dying, it could be nerves because I'm under a lot of stress right now; This is a spontaneous report from a contactable consumer (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), via intramuscular route in the right shoulder muscle on 11Feb2021 (age at vaccination: 76 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included diabetic and drug hypersensitivity to penicillin. Concomitant medication(s) included insulin. On an unknown date, the patient experienced red rash from my top under my chin down to my chest, it has been itching and just making me crazy; deep itching, penicillin allergy, she is in a very uptight state of mind because her husband was dying, it could be nerves because she is under a lot of stress right now. The patient took Benadryl as treatment to see if that would maybe help with these deep itching and everything. She did see rash as one of the things on the paper work that they gave her on 11Feb2021 (Thursday). She don't have any known allergies except to Penicillin. She did not take second shingles shot, because she didn't wanted to and couldn't have it within 30 days of the vaccine. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Started with pain about 5 hours after injection at injection site. On 7/4/19 at 0800 noted to be very red (3 inches in diameter), hot and indurated, centered around injection site and still quite painful. THis was Second Shingrix he had (previous shingrix about  4 months earlier).
Received Fluzone intradermal flu shot on 2/3/2012.  Noticed hives on arms, neck, back, and chest on 2/4/2012.  More noticeable and itchy on day three.  Took Claritin on day one and two.  Prescribed Methylprednisolone on day three, with Claritin and Benadryl.
ALOPECIA AREATA; This spontaneous report received from a physician concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were 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. No concomitant medications were reported.  On an unspecified date, the patient experienced alopecia areata. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of alopecia areata was not reported. This report was non-serious.
February 13,2021 I got the vaccine and everything was fine but on March 06,2021 I woke up with my mouth a little turned to the right and my left eye irritated. As the day went by, I got worse and went to the hospital and they told me I had bell's palsy and to go to my primary doctor. And my doctor told me that it could be a side effect of the vaccine and to make the report.
Patient started with pain, redness and swelling below injection site of R upper arm at 1500 yesterday (day after vaccines) the redness had spread and was started to become indurated and warm. She has some tenderness to palpation. She is also experiencing some headache and nausea. No fevers are noted. She was diagnosed with cellulitis and placed on one antibiotic Duricef.
Patient came in for a Pfizer first vaccination. (Primary Immunization). She was given a Pfizer Bivalent Booster instead of the Pfizer primary vaccination.  Not aware of any adverse symptoms at this time.
Initially had arm swelling and discomfort. Two days later progressed to lip and throat tingling and swelling resulting in ED evaluation for serious allergic reaction.
Approximately 3-5 minutes after vaccine administration pt complained of nausea/dizziness. We called 911, she was transported to hospital.
pt brought to hosp with abdominal pain, jaundice, fatigue, SOB; AHRF due to COVID PNA, ETOH hepatitis, acute pancreatitis; positive COVID test; AKI; dexamethasone; increasing O2 requirements; O2 supplementation; pt's stay was complicated by MRSA PNA; ABX; had a drop in hemoglobin without signs of GI bleed; given 1 unit pRBCs, shortly after transfusion pt had an increase in O2 requirements and tachypnea; placed on BIPAP; transferred to MICU; intubated; later transitioned to comfort care and passed away in the hospital
Sick; Fever; Chills; Horrible headache; This is a spontaneous report from non-contactable consumer via Pfizer Sales Representative. This consumer reported that.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.The patient previously took first dose of BNT162B2 for COVID-19 immunization and experienced sore arm after the first one. The patient experienced sick, fever, chills, and horrible headache on an unspecified date. It was reported that they had both Pfizer vaccines. Nothing but a sore arm after the first one. But the 2nd one. So sick. Fever, chills, horrible headache. It was short lived. Just 24 hours. The outcome of events was recovered on unknown date.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sharp, intermittent pain in  upper right leg (quad muscle) and repeated weakness.  Based on physician consultation, seems like nerve pain.  Currently monitoring for improvement and will follow up with testing.
arm was a little sore from the injection/arm with a little sore for a day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm was a little sore from the injection/arm with a little sore for a day".  Additional information: Consumer stated: "We have both received the Pfizer Covid 19 vaccine since it came out. Last year we got the Pfizer booster and we have not had any problems at all with it, except arm was a little sore from the injection for one day and it was gone, but nothing else. That happens with anything you get.  It wasn't a big deal. We have known people that have had COVID that have been so sick from the vaccine (manufacturer name not provided or clarified) that they are not taking it again, which is a shame. My husband and I have not had any problems with it and have been very lucky that the COVID vaccine from Pfizer has been perfect. This is the only one that we will take will be Pfizer."  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300317543 same reporter/drug/event, different patient;
I received a PREVENAR 13 Pneumonia vaccine, and had a rough reaction. Arm was sore, which I expected, but as the day went on the pain travelled down my arm. Also, my joints got extremely sore, I ached all over, had a fever, acid reflux, tingling in my hands, terrible headache, sick to my stomach, and spent most of a day and a half in bed, sleeping. Two days later, things are much better, although my upper arm remains sore and is quite red. My husband felt, I should report this, just to have it on the record in case other are experiencing similar reactions.
I rec'd call from patient on 10/27/23 with concern that she rec'd tdap immunization on 10/26/23.  States after she got home from clinic, she checked her health portal from another facility and saw that she has rec'd the same vaccine in Feb 2023 at that facility..  Pt also states that last time she rec'd tdap in Feb, arm became warm, red, and swollen requiring drainage by a medical provider at outside clinic.  She was concerned that that might happen again as vaccine just given was in the same arm that had the reaction..  Pt reported "hardness" at the injection site as the only concern/side effect at the time of the call. Denied any other symptoms, but reported concern as previous reaction worsened over the span of several days.  I reviewed CDC website info and relayed that she may not get benefit from an early vaccine, but there is potential for side effects.  Discussed previous (Feb 2023) reaction sounded infectious in nature and current symptom sounds like an immune response.  She was encouraged to seek provider evaluation or call us back should any s/s of infection develop.
Patient with syncopy response to injected about 3-4 second and recovered without complication. Observed 30 min after response.
patient tested positive for COVID19, contracted the covid 19 virus; patient tested positive for COVID19, contracted the COVID 19 virus; This is a spontaneous report from Pfizer Sponsored Program via Regulatory Authority Support. A contactable pharmacist via medical information team reported for a patient that: A 65-year-old male patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Not reported) via an unspecified route of administration on an unspecified date as single dose and first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient who got both doses of the COMIRNATY vaccine. On an unspecified date in Jul2021 (2 months ago) patient tested positive for COVID19, contracted the COVID 19 virus. Reporter also queried about the advised timing of the patient to get a booster dose or considering that he already contracted COVID19, was there a need for him to have a booster dose. Administration of More Than a 2-Dose Series (third dose or booster dose) COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine are (administered intramuscularly as a series of 2 doses (0.3 mL each) 3 weeks apart.1 A third dose of the Pfizer-BioNTech COVID-19 vaccine (0.3 mL) administered at least 28 days following the first two doses of this vaccine is authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.2 A booster dose of vaccine is not currently recommended. Use in Patients with Current or Previous Diagnosis of COVID-19. Interim Clinical Considerations for the Use of COVID-19 Vaccines by CDC "People should be offered vaccination regardless of their history of symptomatic or asymptomatic SARS-CoV-2 infection; this includes people with prolonged post-COVID-19symptoms. Data from clinical trials indicate that the currently approved or authorized COVID19 vaccines can be given safely to people with evidence of a prior SARS-CoV-2 infection. Viral testing to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection is not recommended for the purposes of vaccine decision-making. Patient underwent lab test and procedures which included COVID19-positive. Outcome of the event was unknown.  Follow up(20Sep2021): Follow up information included information about adverse reactions.  No follow-up attempts are possible. No further information is expected.