chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 102.6; shivering; sweating; 24 hours of deep fatigue; Swollen lymph node in left under arm; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: Er8731) via an unspecified route of administration, administered in Arm Left on 22Apr2021 11:30 as Dose Number Unknown, Single for Covid-19 immunization. The patient medical history was not reported. Concomitant medications included vaccines of Probiotics and Zyrtec. It was reported that patient was not took any other vaccine in four weeks. The patient did not have covid prior vaccination nor been covid tested post vaccination. The patient had no known allergies. On 23Apr2021 01:00, the patient experienced fever of 102.6 that only responded to a combination of Tylenol and advil after several hours of shivering, sweating, 24 hours of deep fatigue and swollen lymph node in left under arm.The patient underwent lab tests and procedures which included body temperature increased of 102.6 on 23Apr2021. At the time of report, the patient was recovering from the events.  No follow-up attempts were possible. No further information was expected.
RN assessed patient. Pt presented cyanosis of lips, diaphoretic, incontinent, bp: 76/48, hr: 68, temp 35.1, o2 sat:  75% wife of patient reported pt passed out in observation and that patient took Xanax 0.25 mg at 1400 and again at 1615.   fire dept arrived around 1800- pt left ama per  fire dept .
A report was received from a health care professional on 12/9/03 concerning a group of 8-10 3 year old vaccinees who inadvertently received Fluvirin on 12/8/03. On 12/8/03 the vaccinees inadvertently received Fluvirin vaccine. No adverse symptoms had been reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
chills, fever and body ache/same side effects; chills, fever and body ache/same side effects; Chills, fever and body ache/same side effects; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (chills, fever and body ache/same side effects), PYREXIA (chills, fever and body ache/same side effects) and CHILLS (Chills, fever and body ache/same side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ehlers-Danlos syndrome (Connective tissue disorder) and Mast cell activation syndrome (MCAS).   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (chills, fever and body ache/same side effects), PYREXIA (chills, fever and body ache/same side effects) and CHILLS (Chills, fever and body ache/same side effects). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (chills, fever and body ache/same side effects), PYREXIA (chills, fever and body ache/same side effects) and CHILLS (Chills, fever and body ache/same side effects) outcome was unknown.            Concomitant medication included medication for MCAS and ehlers-danlos syndrome. Action taken with mRNA-1273 in response to the events was not applicable.
Child's eyes got swollen, rash appeared on face and the child turned blue and had difficulty breathing.  Father drove child to emergency room.  Child started breathing with oxygen and what the father believed to be Benadryl given.  A chest xray was performed and the child was discharged home and is to follow up with doctor.
Janssen COVID-19 Vaccine immediately caused injection site pain which lasted for about a week after gradually getting better. About eight hours after injection, a fever and fast heartbeat accompanied by chills began and persisted for about twelve hours. A few mild and extremely brief feelings of nausea were present as well. After taking Tylenol six hours in, the symptoms started improving and were gone after seven hours. Feelings of tiredness were present for about two days after the first symptoms showed up.
Day 1 vax in evening. Minorly sore arm pm.  Day 2- large lump at injection site and extremely sore arm.  Day 3- woke up with headache, took Tylenol, headache went away but returned after 4 hours. Took meds again and it did not return.  Day 4- no issues  Day 5 - sore under armpit and got more sore as day went on.  Day 6- more painful under arm in lymph node but as day went on it subsided.  Day 7- back to baseline
This solicited report was received from an "MR" moderator concerning a 43 year old female patient enrolled in a market research. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with GARDASIL 9 (dose, strength, frequency and lot number were not reported). On an unspecified date, the patient experienced an adverse event reported as a "negative published articles" that the reporter received in her social media account. At the reporting time, the outcome of the adverse event was unknown. The reporter stated that therapy was discontinued for reasons other than the adverse event. The reporter did not assess the causal relationship between the adverse event and vaccination with GARDASIL 9. Additional information has been requested.
PHARAMCIST ON DUTY 1/28/23 AT LOCAL PHARMACY IS SUSPECTED TO HAVE ERRORED IN MEASURING THE CORRECT DOSE OF PFIZER COVID VACCINE. PHARMACIST RECOGNIZED HIS ERROR AFTER PATIENT LEFT PHARMACY.  PHARMACIST IMMEDIATELY CONTACTED Local authority WHO ADVISED HIM HOW TO PROCEED.  Local authority ALSO CONTACTED THE PATIENT AND REMAINED IN CONTACT OVER THE WEEKEND (PHARMACY WAS CLOSED.)  PATIENT EXPERIENCED FEVER BEGINNING THE NIGHT OF 1/28 AND THE FEVER CONTINUED THROUGH THE NIGHT UNTIL MORNING OF 1/29.  PATIENT HAS A VERY SORE ARM AND WAS VERY TIRED THE DAY AFTER RECEIVING VACCINE.  ON 1/30 PATIENT CAME TO THE PHARMACY AND SPOKE TO PHARMACY MANAGER.  PATIENT FEELING  FINE AND BACK TO NORMAL EXCEPT FOR A SORE ARM AND DISRUPTED SLEEP SCHEDULE.
Patient stated pain at injection site on (L) arm began about 1 hr. post vaccine. Continued to worsen throughout evening. Upper (L) arm tender, warm to touch, mild edema noted. Pt. states continuing to spread into (L) axilla & (L) breast area. Burning sensation, pain at 6/10 on pain scale. Decreased ROM.
Headache, Myalgia, Fever, COLD SWEATS. FATIGUE Narrative:
Rash that spread all over body.  Continued for days, moved places and is still there in original place.
Pt was a transfer from an outlying ER following a cardiac arrest while undergoing dialysis.  He has a past medical history of ESRD, COPD, DM type 2, and coronary artery disease with prior percutaneous intervention.
Client called on 03/12/2014 stating that she has a raised area at the injection site from her vaccine given on 03/11/2014 and is experiencing excruciating pain at the injection site as well.
20 hours after the second injection I got a fever of 102.3 that actually subsided to 100.6 by the time I went to bed 36 hours after second injection I woke up with a severe headache (I get migraines once a month) worse than any headache I ever had before. It was so painful I thought I'd have to go-to the hospital. That lasted pretty much all day until 8 pm when the headache just disappeared. Now the initial couple hours were the worst, I vomited 1 hour into the onset of the headache. 72 hours after symptom onset I was having cold chills all morning which stopped maybe after a few hours but after that I'm having pain shooting down the backside of my right arm and into the back of my armpit area, almost like a numb feeling but a little pain
1 inch 1/2 lump on injected arm.     Noticed at 1pm next day ....no treatment was recommended ..disappeared within a week.
A report has been received from a health professional concerning a 15 year old, female patient. No medical history, concomitant diseases and concomitant medications were reported for consumer. Patient received FLUMIST QUADRIVALENT (intranasal) on November 20, 2014 and facial swelling was observed by parent the following morning on November 21, 2014. The outcome for the event of facial swelling was unknown. The report was considered to be non-serious by reporter.
THAT EVENING BETWEEN 10-11 PM HAD A GRAND MAL SEIZURE AND WAS UNRESPONSIVE. TAKEN TO ER WHERE BLOOD WORK WAS DONE AND CT SCAN. SENT HOME AROUND 6:30 AM ON JAN 1ST. (I DO NOT REMEMBER MUCH JUST WHAT MY FAMILY HAD TOLD ME) . I DO REMEMBER BEING SEVERLY SICK WITH VOMITING IN THE ER. CURRENTLY FOLLOWING UP WITH MY FAMILY MD AND HAVE MRI AND EEG TESTS SCHECULED WITHIN THE NEXT COUPLE OF WEEKS.
Swelling and pain of the full L arm and shoulder. Redness as well. Occurred about 10 hours after vaccination.
I had fever, on and off. I started feeling lethargic, achy, and some difficulty breathing. My nose started to run. It got worse 20 hours later. Not much respiratory factors, just a runny nose for a week and a half. They put me on Paxlovid, within 20 hours my symptoms disappeared.  I guess it lasted about 2 weeks. There would be some days that I would have no energy. The medication gave me severe gastric destress, instead of the 5-day dose I did 4 days. I didn't lose my sense of smell. I would say I am 70 percent better today. I am still having a persistent cough.
Covid -19; Covid -19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for COVID-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing). Concomitant medication(s) included: EXCEDRIN [CAFFEINE;PARACETAMOL], start date: Aug2022; ONDANSETRON, start date: Aug2022. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Aug2022, outcome "not recovered" and all described as "Covid -19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) positive; (13Aug2022) positive; (16Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, COVID-19 and included Paxlovid. Clinical course: Anti-viral details: COVID-19 Treatment (Paxlovid) was started from 03Aug2022 and stopped on 08Aug2022. The patient reported: "Paxlovid rebound. I developed COVID on 02Aug2022 and began taking Paxlovid the evening of 03Aug2022. My symptoms were overall pretty mild (low fever, headache, throat congestion), and I began feeling better the next morning, and by 06Aug2022 felt entirely recovered. I continued to feel fine for a week, but then on 13Aug2022, I started having COVID symptoms again (congestion, cough, fatigue, headache) and tested a strong positive using a home antigen test. It is now 16Aug2022, and I am still feeling ill and testing positive."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Injection was given in the apex just below the acromion of the right arm. Woke up the next morning with pain in the shoulder blade, elbow, and wrist.  Was seen in my provider's office that day when symptoms worsened. After about 2 weeks, that pain subsided but left me with pain that felt like it was under the deltoid, and under and in the bicep. Have been using moist heat and ibuprofen without improvement. Another trip to the provider resulted in lab work, MRI, and physical therapy. I am having trouble using my arm for everyday tasks and especially with ADLs and I often have to use my left arm to assist.
Muscle soreness; With pull up, it is like a short pain/If he took his elbow to his side, he can feel pain there too; This is a spontaneous report received from a contactable consumer (patient) or other non hcp. A 43-year-old male patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in Arm Left on 01Jun2021, as DOSE 1, SINGLE and then patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in Arm Right on 22Jun2021, as dose 2, single both doses for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced muscle soreness and with pull up, it is like a short pain/If he took his elbow to his side, he can feel pain there too. It was reported as, the caller stated that he received the first dose of the Pfizer BioNTech COVID-19 vaccine last 01Jun2021 where he developed muscle soreness almost at the back of his top left shoulder behind his arm, in the muscle that forms the horseshoe. Caller mentioned he received the first dose on the left arm. Caller mentioned that he can do everything with his left arm. He is doing calisthenics which includes pushups and pull ups. The only time it bothered him or hurt is with pull ups. He has no problem with lifting and pushups. With pull up, it is like a short pain and after he gets done, it throbs for a minute or two. If he took his elbow to his side, he can feel pain there too, only with that time". Caller had the second dose of the vaccine last 22Jun2021 on the right arm since he still feels sore on the left. Caller wanted to know if this had been reported as a side effect with the vaccine and if there is an expected duration. The patient is assuming the anatomical location of the muscle soreness is the rear tricep; there are 3 heads; but when he does pull-ups he can do them but it is not too good, does not feel too great at all. The muscle soreness is ongoing. He was still experiencing the muscle soreness at the time that he was administered the second dose of Pfizer Covid Vaccine so he had them administer the second dose into the opposite arm as the first dose. The muscle soreness is not around the injection site of his arm; it is behind his arm where the triceps tie to his back. He called to ask if this has been reported, and if there is an expected duration for it to last. He never got a fever, never got sick, but the muscle soreness is not going away. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Patient felt heart racing immediately after getting vaccine.  Vital signs taken: BP163/84 P:150 O2Sa:100%  Patient felt hot flush all over face.  Got patient ice water and had patient call for a ride home.  Friend is coming to get her.  Vitals taken 1802: BP: 147/116 P122 SaO2: 100% Patient sitting resting.  Vitals taken: 1809: BP 156/90 P:113 Sao2:100%  Patient started having chills - warm blankets given.  Vitals taken 1820: BP: 138/94 P: 109 SaO2:100% T:98*F  Patient resting in chair.  Friend arrived to provide ride home.  Vitals taken 1830: 142/84 P:94 SaO2: 100% Vitals taken 1850: BP:127/87 P:102 SaO2: 99% Patient did state that she has been under extreme stress with the death of her husband in November.  And today was her first day back to work. Had patient stand and walk around a little, no dizziness noted.  Gave her some pretzels to snack on and after 5 minutes she stated she was feeling almost back to normal.  Patient's friend is an RN and was going to have patient spend the night at her home. Patient stated she did not feel she needed to see a provider and felt that she would be ok in her friends care.
Approximately 9 hours post vax, the to experienced swelling of the right index finger that became painful. The pt was instructed to take Ibuprofen as directed and follow up if not better in 1 week.
Shortness of breathe after day 3-11 Nausea after day 5-11 Dizziness after day 3-11 All over body pain after day 2-10 Extreme tiredness after day 5-11 Rash at injection site after day 2-8 Redness at injection site day 1-11
ON WEDNESDAY 14TH THE GANGLION BEHIND MY LEFT EAR SWELLD AT 8:30 AM IN THE AFTERNOON IT WENT DOWN. ON SATURDAY 17TH AGAIN AT BREAKFAST GOT INFLAMMED AND UNTIL NOW CONTINUES INFLAMMED.
tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Weakness; Chills; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ASTHENIA (Weakness), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, ASTHENIA (Weakness), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
The patients daughter states that the patient woke up the morning after receiving the vaccine and does not recognize family members, stops eating in the middle of her meal and doesn't remember what she was doing, has a greatly decreased appetite.  Daughter states she is declining quickly.
Patient currently admitted to the hospital in the ICU with an active COVID-19 infection.  Patient on high flow nasal cannula oxygen therapy with significant tachypnea with a respiratory rate in the mid 40s.
PATIENT HAD ALREADY RECEIVED AN INFLUENZA VACCINE FOR THIS SEASON AND THE FLUCELVAX WAS GIVEN IN ERROR.
Chest Pain 10 minutes after vaccine administered. Had previous history of anaphylaxis to penecillin . Transported to Medical Center via ambulance
Fever and rash after immunizations. Temp 102.9. Gastrointestinal upset secondary to Motrin.
A non-serious spontaneous report of 22-month old received FLUMIST was received from a health professional concerning a 22-month-old female. No relevant medical history information has been reported for this patient. Concomitant medication included injectable flu vaccine give on the same day as FLUMIST. On 28-Sep-2011, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
About 4h after injection she started with progressively worsening erythema and swelling that spread by next day from injection site to entire arm (L) side - area started decreasing swelling and redness by 9/20/12 - Erythema, swelling, increased local temperature from entire upper 1/3 of (L) arm - more noticeable on distal 1/3 of arm.
Started with headache, on 11/20/2014 afternoon, legs numb and tingly, on night of 20th, progressed to severe abdominal pain, unable to walk on morning of 11/21/2014 to ER 7 AM on 11/21/2014, transfered 11/21/2014 night, until 12/3/2014 when transfered again, remains hospitalized.
Breaking out in a rash, it itches. All over my arms and chest; This is a spontaneous report received from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant past medical history. Concomitant medications were not reported.  The patient did not have any allergies to medications, food, or other products. Prior to 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 23Mar2021 at 17:00, the patient experienced breaking out rash, it itches all over arms and chest. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event breaking out rash itches all over arms and chest was not resolved.   No follow-up attempts are needed. No further information is expected.
Initial report received on 10 December 2013 from consumer. A 65 year old male patients whose gender, age, medical history and concomitant medications were unknown, received a dose of FLUZONE HD (route was intramuscular, lot #, expiration date unknown and site was left deltoid) on 10 October 2013. Patient reported that on 17 October 2013 developed soreness at site 24 hrs post vaccination and it radiated to elbow. Symptoms lasted to mid-November then resolved until 09-December 2013 when patient notified to health care professional that symptoms came back. List of documents held by sender: none
Arm was very sore the next day along with a strong headache, that I was able to get rid of with ibuprofen. 7 days later 2 small bug bite-like bumps formed and became very itchy. The next day it was a few inches bigger and still itchy.
This spontaneous report received from an office manager who is also a medical assistant refers to a 75 years old male patient. The patient was inadvertently vaccinated with a dose of GARDASIL on 03-AUG-2012. No symptoms reported. This is one of two reports received from the same source. Additional information has been requested.