chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt weak; fever blister on lips; chills; No fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), LIP BLISTER (fever blister on lips), CHILLS (chills) and NO ADVERSE EVENT (No fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 39AZIA and 0481921A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 16-Mar-2020. Concomitant products included CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE (CANDESARTAN HCTZ), METOPROLOL and AMLODIPINE for Hypertension, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and Vitamin Calcium Magnessium and Zinc for Vitamin supplementation, ROSUVASTATIN, ASCORBIC ACID, ECHINACEA PURPUREA (ECHINACEA + VITAMINA C VITATECH), PROBIOTIC 10 and Turmeric powder Mix some in tea                                Herbal for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced ASTHENIA (felt weak), LIP BLISTER (fever blister on lips), CHILLS (chills) and NO ADVERSE EVENT (No fever). At the time of the report, ASTHENIA (felt weak), LIP BLISTER (fever blister on lips), CHILLS (chills) and NO ADVERSE EVENT (No fever) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-074916 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074916:
From telephone contact with patient's daughter, it was stated that a 70 year old female patient received a Fluzone Sv '00-'01 vaccinatiuon on 11/09/00. Reportedly, the patient developed pain at the injection site, duration time not specified. Patient also experienced flu like syndrome altered voice, coughing, chest pain, shortness of breath. Later three symptoms persist. No confirmed diagnosis after numerous tests conducted07/13/2001.
Fever, headaches, body aches, nausea, fatigue,, light sensitivity.
This spontaneous report as received from a pharmacist (also the patient's father) refers to a 14 year old female patient. She had known penicillin allergy. The patient did not have any other pertinent medical history and the patient did not take concomitant medications. In December 2016, the patient received second dose of either GARDASIL or GARDASIL 9 (Pharmacist was unsure)(dose, route of administration, anatomical location, lot # and expiration date were not provided). On an unknown date, the patient experienced stomach issues after eating and at the time of the reporting she still had them. In January 2017, the patient experienced lack of appetite. The patient was seen by an unspecified gastroenterologist in approximately January 2017 (reported as "about a month ago") for the above reported symptoms. Unspecified blood work and "stool samples" were performed on unspecified dates, results were not provided (also reported as "all tests were no"). The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and suspect therapy was not provided. Additional information has been requested.
ON OCT 24TH I GAVE PT HIS 6 MONTH VACCINESS, VAXELIS, HEP B, ROTA, AND PCV13. I GAVE PT AN EXTRA DOSE OF HEP B 0.5 ON RIGHT TIGH,MOM OF PT WAS NOTIFIED OF INCIDENT, AND I CALLED BOTH MANUFACTURES, TO REPORT AND ASK IF THERE WAS ANY DATA ON GIVING AN EXTRA DOSE OF HEP B. THEY GSK AND SANOFI BOTH STATED THERE WAS NO HARM PER THEIR DATA BASE AND THE CDC REPORTS. THERE WAS NO SYMPTOMS REPORTED BY PARENTS.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 03/03/2021 and 03/31/2021. They tested positive for COVID-19 on 09/29/2021 and 09/30/2021. They were admitted to hospital 09/30/2021. They experienced several complications and co-occurring conditions, including: sepsis, hypoxic respiratory failure, severe acidosis, multiple organ dysfunction, coagulapathy (attributed to COVID-19), tension pneumothorax, low paltelet, thrombocytopenia, hyperglycemia, encephalopathy, and COVID-10 pneumonia. The individual remained hospitalized until their death on 10/06/2021. (some clinical documents have date of death as 10/05/2021 but the death certificate has 10/06/2021).
nausea, vomiting, fatigue, body aches by evening of date dose given 1/26/20. headache, fever fatigue 1/27/21. All Resolved by 10 am  1/28/21
Mom states "arm where VAR was placed has become increasingly red/swollen and very painful to touch". Advised to attend ER or PMD if possible. ASAT for treatment and r/o cellulitis.
1/4 Left side pain under my shoulder blade, across top of my left shoulder..woke me up. Site tenderness...then everyday, all day 1/4-1/10...lightheaded/dizziness(couldn't drive) Nausea ( thought i was pregnant) Diarrhea, headache, fatigue, night sweats, injection site became red, size of a half dollar and itching got worse as the week went on. On 1/10, most symptoms got better..On day 9 (1/2) I looked at sight and it was more red, and warm to touch...my face was also bright red...overnight the site grew to cover almost right around and the whole area was bright red. I went to my pcp who is treating as a cellulitis...itching persists, occasional dizziness but nausea and diarrhea have gotten worse..im guessing from antibotic?
Resident coded at / during Dialysis Treatment.  Was transferred to MEDICAL CENTER and placed on a Ventilator with chest tubes per family.  Resident was then transfered to Hospital on 10/6/22.  Resident passed away on 10/10/22 at the hospital.
it was rpt concerning a pt who was vax & the same day exp fever to 104f & a rash on chest & trunk resembling heat rash
The day after receiving the vaccine, the pt noted an enlarged, tender lymph node near her left collarbone (the same side on which she got the vaccine).  She did not seek medical attention; she reports possibly taking ibuprofen.  The swelling and tender ness resolved within a few days.
Entire thigh was bright red;  caused him pain;  on the following day, it became less red, but still continued to cause him pain and itching.
Janssen COVID-19 Vaccine EUA:  Headache, Nausea, Fever, Chills, Fatigue
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was  refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by  COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
As I was driving at 70 mph along the highway 4 days after I had my second dose of the COVID-19 vaccine, suddenly I went blind in my right eye. I was blind in that eye for about 10 minutes. We drove  right away to my eye doctor, who sent me to the ER. The hospital is Stroke Certified. They admitted me and did a stroke workup. I was in the hospital for 1 day (24 hours) which included overnight.  The treating HCP concluded that I had experienced an ocular stroke. Since it was exactly 4 days after my second dose of the Moderna COVID-19 vaccine, it most likely was caused by that vaccine.
12-23-20: Began feeling tired in the evening, felt drained. 12-24-20: Could not raise my right arm,  was very painful, felt very tired, did not get out of bed, appetite was slightly diminished. 12-25-20: Pain in right arm was extending to the right side of my neck, could not raise my arm, very painful.  Did not get out of bed, felt very tired. 12-26-20: Symptoms had subsided, right arm was still sore but I could move it.  I was able to go outside and walk the dog.  I did not feel as tired as the previous days. 12-27-20: Back to normal, symptoms were gone.
Raised, hot, hard, itchy bump at injection site one week post vaccine.; Weakness; Arthritis in left hand; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 09:00 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included psoriasis. 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 concomitant medications. The patient did not receive any other vaccines within four weeks prior to COVID vaccination. On 20Mar2021 at 23:00, the patient experienced raised, hot, hard, itchy bump at injection site one week post vaccine (vaccination site reactions) and weakness (asthenia) or arthritis in the left hand. The treatment received for the adverse event was unknown. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site reactions, asthenia and arthritis were not resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Patient began to experience neck pain on the same side she received her injection along with tightness and stiffness. Patient also experienced pressure, popping and burning in and around bilateral ears. Patient expressed she felt hot, and had a headache. Patient verbalized she had a lot of allergies to environmental substances.
01/04/21  @ 0930 1st dose given. 01/04/21@1600 feeling as though coming down with something - temp 99 .  01/04/21 @ 2000 Chills, body aches, sore throat and mild arm pain temp  100.7 took 2 Tylenol 5oomg PO.  01/05/21 @ 0130 awoke to feeling of increased body aches, chills , nausea  temp 101.8. Continued having symptoms  for the next  36 hours with highest fever reaching 102. Which caused loss of work.  Treated with Tylenol / bedrest . Arm pain lasted 5 days and radiated to the shoulder. Used cold clothes and moved arm frequently. Please note I had covid-19  in october 2020
Pre-syncope while at restraint approximately 45 minutes after vaccine.  She slumped to the ground and lost muscle tone before being caught by her grandparents.
Daughter called to report that patient has been experiencing mild fever (not measured w/thermometer), diarrhea and significant fatigue and weakness.
Janssen COVID-19 Vacccine EUA was administered on March 19th, and I had head ache and fever that night, and was unable to sleep. By the end of the following day (March 20, 2021) my side effects were essentially gone. I felt normal until Wednesday (March 24, 2021) afternoon where the same symptoms returned but were more pronounced (i.e. worse headache). I am writing this Saturday March 27, 2021 and am still having headaches, sensitive skin, and a mild fever.
Irregular bleeding; believe to be menstrual cycle starting 1-1.5 weeks before period should start. Heavy bleeding!
Given vaccine 6/18/07 / 2-3 minutes later patient was standing in hallway, felt weak and fainted. Did not lose consciousness. Allowed to rest, felt better and walked out of clinic in 5 minutes. Vitals ok.
This spontaneous report, as received from a physician refers to a 61 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number reported as K010630, expiry date 30-OCT-2015) (dosing and route unknown). Concomitant medications were not reported. The lot number of the diluent was reported as K010822, with expiry date 16-MAY-2017. On 11-DEC-2014 the patient experienced erythema and rash at the injection site after administration of ZOSTAVAX. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
Pt. received HPV (GARDASIL) in (L) arm. Pt walked down the hall, sat in a chair, passed out, and urinated on herself. She was aroused with Ammonia Inhalant and taken to a room where she continued to c/o dizziness for about 20-30 minutes.
pt recvd DT vax 28AUG92 & exp rash/pruritus neck 8 hrs later resolved w/in 24 hrs; no systemic rash (?hives); 36 hrs p/DT marked swelling, erythema, heat w/resolution in 48 hrs arthus;
10/17/19 patient came in morning after received flu shot with headache and dizziness, lightheadedness that he stated began around 1 hour after he received the vaccine 10/16/19. Patient temperature was 98.8F, BP 150/98 mmHg. Patient sat in the waiting area, and was provided 2 bananas and water. I offered to call medical attention, and he stated that he did not want me to, and that he wanted to call his doctor himself.  He then went to the restroom and retuned saying he had taken one extra of his blood pressure medication. I called the MD office and stated the patient's symptoms, and they stated that he would be able to come to a walk-in appointment that day. Patient went to sit outside and retuned about 1 hour later, stating he felt better but he wanted to sit down in the waiting area until his transportation arrived. He took his blood pressure at the machine in the waiting area and it was 148/91 mmHg. At this time I am not aware if he sought medical attention after he left.
Hip Disorder - Information has been received from a physician and a nurse throught the pregnancy registry for varicella virus vaccine live concerning a 19 year old female who on 04 Apr 2000 was vaccinated with one dose of varicella virus vaccine live (Site unknown).  Concomitant medication included prenatal vitamins (composition unspecified).  The reporter indicated that the patient was about 14 days pregnant on the date of vaccination and the date of her last mentrual period was 04 Mar 2000.  However, contradictory information received from the patient indicated that the patient received the vaccination on 03 Apr 2000 and that she was about 3 months pregnant at the time of vaccination.  Follow up information received on 05 Jun 2000 from a nurse, confirmed that the date of the patient's last menatrual period was documented as 04 Mar 2000.  The reporter also stated that the patient had an ultrasound on 11 May 2000 which verified an intrauterine pregnancy of 9 Weeks plus 1 day gestation which was consistent with the recorded date of the last mentrual period.  On 12 Nov 2000 the patient had a spontaneous rupture of membranes at 35 weeks and 2 days gestation and gave birth to a normal female baby weighing 2892 grams.  At the time of birth, no congenital anomalies were noted.  The patient had well child visit at two weeks, one months and two months.  On 16 Jan 2001, at the two month visit, a physical exam was performed which was normal except that bilateral hip clicks were noted.  the physician's plan at this time was to perform  an ultrasound in order to rule out dysplasia.
This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 09-MAR-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 16 hours with a lowest recorded temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
LARGE KNOT ABOUT 1/2 TO 1 INCH SURROUNDING THE INJECTION SITE; SEVERE/ BAD FLU-LIKE SYMPTOMS; PAINFULLY SORE AT THE INJECTION SITE/ TENDER ENOUGH; EXTREMELY SWOLLEN (INJECTION SITE); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced large knot about 1/2 to 1 inch surrounding the injection site. On 13-MAY-2021, the subject experienced severe/ bad flu-like symptoms. On 13-MAY-2021, the subject experienced painfully sore at the injection site/ tender enough. On 13-MAY-2021, the subject experienced extremely swollen (injection site). The action taken with covid-19 vaccine was not applicable. The patient was recovering from severe/ bad flu-like symptoms, and had not recovered from painfully sore at the injection site/ tender enough, extremely swollen (injection site), and large knot about 1/2 to 1 inch surrounding the injection site. This report was non-serious.
Arm pain began again (sore, hard to raise over head) along with red raised welt looking spots (2 areas) on the arm in the general area of the shot
Four other children in same daycare reported having chickenpox within same time period. Four of the five had varicella immunization.
Right upper arm erythema, edema, induration and tenderness. Cool compresses and Tylenol prn indicated on 9/16/13, by PCP.
Patient got the shot on Thursday evening of Jan. 24,2019. Friday, soreness around injection site with mild fever. Saturday and Sunday, there were red blotches on upper arm and pain going down to the fingers. Monday, it was itching. Tuesday, patient said it's lobster looking. Patient took some BENADRYL and she contacted her doctor but did not go in to the office.
Thrombocytopenia (CMS/HCC) Upper GI bleed Hyperglycemia History of esophageal varices
Got shots yesterday, several hours later, she took a shower, had a headache and c/o feeling tired, dizzy. Pt went to sleep, slept for several hours. When mom tried to wake her up she was very somnolent, did not awaken, did not move, parents were shaking here, pulling eyelids open, shining a light in her eyes. When pt did began to respond, she said her legs were numb, she couldn't stand, in car ride over, pt head was bobbing from side to side, as if she were drunk or passed out. Had to be transferred to a wheelchair, vitals in ER were ok, maybe sl low blood pressure per mom. Pt was in ER x 3-4 hours before seeing the doctor. But by time she was seen, almost everything had resolved. She was talking, thinking normally, but was still sl unsteady on feet.
"can't move my arm at all"; "hard in the middle and then jellified on the outside"; arm of injection swollen the size of a tennis ball, "hard in the middle and then jellified on the outside"; "severe headaches"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT ("can't move my arm at all"), VACCINATION SITE INDURATION ("hard in the middle and then jellified on the outside"), VACCINATION SITE SWELLING (arm of injection swollen the size of a tennis ball, "hard in the middle and then jellified on the outside") and HEADACHE ("severe headaches") in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No history was provided by the reporter.  Concomitant products included LINACLOTIDE (LINZESS), POTASSIUM CHLORIDE, SODIUM BICARBONATE, TRAZODONE, CLONAZEPAM, SEVELAMER CARBONATE and OMEPRAZOLE for an unknown indication.   On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 10-May-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT ("can't move my arm at all"), VACCINATION SITE INDURATION ("hard in the middle and then jellified on the outside"), VACCINATION SITE SWELLING (arm of injection swollen the size of a tennis ball, "hard in the middle and then jellified on the outside") and HEADACHE ("severe headaches"). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT ("can't move my arm at all"), VACCINATION SITE INDURATION ("hard in the middle and then jellified on the outside"), VACCINATION SITE SWELLING (arm of injection swollen the size of a tennis ball, "hard in the middle and then jellified on the outside") and HEADACHE ("severe headaches") outcome was unknown.            No laboratory details was given. Action taken with mRNA-1273 in response to the event was not applicable.
swollen tender R axillary with erythematous rash spreading to the R side of the chest with no pruritic, warmth, or pain.
she had very high blood clots; get the vaccine is like "death"; chest pain; D-dimer, and it came back really high, 0.91; This is a spontaneous report from Pfizer- sponsored program, received from a non-contactable consumer (patient) via medical information team. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that patient consulted her doctor after she had Covid-19 vaccine. She said she had very high blood clots, and chest pain. She got tested for D-dimer, and it came back really high, 0.91. She said her doctor told her not to worry about it, and was not given blood clot medications. She said having her get the vaccine is like death. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient c/o vague myalgias and mild fevers on 3/24, the following day he noted left cheek swelling associated w/ fevers and that night he had nightsweats. On 03/25/2015 morning he awoke w/ both cheeks swollen and noted discomfort chewing, but was able to eat and swallow w/o throat pain. On 3/27 when he came into office he reported feeling a little better, now it no longer hurts to bite down and clinch teeth. Fevers and nightswetas persist. Energy level is mildly depressed.  Patient presented to office with fever of 103 degrees and Bilateral swelling of the parotid glands, firm and tender to palpation. Non toxic appearing.
Information has been received from a licensed visiting nurse concerning a 62 year old male who on 14-FEB-2007, 23-MAR-2007 and 10-AUG-2007 was vaccinated IM with his first, second and third 1.0 ml doses of RECOMBIVAX HB. On 14-SEP-2007 the patient had an anti-HBs antibody titer was less than 5 mIU/ml. On 18-SEP-2007 the patient was administered a booster dose of RECOMBIVAX HB. On 18-OCT-2007 the patient had anti-HBs antibody titers that were less than 5 mIU/ml. It was unknown whether medical attention was sought. The outcome was unknown. there was no product quality complaint. NO further information is available.
A 23-year-old female patient, who had no concurrent illnesses, pre-existing medical conditions, or use of other medications, had received a second, left arm dose of ADACEL (lot # C2989AA), and a left forearm dose of TUBERSOL (lot # C2682AA) on 11 March 2008. The route of administration for both the ADACEL AND TUBERSOL were not provided. A few hours after receiving the ADACEL vaccine in the left arm, the patient developed redness, warmth, and swelling at the site. She also felt feverish, mild muscle aches, and experienced some muscle tightness in the middle of her chest. The patient did not experience any difficulty breathing. All the symptoms resolved spontaneously approximately four days after onset. No medical attention was sought, and treatment was not rendered. The patient recovered.