chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels like a bubble under my skin and like the size of the may be a golf ball; not hard like golf ball but the little bubble is that that big around; place where I got the shot is pink and very warm; place where I got the shot is pink and very warm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer.), for COVID-19 immunization. The following information was reported: SKIN DISORDER (non-serious) with onset Jan2023, outcome "unknown", described as "feels like a bubble under my skin and like the size of the may be a golf ball; not hard like golf ball but the little bubble is that that big around"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Jan2023, outcome "unknown" and all described as "place where I got the shot is pink and very warm".  Additional information: Concern: Consumer stated, "I got a Booster shot (Pfizer COVID-19 Vaccine) on Thursday this week and the place where I got the shot is pink and very warm and feels like a bubble under my skin and like the size of the may be a golf ball." Consumer stated, "Yes, it is not hard like golf ball but the little bubble is that that big around."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
31OCT-present flu sx, sinus, muscle, temp 101-102, swollen upper arm-some general sickness;
03/08/2017, Patient presents today with cold symptoms x 3 days. Associated symptoms include sneezing, nasal congestion, runny nose, productive cough and fever, but no dry cough, no ear pain, no nausea, no vomiting and no diarrhea. Male toddler, fever started 3 days ago with temperature 100-101, runny nose, cough and occasional wheeze. Cough is worse at night and sounds barky to dad. Throughout the day he is still playful, active and eating and drinking normally but the cough is concerning to them. Did notice him wheeze yesterday and gave him a breathing treatment. They felt the treatment was helpful. Has not noticed a wheeze today.
On 10/29/2001 pt received pneumococcal and flu vaccines. Developed swelling, redness, pain and fever at pneumococcal injection site. Flu vaccine was given in opposite arm without problem. Medical record flagged for no future doses of pneumococcal vaccine. Report filed with FDA.
Pt had redness at inj site after MMR inj, no swelling.  Pt has latex allergy. No latex used in conjuction w care of this pt, but this facility is not latex free.  Pt remained on site for approx 30 minutes, redness subsided completely.  I gave pt my tel # to call w any questions or concerns.  Instructed pt to call 911 if any hives or s/sx allergy occured. I contacted pt by phone 2, 4 & 8 hrs after she left my office.  She reported she was fine.   The next morning she called my office & reported Lymph nodes slightly swollen, feeling tired, and sweating & chills.  I instructed her to remain home from work (work related measles exposure)as I was concerned for active measles. I instructed her these symptoms can opccur w MMR but usually 7-12 days after immunization.  I instructed her to f/u w her primary care physician if she had any further or worsening of symptoms or high fever.  Spke w health department to report status.  It was not reccommended to draw labs at this time.  I called pt at approximately 10 am & 12:30 pm this day, pt reported feeling progressively better as day went on.
Runny nose; Sleepy; Sore and achy body; "Left arm is sore"; Mild headache; Very tired; Mild diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP-6955) via an unspecified route of administration in the left arm on 08Apr2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included sjogren's (rheumatological condition) and allergy to bee stings. The patient received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP-6955) via an unspecified route of administration in the left arm on 18Mar2021 at 13:15 as a single dose for COVID-19 immunisation. 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 vaccination. On 09Apr2021 at 07:00, the patient's left arm was sore and experienced mild headache, runny nose, sore and achy body, mild diarrhoea and was very tired/sleepy. 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 "left arm is sore", mild headache, runny nose, very tired, sleepy, sore and achy body and mild diarrhoea were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Itching, redness in about 3 ? diameter at site of injection ( Covid arm).
Neck Stiffness; Neck soreness; This case was reported by a pharmacist via call center representative and described the occurrence of stiff neck in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th June 2022, the patient received the 2nd dose of Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced stiff neck and neck pain. On an unknown date, the outcome of the stiff neck and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the stiff neck and neck pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: The pharmacist reported this case for himself.  The patient reported he received the second dose of the Shingrix vaccine and had been experiencing neck stiffness/soreness. No other information was given during encounter. The reporter denied giving information.
Had a patient that after receiving the Fluvirin vaccine experience a "Funny, weird taste" (as she described). She came back to the pharmacy 30 minutes later and said she feel it two more times but then stopped, no any other symptom. I called Novartis same day and they call back is a side effect not listed but a possible side effect and is being reported before. They reported and told me if happening again they want me to let them know.
PATIENT STATES SHE HAD LOST USE OF BOTH LEGS  FOR APPROXIMATELY 2-4 WEEKS AFTER RECEIVING VACCINE. STATES THAT SHE STILL HAS LASTING EFFECTS OF WEAKNESS IN BOTH LEGS.
warm to touch; red; a little pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), PAIN (a little pain) and ERYTHEMA (red) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Stent placement. Concurrent medical conditions included Diabetes.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (a little pain). On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch) and ERYTHEMA (red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to touch), PAIN (a little pain) and ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: NNI
arm numbness or tingling, similar to what was reported for Guillain-Barré syndrome. Always since vaccination
On 6/9/2021 she developed symptoms of severe sore throat,productive coughing,fatigue and nasal/chest congestion.  No fever
Morning after injection, I sat down at the breakfast table and said to my husband"  I can see you, but everything else out the windows (there is a bank of windows surrounding table) is completely grey....I can't see trees or house next door."  The next I knew he was peeling me off the floor after I completely fainted and fell off my chair.  No injury other than small bruises and head bump.  He got me back to bed and doctor was not needed.
Large area of induration/erythema left deltoid extending down to the elbow, entire circumfrence of the arm.
Fever up to 105 degrees F and severe joint pain for almost 24 hours and still ongoing.
Information has been received from a licensed practical nurse (LPN) concerning a patient who in November 2008, was vaccinated with PNEUMOVAX. The patient had random lot number (lot number not provided). The patient developed severe cellulitis reactions immediately after or by the evening of the PNEUMOVAX administration. The patient had symptoms, which included swelling, redness, pain and heat at the injection site. The patient was treated for cellulitis and was put either on an (unspecified) antibiotic and/or (unspecified) steroid. The outcome of the patient's adverse reaction was not reported. Follow-up information was received from an office manager who confirmed that several patients had injection site reactions. Follow-up information was received from the licensed practical nurse (LPN). It was reported that on 23-DEC-2008, at 14:00, a 41 year old male was vaccinated SQ with the first dose of PNEUMOVAX (lot #: 662663/0980X). Subsequently, the patient developed redness, fever, edema and was diagnosed with cellulitis at a clinic. The patient was treated with antibiotics with symptoms lasting for 7-10 days. At the time of this report, the patient was recovered. This is one of several reports received from the same source. The nurse requested a lot check. Additional information has been requested.
Adverse event: Right foot reveals a large nodule present to the central aspect of the forefoot fat pad. Measures approximately 1.7 cm in diameter. Firm in nature. Appears to be independent of the plantar fascia. Slight blue hue to it. Treatment: Surgery for excision of the plantar mass. Outcomes: Plantar mass was removed and on-going recovery.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2008, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster. During 2016, the patient was treated by a physician, for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. 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.
Runny nose, fever, fussy, red dime-sized circle on left thigh at Prevnar site. Dx'd with URI and Prevnar reaction, approx. 1 cm in diameter.
This spontaneous report was received from a nurse practitioner refers to a 69 year old female patient. On an unknown date in september 2012, the patient was vaccinated with (Merck) VARIVAX, (lot number, expiration date and route not reported) instead of ZOSTAVAX, (lot number, expiration date and route not reported) due to human error. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Lasting 3 days: Severe migraine, loss of appetite, nausea, dizziness, chills, fever, myalgia, arm pain/tingling/severe stiffness in both arms, severe fatigue and joint pain. Lasting 7+ days: joint pain, fatigue, headache.
Done at medical facility. We do not have the lot number or vaccine site. This was pt's 3rd dose .5ml. Pt had cough for 5 days starting on 12.13.21 after receiving vaccine. She took delsum in the AM, on her way to work she felt dizzy and reported blurry vision. She called  emergency number
pt had a positive COVID test on 2/1/22 from the Health Department; 3/3/22 pt brought to ED via EMS due to respiratory distress; EMS witnessed syncope with the pt; weak pulse; intubated; O2 via ambu bag; pt unresponsive; shock; head CT negative; found to still be positive for COVID in ED; placed on mechanical ventilation; given medications for hypotension and shock; suffered cardiac arrest; CPR and full code performed; pt didn't respond; family chose to stop CPR and code due to pt not responding; pt passed away in the ED on Hospital
I have had all of my vaccinations with pharmacy. Almost immediately after receiving it, I could tell it was administered way too high up on the arm. Around an hour after receiving my vaccine, while at my next appointment, my arm became painful and was burning. I came home and iced my arm and just figured that it was administered too high up, but it just kept getting worse and worse. I've seen a joint surgeon and my primary care doctor. The joint surgeon stated that the vaccine went into the tendon. It has continued to get worse. He says that the tendons have shredded and I'm possibly looking at surgery for correction. He did and MRI, which is what led him to state that the tendons had become damaged. He has given me 2 Cortisone injections, but they have not really helped.  I am seeing him again at the end of this week.
redness and heat at the injection site or a quarter inch away; itchy; redness and heat at the injection site or a quarter inch away; A spontaneous report was received from a consumer concerning a 94-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced itchy, redness and heat at the injection site.   The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on 30 Dec 2020 in the left arm for prophylaxis of COVID-19 infection.   A consumer who is the patient called to report she received the Moderna COVID-19 vaccine on 30 Dec 2020. On 08 Jan 2021, she reported her arm was itchy, saw redness and felt heat at the injection site or a quarter inch away from the injection site.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The events, itchy, redness and heat at the injection site, were considered unknown.   The reporter did not provide an assessment of the events, itchy, redness and heat at the injection site.; Reporter's Comments: Based on the established safety profile and a temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded.  Injection site pruritus and injection site redness are consistent with the known safety profile of the vaccine.
This spontaneous report as received from the registered nurse refers to an unspecified number of patients of unknown gender and age. Information about the patients medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB (dose, dose number, lot/batch# and expiration dates were not reported) after being improperly stored. Information about concomitant medications was not provided. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information is not expected as no consent for contact was given.
After work I came home made supper, cleaned and because we recently moved I was unpacking boxes wheb I started noticing sharp, throbbing pains to my feet and legs, I work 12-16 hour day shifts as a nurse I wear compression to minimize pain and swelling from being on my feet constantly but this pain was different. I had to stop what I was doing I got into shower immediately felt like my heart was pounding and I was surely going to pass out. My husband helped me back to bed we took my temp, it read at 104.1, my O2 sats were 92/RA, B/P: 188/44, P: 144, R: 18-20, I felt dizziness, my right arm not my left where I gotten the booster, was completely numb. I took Tylenol, interchanged with Motrin, went to sleep, woke up a few hours later my temp was at 99.1, I felt hungry and calm. Only two hours from that time about 0500 my temp went back up to 103.9, I did the same regimen also pushed fluids and rested. What is striking me as off is the degree of bone and muscle pain, I had some with the second dose but this is bad my skin even hurts. Dry eyes, exhausted, extreme pain in my upper and lower back and feelings of mentstral cramping but I no longer get a period, my teeth even hurt my teeth are aching.
Within 5 minutes of vaccination employee became SOB, pale, weak, rapid heart rate, dizzy and diaphoretic. Pulse ox 98%, HR in the upper 100's, O2 2L via N/C applied.
fever of 101 F; This is a spontaneous report received from a contactable consumer (Husband). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unspecified date, the patient experienced fever of 101 f. Reporter called on behalf of wife who received the second dose of the Pfizer covid vaccine yesterday and currently had a fever of 101 F. Asked if ok to give advil. The patient underwent lab tests and procedures which included body temperature increased: 101 fahrenheit. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Fever, nausea, vomiting, shaking - blacked out x 3, CP, throat swelling - ER was give ZOFRAN, SOLU-MEDROL, BENADRYL, TACLONEX, PEPCID.
Pt with tuberculosis, who was vaccinated with one dose of varicella virus vaccine live and MMR, subsequently found out that she was pregnant.
Breakthrough case admission after 3 vaccines Moderna 1/14/21 Lot# 012L20A;  Moderna 2/11/21 Lot# 010M20A;  Moderna 12/30/21 Lot# 033H21A
Left arm red, swollen, warm to touch. MD. measured 16 1/2cm x 15cm. Applied ice pack, Q-Dryl prescribe by MD.
This spontaneous report as received from a physician assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided). On an unknown date, the day after the patient received ZOSTAVAX, the patient developed Arthus reaction to ZOSTAVAX. The patient presented with "arm really swollen" to clinic. The outcome of Arthus reaction was unknown. Additional information has been requested.
Intransigent migraine for five days following the second shot that wouldn?t respond to usual medication regimen
Hives and swelling began on forearms and hands 12/27. By evening hours, full arms and hands were swollen.  12/28 went to medical facility and received prednisone taper.  Hives and rash had spread to feet, thighs, trunk.  12/29 went to ER because antihistamine and steroids were not controlling itch and swelling spread to the face.  Received IV steroid, antihistamine and antacid.  Sent home to continue prednisone and remain on Benadryl.  12/31 at 0330 went back to ER for lip, tongue , mouth swelling and tightness in chest in addition to uncontrolled itching and hives.  Received IM epinephrine, IV steroid, antacid and antihistamine.  Continued on round the clock oral prednisone, topical creams, antihistamine and antacid at home
6 cm redness & induration of site of Pneumovax. Fever 102-103, evening after the shot and the next day. Nausea & vomiting for 2 days, general malaise. Received IV fluids and Phenergan for nausea and improved.
I felt very fatigued and some nausea not a great deal. I had vertigo and experience increase tinnitus. The fatigue was the biggest part of it. There were some headache, and I have a history of migraines.
Patient came in on 9/17/2019 to get a rx for Cephalexin and she told me that the Urgent Care Doctor said that it was from the flu shot. Patient said redness in area of injection site was getting worse and that is why she went to the doctor. Left message with patient on 9/21/2019 to follow up.
Pt complained of "scratchy throat , swelling of face and mouth" Stated had had flu vaccination at 10:30 am and now felt post nasal drip and above symtoms. Vital signs taken with B/P 120/70, Pulse 80, Resp 24. Lungs clear to auscultation. Patient alert, oriented and in no respiratory distress. Given Benadryl Elixir 50 mg po at 3:15pm. Slight amount edema to  area around mouth- no edema to lips or tongue. Contacted area ambulance via 911 and transported to Hunterdon Med Center at 4:15 PM.Pt. escorted ambulatory to waiting ambulance outside. Given Benadryl Elixir 25mg before leaving with ambulance squad.
On 3/25/2021 POC alleges that the resident begin to develop fever and urine infection. He was transferred  to the hospital on 3/26/2021 where he had white secretions in his mouth. On 3/28/2021 he died in the hospital from respiratory cardio failure.
Experienced slightly swollen and sore arm, headache and muscle aches after the initial injection for approx. 48 hours.  No fever.  8 days after the injection I experienced a swollen, sore red patch on my arm and muscle aches and headache again.  Today is day 3 of the delayed reaction and the redness and swelling has subsided.  I am still feeling achy and tired, along with shakiness and nausea.
Hearing loss; Vertigo; Dizziness; Aural fullness; This is a literature report.  A 55 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Meniere's" (unspecified if ongoing), notes: 5+ years - stable. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss"; VERTIGO (non-serious), outcome "unknown", described as "Vertigo"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; EAR DISORDER (non-serious), outcome "unknown", described as "Aural fullness". The events "hearing loss", "vertigo", "dizziness" and "aural fullness" were evaluated at the physician office visit.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  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.
12:00 yesterday, pressure across bottom of chest, heavy sweat, shakes, 101.4 temp, lost 10 pounds