chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient received Pfizer Booster shot on Wednesday 12/8, complained of severe arm pain and lack of mobility following day. Patient saw urgent care physician who diagnosed bursitis, prescribed Medrol for inflammation and suggested an MRI if no improvement. MD suggested that the shot may have been placed too high, but reviewed technique with intern who administered and it was appropriate. The administrator has had alot of experience giving vaccines here at the store and at her place of work.
Diarrhea 2 weeks after second dose; Headache after second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea 2 weeks after second dose) and HEADACHE (Headache after second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea 2 weeks after second dose) and HEADACHE (Headache after second dose). At the time of the report, DIARRHOEA (Diarrhea 2 weeks after second dose) and HEADACHE (Headache after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information provided. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up does not contain any new information.
Itching and burning of my feet; Itching and burning of my feet; My body was painfully itchy and burning; My body was painfully itchy and burning; My body was painfully itchy and burning; Red blotches on various areas of my body, including chest, back, buttocks, thighs, knees, and feet; My heart was racing; Finally fell asleep about 4:00 AM on Friday/Interrupt my sleep; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration in arm left on 23Feb2021 at 14:00 (at the age of 67-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history included known allergies: some cosmetic or cleaning products, so she use only natural dye-free, fragrance-free, preservative-free products. The patient's concomitant medications in two weeks were reported as no. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. The patient stated that, prior to falling asleep on Thursday, 04Mar2021 at 11:45 PM, her heart was racing and she finally fell asleep about 4:00 AM on Friday. On Friday, 05Mar2021, the patient was awoke at 7:00AM. Stated that, her body was painfully itchy and burning. There were red blotches on various areas of her body, including chest, back, buttocks, thighs, knees and feet. It became so unbearable that she finally took an antihistamine and fell asleep. The same thing occurred Friday night into Saturday morning and Saturday night into Sunday morning, but to a much lesser degree. Stated that, the worst part of it on Saturday morning and Sunday morning was the itching and burning of her feet accompanied by a big red blotch. This passed after a couple of hours. Stated that, on Sunday night, the patient heart was racing and she took an antihistamine before sleeping for fear of experiencing the itching that might once again interrupt her sleep. Stated that, this morning upon awakening, the patient did not experience the severe itching and burning of her feet, just some light itching of her body. Treatment medication included was antihistamine. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
On 3/17/11 mom reported concern re: severe swelling & redness to rt arm at site of vax. Using ice packs for comfort. Has worsened since day of vax. Improved since 3/17/11. Ext with erythema, warm & no TTP. Painful to touch.
Vaccinated at mass vaccination event for nursing home staff and residents on 12/18/2020. Developed cough, runny nose, sore throat, loss of taste and smell and tested positive for COVID-19 on 12/24/2020. Had exposure to COVID+ mother whom she takes care of.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 14-MAR-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 672 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
We could not get a hold of the patient. We have tried calling several times, but the patient is not answering.
2nd dose - swelling in face. 3rd dose - vomiting/diarrhea HA x 1 1/2d No issue after 1st dose. Did not take 4th dose.
Red, swollen, heat in area, hard knot. Erythemic flap 2 inch from clavicle to elbow. Painful, itching with vesicles --> 3cm diameter.
*Not sure exactly which Flu Vaccine was administered, but still having shoulder pain one month later.
Reaction to pneumonia shot. Patient is here because he is having a reaction to a pneumonia shot, L arm swollen, sore in shoulder and elbow, had shot on 12/15. Soreness started at injection site that night. Started 12/16 sl swelling L inner forearm, bruise on L forearm started with redness around and then ecchymosis around bruise progressed. No fever. Arm hurts to use it or lie on it at night. Hurts to use shoulder. No sx of fever. Patient reports no fever, no night sweats, no significant weight gain, no significant weight loss, and no exercise intolerance. He reports no difficulty hearing and no ear pain. He reports no frequent nosebleeds, no nose/sinus problems, and no rhinorrhea. He reports no sore throat, no bleeding gums, no snoring, no dry mouth, no mouth ulcers, no oral abnormalities, and no teeth problems. He reports no chest pain, no arm pain on exertion, no shortness of breath when walking, no shortness of breath when lying down, no palpitations, no know heart murmur, and no leg swelling. He reports no cough, no wheezing, no shortness of breath, and no coughing up blood. He reports no abdominal pain, no vomiting, normal appetite, no diarrhea, not vomiting blood, no nausea, no acid reflux, and no constipation. He reports no depression, no sleep disturbances, feeling safe in relationship, and no alcohol abuse.
Arm became reddened and swollen and progressively got worse over the course of the next three days.  On March 27, 2015 arm, hand, shoulder, and neck became swollen.  On March 29, 2015 hives on chest, back, and throat.  Patient saw her physician on March 27, 2015 and physician prescribed antibiotics and stated it was cellulitis.  Patient took Benadryl and reactions began to subside; however, she is continuing with the Benadryl at this time.
This spontaneous case, initially received from the pharmacist on 21-Sep-2018, concerns a 71-year-old, elderly, female patient. The patient's concomitant medication included prednisone for an unknown indication. On 21-Sep-2018, the patient was administered incomplete dose of FLUAD (TIV) (dose: 0.25 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250793, expiry date: 30-Apr-2019), as the needle was wrongly attached to Luer Lock (explicitly coded as under dose and needle issue). No adverse event was reported after administration. The reporter assessed this case as non-serious. Non-significant follow up received from the reporter on 25-Oct-2018: No new information received. Hence, no changes were made in narrative.
4/23/09 19m WCE 4/24- fever 102, fussy, lethargic, fussy. ? imm- Rxn -> amox given, no source.
DEVELOPED A RASH AT INJECTION SITE, PATIENT ADVISED TO TAKE BENADRYL
Patient received monovalent vaccine instead of bivalent booster. Patient has been contacted to receive bivalent booster in 8 weeks, per CDC recommendation.
Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-JUN-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) as prescribed and/or administered by a health care provider (HCP) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a HCP for shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). On an unknown date, the pt was admitted to the hospital due to the events. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt 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 would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of herpes zoster and ill-defined disorder was unknown. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Swollen arms, painful, itching at the site of injection. Patient was seen in the clinic two days later and was prescribed MOTRIN and BENADRYL.
Rash NUMBNESS, TINGLING Narrative: Pt received 2nd dose of covid vaccine and experienced numbness and tingling in left arm, radiating into thumb and forefinger. Pt then reported new onset sore throat. Nurse noticed blotchy rash on left forearm where vaccine was placed. Given epinephrine and Benadryl injection.
Last night eye felt itchy. Had some puffiness on both eyelids. Today, right side face swelling. No SOB, no swelling of the tongue or lips.
Pt exposed to varicella 31Dec97. 07Jan98 Pt recv 1 dose vax SC. No concomitant med. 15Jan98 Pt exp fever 101. 16Jan98 Pt exp papulovesicular rash, erythematous & pruritic w/greater 50 lesions.
This spontaneous report as received from a physician as part of a marketing research program refers to few patients of unknown age and gender. Patients' concurrent conditions and medical history was not provided. On an unknown date the patients were vaccinated with ZOSTAVAX, (dose#, route, lot# not reported). Concomitant therapy was not mentioned. A few patients who received the ZOSTAVAX, still had shingles (vaccination failure) and some of them 'would get a site reaction' (injection site reaction). The outcome of the events was not reported. Causality assessment was not provided. Additional information is not expected since the physician wanted to remain anonymous.
Patient's initial symptoms started in March 2020 with unexplained headaches. Those symptoms worsened after COVID-19 vaccination in February 2021. Patient fell in her bathroom in March 2021 and presented the emergency room. She was treated for finger dislocation, hip contusion and notably hypoglycemia. Headaches worsened from March through June and eventually became daily headaches. She was seen by local neurologist in June 2021 and recommended for MRI. She completed MRI on 6/25/21 with multiple nonenhancing T2/FLAIR hyperintense lesions in juxtacortical, deep, periventricular white matter, as well as lesions along the septal callosal interface suspicious for multiple sclerosis. She was referred to our clinic and ultimately diagnosed with primary progressive MS in November 2021. Patient noted they had worsening in balance that started late 2020 to early 2021. While symptoms clearly started before COVID-19 vaccination, the worsening in MS symptoms appears to correlate at least temporarily with initial COVID-19 vaccination.
Cold; Ache all over; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), PAIN (Ache all over) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalized) in January 2021.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced NASOPHARYNGITIS (Cold), PAIN (Ache all over) and PYREXIA (Fever). At the time of the report, NASOPHARYNGITIS (Cold), PAIN (Ache all over) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Initial report received from a health care professional on 02 November 2006. A 42 year old, male patient experienced pain and paraesthesia after he received an injection of Fluzone (lot number U2194AA) in the left deltoid (route and date of administration not reported). The pain was severe that he took Vicodin. The patient was referred to a neurologist. At the time of the report, the patient did not recover. Follow-up information received on 27 December 2006. Fluzone SV 2006-2007 was administered intramuscularly on 16 October 2006. Immediately post-vaccination, the patient experienced numbness and tingling of the chest wall and arm pain. The patient continues with pain. He had improved markedly and then symptoms reappeared. He was treated with therapy, a prednisone dose pack, and Darvocet. Unspecified x-rays were negative, and an EMG was negative. The patient was to follow-up with a neurologist. At the time of this report, the patient had not recovered. Follow-up information received on 20 April 2007. The patient had an EMG performed on 17 November 2006. The referring neurologist had the following impression: Musculoskeletal pain with a suggestion of possible very subtle brachial neuritis which was completely improved. The EMG nerve conduction study did not show any suggestion of neuritis when done. He has a very subtle left arm median neuropathy as seen in carpal tunnel syndrome. This would require further follow-up before any interventions. This case is upgraded to serious adverse event internally based on follow-up information.
patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Information has been received from a nurse practitioner concerning a 58 yr old white female with no medical history who on 10Feb06 at 2:00PM (also reported as 1:00PM) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 651322/1044P), IM in the left deltoid. Concomitant therapy included sertraline HC1 (Zoloft), alendronate sodium (Fosamax) and atorvastatin calcium (Lipitor). There was no illness at the time of vaccination. On 11Feb06 the pt developed hives, swelling, warmth, redness at injection site and decreased use of limb for 4 days. Hives lasted for 3 days, no treatment. It was reported that the pt recovered on 13Feb06. There were no relevant lab or diagnostic tests. Additional information is not expected.
Almost immediately following the vax, the pt experienced a rash on his abdomen and within 10 minutes had spread to his face. The pt remained in the clinic for 30 minutes for follow up following Benadryl administration.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Additional Details: patient bp was recorded as 85/75mmhg at the time patient felt light headednes. rechecked again after 15 minutes and pt felt better and bp recorded-120/79mmhg
Information has been received from a registered nurse, concerning a male baby whose 35 year old female mother with asthma and penicillin allergy, on 17-AUG-2010 was vaccinated with her first dose of GARDASIL (lot number not reported). There was no concomitant medication. The registered nurse reported that on 01-APR-2011 the mother delivered via vaginal a normal male baby, with no congenital anomalies. The baby's weight 4 pounds 15 ounces. The registered nurse stated the baby was "small for dates" during pregnancy. It was also reported that oligohydramnios was noted. The mother's experiences were captured in WAES1008USA03850. Additional information has been requested.
bruising @ L proximal thigh @ injection site 6mm diameter bruising @ R proximal thigh with tenderness and area of induration 9mm diameter patch of erythema without warmth @ R lateral mid thigh
Information has been received from a health professional concerning a 3 year old male who on 29 OCT 2007 was vaccinated with 0.5 ml, a second dose, intramuscularly into the left arm with hepatitis A virus vaccine inactivated (lot # 654514/0304U). On 29-OCT-2007 the patient developed a black pin point size dot immediately after the injection. It was noted that the patient did not experience any adverse events after receiving the first dose of hepatitis A virus vaccine inactivated. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. At the time of reporting the patient's status was unknown. Additional information has been requested.
Alterations in her mouth that seemed Bell´s Palsy; Not sure whether patient has Bell´s Palsy or shingles; This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2020, the patient received the 1st dose of Shingrix. On 4th December 2020, 9 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the bell's palsy and shingles were unknown.   It was unknown if the reporter considered the bell's palsy and shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however it could be 75 or 76 years old. On 4th December 2020, the patient experienced little alterations in her mouth that seemed Bell´s Palsy. Her VZV (Varicella zoster virus) IgM antibodies levels were measured 4 weeks after vaccination and they had increased.  The reporter was not sure whether patient had Bell´s palsy or shingles. The reporter was reticent to provide details but agreed to follow-up.
This spontaneous report has been received from a registered nurse concerning a patient of unknown gender under the age of 50 years. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that the patient was administered ZOSTAVAX outside of the age recommendation from the prescribing information as on 19-SEP-2017, the patient was vaccinated with ZOSTAVAX one shot, with lot number M038864 and expiration date on 12-DEC-2017 (concentration, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using the sterile diluent (MERCK). The reporter denied any adverse effects with the patient. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA002538.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Morphene, reaction(s): "known allergies: Morphene", notes: known allergies: Morphene; Valium, reaction(s): "known allergies: Valium", notes: known allergies: Valium; Vicodin, reaction(s): "known allergies: Vicodin", notes: known allergies: Vicodin. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.