chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First three knuckles on hands swelled and burned. Started mid to late afternoon and has lasted for four days. Today is fourth day and very little pain is left now as it has gradually disappeared. What is left is in first knuckle on left hand. Same side as injection.
sleep lose due to the pain; sleep lose due to the pain; pressure behind his eyes; fever of 102.8; trouble moving his head due to pain; pain in all his joints; Malaise; coughing; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves a 61 year old male patient who had pressure behind his eyes (Ocular discomfort), sleep lose due to the pain (Insomnia and Pain), fever of 102.8 (Pyrexia), trouble moving his head due to pain (Headache), pain in all his joints (Arthralgia), malaise and coughing (Cough), while he received vaccine quadrivalent recombinant influenza vaccine (Flublok QIV).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On 05-Nov-2020, the patient received quadrivalent recombinant influenza vaccine at a dose of 0.5 ml once via an unknown route in the left deltoid (lot QFAA2026, expiry dates were unknown) as prophylactic vaccination.  On 06-Nov-2020, 1 day, after taking the suspect, the patient had pressure behind his eyes (Ocular discomfort), fever of 102.8 (Pyrexia), trouble moving his head due to pain (Headache), pain in all his joints (Arthralgia), malaise and coughing (Cough).  On an unknown date (latency unknown) after taking the suspect, sleep lose due to the pain (Insomnia and Pain) was reported for the patient. On the same date, coronavirus (COVID-19) test reported negative.  Action taken was reported as unknown and therapy status with the suspect was not reported. Corrective treatment was not reported. Outcome was reported as unknown for all the events.  No further information was reported.
After administering dose of 5-11 year Pfizer COVID-19 vaccine, it was discovered that the vaccine was mixed with 1.8mL of diluent instead of 1.3mL of diluent.  According to CDC guidelines, the dose should be repeated immediately in this scenario. Confirmed with pharmacy and they agreed with CDC guidelines. Staff from Pharmacy spoke with Pfizer and they stated they do not give treatment recommendations but they would follow CDC guidelines. She stated we can give the mother the option to administer another dose of the vaccine or to wait 3 weeks and draw antibody titers to see if he has antibodies. Mother chose to have another dose administered since they were in the office already. Second dose administered in different leg from first administration and patient was watched continuously for 15 minutes with no reaction, discharged home.
erythematous plague on (L) upper thigh at vaccine site 1.2 x 1.2 cm noted 1-2 days after shot and still persists 2 wks after shot-seems less thickened now
Per note in patient chart: Pt experienced fatigue and fever and diarrhea and left upper arm red+warm+itching+painful+edema, all is resolving pt declines need for further medical care for reactions, advised pt to take BENADRYL if itching is bothersome, pt verbalized understanding. Sedation, rash, urticaria pruritus and diarrhea.
Suspected Vaccination failure; have had them 3.times / believe I have them now / have had the shots; This case was reported by a consumer via interactive digital media (Facebook) and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles (3 times).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received shingles shots. The patient reported that he or she had shingles 3 times and he or she believed having shingles at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Shortness of breath; fluttering heart rate; left neck pain; facial numbness in tingling on left side of face, dizzy, flushed, sweaty.
Dizziness, weakness, fatigue, aches and pains, headache, sinus problems - runny eyes, stuffy nose.
Soreness of left arm radiating to left upper neck and numbness of left hand, pulling sensation of left side of neck
Several days after injection pt noticed increased soreness, itching, significant redness, was over the weekend when provider office closed. Pt's dgtr outlined red area with marker; on Monday 8/22/16 pt seen by MD, redness spread to pt's elbow, treated w/2 injections of 1 gram each of ceftriaxone (1 gram on 8/22/16 and 1 gram on 8/23/16) for cellulitis.
vaccine administration error- left deltoid injection site bleeding moderately immediately following administration, the bleeding stopped with approx 30 seconds of pressure to site. No other adverse reactions. Evaluated by the medical provider at the site and injection appeared to be in the correct area.
Pt received her second dose of Moderna in her right arm by a member of the pharmacy staff, but the injection was placed in the SQ tissue on the posterior side of her arm, approximately 5cm above the elbow. Since she does not have any medical background or knowledge, she did not know that it was placed in an incorrect site. That evening, her arm began hurting at the injection site, and became very swollen, tender to palpation, and hot to the touch. By the next morning, she was unable to lift her arm any higher than her shoulder. I saw her at a function that morning around 0915 and she asked me if the pain she was experiencing was normal. I informed her that some injection site soreness and swelling could be a normal reaction, but when I asked to see the site, instead of her deltoid, she showed me the lower posterior area of her arm above the elbow and it was very swollen, tender to palpation, hot to the touch, erythematous, and she had very limited range of motion.
pt had a positive COVID test on 10/12/21 at Hospital; pt was transferred to different hospital on 10/17/21 with extreme SOB, on BiPAP, hypoxic respiratory failure secondary to COVID pneumonia; admitted to ICU; given Dexamethasone, Remdesivir; O2 needs increased; DNR/DNI; pt transitioned to comfort care and passed away in the hospital
Myalgia, fatigue Narrative: fatigue and sore arm for 3 days
Husband reports. 10/5/14 L leg tingling, heavy numb and L arm  numb, L shoulder tingling, L tips of fingers and loss sensation . 10/15/14 L arm heavy. As of 11/4/14 only sx L hand loss sensation can't hold onto things and top of L foot loss sensation.
After receiving these vaccine on 10/13/14 pt. stated that on or about November 1, 2014 he started to develop an itchy rash that spread over all his body; pt went to doctor on 11/14/14 and he was prescribed prednisone 10 mg po TID x 4 days afterwards pt was advised to us BENADRYL when itching. Finally, on November 24, 2014, pt stated most of rash had subsided.
Pain and tingling sensation in arm. Unable to use full motion of arm without pain or stiffness.
This spontaneous report as received from a physician assistant, via a company representative, referring to a 12 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 02-JUL-2018, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). Other suspect vaccines administered on the same day,  included MENACTRA and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (indication, strength, route, dosage schedule, lot number and expiration date were not reported). On 03-JUL-2018, according to the patient's mom, the patient turned manic, started having awful tantrums (aggression), memory loss (amnesia), and cannot sleep (insomnia). The patient had sleep studies done (no results provided) and a referral to a neurologist who basically said that the patient should see a psychiatrist. The outcome of aggression, insomnia, amnesia and mania was reported as not recovered. Causality assessment was not provided.
Local reaction to vaccination (L) anterior thigh with minimal flat rash surrounding injection site with no edema no limping with walking.
-swelling at injection site -redness at injection site -stiff neck -night sweats -hot to the touch at injection site -head ache -pain after moving left arm
pt recv vax;exp rash & fever described by reporter as serum sickness;recv further vax w/ no adverse events;
fever; chills; body aches; nausea; joint pain; headache; cluster like migraine headaches; Also had severely heavy period which is not normal for me.; 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), administered in arm left, administration date 09Sep2021 (Lot number: 30135BA) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Interstitial Cystitis" (unspecified if ongoing), notes: other medical history: Interstitial Cystitis, IBS; "IBS" (unspecified if ongoing), notes: other medical history: Interstitial Cystitis, IBS. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; DYMISTA; KARIVA. Vaccination history included: Bnt162b2 (Previous Dose dose number=1, Previous dose Lot number: EC3180, Previous dose Administration date= 19Aug2021, Previous dose Administration time: 11:00 AM, Previous dose Vaccine location= Left arm), administration date: 19Aug2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "fever"; CHILLS (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "chills"; PAIN (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "body aches"; NAUSEA (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "nausea"; ARTHRALGIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "joint pain"; HEADACHE (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "headache"; MIGRAINE (non-serious) with onset 10Sep2021, outcome "not recovered", described as "cluster like migraine headaches"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "Also had severely heavy period which is not normal for me.". Therapeutic measures were not taken as a result of pyrexia, chills, pain, nausea, arthralgia, headache, migraine, heavy menstrual bleeding.  No follow-up attempts are possible. No further information is expected.
A nurse practitioner reported that a 6 year old female experienced profuse bloody nose within 10 minutes of FluMist administration on Oct 17 2005. Bleeding resolved with ice pack and maintaining patient on a supine position. No other information was available at the time of the report. The reporter causality is not provided. A nurse practitioner reported that a 5-year-old female experienced profuse bloody nose within 10 minutes of receiving FLUMIST on 17Oct2005. The bleeding was resolved with ice pack and placing her in a supine position. On March 28, 2006 the nurse reported the event has completely resolved. Additional information date of birth and adverse event onset date/time and outcome.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about on 23-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.    On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.    The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).    Additional information has been requested.
Severe cramping in left leg and left foot. Small brusing with pea size nodule under skin on left bicep and return of blisters on lower right ankle area.
Erythema, heat, inflam and tenderness at injection site 10 x 13 cm.
This case was reported by a consumer via call center representative and described the occurrence of vaginal bleeding in a 48-year-old female patient who received BOOSTRIX. Concurrent medical conditions included fibroids (caused bleeding in the past, but they had been inactive for a long time). On 27th July 2017, the patient received BOOSTRIX (intramuscular). In July 2017, 12 hrs after receiving BOOSTRIX, the patient experienced vaginal bleeding. On 27th July 2017, the patient experienced vomiting, abdominal pain and cold sweat. On an unknown date, the patient experienced hemoglobin decreased and decreased appetite. The patient was treated with ibuprofen. On an unknown date, the outcome of the vaginal bleeding and hemoglobin decreased were not recovered/not resolved and the outcome of the vomiting and cold sweat were recovered/resolved and the outcome of the abdominal pain and decreased appetite were recovering/resolving. The reporter considered the vaginal bleeding, vomiting, abdominal pain, cold sweat, hemoglobin decreased and decreased appetite to be related to BOOSTRIX. Additional details were reported as follows: The patient's concomitant medication included Multivitamin. On 27th July 2017 at 14:00, the patient received BOOSTRIX on the left arm. Four hours after the vaccination, the patient had sudden onset of vomiting, a sharp pain in her abdomen and cold sweats. The patient had to take 2 ibuprofen because the pain was so bad. A few hours later, the abdominal pain had settled into a dull ache but she began experiencing vaginal bleeding. Less than a week after the vaccination, over the weekend the patient could barely eat and had no appetite and had low haemoglobin. At the time of reporting she could eat, but her appetite was still down. On 2nd August 2017, the bleeding had continued and was worse, which was described as haemorrhaging. The patient visited her OB/GYN on the day of reporting and would have visited day before reporting, if she could have got an appointment. The patient was not hospitalized, but if the haemorrhaging continued she was afraid if she would have to have a transfusion. The patient already told that her haemoglobin had dropped. The patient stated that the bleeding was worse than any of her previous fibroid surgeries and this might have caused by BOOSTRIX, because she was fine when she walked into her physician's office to receive the vaccine. While the patient did not provide her own address, but she had given permission to contact her physician with the required information.
Onset within  3-4 hours. Nausea, vomiting, feverish, chills, shaking, headache, injection site pain, fatigue, tiredness.
This spontaneous report was received from a medical assistant (clinical coordinator) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2017, between 27-JUL-2017 and 03-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # reported as N008077; expiration date: 09-MAR-2019; dose and route of administration were not reported). Concomitant therapy included properly stored sterile diluent (MERCK) injection. The reporter stated that the administered dose of VARIVAX was stored at temperature of -10.7 degrees Celsius for 2 hours 10 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of seven reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA003358: US-009507513-1708USA005841: US-009507513-1708USA005839: US-009507513-1708USA005840: US-009507513-1708USA005836: US-009507513-1708USA005838.
Broke out in hives consistently, shortness of breath, throat tightening. Hives are not clearing up. D dimer 1450.
No adverse effects. The patient was given the pfizer bivalent covid 19 vaccine erroneously as the first dose of the covid19 vaccine series instead of a monovalent vaccine.
was accidentally given a second dose of the Moderna version of the shot, instead of a second dose of the Pfizer shot; A spontaneous report was received from a other healthcare professional concerning an unknown patient who was accidentally given a second dose of the Moderna version of the shot, instead of a second dose of the Pfizer shot.  Lot number and expiration date for mRNA-1273 were not reported   Medical history and concomitant medications were not reported. No additional information relevant to the event was reported.  Action taken with the second dose of mRNA-1273 in response to the event was unknown.; Reporter's Comments: This report refers to a case of accidentally given a second dose of the Moderna version of the shot, instead of a second dose of the Pfizer shot for mRNA-1273, lot# (unknown) with no associated adverse events.
More than expected redness and warmth lateral to injection site. Injection was Hib on Left thigh. Patient was given antibiotics and will follow up in clinic on 8/16/17.
pt recv vax 8AM 17MAY95 by 930PM aching all over nausea, hot & cold; 8AM 18MAY dizzy, aching, cold & hot-sore arm;
Shingles; This is a spontaneous report from a contactable consumer (patient). A 47-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: PL3183, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 20Aug2021 at 05:00 PM as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included myasthenia gravis, rheumatoid arthritis, Known Allergies with Gluten and Celiac disease. No other vaccine received in four weeks, no covid prior vaccination, not tested covid post vaccination. Concomitant medication(s) included tofacitinib citrate (XELJANZ) taken within two weeks. The patient experienced shingles. Ae resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles with Valacyclovir HCL. The outcome of event was not recovered.
Patient walked into clinic to report his left arm was swollen and red from recent pneumonia 23 injection received 3/29/17. Patient left arm assessed, visible area of cellulitis radiating from deltoid to antecubital, approximate area of redness 32Lx20W, warm to the touch; no areas of induration or drainage noted. Patient given cephalexin 500 mg TID for 10 days.
Arm pain, fatigue, weakness, general malaise x 2 days unable to report to work day following vaccination
LEFT ARM DEVELOPED CLEAR FLUID FILLED BLISTERS  4 INCHES BY 6 INCHES AREA SIZE MEDIAL AND DISTAL TO IM INJECTION SITE
Pt her today with mother due to vaccine reaction to left leg after receiving PedvaxHib 12/27/22. Mother states he developed an inflammatory reaction last evening about 2000. No fever, eating/drinking the same- no irritability. Left thigh shows reddened swollen area about 9cmX7cm. Tylenol  given last night about 2300- baby fell asleep.  Provider assessed and offeredRx: Clindamycin pediatric 75mg/5ml       Take 8mg orally every 8 hours with food for 7days ***** Provider call number given to patient with concerns
On 4/22 she developed R side facial weakness - Bell's palsy diagnosed in clinic on 4/26 when she sought medical treatment. Started on prednisolone and valacyclovir as well as lubricating eye drops/ointment. Told to follow-up in 2 weeks.
This case was reported by a healthcare professional and described the occurrence of pityriasis rosea in a 48-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The subject's medical history included autoimmune disease for 25 years and drug allergies to erythromycin, minocycline, contrast dye, codeine, betadine and iodine.  Concurrent medications included Hydroxychloroquine sulphate (Plaquenil), Thyroxine sodium (Synthroid) and Montelukast sodium (Singulair).  On 15 October 2007 at 08:00 the subject received unspecified dose of Fluarix (.5 ml, unknown, left arm).  Fifteen minutes after vaccination with Fluarix, the subject experienced itching at the injection site.  She also experienced unspecified itching fifteen minutes after vaccination.  A couple of hours later, she experienced a rash at the injection site.  During the evening, the rash had gone down her arm and back.  One to two days after vaccination, the rash had spread to her stomach and chest.  The rash was described as being scaly and irregular.  The reporter thinks that it is pityriasis rosea.  The reporter considered that the reaction was systemic.  Medical attention was required at the physician's office.  The subject was treated with hydrocortisone (Hydrocortison) and fexofenadine hydrochloride (Allegra).  At the time of reporting the events were unresolved.  The healthcare professional considered the scaly, irregular rash, pityriasis rosacea and itching were probably related to vaccination with Fluarix.  Follow-up received on 27 November 2007 via the healthcare professional who is also the subject.  She reported that she was diagnosed with pityriasis rosacea.  She reported that the events improved.  She considered that the events were not serious and were possibly related to the use of Fluarix.  She noted that she had received Fluarix before and did not experience any adverse events following previous vaccinations.
Pain & burning sensation & sweating feet - bilateral.  2 days later began with pain bilat elbows, arms, hands.  To MD - to ER 5 days after onset.  She refused all tests except blood tests.