chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid test came back positive; covid test came back positive; This is a spontaneous report from a contactable other hcp (patient). The patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 17Dec2020 (first dose) and 07Jan2021 (second dose) at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported "I am a healthcare professional and I have had both doses of the vaccine (17Dec and 07Jan). I was scheduled for surgery this past Wednesday but it was cancelled as my covid test came back positive. I have no symptoms. I was advised to get antibody testing. This showed I have antibodies for both IgG and IgM. I was still told I cannot have the surgery. " The outcome of the events was unknown.  No follow-up attempts are possible, information on batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Continued and persistent pain in hips, back of thighs, and down my calves. There is a cramping sensation in my calves. Head pressure and sinuses are filled. I do not have a history of allergies or sinus issues. My main concern is the leg cramping/inflammation. I am 22-days post vaccine and still have this symptom.
pt recvd vax;running fever;began to seize w/ limb stiffness & mild intermittent tonic clonic movements;resolved 3-5 mins;all of sxs occured around 20 hrs p/ vax;
I have been nauseous since about 10 minutes after the vaccination. It subsided for a few hours and came right back.
Patient was hospitalized for an episode of A-fib; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0179 and expiry date was not reported), via intramuscularly, in Arm Left, on 29Apr2021, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included that she was diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lurasidone hydrochloride (LATUDA), Metoprolol, Lorazepam, rivaroxaban (XARELTO), Quetiapine, Bupropion, Oxybutynin, Atorvastatin, Diltiazem, Losartan, Gabapentin and Furosemide. Since the vaccination, the patient was not tested for COVID-19. It was reported that on 03May2021, the patient was hospitalized for an episode of A-fib which resulted in emergency room/department or urgent care. The patient was hospitalized due to the event from an unspecified date in May2021 to an unspecified date in May2021. Device date was reported as 11May2021. Outcome of the event was recovered with sequel.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event atrial fibrillation and the suspect drug.  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.
Started having sore R arm Friday PM.  Had fever of 104 degrees Saturday.  Went to Hospital ER 11/9 AM.  Said she had 2 IV's with antibiotics. Was informed she had; Bacteria in her Blood- Not UTI.  Is on AUGMENTIN - 11/12/08 still has 4 inch round inflamed area surrounding pneumonia injection site.
The pt complained of swelling of the upper lip only 1 day post vax. the swelling resolved 1-2 days after it appeared. No other symptoms.
One day after the 2nd shot, I had severe asthma. I have had it every single day since today, May 14, 2021. I went to my doctor and have been on inhalers (Albuterol and Flonase daily) with no change in symptoms.
SUDDEN LOSS OF MOTION OF THE LEFT INDEX FINGER AND LEFT THUMB 9 DAYS AFTER RECEIVING VACCINE. WENT TO ER AND HAD A STAT CAT SCAN TO R/O STROKE AND A CHEST X RAY BOTH NEGATIVE. DISCHARGED FROM ER . SAW NEUROSURGEON FOLLOWING DAY, NECK X RAYS DONE.  WAS PLACED ON PREDNISONE FOR 6 DAYS AND REFERRED TO NEUROLOGIST. EMG TO BE DONE IN THREE WEEKS FROM 1/22/21.
01/16/22 presents to EC ED for "nausea, vomiting, myalgias, decreased PO intake, and lightheadedness". PMHx of "lupus nephritis s/p renal transplant 3/2020, bipolar disorder requiring hospitalization, GERD, ADHD"
Edema, erythema 6 cm x 6 cm, tender left mid thigh.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/28/2021pfizer,Lot#EN5318 2nd dose: 02/18/21,Pfizer,Lot# EL9266 Diagnosed covid positive:07/15/21 Exposure:Community esposure Symptoms:cough, fatigue,muscle aches,loss of smell/taste, nasal congestion.
Case number PHEH2016US029308 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to 71 year old female patient. Medical history and concomitant medication was not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent on 18 Oct 2016 at 52 Fahrenheit (F) for 1 hour, second excursion of FLUCELVAX Quadrivalent on 23 Oct 2016 dropped low 6 times to 34 Fahrenheit (F) and lasted 30 minutes each time, it was unknown if vaccine was frozen. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on 25 Oct 2016. Third time excursion on 02 Nov 2016 down to 32 Fahrenheit (F) 3 times over the course of 12 hour it was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error (incorrect product storage).
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients (unknown age and gender). The patients current conditions, medical history and concomitant medications were not reported. On unknown dates, unspecified number of patients received improperly stored doses of ROTATEQ (lot # L029617 and expiry date 19-MAY-2017, lot # L020859 and expiry date 19-JAN-2017), which was exposed to temperature of 51 degree Fahrenheit (F) for 3 hours of time (incorrect product storage). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Nothing after the vaccine, no reaction at all. I started like sore throat, tired, I thought it was a cold, got headache. I took the home test for COVID-19, and it was positive. I called the doctor (telehealth visit), and she prescribed PAXLOVID. For 2 1/2 weeks I had sore throat, a dry cough, and I was very tired (fatigue). I feel better now, just a little fatigue, for the last 2 days no more cough.
E.R. Almost Loosing consciousness.  Bad headache, swelling and numbness  in extremities and L face.  Severe fatigue, vomiting.  Swelling then continued to crawl up and broaden over face and other side.   Body swelling , stiffness, congestion, swelling of inner ears, nasal congestion, chest congestion,  severe fatigue
This spontaneous report as received from a Practitioner Nurse refers to a 62 year old female patient. The patient's current conditions or medical history were not reported. On 09-JAN-2014, the patient received her first dose of PNEUMOVAX 23 (route was not reported) lot J005071 expiration date 19-JAN-2015. On 15-JAN-2014, the patient received a second dose of PNEUMOVAX 23 from the same lot as the first dose (lot J005071 expiration 19-JAN-2015), the patient has not reported or demonstrated any adverse effects. At the time of the report the outcome was unknown. Additional information has been requested.
Patient fainted after fluzone administration. Pt was standing with her parents while pharmacist was administering another vaccine for another family member. Patient was laid down and regained consciousness. Patient denies hitting her head or any other injuries. Pt provided water after regaining consciousness. Management notified, store incident reported. VAERs reported.
Diagnosis of Guillain-Barre Syndrome July 2011. Peripheral neuropathy sx started 4/2011.
Rash began at vaccine site on January 23rd then within a few hours it spread to my whole upper body (front and back) and has not gone away
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER2613) at the age of 61 years, in left arm for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: CRESTOR; LISINOPRIL. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Soreness at shot location"; PYREXIA (non-serious) with onset 20Mar2021, outcome "recovered", described as "fever of 102.5". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information:  No other vaccine in four weeks. Adverse event: Within 24 hours of the first dose, a fever of 102.5 developed and lasted about 12 hours. Soreness at shot location. Within 12 hours of second shot, a fever of 104.2 developed and lasted about 60 hours. He did not know where he was or why he was where he was. He did not recognize my own dog. His doctor was not sure if he should even think about getting a booster shot because of reaction to first two shots. He had covid prior vaccination. He was not tested covid post vaccination. Adverse event treatment: Fever reducer.; Sender's Comments: Linked Report(s) : PFIZER INC-202200996885 Same patient, same vaccine in different dose, partial same event;
1 hour later, participant got a headache, pain in arm and at injection site and felt achy. She took Tylenol and laid down to sleep.  Woke up with flu like symptoms and right arm started to swell and the underarm had a big knot.  The injection site was huge, hot and red. Participant went to the doctor the next day and the doctor took measurements. No medications prescribed.  Participant continued to take Tylenol and Motrin. About 2 weeks after the vaccine, participant lost taste and smell.  About 3 weeks after the 2nd dose, participant developed a pain under the right breast to the arm pit. Participant was diagnosed with Shingles and prescribed Valtrex for treatment.  Currently, participant  symptoms have all resolved except for shortness of breath.
I was in shower and right arm began to tingle. Right side of face went numb including tongue but only on right side. The tingling in my arm became less. Numbness of tongue and lips on right side remain numb (6pm CST). Slight headache.
Had PVC's, feeling like I was going to pass out...4 days after getting the vaccine. Lightheadedness was off and on for about a month.
cough; wheezing; Major congestion; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the arm left on 13May2021 at 08:15(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included colecalciferol (manufacturer-VITAMIN D3), cyanocobalamin (manufacturer-VITAMIN B12), calcium (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN)and glucose (manufacturer-GLUCOS) and multivitamin all taken from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14May2021 at 08:00 the patient experienced Major congestion(Nasal congestion), cough and wheezing. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event Major congestion(nasal congestion)  cough and wheezing were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing), notes: other medical history: Osteoporosis; "known allergies: Can't take aspirin (1 kidney)" (unspecified if ongoing), notes: known allergies: Can't take aspirin (1 kidney). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies: Can't take aspirin (1 kidney)", notes: known allergies: Can't take aspirin (1 kidney). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment with paxlovid from 27Jan2023 to 01Feb2023. The patient did report administration other medication as ORACEA (doxycycline) and vitamin D within 2 weeks of paxlovid therapy.
1st dose on Nov2021, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 29-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt Date: 17-OCT-2022 Reporter's Comment: The reporter reported that , the patient had not received dose 2 of Shingrix as of yet.  No reactions were reported. The reporter consented to follow up via e-mail. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
within a few minutes of vaccine was very light headed (as if drunk) for 24 hours - nauseous and very bad headache.  2 weeks from the date of the vaccine I began getting nerve pain in my left hand ad forearm - it travelled to my back. By the next day I had sores on my back - diagnosed with a very severe case of the shingles -   by Saturday underarm, forearm left breast to cleavage along with spine to my shoulder blade and where it wraps around to my armpit was broken out in sores and terrible nerve pain
1st shot of the Comirnaty vaccine 4 weeks ago/might go into Covid; 1st shot of the Comirnaty vaccine 4 weeks ago/might go into Covid; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced 1st shot of the Comirnaty vaccine 4 weeks ago/might go into COVID on an unspecified date in 2021. It was reported the patient received the 1st shot of the Comirnaty vaccine 4 weeks ago where she got a cold that she said might go into Covid. She decided not to get the 2nd shot out of fear and that she should never have gotten the 1st shot in the first place. With this, the patient wanted to have more information regarding her understanding that a molecule is injected and that it contains DNA which produces spike protein. She also asked for information if in case those that she mentioned has a malfunction inside her body. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
17 year old had sob and nauseated shortly after vaccine adminstration . pt having mask over his nose may have contributed to it since he never wore mask over nose and also did not eat breakfast
pt fainted & fell to the floor p/receiving vax; pt was seen @ hosp; had a bone in the nose broken apparently due to the fall;
Moderna COVID-19 Vaccine EUA: patient presents to emergency department one day after vaccination reporting shortness of breath and left flank radicular pain. Found to have widely metastatic urothelial cancer involing the chest, abdomen, and pelvis. Patient admitted to the hospital for medical management. Discharged to hospice care.
Myalgia, Rash, ErythemaMultiform, UrticariaPruritus right arm redness itching arm pain Narrative:
Pt leg swelled, very warm to touch, hard and red. Pain to touch, This is in right leg.
Severe pain in left shoulder where vaccine was given. It hurt to move the arm in any direction. It was not the kind of soreness that is generally associated with a vaccine. I could not move my arm and the pain was so severe that I could not even drive my vehicle. I went straight to medical back to the vaccine administration department and explained the symptoms and they gave me an ice pack and told me to make an appointment with my primary doctor. She explained that the pain was normal and should subside within a week. I ended up going to the emergency room on the 12th of December in excruciating pain. At this point my shoulder was completely frozen and I could not move it or engage the muscle without severe pain.
This spontaneous report was received from a physician via company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 19-JUN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -1.11 Celsius Degrees for 80 hours, 15 Celsius Degrees for 56 hours, 8.33 Celsius Degrees for 416 hours, 9.44 Celsius Degrees for 168 hours, 8.88 Celsius Degrees for 24 hours and -3.0 Celsius Degrees for 1172 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Hearing has been impacted. Enconutering a constant woshing whistling  sound.
Red swollen, itchy, bumpy patch, ~2 inches in diameter, on the upper left arm around the injection site.
did not feel great; having no energy but not sick; This spontaneous case was reported by a non-health professional and describes the occurrence of FEELING ABNORMAL (did not feel great) and ASTHENIA (having no energy but not sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient ever been diagnosed with or tested positive for COVID-19. It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before or any chronic or long-standing health conditions.     In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced FEELING ABNORMAL (did not feel great) and ASTHENIA (having no energy but not sick). In November 2021, FEELING ABNORMAL (did not feel great) and ASTHENIA (having no energy but not sick) had resolved.            No concomitant product reported by the reporter.  Patient did not felt good the next day after receive a Moderna booster. Patient described as having no energy but not sick. Symptoms lasted just one day. He felt fine the next day and considered symptoms fully resolved.  No treatment medication reported by reporter.
Severe pain in feet on May 17, 2021.  Severe cramping in feet after both shots. Severe blood circulation issues. I believe these issues stem from the vaccine as I didn't have these issues prior to the shots being given.
Stiffness (going to the elbow) in the left arm; Sleepy for 3 days; This is a spontaneous report from a contactable consumer or other non-HCP. This is one of two cases from same reporter. A 57-year-old non-pregnant female patient (at the age of 57-years) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Left Arm on 09Feb2021 02:15 PM as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive other vaccines 4 week prior to Pfizer vaccine. The patient had not diagnosed with COVID prior vaccination. And post vaccination, patient had not tested with covid. On 09Feb2021 04:00 PM, the patient experienced stiffness (going to the elbow) and sleepy for 3 days. No treatment was received for the events. The outcome of events was resolved approximately on unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.