chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have never had such anxiety, I could not sit down and I was pacing back and forth; I was so wired; Severe sinus issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Lot number: EN6202) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUS DISORDER (non-serious) with onset Feb2021, outcome "recovering", described as "Severe sinus issues"; ANXIETY (non-serious), outcome "unknown", described as "I have never had such anxiety, I could not sit down and I was pacing back and forth; I was so wired". The events "severe sinus issues" and "i have never had such anxiety, i could not sit down and i was pacing back and forth; i was so wired" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sinus disorder, anxiety.  Additional information: The consumer stated, "I had the Pfizer shot (Covid Vaccine) on 24Feb (not clarified) and when I went in, I was feeling good, no issues. Probably, that evening and the next day and up until now, I have severe sinus issues and they have ease some. I went to ENT and primary care; they didn't inform anything. It was reported that consumer stated, "As well as one other side effects which was anxiety and I have never had such anxiety, I could not sit down and I was pacing back and forth." Consumer stated that, "I am about 165 pounds weight." Consumer stated, "I got it from super market chain, that was (name withheld) was details of prescribing healthcare professional. Consumer stated, "I have no idea regarding dose." Consumer stated that regarding treatment, "Well they told me to take Flonase and they told me to take Saline, they tried to clear it up, they told me to drink lots of water. There was no infection, there is nothing like that. They tried to give me something to relax because he was so wired." Consumer stated, "They did a culture which was normal." (not clarified further) on lab test. Consumer stated, "I am due for the second shot. I don't know whether he should have taken it or not now because was this a common side effect or have you seen a lot of this. Consumer was informed about Pfizer Medical Information department and provided with the number "He guess that was like an emergency number for Pfizer or something." Consumer was informed that Pfizer medical information was the concerned department for all queries and suggested to call on the number provided and if there is any emergency than advised to call 911.  No follow-up attempts are possible. No further information is expected.
Body aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Exercise induced asthma (Had for most of her life and have needed to use albuterol throughout her life to deal with asthma) since 01-Jan-1989 and Seasonal allergy.  Concomitant products included ALBUTEROL [SALBUTAMOL] from 01-Jan-1989 to an unknown date for Asthma exercise induced, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 01-Jan-2019 to an unknown date for Seasonal allergy, EMERGEN C from 01-Jan-2019 to an unknown date for Vitamin supplementation.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021 at 7:00 AM, the patient experienced MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache). On 28-Jan-2021, MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) had resolved.      It was reported that the patient did not have any allergies to medication, food and other products, and also patient did not have any acute illness at the time of vaccination and up to one month before. The patient had never been diagnosed with/ tested positive for COVID-19.  Patient did not seek medical care for the event.  There were no other potential causes for the event.  The patient did not experience similar event in the past.  No treatment information was provided.   This case was linked to MOD-2022-515889 (Patient Link).
CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 51 year old female. Initial information was processed along with the additional information received on 16-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression, poly-cystic ovarian syndrome, latex allergy, and beef allergy. The patient was not pregnant at the time of report. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 to right arm for prophylactic vaccination. Age at time of vaccination 50 years old. No concomitant medications were reported. The patient received additional non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 039F21A, expiry: UNKNOWN) dose was not reported, administered on 05-NOV-2021 to right arm for prophylactic vaccination. The patient was treated with Paxlovid for the treatment of covid-19 infection with the start date of 27-MAY-2022 and end date of 31-MAY-2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. On 05-JUN-2022, the patient was rebounded with positive PCR (Polymerase Chain reaction) test five days after finishing treatment, coded as confirmed covid-19 infection (Dose number in series 2) which led to confirmed clinical vaccine failure (Dose number in series 1).  On same day, the laboratory data included: COVID-19 PCR test Positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable, elasomeran (Moderna Covid-19 Vaccine) was not applicable and with paxlovid was drug discontinued. The patient had not recovered from confirmed covid-19 infection and confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000235983.; Sender's Comments: V0-20220630549-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Heat, bruise like patch (possible rash) below injection site, edema around injection site. Personally feel it is localized cellulitis.
J96.00 ACUTE RESPIRATORY FAILURE 5/7/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 9/10/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 5/16/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 9/15/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/6/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE
-Consistent fever between 99-102 degrees continuous for three days following vaccine, from early morning of 4/17/21 until evening of 4/19/21.  Extreme fatigue, headache, chills, and muscle pain throughout body during this same period. -Intermittent nausea during the day of 4/17/21. -Flare of Sjogren?s Syndrome symptoms consisting of swollen lymph nodes and extreme fatigue starting morning of 4/18/21 and lasting through morning of 4/21/21. -All symptoms except fatigue cleared up on 4/21/21. -Fatigue gradually subsided from 4/21/21-4/22/21.
Swelling and redness at site of injection, about size of tennis ball. Headache (which continues slightly), painful muscle aches in extremities. Continuing.
Pt was admitted with slowly increasing O2 requirement and volume retention as DC PO dose of lasix may have been inadequate. Pt was re-initiated on diamox within a few days of admission in an attempt to improve UOP, but this was inadequate. Despite multiple attempts to get pt to wear CPAP or BIPAP she would not. Repeat evaluation with CT chest showed slowly worsening volume overload and/or possible pneumonitis presumed related to her decitabine. On 7/10/23 she precipitously declined in the afternoon and family requested her goals of care be moved to comfort. Comfort measures were initiated and pt passed peacefully with family at bedside early on 7/13/2023.
He was positively diagnosed with COVID-19 in October 2020.  He experienced fever, muscle aches, joint pain, trouble breathing, chest pain, and hives.  He received his second dose of the Moderna vaccine yesterday afternoon.  In the early morning today, he is again having fever, muscle aches, joint pain, trouble breathing, and chest pain.  The hives have not returned at this point.
This case was reported by a pharmacist via call center representative and described the occurrence of rotator cuff tear in a female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 1 day after receiving SHINGRIX, the patient experienced rotator cuff tear, injection site pain and shoulder pain. On an unknown date, the outcome of the rotator cuff tear was not recovered/not resolved and the outcome of the injection site pain was recovered/resolved and the outcome of the shoulder pain was unknown. It was unknown if the reporter considered the rotator cuff tear, injection site pain and shoulder pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The day following the injection, the patient experienced pain at the injection site and that was so severe. The patient went to the emergency room. The patient continued to have pain in her shoulder area since July's injection. The patient referred to an orthopedic physician after an appointment with her physician care provider. The orthopedic surgeon informed that, it was the SHINGRIX vaccination that caused her rotator cuff to be torn.
Heavy menstruation began shortly after first dose and continues to the present. Includes abnormal amounts of clotting and what appears to be tissue discharge. Severe cramps. The first indication of the adverse reaction was menstrual cramping so severe that I had to exit the freeway and park at nearest gas station. While I was inside the restroom facility, the cramps became so severe that I had to lay on the floor and go fetal position. I experienced cold sweats and nausea and could not get off the floor for approximately 45 minutes.
1/14 right after the shot I had numbness on my left side and tongue tingling and swelling. Went to the ED to be monitored. 1/16 went back to ED for difficulty breathing. Since then to today I?ve had difficulty breathing, chest pain, muscle weakness, numbness, difficulty swallowing.
Patient complained of headache 15 minutes post vaccination. He stated he has a history of migraines.  After additional 15 minutes of enhanced observation headache abated,
Became itchy and then large area of hot, hard snd red with a 3 inch diameter. Was not painful.  Lasted 3 days before it began to subside; gone after a week.
can't eat; lost weight; can't sleep; started peeing; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (can't eat), WEIGHT DECREASED (lost weight), INSOMNIA (can't sleep) and URINARY INCONTINENCE (started peeing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEEDING DISORDER (can't eat), WEIGHT DECREASED (lost weight), INSOMNIA (can't sleep) and URINARY INCONTINENCE (started peeing). At the time of the report, FEEDING DISORDER (can't eat), WEIGHT DECREASED (lost weight), INSOMNIA (can't sleep) and URINARY INCONTINENCE (started peeing) outcome was unknown.            No concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2022-461423 (Patient Link).
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 3 of 15.   No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 3 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
fever; pain and burning at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and VACCINATION SITE PAIN (pain and burning at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Patient has never been diagnosed/tested positive for Covid-19. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy, Arthritis (on her left wrist) and Raynaud's syndrome.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (pain and burning at the injection site). The patient was treated with TRAZODONE at a dose of Only as needed. At the time of the report, PYREXIA (fever) and VACCINATION SITE PAIN (pain and burning at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided.   This case was linked to MOD-2022-550368, MOD-2022-550270, MOD-2022-550346 (Patient Link).
Myalgia Narrative:  R EYE SWELLING;TEARING;PAIN; BODY ACHE
Breakthrough Infection, positive test 2/2/2022.  Illness lasting 8 days, plus additional symptoms for an additional week.  In the weeks following she developed chest pain and breathing difficulties.  She has seen specialists in both the cardiology and pulmonary department.  Has been diagnosed with Asthma, did not have Asthma or any pulmonary issues previously.
Patient passed out after vaccination and states that she felt dizzy. Emergency services were called patient did not want to go the hospital. Patient was given an ice pack to apply
Hives; didn't feel well; she was feeling really tired; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (patient). A 35-years-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Time the Vaccination Was Given: thinks around noon) (Batch/Lot number was not reported) as DOSE 1, SINGLE to prevent from getting COVID. Patient Age at Time of Vaccination was 35 years. Medical history was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced hives on 25Mar2021, didn't feel well and she was feeling really tired on 16Mar2021. Reporter was calling because she said she got the first dose of Pfizer COVID 19 vaccine on 12Mar2021, doesn't have a schedule date for second dose, she was not done with the second dose, because she said she had hives and didn't feel well for 12 days right after the first dose, and she wanted to know if she will take the second dose, or if she needed to take the first dose again. Stated she didn't get any sort of anything until 4 days after she received the vaccine. The hives lasted four days. She has recovered completely. Didn't felt well started on 16Mar2021, lasted for like 12 days, states she was feeling really tired. She had recovered completely. When dose was queried, Reporter states she doesn't know, she sees her boyfriend's vaccine card and his card doesn't show dose. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care was not reported. Lab tests was none reported. The outcome of event urticaria and malaise was unknown. The event fatigue recovered on unspecified date.  Information on Lot/Batch number has been requested
After 2 yr well check & shots, he developed hives - treated with BENADRYL but still present following day.
Pt had a TB skin test placed in her right forearm just before receiving her initial Bexsero dose in her left deltoid on 11/15/22 at 0945. She returned to the clinic on 11/17/22 around 1000 for the TB read. At this time she notified this provider that she started experiencing dizziness about 2 hours after the vaccine. The dizziness occurs with position changes such as when going from lying to standing, particularly with quick position changes. She denies syncope. She was not experiencing any symptoms at the time of the TB read visit. She was offered a more in depth visit but declined the need. No treatments were indicated. She was advised to continue to monitor and seek follow medical evaluation if symptoms worsen or persist rather than resolve.
Administered Hep B and Td in separate deltoid without incident.  After asking pt if ok and taling with him approx 1 minute, pt walked approx 12 feet down hall; stood in place aprox one min then collasped and hit his head on teh floor; pt started to seizure for approx 2 minutes, then stopped and pt became alert.   EMS ambulance staff transported pt out of the building at 5:00 p.m.  TETANUS AND DIPTHERIA TOXIOD ADMIN WAS DECAVAC
Dizziness, Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, inj site pain, fatigue Narrative:
I started with sinus infection. I did not think much of it. On the third day, I started to loss my taste and smell. I got tested for COVID and I tested positive. I started at a week into the COVID I had trouble breathing and I started to have weakness.
08/24/21 with intermittent pain (thought a kidney stone). By 9/2/21, pain was severe. CT scans, MRI of abdomen, endoscopy of stomach. Ruled out kidney stone. Unable to determine source of pain. Sent home 09/04/21 with Aciphex and Dilaudid.  2nd Moderna 09/09/21. On 09/19/21 to ER, ER doc believed ultrasound showed infection of gall bladder. 09/20/21, Dr. performed surgery and did not remove gall bladder due to inflammation described as "angry" tissue around the stomach. She had another surgeon come into the operating room to view the inflamed tissue. IV antibiotics, home 09/21/21. On 09/29/21, back to hospital with severe vomiting, diarrhea, low body temp, acute pancreatitis (lipase levels normal 9/19/21 in hosp). CT scans, endoscopy, labs. TPN, IV abts x7 days. Almost died. Lost 20+ lbs. Unable to determine reasons for inflammation.  No justifiable reason for the massive inflammation and pain. Believe could be inflammatory response to Moderna vaccine.
Traveling pain to neck; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Traveling pain to neck) and ARTHRALGIA (Shoulder pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced NECK PAIN (Traveling pain to neck) and ARTHRALGIA (Shoulder pain). At the time of the report, NECK PAIN (Traveling pain to neck) and ARTHRALGIA (Shoulder pain) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Weakness; Achy; Fever; Headache; Tiredness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MYALGIA (Achy), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (Chills). On 14-Jan-2021, the patient experienced ASTHENIA (Weakness), MYALGIA (Achy), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Tiredness). On 13-Jan-2021, CHILLS (Chills) had resolved. On 14-Jan-2021, MYALGIA (Achy), PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, ASTHENIA (Weakness) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported by the reporter. Treatment details were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt got PNEUMOVAX on 8.26.08. Six hours later developed chills, fever, severe headache, lips swelling, SOB and chest pains, difficulty swallowing-choking. Also having reaction local-erythema 10x10 cm with induration. Seen in the office on 8.28.08. When most of the sx already resolved-still had fever, HA, SOB on exertion. Given Prednisone 60 mg x 5 days. Benadryl, Albuterol inh. 9/22/08-records received-office visit 8/26/08-seen to discuss problems, despondent, slight temp. Office visit 8/28/08-C/O fever, shortness of breath for two days. Chills, headache, spine pain. Two days prior difficulty breathing, unable to drink without choking. Swollen lips. Assessment: allergic reaction to Pneumovax. Local reaction right upper arm with circular erythema with slight induration, skin warm.
The next morning after the shot pt noticed 1 1/2" diameter inflammation around injection site. Pt took 2 Ibuprofen to treat that and repeated x 1. There were no pus or necrotic tissue seen. It can be described as injection site rxn. Pt's nurse was contacted pt still has some redness today (10/8/11).
Pt reported severe allergic rxn to flu vaccine (hives, itching, fever, spotty swelling and difficulty breathing) for which he sought treatment at medical center on 10/5/16 and 10/10/16. Was treated with prednisone, hydroxyzine and benzonatate. Pt reported this to us at a routine visit on 10/21/16 and reported feeling good at that time.