chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tumor feels bigger; Product use error; lung congestion/ coughing- 30 minutes; lung congestion/ coughing- 30 minutes; i start cough/wheeze; This is a spontaneous report from a non-contactable Healthcare Professional (Clinician/Other HCP). An adult female patient received second dose of BNT162B2 (PFIZER COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization, and palbociclib (IBRANCE, Capsule) orally from 01Jun2021 and ongoing at 75 mg daily for breast cancer (off label dosing). The patient's medical history included ongoing asthma, blood pressure, black circles around eyes/bridge of nose, severe dry skin and itchy red rash. Concomitant medication included fulvestrant (FASLODEX, Injection). The patient previously took hydrochlorothiazide for blood pressure and experienced skin cancer, and astaxanthin 12 mg daily. Verbatim and event description or product use error was reported as "Tumor feels bigger, not sure if related to covid vaccine- second one 2 weeks ago. Tumor markers fluctuate. Lab in 2 weeks. MD aware. Current dosing: 75 mg daily for 21 days and off 7 days with FASLODEX injections. Off label dosing. Patient reported that " had huge issues with skin- skin was fine, itchy red rash then resolved. Local pharmacy- organic/homeopathic advised astaxanthin 12 mg daily anti-inflammatory had cleared up the skin. Blood pressure medication hydrochlorothiazide, had side effect skin cancer, so cardiologist switched back to previous medication. She went to dermatologist and was so happy with skin. So with the change in blood pressure medication and astaxanthin. Rash has cleared, black circles around eyes/bridge of nose, then used vita rich serum- sensitive skin, had helped her severe dry skin, wrinkles had helped. Had lung congestion/coughing- 30 minutes after taking dose. She started cough/wheeze, clear throat notice at night when sleeping; she had a history of asthma. Outcome of the events was unknown.  Follow up attempts are needed, Information on the lot/batch number has been requested.
Leg pain, edema. Rt leg (site of injection) so tender, that pt refused to walk on it.
Reaction began locally at site of injection with redness and swelling. Then rash developed at site of injection.  The next day the rash spread down the right side of the body and then to the legs.  Patient was seen on 1/10/11 for treatment.
Directly after the shot I had no soreness of the arm like I had the first shot. Around 7 p.m. (the day of the vaccine) I had joint pain on my left wrist and left elbow. I also had joint pain on my left knee and left toes. Additionally, I had muscle pain on the back of my left thigh. Around 12 a.m. my whole body experienced joint pain and muscle pain. Additionally, I had a fever. That morning, I had an excruciating head ache which continued into the night. Also the body aches continued into the night. Throughout the day of April 17, I treated symptoms with Tylenol, which only relieved pain slightly. On April 18, I felt fine.
This vaccine was administered in the right thigh.  This area was red, warm, swollen. 1-2 days later.  Patient placed on Benadryl and Keflex.
Vasovagal syncope during fingerstick procedure approximately 3 minutes after HPV #1 IM injection. Pt noted to be shaking and not responsive, immediately laid down and immediately began to respond. No loss of urine, no previous hx of seizures or fainting. BP 110/70, pulse 71, Sat 100%. No post ictal period. Feeling fully recovered in a few minutes. Stayed lying down x 20" 98/68, 62, 98%. Sat up x 20" 100/70, 71 and 99%. Felt well and stable when left office.
Injection site feels hot; Redness at injection site; Swollen arm at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site feels hot), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swollen arm at injection site) and VACCINATION SITE PAIN (Soreness at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007621A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site feels hot), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swollen arm at injection site) and VACCINATION SITE PAIN (Soreness at injection site). On 30-Apr-2021, VACCINATION SITE SWELLING (Swollen arm at injection site) and VACCINATION SITE PAIN (Soreness at injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site feels hot) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient started experiencing redness, soreness, and swelling about an inch long and wide at the injection site on 27 Apr 2021. The soreness only lasted for 3 days but her arm was still red and hot as of 11 May 2021.  Treatment medications were not reported.
About an hour after vaccine became very light headed during shower. Got out of shower and felt fine. Also became somewhat lightheaded when driving the day after. Left arm quite sore.
Lt swollen hot red arm, fever 105, flu like sx; Hospitalized x 3 days; dx prob cellulitis; tx ATB
hallucinations; I did not sleep for the rest of the night; tired; laid in bed borderline shaking; afraid someone was in my home; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2022 11:00 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Vaccination history included: Bnt162b2 (Dose 2; arm left), administration date: 04Sep2021, when the patient was 20 years old, for Covid-19 immunization; Bnt162b2 (Dose 1; arm left), administration date: 05Aug2021, when the patient was 20 years old, for COVID-19 immunization. The following information was reported: HALLUCINATION (medically significant) with onset 11Feb2022, outcome "not recovered", described as "hallucinations"; INSOMNIA (non-serious) with onset 11Feb2022, outcome "not recovered", described as "I did not sleep for the rest of the night"; FATIGUE (non-serious) with onset 11Feb2022, outcome "not recovered", described as "tired"; TREMOR (non-serious) with onset 11Feb2022, outcome "not recovered", described as "laid in bed borderline shaking"; FEAR (non-serious) with onset 11Feb2022, outcome "not recovered", described as "afraid someone was in my home". A few hours after receiving booster the patient began to feel very tired. He drank roughly 120 ounces of water through the day to help minimize any side effects. When he went to sleep he woke up after a few hours and began to have hallucinations that someone was in his home. It took him about an hour to build the courage to do a walk through of the home to ensure than no one was there. He did not sleep for the rest of the night and laid in bed borderline shaking, afraid someone was in the home. He had never had any time of hallucinations before. He was a healthy individual, ate healthy and went to the gym three times a week. He had no history of anything even remotely close to this.Therapeutic measures were not taken as a result of hallucination, insomnia, fatigue, tremor, fear. The patient had not been tested for COVID-19 since the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
SEVERAL FAILED ATTEMPTS TO CONTACT THE PARENT/GUARDIAN WERE MADE.  VOICE MAIL WAS LEFT ON 5/16/2023- WILL INFORM PARENT OF ISSUE WHEN OUR CALL IS RETURNED.
Information regarding PREVNAR was received from a healthcare professional regarding an unspecified number of patients who were administered the vaccine that was exposed to a temperature of 1 degree C. for 2 days. The patients received a dose on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. An unspecified number of patients were administered the vaccine that was exposed to a temperature of 1 degree C. for 2 days (medication error). No additional information was available at the time of this report.
Discharge Provider: MD  Primary Care Provider :  MD   Admitting Service: Internal Medicine Service Admission Date: 11/2/2022 Discharge Date: 11/08/2022 PRESENTING PROBLEM:  Acute encephalopathy    HOSPITAL COURSE:   Patient is an 82-year-old male with a past medical history significant for hypertension, PCA CVA, dementia, alcohol use disorder remotely who presented to the emergency department with a chief complaint of 2 falls in the 48 hours prior to admission.  The patient tested positive for COVID-19 on 11/01/2022 with a home test.  He had mild symptoms of fever and dry cough.  His wife also was sick with COVID-19 and was unable to care for him due to generalized weakness and falls in the setting of dementia.  His memory issues had worsened with his acute illness.  He fell on the day prior to admission and hit his face per his wife's report.  He was brought to the emergency department.  In the emergency department, he was hemodynamically stable, not hypoxic and afebrile.  Complete blood count and CMP were unremarkable.  COVID-19 PCR was positive.  Urinalysis was negative for infection.  EKG showed normal sinus rhythm.  Chest x-ray was unremarkable.  CT head showed moderate volume loss and old right PCA CVA without acute process.  He was given fluids and Tylenol.  He was admitted to the hospitalist service for COVID-19 with fall and placement. PT/OT re-evaluated him on 11/07/2022.  They recommended Home with home health, eventually discharged home in relatively stable condition on 11/08/2022.
Extremely sore arm beginning the following day. So sore I could not lift it. Beginning 9/17/2021 My lymph nodes under my left armpit became very swollen and painful and has continued on without going away. On 9/20/21 exactly 1 week after injection I started having chest pain on the left side where my heart is. I have continued, since that day to have a fluttery irregular heartbeat with pain. I have felt short of breath and dizzy as well. I visited my cardiologist on 10/29/2021. I am waiting to have tests done.
1. Rash on both arms  2. some hair loss on left forearm  3. worsening of arthritis in hands, wrists, knees & back
Low grade fever; This is a spontaneous report from a contactable consumer (patient's husband) from Pfizer-sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation; metronidazole (manufacturer unknown), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 500 mg for an unspecified indication; doxycycline hyclate (manufacturer unknown), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 100 mg for an unspecified indication; enoxaparin (manufacturer unknown), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg for an unspecified indication. Medical history included skin infection. The patient's concomitant medications were not reported. Patient has gotten an appointment tomorrow morning to get her second Pfizer, Covid-19 (vaccine) shot and she just had an operation 4 days ago. Her doctor (said) that she could get the second shot after the enquire search to do so. But the problem was she had developed a low grade fever, she has "100" (not clarified) something temperature right now. When called after, they think it's from skin infection that she previously had and it's not from the operation but it might be. She was on three types of medications, the first antibiotic is Doxycycline 100mg, Metronidazole 500 mg, these two were antibiotics and the last one was, the third one, it's an injection and it's a type of blood thinner for blood clots, it Enoxaparin 40 mg syringe (injection). It was further stated by the reporter that it's not from the first vaccination that was 3 weeks ago and she was not having any symptoms. Reporter asked if his wife still can proceed with her second dose (14Mar2021) or should be rescheduled. His wife got her first dose on 21Feb2021 and had an operation four days ago 09Mar2021 and taking antibiotics. The action taken in response to events for doxycycline hyclate, metronidazole and enoxaparin was unknown. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on data provided, the event pyrexia is assessed as unrelated to BNT162B2 and is possibly related to metronidazole and/or doxycycline. This case will be reviewed. upon receipt of more information.
it doesn't feel right, it feels weird/weird symptoms in his back; Throbbing is consistent and is becoming more and more and more; Throbbing in lower back/throbbing was on his left side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EN6208) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2002 (ongoing), notes: asthma was diagnosed years ago. He thinks it was in 2002, maybe longer. There were no concomitant medications. The following information was reported: BACK PAIN (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Throbbing in lower back/throbbing was on his left side"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it doesn't feel right, it feels weird/weird symptoms in his back"; CONDITION AGGRAVATED (non-serious) with onset 19Mar2021, outcome "unknown", described as "Throbbing is consistent and is becoming more and more and more".  Additional Information: Caller reported the throbbing was by his kidney. He later clarified that the throbbing was on his left side, that it could be his kidney, liver, or lung, he didn't know. He reported that it doesn't feel right, it feels weird. At first after receiving the Covid-19 vaccine it was ok, the second day the throbbing in his lower back was off and on, and that today, 19Mar2021, the throbbing is consistent and is becoming more and more and more. Caller reported that he felt the throbbing in his lower back when he went to bed the night of 17Mar2021.  No follow-up attempts are possible. No further information is expected.
Day after vaccine was administered to R deltoid, pt developed pain, which was explained was expected. But decided to come when the pain, and the inability to fully move his arm and the tingling that developed to that arm after 7 days post vaccine.
Breakthrough case. Started coughing and running a fever, so took a home test and tested positive for COVID, 3 months after dose 4. Called Dr. the next day and had Telehealth appt, and was prescribed Paxlovid. Finished prescription and feeling better.
Systemic: Swollen lympnode in left axila-Mild, Systemic: Lymph Node Swelling-Mild
side effects, hit him pretty hard; pretty sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects, hit him pretty hard) and ILLNESS (pretty sick) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects, hit him pretty hard) and ILLNESS (pretty sick). At the time of the report, VACCINATION COMPLICATION (side effects, hit him pretty hard) had not resolved and ILLNESS (pretty sick) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       It was reported that the patient was having side effects. He was pretty sick after getting the shot and had hit him pretty hard.   No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2022-522567 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow up contains no new information.
Patient c/o numbness over right arm approximately 10 min s/p injection. Patient had good pulses, capillary refill, and No cyanosis or skin color changes.  She had similar reaction to the zoster vaccine in the past.
Itchy,swollen, red rash.  Still persisting 2/1/21
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a mild fever. The next day the pt experienced a varicella like rash that consisted of 50 - 60 lesions.
This case was reported by a physician and described the occurrence of arthralgia in a adult patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX QUADRIVALENT. This case is one of the 10 cases reported by the same reporter for the same vaccine. Additional information received: MD updating previous AE report of shoulder arthralgia in 10 patients following vaccination with FLUARIX QIV, with lot number and expiration date info. He was unable to obtain more information on the patients, though he states that they were all adults.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 04-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Pt recvd 3 doses of Engerix-B on 13FEB90, 15MAR90, & 22AUG90 for antibody protection against Hep B; 29MAR91 HBSAB RIA resulted in neg;
Information has been received on 10-JAN-2017 from a nurse regarding a 6 month old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 09-JAN-2017 the patient was vaccinated with a dose of ROTATEQ, lot number M029681 expiration 22-JAN-2018, unknown route for prophylaxis that was improperly stored. No adverse effects reported. No further information was reported. Additional information has been requested. Lot number M029681 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent.
After second dose about 16 hours after experienced chills bodyaches sore joints muscles and low grade fever and fatigue
Received vaccine 1-16-09 - On 1-21-09 came to office c/o mild fever for 1 day- Friday not feeling well post injection- falling a lot- Generalized rash- decreased appetite, some diarrhea
Small White bumps on legs at 7:00 AM. Red bumps too on legs later that first day. Spread to arms and feet the next day small white itchy bumps and red itchy bumps much like Hives for a little more than a week. Today, (12/15/09) Still have the bumps and itchy arms and legs, went to a family clinic to get it checked by P.A.
After administration of his DaPt booster and mantoux test, upon arrival at his home, less than 30 minutes his father how took him to be inmunized, started to notice welts over his arms and neck. The father contact the office right away and as we did not observe any breathing difficulty dyphenhydramine(Benadryl) in a dose of 5mgr/Kg?day was administer oraly.  I was able to exam him  30 minutes after the Benadryl dose. No  breathing difficulty and no wheezing was present , multiple polyform wealts were present in upper torso and both upper extremities. None in lower extremities. Patient had good capilary refill.  Instructions to continue Benadryl at 25 mgr po every 6 hours, and topical use of calamine lotion. Next morning hives were gone but left arm where DaPT was administered was erythematous, swelling but not warm to touch and did not look like an abcess was been forming in the area of injection. Instructions at that point were to apply warm compresses , continue using Benadryl as needed and any changes or temperature to contact Dr.
After 1st dose, 15 min later, right elbow hurt and right ring finger got real stiff, hurt and could not bend it.  After 2nd dose, both of my legs started to hurt, muscles got real tight and am having trouble walking.  This is still going on today.
Pt erroneously received expired Pfizer dose on 12/1/21. Staff contacted Pfizer to inquire if this lot batch were still viable at the time of vaccination provided.  Following discussion with Mfr,  pt did not need to be revaccinated as Pfizer Mfr had stability data to support this excursion for 1 day post expiry from manufacturing data.
Patient stated at time of administration there was slight pressure; no indication of allergic rxn during administration; patient stated swelling and redness occurred that evening; she took APAP that day and again the next day; iced down the arm as well on 2 days. Went to the MD on Tuesday, October 9th. Doxycycline 100mg bid x 7 days written for and filled on 10-7-18; Saw her arm--redness had gone down the arm and to the inside of the arm; hot to touch.
I went in to the clinic and I got the vaccine and sat there for 15 minutes and ended up with a bad headache in that 15 minutes. Then I went home and I fell asleep. I had a headache for 3 days from it. Then a week later, I had shingles on the right side under the breast around the ribs. The doctor gave me Elavil 25mg once daily for 7 days for the shingles and I was also given Valtrex 1000mg 3 times daily for 7 days. I took that and it started to go away until I had the 2nd vaccine and I broke out on the other side. I still have the shingle pain in the nerves.