chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PCR test yesterday that came back positive today; This is a spontaneous report from a contactable consumer (patient's friend).  A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) solution for injection, via an unspecified route of administration on 18Jun2021 (Batch/Lot number was not reported) as dose number unknown, single (at an unknown age) for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The consumer stated the patient received the BNT162B2 (reported as Pfizer BioNtech COVID 19 vaccine) last Friday (18Jun2021) and did a polymerase chain reaction (PCR) test yesterday (22Jun2021) that came back positive today (23Jun2021). The consumer wondered if a positive PCR test after BNT162B2 was normal.  Outcome of the event was unknown.  Information about Lot/Batch number has been requested.
Patient received Pfizer COVID vaccine on 1/31/21 (lot # EN5318), 2/28/21 (lot # EN6198), and 12/28/21 (lot # FE3594). On 1/5/22, patient tested positive for COVID. On 1/16/22, patient admitted to our inpatient med/surg unit for acute respiratory failure with hypoxia secondary to COVID-19 pneumonia likely with superimposed bacterial pneumonia. As of today (1/18/22), patient is still admitted in our med/surg unit.
This spontaneous report as received from a consumer regarding her child of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with oral, ROTATEQ (dose strength unspecified). No concomitant therapy was reported. The reporter stated that once an unknown date the patient had been experiencing muscular weakness after receiving oral, ROTATEQ. The outcome of muscular weakness is unknown. No product quality complaint was involved. Additional information is not expected as there are no contact details of the reporter provided.
Varying degrees of redness on left shoulder (same arm as shot administration). States feels bruised, warm to touch, denies itching.  In shot area of left deltoid pt has redness in shape of the bandaid.
I had a fever for 4 days and along with the fever I had a headache and was achy with chills. Then about the 3rd day I got real congested in my head and I'm still that way and this is day 6. I didn't cough much, only a little bit. And I didn't have a sore throat. It's been mostly a sinus thing with the fever being the worst part. I was so stuffed up I couldn't smell and I'm still stuffed up. This is my first time having COVID-19.
Day 2 patient noticed redness and hot to the touch in area of vaccine site  Day 3 patient noticed increased redness and pain in area of vaccine site Day 4 pain has subsided but hot to touch and red
runny, itchy eyes, congestion, redness, swelling & itchiness @ inj site;
Felt feverish; Fever; Headache; A spontaneous report was received from a 40-years-old  male patient concerning himself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt feverish, had fever and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the events felt feverish, had fever and headache.  Treatment details included was not reported. Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events felt feverish, had fever and headache was unknown.
NO ADVERSE EVENT. FOR FILLED OUT AS PRECAUTIONARY MEASURE D/T LATEX ALLERGY.
chills; nausea; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness). On 10-Mar-2021, CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Around 6:30 pm my legs started to  feel as if wearing weights and then around 8 pm started to feel as if getting the flu. At 10:30 am this morning body feels heavy and where I got the injection in arm has a slight burning sensation.
pt recv vax 24SEP97 & mom report on 25SEP97 pt cried constantly all noc & until this time;pt was inconsolable;temp was 100.2;seen by MD for eval;pt exp inc irritability, cough, nasal congestion & vomiting;
chest pain occurring on 2nd day after Moderna booster which lasted entire day, was gone the next day. Did not go to ER No treatment.
fractured a rib; My wife fell because she tripped - 6 months after she took Moderna.; This spontaneous case was reported by a consumer and describes the occurrence of RIB FRACTURE (fractured a rib) and FALL (My wife fell because she tripped - 6 months after she took Moderna.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 3.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RIB FRACTURE (fractured a rib) and FALL (My wife fell because she tripped - 6 months after she took Moderna.). The patient was treated with OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Rib fracture, at a dose of 1 dosage form. At the time of the report, RIB FRACTURE (fractured a rib) and FALL (My wife fell because she tripped - 6 months after she took Moderna.) outcome was unknown.            No Concomitant medications was provided.  Reporter stated that - There was NO CONNECTION between the fractured rib and the injection. they were very happy with Moderna and the vaccine. The report was wrong.  Reporter asked that - how many days to stop (meds) before taking the vaccine (third dose) for his wife.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Updated the current condition, New event added and information added in narrative. On 07-Sep-2021: non significant follow-up.
Day following vaccines patient complained of chest pain and shortness of breath while she was sitting at school. No dizziness and no palpitations. Per patient O2 Sat was 94% and then quickly came up. A similar episode happened before approximately 1 year ago. Got shots yesterday and school nurse said she looked very pale and when she went back to desk her chest hurt (hurt in very middle of chest), she felt like it was hard to take deep breath. No trouble now and chest does not hurt now. Chest started to hurt and difficulty breathing. O2 was 94% and then got higher. Was pale initially. No palpitations. When chest pain started she was sitting. No anxiety. This has happened 2-3 times before last episode was 1 mo ago. Lasted about 40 min. BP was fine yesterday. Rash on upper arms.
I felt like I was having a hot flash and felt like I was hungover, tired achey, and nausea,  the next day 12/18 I couldn't sleep on my left side because my arm hurt, no rash and Saturday I had horrible itching all over my body, I called the Dr and he had me take Claritin,  and it calmed down after 6 hours . I have similar symptoms with extreme stress.
pt states about a week after he got the covid vax he developed a head ache and a rash all over his body from head to toes.  Pt went to PCP on where he was prescribed Triamcinolone acetonide cream USP 1%.  It temporally eases the itching but rash has only gotten worse. Pt is going to Dermatologist on 3/16/2021 since his rash is not getting any better.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 17Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "hypertension" (unspecified if ongoing); "seasonal and environmental allergies" (unspecified if ongoing), notes: other medical history: seasonal and environmental allergies; "environmental allergies" (unspecified if ongoing), notes: other medical history: seasonal and environmental allergies. Concomitant medication(s) included: LOSARTAN; HCTZ. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Negative. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course included Return of symptoms - runny nose, fatigue, then cough and tested positive for COVID with home test. I had no symptoms by day 3 of Paxlovid treatment and tested negative 3 days after my final doses. (day 10 of my COVID infection)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 28-OCT-2014 at a physician's office, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 07-NOV-2014, the patient was treated at physician's for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed diclofenac and gabapentin for management of his painful symptoms. On or about 25-NOV-2014, he had additional treatment for ongoing and worsening symptoms which was then diagnosed as post-herpetic neuralgia, a chronic condition or nerve pain and damage secondary to shingles infections. The patient was prescribed prednisolone along with continuing tramadol for management of his persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient received a second dose of influenza vaccine, she received first dose one week prior. NO adverse events reported, no treatment warranted.
Corneal Transplant Rejection. Severe Burning, Redness of Right eye and extremely blurred vision. Treated with Steroid drops.
Acute bronchitis; Touch of pneumonia; Didn't feel well; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the BNT162B2 vaccine on 04Mar2021. She stated she didn't feel well since then. On 22Mar2021, she went to the doctor, had an X-ray and was advised that she has acute bronchitis and also stated that she may have a touch of pneumonia. She would like to know if she should receive the second dose of the vaccine scheduled on 25Mar2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Diluent not mixed with  powder; Only diluent was administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number B2C9F, expiry date 11th February 2024) for prophylaxis.   On 19th January 2023, the patient received Shingrix. On 19th January 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 19-Jan-2023 Reporter's comment: The licensed practical nurse called to inquired that any guidance. The reporter did not consent to follow-up. Additional supportive information: The patient was inadvertently administered the Shingrix diluent (AS01b) component only without the lyophilized powder component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
4/10/21 Immediate headache, dizziness and tachycardia requiring monitoring for 45 minutes. Within 36 hrs spiked a temp of 101 that resulted in night sweats, lethargy & nose bleeds 5/5/21 0 symptoms until 5/5/21 @ 5pm 5/5/21 Vaccine #2 continued. 2nd vaccine was @ 10:40am on 5/5 but by 5pm on 5/5, went to bed with lethargy, headache that intensified over night. Severe low back and hip pain, fever, loss of appetite that was so intense, I remained in bed for 25 hours. I was slightly nauseated and only drank water until I was able to make some soup on 5/6 @ 6pm. I've never been this sick & the headache was intense. 5/7/21 I began moving more, pushing fluids and getting out of bed. Two weeks later, 5/19/21, my left upper thigh hurt, followed by three herpes blisters and general malaise. I haven't had a herpes outbreak since 1991. It took several weeks for the blisters to resolve. Then I began experiencing menstrual discharge (I'm 66 and post-menopausal) I hadn't had a menstrul flow or discharge since menopause 13 years earlier. I am still spotting and waiting another couple of weeks since I have numerous women clients experiencing menstrual abnormalities. I'm assuming all of the carrier and preservative vaccine ingredients are a huge to my llver detoxification and of estrogen metabolism. I'm sad that I got the vaccine but am a traveler and will most likely require proof to
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 04-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 328 hours with a lowest recorded temperature of 29 Fahrenheit (F) (-1.666666667 Celsius (C)) and other one of 128 hours with lowest recorded temperature of 33 F (0.555555556 C). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
following a call from Immunization System that informed us that this pt had a Moderna vaccine 3 days prior to his Janssen vaccine I called the patient on 05/04/2022 to verify he had both vaccines, get details and information about adverse reactions.  He stated that he has had nerve pain since the 2nd vaccine was administered from his shoulder to his elbow.  He stated that he has not sought treatment for this at this time.  I advised him to see a doctor regarding this.
Patient reported left sided facial swelling after receiving the second dose of Moderna COVID-19 vaccine. Patient advised to take 50mg of diphenhydramine and 20 mg famotidine.  Patient reported symptom resolution after one hour of taking medications without reoccurrence.
PATIENT REFERS THE DAY AFTER RECEIVING THE FLU SHOT HE BEGAN FEELING TIRED, WITH SORE THROAT AND SIGNS AND SYMPTOMS OF THE FLU.
Flu like symptoms: headache, skin dryness, body ache, nasal congestion, left arm soreness, fatigue
Pneumonia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (Tested positive for COVID-19 virus after first vaccine dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025AZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID-19 virus after first vaccine dose) (seriousness criterion hospitalization). On 13-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 13-Mar-2021 to 17-Mar-2021 due to COVID-19 and PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia) and COVID-19 (Tested positive for COVID-19 virus after first vaccine dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
COVID rebound. Finished Paxlovid on July 2nd, tested positive July 10th; COVID rebound. Finished Paxlovid on July 2nd, tested positive July 10th; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 20Apr2021 as dose 2, single (Lot number: ER8735), in left arm, on 09Nov2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 21Jun2022 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient's relevant medical history included: "One kidney" (unspecified if ongoing); "eczema" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; BUPROPION; CETIRIZINE; ACETAMINOPHEN; IBUPROFEN; ATORVASTATIN. The following information was reported: COVID-19 (medically significant) with onset 10Jul2022, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "COVID rebound. Finished Paxlovid on July 2nd, tested positive July 10th". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (10Jul2022) Positive, notes: Finished Paxlovid on 02Jul, tested positive 10Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Within 24 hours fever, chills, loss of appetite/taste and lethargic gradually subsiding over a week. 2nd week after shot - Still no appetite /taste. Lethargy continues (needing multiple naps) and just not feeling well. Severe pain scale of 1-10 (1 being least and 10 being most) at  varying  from 5-10  (non specific to joint or muscles and including both muscle and bones) Bilaterally across both lower legs . Gradually subsiding in left leg, continuing in Right leg (2 weeks out still a 4 in right leg) . Still not able to walk normal. Still no energy and loss of appetite and smell.
I gave the patient the Shingrix shot. She complained of pain as I gave it but she expected it to hurt. After receiving her flu shot and Prevnar 13 in the opposite arm she felt dizzy. She sat down and I gave her a water. Within a few minutes she felt okay to leave and her husband drove her home. Her husband called the pharmacy and said the patient's arm was hurting very badly and pulsating. He said she already had a primary care doctor appointment within 2 hours and they would let the doctor look at it.
Patient stated that there was pain after the injection. She states the pain did not subside and she went to a doctor. Patient states the injection caused her bursitis in the arm.
Developed left parotid swelling and low-grade temperature. Looks like mumps, 1 week, post vax.
Subject in pneumococcal vaccine trial, with severe COPD died on 1/30/09. Vaccination took place 4/17/2008. According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.  3/14/2009 SAE received from reporter. Pt experienced L sided pain and increasing SOB on 1/22/09 x 2 days.  Presented to ER where dx with L Pneumothorax and Pneumonia. Unresponsive to tx.  Pt died 1/30/09.