chrisvoncsefalvay/vaers-outcomes huggingface dataset:
World's largest mosquito bite, welt 4" dia; hot to touch; painful; extreme itching; red; swollen/hard in thecenter; sleepiness; osteoarthritis; flair-up of mucous cysts on my fingers; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 07Apr2021 at 15:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (High BP), hereditary hemochromatosis, osteoarthritis, mitral valve prolapse (MVP), rheumatic fever (2 times), diverticulitis, acid reflux (oesophageal), irritable bowel syndrome (IBS) and osteopenia. Patient did not report any known allergies to food, medications or other products. Concomitant medications included dexlansoprazole (DEXILANT), metoprolol (MANUFACTURER UNKNOWN), solifenacin succinate (MANUFACTURER UNKNOWN) and diclofenac (MANUFACTURER UNKNOWN); all for unknown indication and from an unknown start date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 17Mar2021 at 15:30 (at the age of 64-years-old) 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 COVID vaccine. On 08Apr2021 at 13:00, the patient experienced world's largest mosquito bite, welt 4 dia, hot to touch, painful, extreme itching, red, swollen, hard in the center, sleepiness, osteoarthritis and flair-up of mucous cysts on fingers. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the event world's largest mosquito bite, welt 4 dia, hot to touch, painful, extreme itching, red, swollen, hard in the center, sleepiness, osteoarthritis and flair-up of mucous cysts on fingers were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Weakness; The weakness is mostly in my head like wooziness; Not feeling myself; Temperature; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (The weakness is mostly in my head like wooziness), FEELING ABNORMAL (Not feeling myself), PYREXIA (Temperature) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (The weakness is mostly in my head like wooziness), FEELING ABNORMAL (Not feeling myself), PYREXIA (Temperature) and CHILLS (Chills). At the time of the report, ASTHENIA (Weakness), DIZZINESS (The weakness is mostly in my head like wooziness), FEELING ABNORMAL (Not feeling myself), PYREXIA (Temperature) and CHILLS (Chills) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken for mRNA-1273 in response to the event was not applicable.  No concomitant medication was provided. Treatment medication was not reported by the reporter.   This case was linked to MOD-2021-044424 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Reporter's address was added.
Patient called stating after vaccination her arm hurt, right leg around knee hurts too. She stated a can was needed to get around. Furthermore, head, groin, lower back also hurts. No swelling at injection site.
Initial unsolicited report received from a consumer on 26 October 2015. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE (batch number, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient experienced an adverse event. Lab data and corrective treatments were not reported. Outcome of event was not reported. List of documents held by sender: none.
Pt received 3 vaccines on 10-14-14. Next AM noted red, swollen RA only. (10 AM). Had headache evening of vaccine date - MOC gave ibuprofen. Site was pink. Next AM went to school -arm noted by pt to be red/swollen. Did not go to nurse at school. Seen here after school. Still red/swollen. See note from nurse earlier. Vaccines yesterday - Tdap (L) deltoid. MENVEO (lower) and influenza (higher) in the (R) arm. Pain and some bleeding from MENVEO site when given. Patient changed Band Aid. Headache last evening and did not participate in her swimming. This am (R) arm with some redness, not tender till 10 am, after running at school. Had temp to 101 per Mom. After school arm red per mother and advised to come for exam. Smiling and joking with mother. (R) upper arm remarkable swollen and red. Upper puncture site (flu) is not center of reaction and is not as swollen as the lower puncture site which is more than an inch lower. Lower site is edematous and swollen. Lightly indurated with borders out 9 x 9 cm, pink but not esp hot. No pustule in center, no fluctuance. Moves arm. Local vaccine reaction to MENVEO. I do not feel that this is an infection. I discussed this with mother and she agrees with watching the site and not treating with antibiotics. It is possible that because there was some bleeding from the site yesterday that there was more opportunity for a reaction. Fever would be more likely due to the Tdap than the MENVEO. Certainly headache can be a vaccine reaction. Observe borders, call with enlargement. (Black dots were marked at the borders for reference). Ibuprofen for fever, headache, inflammation. Cool compresses - one was given here. BENADRYL 25-37.5 mg dosing in case there is local histamine release. We will file VAERS. Call with questions. Especially let me know if you think anything is worsening.
Swollen, red, area shoulder -> elbow 8cmx11cm treated with Allegra 30 mg BID
Pt vaccinated with FLUOGEN passed out at school. Taken to private MD for evaluation.
Immediately after receiving HPV9 (second dose) as well as intranasal flu vaccine, pt experienced near syncope and fully recovered at clinic.
Pfizer on 12/21/20 and 1/11. Positive on 9/2 admitted on 9/2 to current
Left deltoid area redness, warmth, pain, induration and itching at the injection site morning after injection given (12-30-2020).   Fatigue and mild headache were only other symptoms.  Affected area progressively got larger on day 3.   Took Benedryl 25mg and Aleve 220mg on 1-1-21, affected area better on 1-2-21 (day 3).   Swelling , redness, warmth, induration returned on day 7 (1-5-21) with left axillary lymph node swelling and tenderness.   Day 8 currently, redness and induration measures 2 3/4 inches by 1 1/2 inches.   Called occupational health to report.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 22-SEP-2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-JUL-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pt went to the ER on 4/19/21 with vaginal bleeding and cramping at approx. 6 wks gestation per LMP. HCG >7,000 on 4/19/21. Presented to clinic on 4/22/21 with chills, nausea, vaginal bleeding, sent for u/s, no IUP seen, HCG today 500.
Red, raised area shaped circle, approximately 2-5 inches, warm at injection site. MD was contacted both MD and RPh stated take antiinflammatory, antihistamine and ice pack.
client reports history of fainting with injections and blood draws. Client received her second dose vaccine and was in Observation unit: NP onsite remembered client from 1st visit client fainted at that time and was with client the minute client arrived in observation unit. approximately 15 mins after vaccination client reports feeling lightheaded and sweating. EMT on site as well  vitals monitored: at 1115am o2 sat 100%, BS118, BP 107/54 and HR of 63. AT 11:25am Vitals were: 02Sat 100%, BP  124/71 and HR of 69. Client remained in observation at 11:31 am BP 143/76 remained in observation an additional 20 mins. Was given drink and cool packs. CLient left facility at 1145am with her sister at her side, client reported she felt better at this time
This spontaneous report as received from a medical assistant refers to 2 patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unspecified date, the patients were vaccinated with a dose of VAQTA 25/0.5 (dosage form not reported) 0.5 ml intramuscular injection (location, lot number and expiration date not reported) that had been improperly stored. No adverse effects were reported. Additional information has been requested.
Patient a a tonic-clonic seizure about 2-4 hours after administration of the vaccine.  He was evaluated in the ER and discharge.  At this time no subsequent seizures.
Shingles rash on face and ear 10 days after vaccine. Treated initially with ABx and then with ZOVIRAX with improvement.
Red line coming down from injection site, approx 2 1/2 Long + 1" wide, soreness at site. 10/20/2008 9:45am
Left arm injection (felt no injection pain), within  hours of the injection pain radiated down the left arm into wrist, within twenty four hours weakening of the left arm, arm use became more and more challenging, shoulder pain radiated through arm at various arm positioning, weakening of the arm and use ability, used ibuprofen for pain treatment, could not sleep due to arm and shoulder pain, loss of arm use completely by April 16th. when patient sought out and received a Cortisone injection.
The day after the vaccination, woke up at 0600 and noted numbness and tingling down right lower extremity from thigh down to toes. Leg was completely ?asleep? and unable to bear weight. Lasted for approximately one hour. Tingling in extremity lasted throughout day and continued for about 1 week. Also noted minor tingling in left toes and right side of face.
I don't know it is stroke or something; heart burn something; its like I am having a heart attack; feeling crappy/ feeling funny/ I can feel like the drug was inside me like something was changing/ something happening with my body; Headache/ slight headache; Chest pain/ I can feel a pain where my heart is; arm was sore; heart burn; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 09Apr2021 at a single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 18Mar2021 for COVID-19 immunisation (left arm). Patient stated, "the second was really bad my arm was sore for like over a week I mean it was sore. I don't know I have not felt the same since. I can feel like the drug was inside me like something was changing and I never had no problem for anything but now its been like at the last when I got the shot was 9th of April of this month, its been like 2 weeks now almost and it is like I feel crappy. I have headache I have like a chest pain u know in my chest. I have like my heart is I don't know its like I am having a heart attack or something I don't know it is stroke or something. I do not know it is feeling funny. I have no problem I do, may be I have may be heart burn something. I don't know because on every single day everyday I have chest pain my heart, headache I have slight headache now. I don't know why I can feel a pain where my heart is on left side now I got the pain on right side you know I have the pain there and I wondering what's going on so I don't know". Consumer stated, "First its both side that is what I am saying now right now so as I am talking to I have pain in my heart and like it feels the heart u know I don't know there is a weird thing in my heart. I feel like you have a heart attack or so, I you feel like a chest pain or you had a heart burn or something and then on my right side has started it is like something happening with my body you know now its the right side. I don't really know, I can feel me liver, my kidneys are like something is like I can feel something is going I don't know what's going on with my body. You know after getting the shot right now I have the slight headache. I took a quite couple of Tylenol as stuff but that seems like no. This every single day you know that you I thought it will go away but it did not go away". Consumer stated, "Yes, it is the first time. Like I said I thought it will go away but it is not getting any better. I am getting concerned. I do not know I have to be admitted to hospital. I do not have no insurance or anything. I am really worried." The patient hasn't been to the doctor, he was calling first for help. He has no insurance so he cannot just go to the doctor. Consumer stated, "It never improved no. Persisting." Outcome of the events was not recovered.   Information on the lot/batch number has been requested.
1/9/21 At 3:50 am started with nausea, weakness, and complaints of body aches. Required more assistance with ADL's than previous. @ 4:28 am: complaints of SOB, O2 sats 85% on room air. Required supplement O2, with tremors noted. PRN Zofran administered for nausea. 7:42 am noted with fever, decreased O2 sats, Tylenol administered for fever. Fever continue to climb despite Tylenol, supplemental O2 increased to 4L, rapid covid test negative, new orders to start Rocephin IM x 3 days and stat Xray which showed pneumonia. Temperature continues to remain elevated- O2 status continues to decline. Sent to ER 1/9/2021 @ 4:53 pm via ambulance. Admitted to Hospital with ABT tx for pneumonia and UTI. Respiratory status continued to decline- pulmonology consulted- Placed in ICU 1/13/21 and started on steroids. Required BiPap and was eventually weaned to supplemental O2. Multiple Covid tests- all negative. GI complaints addressed with GI consult- unremarkable. Started on PPI and Linzess. Eventually was placed on telemetry floor, closely monitored by pulmonology, and was cleared for discharge on 1/19/2021 back to nursing home.
dizziness/lightheadedness/when he turns his head he gets dizzy; pain behind eye; headache/Pain behind forehead; feels nauseous; Pain behind nose; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness/lightheadedness/when he turns his head he gets dizzy), EYE PAIN (pain behind eye), RHINALGIA (Pain behind nose), PYREXIA (fever) and HEADACHE (headache/Pain behind forehead) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced RHINALGIA (Pain behind nose) and PYREXIA (fever). On an unknown date, the patient experienced DIZZINESS (dizziness/lightheadedness/when he turns his head he gets dizzy), EYE PAIN (pain behind eye), HEADACHE (headache/Pain behind forehead) and NAUSEA (feels nauseous). At the time of the report, RHINALGIA (Pain behind nose) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-103438 (Patient Link).  No treatment information was reported.
Throbbing pain in left arm from shoulder to elbow. Broke out in a sweat. Doctor said I should go to ER. Could not lift arm. It lasted until Thursday 2 days. Was given injection of pain medication.
Received vaccination at approximately 1830 hours on Thursday 01-14-21.  Felt ok until approximately 0900 hours on 01-15-21 when I felt my heart racing and felt hot.  Upon EMS arrival I was advised I was sinus tacky and my sugar was 157.  Was taken to the hospital where I has a 102.5 fever.  Remained in the ER until fever broke and was released at approximately 1800 hours.  Off and on fever and rapid heart rate continued at home on 01-16-21.
10/24 nurse at doctor's office telephoned requesting what vaccinations child received in left arm on 10/22. A red, swollen arm was reported. Large cellulitis of left arm about 8cm in leg (lower left) and about 80% circumferential around arm.
About one minute after injection patient became pale and was notified she should lay down.  Patient layed down, legs were elevated.  Patient became unresponsive and her body tightened and convulsed for about 30 seconds. Patient then regained consciousness and remained pale.
Flare of symptoms/pain and swelling in her joints that has lasted for several weeks; This serious solicited report (USASL2021195793) was reported to Agency on 08/DEC/2021 by a consumer from a commercial program and involves a 47 year old female patient who had flare of symptoms /pain and swelling in her joints that has lasted for several weeks [PT: psoriatic arthropathy] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis. No concomitant medications were provided. The patient's co-suspect medication included COVID-19 (Coronavirus disease of 2019) Vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date in 2021, the patient had a flare of symptoms after receiving her COVID-19 booster. The patient did not miss any of her injections but a day after her booster she had pain and swelling in her joints that has lasted for several weeks. The patient could not remember the exact date she received the COVID-19 booster but stated it was several weeks ago of an unknown date in 2021. The patient takes her weekly injections on Fridays. No treatment information was received. The outcome of the event psoriatic arthropathy was reported as recovered/resolved. The event psoriatic arthropathy was resolved on an unknown date in 2021. Action taken with Enbrel with Single Dose Prefilled Autoinjector was continued for the event psoriatic arthropathy. The causal relationship between the event psoriatic arthropathy and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The patient declined to provide lot number. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.  Amgen comment: This individual case report does not change the safety profile of the product.  Etanercept (ENBREL) is under agreement with Amgen.  The event "Psoriatic arthritis aggravated" was considered serious and unrelated to etanercept.; Sender's Comments: Based on the temporal association, the event Psoriatic arthritis flare is considered as related to the use of COVID-19 Vaccine and unrelated to the use of Etanercept. 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.
24 hours after second Varivax she developed  a 3 1/2 x 3 1/2 red hot warm papule on her right arm that was swollen and puritic. Parents were afraid it wa infected.  I told them it was a local reaction to the vaccine and instructed them to use benadryl or loratadine 10 mg a day and cold compresses and to call if it got larger. Today it is smaller but still itches. It is slowly resolving. There were no vessicles.