chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 03-OCT-2013, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # H018455 and expiry date: 09-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Arm Pain that developed into Bursitis.  Felt like injection went into bone and not muscle.  Noticed gradual onset of fatigue resulting in being nearly bedridden in September.  Saw Doctor about this on 9/21.  Doctor ordered some tests,  CBC, Chem Panel, Cortisol; CRP; CK; Epstein Bar panel.  Doctor surmised Orencia may have been causing issue and so he ordered discontinued use of it. I didn't feel functional until November of 2021
Site developed a nodule. After a couple of weeks the skin above the nodule turned purple. 12-30-2019 the nodule formed a white head right in the center and drained about ½ tsp of thick yellow pus. Area drained again 1-4-2020. Was seen by a doctor and told to wait and see and that it had likely drained all and would heal. Area again drained thick yellow pus 1-21-2020. Patient had no fevers, no excessive swelling. Currently is being re-evaluated. Patients sibling also had an exaggerated skin rash response to same vaccine on the same dya, same lot number. No abscess in sibling, and rash resolved itself in a couple of days.
55 y/o F with hx of HTN and allergies who complained of mild erythematous papules (b/l forearms) and mild forehead pruritis. Exam with stable VS. No evidence of respiratory distress, urticaria, abdominal pain, nausea. No evidence of anaphylaxis. Pt observed for 60 minutes. Recv'd benadryl 25 mg PO. Discussed options for care and pt opted to return to work. She recv'd anticipatory guidance and precautions for what symptoms should prompt an ED visit. Pt stable and well appearing on d/c from the vaccination clinic.
Starting 04/01/2022, I started getting a sore throat that progressively worsened over the next few hours. I am a pediatrician and I tested myself for strep and COVID-19 in the office. It was positive for COVID-19. I reached out to my PCP on 04/03/2022 and they just recommended "supportive care". I had a fever for a few days that went away and then came back. On 04/09/2022, I contacted my PCP again and they prescribed me doxycycline and prednisone. I took the doxycycline but not the prednisone. I was testing negative at about 10 days in and by then I was able to go back to work. However, it took probably about 14 days for me to feel normal.
Approximately 48 hours after receiving the "booster" (third) dose of COVID19 (Moderna), I started to experience unusual upper arm and shoulder blade (deltoid) pain.  During the following three weeks, the pain level increased and moved into other parts of my arm, including the elbow, wrist, hand, and fingers.  I contacted my doctor on December 10, 2021, to report the symptoms and to get some treatment for the pain.  My doctor has requested an ultrasound (not yet scheduled) as well as an MRI.  She prescribed Gabapentin to assist with pain, which I am still taking.  I expect to start physical therapy in January 2022.  Next course of treatment will be scheduled following results of ultrasound and/or MRI.
Moderna COVID-19 Vaccine EUA: Developed an instant rash at injection site. Over the course of the week since injection the rash has grown in size. Topical cream to reduce itch, cold pack application has temporarily provided relief but the rash has grown in size since initial onset. Doctor is aware of situation, as it is the weekend nothing can be done to create a course of action until Monday (3/15/21). A lymph node feels swollen under my arm,  the rash is raised and slightly circular, the rash is hot/warm to touch like it is sunburned but the rest of the arm is normal temperature. Wanted to report this side effect in full as I understand this can happen days after the vaccine. Mine was immediate. Again emphasizing that I am seeking medical assistance on Monday March 15th, 2021 to ascertain what can be done to alleviate symptoms.
Pt complained of red, itchy eyes, wanted a eye drop. Recommended ZADITOR eye drops. Patient stated drops worked and everything cleared up.
Pt vaccinated with DTP child c/o wanting to go nite, nite ( 1 hr after inject given) started to "shake" & mom said got blue around mouth.
pt recv vax 19OCT95 & 4DEC95 pt devel a cough,fever,flu-like illness & a vesicular rash in the rt arm;presented to MD & was dx w/herpes zoster. Follow up information received. Concomitant vaccination included patient's fourth dose of inactivated diptheria-tetanus-pertussis vaccine (ActHIB). There was no other concomitant therapy. On Dec 3, 1995, the patient developed a fever of 39 degrees C (also reported as Dec 4, 1995) and flu-like illness with irritability, followed by cough on Dec 4, 1995, and a red, papulo-vesicular, pruritic rash (15-20 lesions) on the right arm and forearm on Dec 5, 1995. She presented to her physician and was diagnosed with herpes zoster. A specimen from the rash was obtained on Dec 8, 1995. PCR analysis revealed the Oka/Merck varcella virus strain. The patient recovered on Dec 20, 1995. The reporter felt that the herpes zoster was related to therapy with varicella vaccine. No further details were provided.
11:50 Am vaccine given, stated that at 12:30 PM eyes itchy, 2:15 PM presented with face swollen and itchy. No acute distress. Pt's physician uncooperative. given 0.2 epi per MD at 2:30 PM and at 2:40 better and at 4 PM much better. Fine the next day.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 120 hours with the highest recorded temperature of 53 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Information regarding PREVNAR was received from a pediatrician regarding a 12-month-old patient who experienced diarrhea.  At 12 months of age, the patient received a dose on an unspecified date.  The patient experienced diarrhea.  No additional information was available at the time of this report.
Patient came in on 3/1/12 reporting minor slight swelling and pain around injection site.  Today, 3/2/12, she returned and it has spread to about a 2-3 inch radius in swelling around injection site.  Patient has not taken any treatment.  Referred to physician.
Patient called the morning of 9/20/19 .   Patient reports that late last night she noticed that her arm was really sore and painful.  She also states that on the same side (left) she has a significant lump under her clavicle that she believes to be a swollen lymph node.  I advised patient to call her Humira doctor, to take Benadryl, and to call me with questions.
Bad Body Aches; Legs Hurting/Leg pain ful to touch; Leg cramps; Leg tingling; hard time sleeping; Bad Muscle Aches; Fever; headaches; Fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bad Body Aches), PAIN IN EXTREMITY (Legs Hurting/Leg pain ful to touch), MUSCLE SPASMS (Leg cramps), PARAESTHESIA (Leg tingling) and INSOMNIA (hard time sleeping) in a 30-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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Bad Body Aches), PAIN IN EXTREMITY (Legs Hurting/Leg pain ful to touch), MUSCLE SPASMS (Leg cramps), PARAESTHESIA (Leg tingling), INSOMNIA (hard time sleeping), MYALGIA (Bad Muscle Aches), PYREXIA (Fever), HEADACHE (headaches), FATIGUE (Fatigue) and CHILLS (chills). At the time of the report, PAIN (Bad Body Aches), PAIN IN EXTREMITY (Legs Hurting/Leg pain ful to touch), MUSCLE SPASMS (Leg cramps), PARAESTHESIA (Leg tingling), INSOMNIA (hard time sleeping), MYALGIA (Bad Muscle Aches), PYREXIA (Fever), HEADACHE (headaches), FATIGUE (Fatigue) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided Treatment information was not provided.
urinating blood; might be a UTI; arm pain; fatigue; blood clots; he started bleeding after the first shot; This is a spontaneous report from a contactable consumer, the patient. This 63-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249) on 18Feb2021 (also reported as 17Feb2021) (at the age of 63-years-old) via an unspecified route as a single dose for COVID-19 immunization. Medical history included enlarged prostate, urinary health issues (gets up in the middle of the night), and has glasses as he had cataract surgery last year (2020) so he lost his close-up vision. Concomitant medications were not reported. On 18Feb2021, the patient got his first shot. Three weeks later, he had an episode of urinating blood and blood clots profusely. The patient stated the amount of blood and blood clots was scary at best. The patient reached out to his daughter who is a nurse who advised him to go to the Emergency Room (ER). He reached out to the nurse hotline as well, which recommended that he go to the emergency room that day as well. He went to the ER (it was a Sunday). They did a blood test, a sonogram or some kind of sonogram, and a urine sample. They also flushed the patient's bladder out with a catheter. This emergency room visit determined that it might be a urinary tract infection (UTI) and started him on antibiotics. The patient confirmed he was not admitted to the hospital. The patient then made an appointment with his doctor because that was on a weekend. He saw his doctor who referred him to a urologist. The patient also reported that he did have the normal arm pain and fatigue the second day or the day after the shot. The patient reported 11Mar2021 or 12Mar2021 was when he started bleeding after the first shot, he was unsure of the exact date, and stated he went to the hospital on 14Mar2021. The patient reported he is going to the doctor today (21Apr2021), to see the urologist but the urologist is going to do a scope in his bladder because that is the only thing that they cannot see. The clinical outcome of events urinating blood, blood clots, UTI, bleeding, arm pain, and fatigue was unknown.; Sender's Comments: Linked Report(s) :PFIZER INC-2021471072 same patient/reporter, different AE/2nd dose
Patient received exact amount of vaccine in her left deltoid through injection site bandage. She was in observation tent when she notice a drop of liquid that is not red rolling down from her bandage for about 2 inches. She videotaped it and came back to pharmacy and show staff.  Moderna was called and case # assigned with safety team to follow up  from Moderna. We spoke with patient  before she left and 2 hours later on the phone and told her that Moderna will follow up.
pimples on skin; Itchy skin; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration on 14Feb2021 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took tetracycline for an unknown indication on an unknown date and experienced drug allergy. The patient previously took nexium for an unknown indication on an unknown date and experienced drug allergy. 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 concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Feb2021, the patient experienced pimples on skin, itchy skin and nausea. The adverse events did not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care.  The patient did not receive any treatment for the reported events. The clinical outcome of the events of pimples, itchy skin and nausea was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Pt recvd 3rd dose of vax & devel bleeding @ inject site, also devel hematoma, a feeling of faintness & was very pale; ice was applied to the inject site & pt's face; pt also devel an induration under the hematoma; pt felt flushed & sweaty;
Initial report was retrieved via the scientific literature on 26 September 2011. Objective: "To report on a multifaceted approach to increase update of the H1N1 vaccine in our ethically diverse obstetrical population". Methods: This was a retrospective study of H1N1 vaccine coverage in 157 pregnant women. The author collected data regarding age, ethnic background, spoken language, acceptance or refusal for the vaccine, whether patient required clinic or hospital evaluations for influenza symptoms and confirmed cases of H1N1. Interventions included educational sessions for team members, a prevention video to educate the patients and an electronic vaccine registry that was updated daily to identify the patients who had not yet received their vaccine. Results: Of the 157 obstetrical patients enrolled 120 (76%) were immunized. Of the remaining patients, 17 declined, 5 delivered before released of the vaccine, 2 contracted H1N1, 9 were lost to care and unreachable and 9 planned to receive the vaccine at their next appointment. The reporter had three confirmed cases of H1N1 in their practice. One of the three received the H1N1 vaccine at seven weeks gestation and seven days later contracted H1N1 (no further information was provided on this patient). The other two patients did not receive the vaccine. Conclusion: Cognizant of the historically low coverage rate for H1N1. The reporter began planning weeks in anticipation of the vaccine. They proactively instituted educational sessions for workers that stressed three strong reasons to immunization which were "pregnant women are more likely to acquired influenza after an exposure, they become more sick when they contract influenza and immunizing the mother during pregnancy decreases hospitalization and respiratory illnesses in their infants". Limitations: The 76% success rate is reported from a single clinic which acknowledges they instituted multiple interventions simultaneously. They additional allocated resources provided by their hospital including increased staffing. Finally, they had no comparator clinic where these interventions were not instituted. Per the reporter, this study may be useful as a model for other clinics and may improve vaccine coverage in this "typically under vaccinated population". Documents held by sender: none.
Fever, extreme drowsiness, upset stomach, headache, chills. This went on for 3-4 days
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose and route were unknown, lot # L015460 with expiration date 20-JUL-2017, and lot # M011116 with expiration date 17-JUN-2017). The vaccines were exposed to temperature excursion of 57.0 degrees Fahrenheit (F) for 1 hour and 50.8 degrees Fahrenheit (F) for 1 hour. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
At roughly  5 minutes post vaccination client C/O feeling  lightheaded and just not feeling well. Skin pale and diaphoretic. Client with positive loss of consciousness. Client assisted to floor and placed in shock position with legs elevated. At which point client regained consciousness. BP 80/40  HR 55  RR 18, A&O x4.  Client stated she had only a "smoothy for breakfast" No S&S of anaphylaxis no SOB, no swelling of tongue or face. 911 notified. At 15 minutes post vaccination client stated still feeling lightheaded and shaky client states no allergies to food - given small piece of chocolate,  client was able to sit up and drink water.
A week after my vaccination, my right arm where the injection was given to me started swelling pretty badly.  It is itchy, raised, and very red. After 24 hours of taking Benadryl and applying hydrocortisone cream it still has not gotten any better.
The patient developed hives at the site of injection the following day. The hives spread to his face within 2-3 days. He continued to have intermittent hives over the course of the next month. He was evaluated by allergy who thought the hives were likely due to the vaccine.
Patient had syncopal episode approximately 2 minutes after HPV vaccine injection, lasting approximately 15-20 seconds. Patient was sitting in a chair, no injury occurred. Patient regained consciousness immediately after ammonia inhalants were given. No ongoing effects noted.
fever, rash, aches,headache, postauricular lymph nodes, itching--began on day 11 or 12 after vaccines given.  Rash --macular on arms, a few papules on neck, no vesicles.  Temp went up to 100.4.  OTC benadryl for itching.  If not resolving or worsens--RTC
At the time of the injection, it took a long time for pharmacists to inject the vaccine into my arm I could also feel the fluid moving thru my arm. Six days later the pain in my arm went to  my left shoulder across my back to my spin and up my neck. Three days after that the pain went to my right shoulder and down my arm to my fingers also it went down my left arm to my fingers. I can not lay on my back when I sleep I can not lay on my left or right side when I sleep because of pain in my shoulders.  I have a hard time grasping anything with my left hand I drop or it causes me pain.
Brachial neuritis in left arm.  Severe nerve pain in the brachial nerve, loss of movement due to pain I left arm
Patient stated they felt difficulty breathing shortly after injection but left observation area after 15 minutes without saying anything to staff. Patient got into their car and drove several blocks away but decided to return to observation area. Patient then complained of a swollen tongue. Vital signs stable. Physician ordered Zyrtec, 10 mg given at 9:20am. Symptoms resolved and patient was discharged with physician approval.
Extreme itching and hives off and on  for approximately a week. OTC anti itch med helped a little. Also had a decrease in B/P since vaccine (checked daily at home) .
01/23/2021 Vaccination. Within 5 minutes, I had experienced brain freeze and tongue swelling. Then the week after, I got a large rash on my arm, super hot and painful to the touch. I called the numbers provided; Benadryl.  The rash persisted for 3 weeks.
Pt presented with erythematous macules on her face while complete the refugee medical history.  She began itching her Left Shoulder and after a few minutes held our her left arm and said, "Look".  Her shoulder to elbow was erythematous with urticaria. Gave pt 50mg diphenhydramine oral stat.
Information has been received from a physician concerning a 24 year old patient with a history of papanicolaou smear abnormal who on 20-FEB-2007 was vaccinated with the first dose of GARDASIL (lot no. 656049/0187U), second dose of GARDASIL (lot no. 657621/0387U) was given on 20-APR-2007 and third dose on 20-AUG-2007 (lot no not reported). In August 2008 the patient was diagnosed with carcinoma in situ. A colposcopy was performed and result was high grade squamous epithelial lesions. On an unknown date a uterine dilation and curettage was performed. It was also reported that a cervical cone biopsy was made (results not provided). Upon internal review, the patient's carcinoma in situ was considered an other important medical event. The patient's sister had a similar adverse experience following vaccination (WAES 0902USA00938). Additional information has been requested.  2/25/09 GYN records received from 11/2005 to 12/2008.  Seen 2/9/07 for annual exam.  Normal PAP.  HPV vax series started. Returned 8/7/08 for exam. PAP  (+) for mild dysplasia.  Colposcopy 9/2/08.  Cone bx (+) for carcinoma in situ and severe dysplasia.
Husband reports that about 4 hours after shot, patient started experiencing severe pain then developed fever and inflammation the next day. The following wednesday, patient went to hospital and had MRI and surgery to drain puss
Patient received initial Moderna primary series on 9/26/22 and 10/24/22. Patient then on 11/21/22 requested for and received a Moderna bivalent booster 1 month earlier than advised. The interval between the primary series and booster was inadvertently too short/close.
Patient received 1st dose Moderna COVID19 on 12/30/20. On 1/7/21 he noticed itching at injection site,  then on 1/8/21 he noticed solid circular redness and warmth at injection site. Area is tender to touch. There is right axillary lymphadenopathy as well.
Had my 2nd  Moderna Covid vaccine on 3/29/21 started with a itchy arm in the afternoons of 4/5/21 and by late evening had a raised, itchy, red, rash/hive at the injection site that was warm to the touch.
Swelling ++, erythema and pain-mother instructed to ice area, Cephalexin prescribed, Benadryl. Saw Dr 3/26/04 at 410 appt in after clinic. Pt returned to ER later evening of 3/26 and was admitted for cellulitis. Discharged home 3/28/04 at 9:30 am. Pt seen by Dr 3/25 for asthma recheck.
Red rash about 3 inches in diameter around site of injection, non-warm, no swelling, minor itching. First noticed 2+ hours after injection. No other symptoms. No topical or oral meds taken for treatment. Pt seen incidentally for another purpose.
Hives developed shortly after vaccine was given.  Hives continued through the following day.  On the day after vaccination, pt was sent to ED at Hospital because of coughing, vomiting, diarrhea.  While there, he developed fever.   The impressions listed on ED report were: urticaria, HSP, vomiting, and fever.   He was started on steroids and continued on benadryl that parents had already started at home.  He was discharged to home on a three day oral steroid course.  He continued to have hives after discharge.  I saw him in clinic for follow up on 8/3/22.  He was back to normal state of health.
Mother called to report a fine reddened rash all over her child's body. Mom denies any fever, loss of appetite or any change in her baby's activities.
Patient has been seen by many specialists. Patient had to give up diving. Patient has missed lots of school. Patient is taking lots of medications. Doing alternative methods also. Slowly improving.
Fussy Friday PM t99.8 on Saturday; c/o pain in neck; played on Trampoline on Sat denies injury; Sunday 8AM c/o stiff neck; Sunday in ER; MD said dx due to pulled muscle;
3pm shots administered. 6pm dinner time - no appetite. 10:45pm crying, no appetite, vomited once, had shivers, limp in the knees, cried until nursed to sleep. It's currently 11:45pm so I hope this is the end of these reactions to the vaccines.