chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt pain at injection site; dry mouth; feeling cold; dry eyes; rapid pulse; his breathing changed'; states it was hard to breathe; felt like he had fever; This is a spontaneous report from a contactable consumer (patient). This 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 04Apr2021 for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient stated after injection, felt pain at injection site and felt like he had fever; fever lasted 2 days (as reported). Patient also added immediately after receiving the shot, he had a 'rapid pulse and his breathing changed' on 04Apr2021; stated it was hard to breathe. Patient stated he calmed himself and he was ok. Patient reported 2 weeks later after the first dose, he reported shortness of breath, dry mouth, feeling cold and dry eyes (unclear timing/onset). Patient stated these were ongoing currently. Patient was  asking if these could be side effects. Patient also reported that he cannot take medications; he had allergies to medication (did not specify). Patient asked should he delay second dose given he had ongoing side effects from the first dose. The outcome of events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hypothermia, chills, itching,  and nausea lasting 6 hours. Muscle and jount pain lasting 18 hours and treated with ibuprofen
Titer negative. Dose #1 Varivax given 6/8/07. Dose #2 7-9-07 on 7/18 began with pox eruptions, on 7/23 more pox erupting and cellulitis on anterior neck referred to MD for evaluation. 7/23 MD started antibiotic and "salve" per patient.
Influenza vaccine administered at 10 am.  Developed headache and fever at approx 7 pm; maximum fever 102.3 (Rectal), subsided by 2 pm.
Patient stated he felt dizzy after injection. Had the patient take slow deep breaths. Patient began to lightly shake, then patient was unresponsive with blank stare. Pt clammy, pale, and diaphoretic, Pt transferred via w/c and taken to medical monitoring.
Red area, warm to touch at the site on the back of the left arm was noted. 2- 5/8 inches by 1- 1/4 inches, warm and soft.
Systemic: Other- Patient said he suffered from confusion, fatigue, and had a hypertensive emergency in which he had to increase his amount of blood pressure medication. Highest reading was 198/116.-Severe;  symptoms lasted 2 days
What started as a bandaid size red rash underneath the skin when first noticeable on the morning of 3/10/2021 has now spread into a bit bigger blob like rash today 3/11/2021. No soreness or pain in the area and no itchiness, but slightly warm to the touch of it. Rash appears to be in the area of the injection site of the upper left arm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 31May2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "known allergies: Ibuprofen", notes: known allergies: Ibuprofen; Naproxen, reaction(s): "known allergies: Naproxen", notes: known allergies: Naproxen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not received any other medications/products within 2 weeks of starting COVID-19 treatment. Patient received treatment drug as Paxlovid (lot number=GC8124) from 27Jun2022 to 02Jul2022 for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Pt came into the office 2 days later, with reddness, swelling, and a very painful arm, not feeling good.  Pt was given Vicodin and taken off work for 2 days.
Initial report received on 11/Aug/2006 from a health care professional. A five-year-old female patient with no known allergies and no illnesses had received a fifth intramuscular dose of Daptacel, lot number C2243AA, in the left thigh on 09/Aug/2006. Concomitant vaccines received that day were a fourth dose of IPOL, lot number X1240, in the right thigh, and a second subcutaneous dose of MMR II (manufacturer reported), lot number 0634P, in the right thigh. The patient experienced a two and a half raised reddened area with itchiness 48 hours post vaccination. The adverse events occurred in the left thigh where the Daptacel vaccine was administered. The patient was evaluated by a physician that day, and prescribed benadryl and cool packs to the area. The recovery status of the patient was reported as not recovered. Follow-up information received on 01/Sep/2006 from a health care professional. Per the reporter, the patient's parent had reported itching and rash at the "injection site only". It was treated with Benadryl and resolved in three days. The patient had experienced no further symptoms and recovered from the event.
Fever and large baseball sized knot in arm. Very large red welt, extremely hot and painful at slightest touch
Symptoms occurred about a week after the first AND the second covid vaccination.   Lot number of first is EI9262 and of second (as above) EN6201.     In addition to expected fatigue and chills (I experienced no sore arm or fever)  I developed symptoms of gallbladder attack with extreme abdominal pain and vomiting.  These lasted for just over 2 days.
redness at injection site; swelling at injection site; pain at injection site; flu like symptoms; chills; body aches; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received Shingrix. On 24th July 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, influenza-like symptoms, chills and general body pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain, influenza-like symptoms, chills and general body pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, influenza-like symptoms, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the GSK employee for his/her relative. The patient received Shingrix later that same day, the patient experienced pain, swelling, and redness at the injection site. The patient also experienced flu like symptoms described as chills and body aches on the same day. The patient, a relative of field employee gave permission to contact their physician and provided correspondence contact details for the same.
Information has been received from the mother of a 6 year old male with no known allergies and no concurrent medications who on 02/18/2002 was vaccinated with varicella virus vaccine live. Prior to vaccination, the pt was exposed to an outbreak at his school and to a child who had an outbreak on 02/17/2002. On 02/28/2002, the pt developed 3-5 lesions and headache. A few days later, the pt had 120 lesions. Unspecified medical attention was sought. Additional info has been reqeusted.
pain at injection site (for 1-3 days)/Pain during injection of second dose; More fatigue; Some stomach discomfort; Flushing- redness of face; This is a spontaneous report from a non-contactable consumer (Patient). A 68-years-old (non-pregnant) female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Unknown) 07Apr2021 at 14:45 via an unspecified route of administration in the left arm as DOSE 2, SINGLE for COVID-19 immunisation (age at vaccination:68-years-old). The patient medical history included unspecified allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination.Previously the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Unknown), via an unspecified route of administration in the left arm on 10Mar2021 at 15:15 as DOSE 1, SINGLE for COVID-19 immunisation. After the first dose, the patient experienced pain at injection site (pain at site for 1-3 days), slight swelling at injection site and fatigue. The patient concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin and ibuprofen since an unspecified date for unknown indications. On 07Apr2021, the patient experienced pain during injection of second dose, flushing-redness of face. The patient also experienced pain at injection site (for 1-3 days), fatigue, some stomach discomfort. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events flushing-redness of face, more fatigue and "some stomach discomfort" was unknown. The outcome of the event pain at injection site (for 1-3 days)/Pain during injection of second dose was resolved on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
had COVID twice. She was worse both times.; had COVID twice. She was worse both times.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had COVID twice. She was worse both times.".  Clinical course: Reporter had a friend who fits nearly all of high risk areas. He is an overweight, diabetic, that uses a CPAP machine to sleep. He and his wife have had COVID twice. She was worse both times. She is vaccinated he is not. Reporter asked about side effects treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
fever; arm pain; vomiting; diarrhea; body aches; was not able to sleep; This is a spontaneous report from two contactable nurses via a Pfizer Sales Representative. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration in arm on 03Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever, arm pain, vomiting, diarrhea, body aches, not able to sleep on 03Jan2021. Approximately 24 days ago, the patient received shot in dominant arm. Within hours that arm was sore and hard to move without pain. Could not get keys out of pocket without pain. Pain continued for 12 days. 3 days ago, same patient got second shot in non-dominant arm to avoid the lack of mobility. 5 hours post shot, arm pain, vomiting, diarrhea, body aches and a fever of 104. Doctor was not able to sleep due to all side effects. The patient underwent lab tests and procedures which included body temperature: 104 on 03Jan2021. The outcome of events was unknown.  Information about Lot/Batch has been requested.
On 5/19, there were two lumps grew on his left neck.   He visited his family doctor on 6/2, and some exams were done.  He got the exam report on 6/3.  It showed that his hemoglobin dropped to around 12, and he is severely dehydrated.    Second Covid shot on 6/6/2021,  2 weeks later, he couldn't walk any more due to weakness and pain, around 6/21/2021.   He went to the family doctor on 7/7, and did more test.  His hemoglobin dropped to around 11 as the result showed on 7/8.  He was sent to the emergency room at  Hospital on 7/14.  He found 1 lump in his brain and he was admitted to the hospital immediately.   He was diagnosed lymphoma. There was no treatment.  He was transferred on 7/15.  They found 3 lumps in his brain.  There was no treatment.  He was then diagnosed Goblet Cell Adenocarcinoma.   He was then transferred on 7/15 at 3am.   He had open skull surgery on 7/28, and there 7 tumors in his brain, 1 in his right eye, and numerous in his body.  No treatment.  He passed away on 8/19.
Systemic: Fever-Severe, Systemic: neck and back pain; fever over 102.4-Medium, Additional Details: patient has complained of fever over 102.4 even after alternating Motrin and Tylenol around the clock.  Also moderate to severe neck and back pain
8pm - Severe body aches began and skin sensitive to touch  10pm - Temperature begins to climb and chills start 12am - Tylenol taken  1am - Temperature reaches 103.1  3am - Temperature begins to decline  Next day: extreme fatigue, chills continue, low grade fever (99.5-100.4), pain at injection site, and vomiting (3 episodes)
Patient is a 58 yr old female presented to ED on 12/27 with SOB and hypoxia.  Patient was tried on BiPAP but was still hypoxic in the 60s hence was intubated in the ED.  COVID was positive.  Patient admitted to ICU and self extubated yesterday was placed on 6 L nasal cannula.  Patient is doing better she has been nitroglycerin gtt. for hypertensive emergency which is improved.  Transferred to intermediate care and PRIVATE is consulted for transfer of care.   Covid-19 Virus Infection Severe sepsis - POA Date of onset of symptoms:  Symptoms present on admission: SOB Date of covid positive test: 12/27/2022 Vaccination status: vaccinated Imaging: CXR showed pulmonary vascular congestion with left lower lobe atelectasis and/or airspace disease CT PA negative for PE, did show partial collapse of the bilateral lower lobes with superimposed consolidative opacities along with multifocal areas of groundglass opacity. Oxygen requirements on admission: Intubated Current oxygen requirements: 3 liters nasal cannula Home oxygen: 2-3L baseline Medical therapy: steroids and rocephin Consultants following: ID Anticipated special isolation end date: 01/05/2023  Recheck PCT wnl, ok to dc home per ID recs off abx. Complete steroid course for 10 total days. Medically stable for dc home   Acute on chronic respiratory failure with hypoxia Secondary to above Patient intubated on admission Self extubated on 12/29/2022 Patient currently on 3 L nasal cannula Wean as able to home 2-3L Procalcitonin 0.54, recheck today wnl. Chest x-ray and CTA as above Patient initially was started on cefepime and vancomycin De-escalated to ceftriaxone, ok to stop on dc.   Nonischemic cardiomyopathy with combined systolic and diastolic heart failure with recovered EF Echo in July 2022 showed EF of 60 to 65% BNP 4100. Echo showed concentric LVH EF 50+/- 5% Continue atorvastatin, Coreg, lisinopril and hydralazine Coreg dose reduced given bradycardia. On Lasix 40 mg daily IV, on 20 PO BID at home Resume PO lasix on dc.  Hypertensive crisis Was initially on nitroglycerin gtt. Weaned off, BP improving Nifedipine, hydralazine and coreg resumed Reduced coeg dose. Tolerating IV lasix well, on  Resume home PO lasix on dc.   Elevated troponins Troponin of 27 -- > 37 EKG nonischemic Likely demand ischemia secondary to acute infection Echocardiogram with EF of 50% and grade 2 diastolic dysfunction   Paroxysmal A. fib Takes Coreg 25 mg twice daily at home Dose decreased to 6.25 due to bradycardia Home Eliquis resumed   Hypertension Takes Coreg, hydralazine and nifedipine at home Coreg dose decreased due to bradycardia, continue hydralazine and nifedipine On IV lasix, resume home PO on dc. Added lisinopril    OSA with obesity hypoventilation syndrome Obesity with BMI of 34.49 Patient unable to complete sleep study outpatient advised patient to follow-up with PCP. Uses CPAP at night at home  Type 2 diabetes without long-term insulin use Takes metformin 1000 mg twice daily at home Hemoglobin A1c 6.5 Continue sliding scale insulin while inpatient
nausea; felt tired; Rash is red and she can feel bumps; rash is red and she can feel bumps; pain at the injection site; itching going on in my face, my left arm, in the elbow / stomach about 2 inches to the left where they made the incision for the cancer removal; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL9269), via an unspecified route of administration into left arm on 06Feb2021 (at the age of 67-years) as a single dose for COVID-19 immunization. Medical history included allergic to peanuts, allergic to Penicillin, cancer and hysterectomy. There were no concomitant medications. The patient previously took vancomycin, cefalexin (KEFLEX) and zelnorm and was allergic. On 06Feb2021, the patient had pain at the injection site, but that was gone now. She also experienced rash, which was elaborated as an itch, like a rash that started since she got the shot. She had the itching rash going on into her face, left arm, the elbow, and also 2 inches from naval on the left side where she had incision from cancer removal, hysterectomy. The rash was started in the area of the hysterectomy. The patient elaborated that the rash was red and she can feel bumps. The patient was taking diphenhydramine hydrochloride (BENADRYL) which usually stop the itching. Last night 06Feb2021, the back of her left elbow and her face started itching as well and at 23:30 the patient experienced nausea and felt tired. The patient is scheduled for second dose on 27Feb2021. The clinical outcome of event rash is red and she can feel bumps was not recovered. The outcome of pain at the injection site was recovered in Feb2021. The clinical outcome of other events was unknown.
Patient experienced a small rash and itching around site of vaccine on left arm on 2/27/21. Then at 2:30 am on 3/2/21 patient woke up to significant facial and lip swelling and hives. NO shortness of breath or difficulty breathing.  AN outside provider started patient on Benadryl and prednisone.  Symptoms resolved over the following 3 days.  Patietn had never experiences allergic reactions in the past or lip/facial swelling.
Diffuse rash legs, Abd, back. Slight increased erythema right thigh at site of vaccine given 2 weeks ago.
11x11 cm area of erythema and swelling with central large vesicles over 3x3 cm base
Sore arm within 15 mins of receiving vaccine. Developed a rash on the arm that received vaccine approx eight days after injection. Rash was on my left upper arm as well as a 2" x 2" square around the injection site.  Today is about four weeks out from first dose and I still have pain in my left arm, it hurts to touch my skin.
PATIENT CALLED THE PHARMACY AND STATED SHE HAD BROKE OUT IN BLISTERS ALL OVER HER TRUNK AND ARMS; INJECTION SITE WAS RED; NO FEVER WAS REPORTED
presented w/whelps on face, trunk, extremities about 1hr post recv inj;
Every time I work out or my heart rate goes up, I get incredibly dizzy, lightheaded, and I feel like I?m going to pass out.
I'm self reporting this and didn't need emergency medical attention. About 20hrs after receiving the shot I started to run a low grade fever floating from 99.5-100.5F; I normally average around 97.5-98F. Thursday night/Friday morning I had the most prolonged fever break I've ever had; my entire bed was soaked.  Fever was gone by Friday sunrise.   Saturday I experienced a sever headache, stomach ache and in the evening shortness of breath. I felt extremely light headed. All symptoms cleared by Sunday.   I just drank plenty of fluids and rested as much as possible.
Fever of 101.4; Chills; A report was received from a consumer on 19-01-2021 concerning a PATIENT AGE 78 years old, Male   was participating in the mRNA-1273 Emergency Use Program and experienced Fever and Chills.  The patient stated that first dose had antibodies from previous COVID infection  The patient was treated with acetaminophen 1 Gm afebrile next day for the events.  The patient received their first of two planned doses of mRNA-1273 on  unknown date , Unknown route,  LOT/BATCH Lot number 039k202a  for prophylaxis of COVID-19 infection.  The Chronological order of the events were fever and chills.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events were unknown.  Report Source- Non-Health Professional,   Age- 78 Years,  Sex- Male,   Suspect Drug- Moderna COVID-19 Vaccine,   Treatment : acetaminophen 1 Gm Diagnosis  : Fever and chills Outcome - Unknown.
it was rpt fr mom concerning pt who was vax & approx 2wks following pt developed shingles. no further info avail
first excursion was due to leaving the vaccine on the counter for 1 hour; Initial information received on 04-Feb-2022  regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves patient with unknown gender who first excursion was due to leaving the vaccine on the counter for 1 hour while receiving vaccine [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ759AB via (unknown strength, dosage, administration site) for prophylactic vaccination.   On an unknown date the patient had excursion which was due to leaving the vaccine on the counter for 1 hour (product temperature excursion issue) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (first excursion was due to leaving the vaccine on the counter for 1 hour).  At time of reporting, the outcome was Unknown for the event first excursion was due to leaving the vaccine on the counter for 1 hour.
(LD) headache, fever, chills, hot-to-touch, painful Tx with KEFLEX.
Moderna covid vaccine given on 4/24/23 was a 0.2ml dose with the wrong vial (pink top Bivalent) but should have been 0.25ml with blue top. This change was implemented on 4/20/23 and we were unaware of the vial and dose change. Patient needs one more dose as she is currently now considered undervaccinated.
Narrative: Patient received Moderna vaccine on April 7th. On May 19th patient reported that day after after vaccine, he developed weakness & nausea. 2 days after receiving the vaccine, he said he had balance problems and extreme fatigue (slept for 32 hours straight. he was tired and nauseated for almost a month - at the time of reporting patients symptoms had completed subsided.
Whelping rash to hands, arms, chest, back, legs. Itching to face. Rash present before injection. Symptoms occurred within one hour post injection. To ER. Given Benadryl 12.5/5cc tsp qid for 5 days. (History received from Nurse Practitioner and ER record)
Half dollar sized red area with raised small bumps within reddened area, at site of varicella immunization.
On January 15, I noticed a rash on my  left arm, neck and face. Symptoms  persisted for one week, then the rash traveled through my whole body and continued to worsen everyday. It is swollen, itchy and red and continues this way now.