chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fainting episode; severe diarrhea; This case was reported by a consumer via call center representative and described the occurrence of fainting in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant) and diarrhea. On an unknown date, the outcome of the fainting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the fainting and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix approximately 2 months prior to the reporting date at the age of 73 years. The patient reported experiencing severe diarrhea and a fainting episode approximately 12 hours after receiving Shingrix.  Severe diarrhea and fainting episode occurred simultaneously.  Severe diarrhea and fainting episode lasted approximately 10 minutes. The reporter consented to follow up.
5 minutes after the shot was given experienced a tingling and all muscles shaking of hands and then hot flash.  This lasted about 6 to 7 minutes before it dissipated.
4:40pm:  Patient complained of arms cramping, back of head pounding, coughing blood, tachycardia;  16:48pm EMS called. 17:08 EMS Arrived; Vitals: 16:50pm 148/90 101 18 O2 100%;  1700pm 144/100 100 20 O2 100%;  1730pm EMS departed to hospital. Pt. status when transported to hospital:  Stable, no longer vomiting.
This spontaneous report was received from a medical assistant via a company representative and refers to a 62-year-old female patient. No information regarding the patient's concurrent conditions was reported. The patient had no medical history. The patient did not have any known drug reaction/allergies. On 16-MAY-2017, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) in the right arm, on the front side, pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDAP) (dose, route of administration, lot# and expiration date were not reported). On 16-MAY-2017, shortly after the injection, the patient became red at the injection site and developed a knot. It was not known if the patient received care from the physician's office. No treatment information was provided. No laboratory test diagnostic was performed. The outcome of the events was unknown. The causality between the events and suspect therapies was not provided. Additional information is not expected as there was no consent to contact the reporter.
reports awakening at 1 am with panic attack-sob, chest tightness, dry mouth.  Symptoms resolved within one hour and he fell back asleep.  Has never had panic attack in past.
17 patients administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
She is having problems with her arm, she can't raise her arm fully and can't raise her elbow out; The symptoms mimic bursitis; This initial spontaneous report was received from a female patient of unknown age concerning to herself. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided.  On 26-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S006778, expiration date not provided but upon internal review stablished as 28-NOV-2020 (strength, dose, route of administration not provided), in the left arm as prophylaxis. On the same date, after vaccination, the patient was having problems with her arm, as she could not raise it fully, as well as she could not raise her elbow out (movement disorder). She reported that the symptoms mimicked bursitis, and she sought for medical attention, but she had not been diagnosed with this as per her physician.  At the reporting time, the patient had not recovered from the events. Additionally, she would like to know what kind of "filler" was in the vaccine, and if there was any recommendation for the management or treatment of symptoms.   The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported. . combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S006778; expirationdate: 28-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Pt felt a knot to her right arm on 08/07/08 around 9:00 pm. Pt felt a "knot" to her left arm around 8:00 am on 08/08/08. Pt states both left and right arm hurts only to touch.
Swelling and redness to left arm at site of immunization. Treated with Benadryl. Also warm locally, this was treated with ibuprofen and ice packs.
Information has been received from a medical assistant referring to an unspecified number of unspecified patients of unkonwn age and gender. In July 2015 (also reported as unspecified dates since 01-JUL-2015) the patients were administered an unspecified number of improperly stored doses of VAQTA (route, lot#, strength and dose were unknown). No adverse effect was reported. This is one of several reports receive from the same reporter. Additional information has been requested.
Woke in middle of night 16 hours post booster vaccine with intense menstrual cramps and heavy bleeding. Past month's menses was on time and normal and ended 1 week prior to receiving the booster vaccine.
Low grade fever for 4 days prior to 3/7/11 and fine red rash all over body.
9/12/2020 The patient's wife called around 5pm to report that patient was having severe shoulder/arm pain and shivering following his second dose of Shingrix earlier that day  She stated he had iced the area and taken half a tablet of pain medication he had on hand, as well as an anti-inflammatory medication, but was still quite uncomfortable.   Discussed potential adverse effects of vaccination and that some effects will resolve in 2 to 3 days, but if his discomfort continued or became worse he should consider following up with an urgent care or his family practitioner.  Upon follow up an hour and a half after her initial call she reported he had some improvement in his pain following taking the second half of the pain medication.  She said his shivering had subsided.  She stated he didn't feel applying ice provided any comfort, but he applied heat and it helped some.   9/13/2020 - The patient's wife stated he had some improvement and his pain was being managed with ibuprofen.   9/15-2020 - placed f/u call to wife. She stated pt. is still in pain, but has not taken any medication for it. She statesethat he is having trouble "barely raising his arm."  They scheduled an appointment with their primary care doctor that evening .  9/17/2020 f/u with wife - family doctor did a physical exam and said his upper arm was very swollen and mentioned the injection might have been given too high on the arm - he prescribed a seven day course of a steroid.  Too soon to determine if steroid will result in total recovery.
Patient experienced worsening side effects of her current medication, dupixent after the vaccine. she also reports a flare of her atopic dermatitis.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information in response to event was not provided.
I have had ongoing at times debilitating pain from lower left side back area to parts of my leg on the same side. After a week or two of the pain getting worse, I was advised by my Dr. to get checked. I went to urgent care and was evaluated by an ER trained Dr. who believed I have sciatica. The pain has lasted about a month, but is much better since the past week.
Very sore left arm. Radiates from shoulder to finger tips on left arm. Also radiating to left pec. Ongoing and getting worse9
20 minutes after receiving shot had difficulty in breathing  Wife rushed home and started using nebulizer, had to take two treatments before able to breathe a little better
A spontaneous report was received from a certified medical assistant concerning a six month old female infant. On 24-NOV-2014, the six month old received VAQTA 25/0.5 injection (route not specified). Medical history and concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 02-FEB-2010, the patient was inoculated with ZOSTAVAX by a physician at a clinic as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated by a Dermatologist for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered not resolved. Causality assessment was related. Additional information has been requested.
pt to ED from SNF due to desaturation; positive for COVID; didn't want admission to hosp but SNF couldn't take her back due to the desaturation; pt given remdesivir, dexamethasone; comfort care; pt's condition worsened and she died in the hosp
Patient received 1st dose Moderna vaccine on 4/9/21; on 4/15/21 patient began with symptoms of shingles.
mom called clinic 5SEP95 stated was concerned pt would have periods-usually in p/noon would be limp & stare; no temp on or cont crying noted; pt recv hit on head by a plastic bottle-taken to MD no dx made; appeared nl @ visit next day limp
Patient experienced aches, chills, fever 12 hours after receiving SHINGRIX. Patient also complained of arm soreness for 4 days.
Fever of 103 started at 7pm on 4/19 and continued through 4/20.  On 4/20 arm was red and swollen at injection site.  4/21 the redness and swelling doubled in size with streak like marks over bicep.   Treatment  -IM injection of Rocephin -doxycycline hyclate 100mg - 10 day treatment
chest pain, dyspnea, dizziness, possible myocarditis found during ER visit
Horrible headache. Bad muscle pain  stiffness, pain in throat. Burning in throat and ears, severe anxiety
Patient had hotflush, passed out and became unconscious, when patient came to, felt nauseated, was clammy to touch and hot. Pt was given water and ice pack and put head between legs. After 20 minutes she felt better and left.
Information has been received from a physician concerning a child who on an unspecified date was vaccinated with a dose of varicella virus vaccine live. The physician reported that several months later, the child developed a severe case of varicella. The physician reported that the case of varicella was so severe that it scared her to the point that she thought it could be "small pox". The physician would not pull the pt's chart to disclose or provide the release of any additional information, and cited the regulations. The lot number was not available. No other information was provided. It was unknown as to whether prescription medication was required and if the adverse event abated. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
A VERY, VERY MINIMAL SORE AREA IN ARM; This spontaneous report received from a patient via a company representative concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.No concomitant medications were reported. On MAR-2021, the subject experienced a very, very minimal sore area in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a very, very minimal sore area in arm was not reported. This report was non-serious.
Myalgia, Arthralgia, Employee reported pain and discomfort and swelling at injection site. Employee also reported chills, joint pains, muscle or body aches and fatigue or tiredness. Narrative:
5yr-11 yr vaccine given to 13 year old.  No known adverse outcome.
Pt recv vax on 5/11/98; on 5/12/98 pt exp mouth sores
Vial was opened, then punctured and was returned  back to the refrigerator for 2 weeks and was then used to administer to the patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was opened, then punctured and was returned  back to the refrigerator for 2 weeks and was then used to administer to the patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was opened, then punctured and was returned  back to the refrigerator for 2 weeks and was then used to administer to the patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was opened, then punctured and was returned  back to the refrigerator for 2 weeks and was then used to administer to the patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  No treatment of events was reported.
-Temperature of 101-102.3 for 36 hours, did not reduce with anti-pyretic medication (Tylenol/Ibuprofen). -Chills with shaking -Nausea/diarrhea -Body aches and joint pain -Fatigue
Mom states a few minutes after receiving the immunizations he began crying his stomach hurt, his heart was going to "explode" and his eyes/lips began to swell.  Mom was told by a triage nurse at Pediatrics to give benadryl and claritin.  Mom states shortly after giving these his symptoms went away.  Per Dr he did still have a rash to legs on 9/6/19.
Armpit hurts - just outside of her armpit.; She was thinking maybe it was a swollen lymph node.; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 28 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (non-serious), outcome "not recovered", described as "Armpit hurts - just outside of her armpit."; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "She was thinking maybe it was a swollen lymph node.". Therapeutic measures were not taken as a result of axillary pain, lymphadenopathy.  Additional information: Patient had no COVID prior vaccination, Patient had not tested COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient got very lightheaded, fainted, sweated profusely, dry heaved. Patient declined calling 911. Patient was seated, had them put their head down. Got water and ice pack for him. took Blood pressure/pulse was  111/84 Pulse 74. Patient improved significantly in 5 mins and was able to leave walking
Diagnosed with Bell's Palsy on right side of my face; administration date 02Mar2021/ number 2; administration date 09Mar2021/dose number 1; administration date 02Mar2021/ number 2; administration date 09Mar2021/dose number 1; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration at 32-years, at single dose in right arm on 02Mar2021 (as source reported; pending clarification) at 13:00 (Lot number: unknown) for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Concomitant medications included atenolol, amlodipine and atorvastatin, all taken for an unspecified indication, start and stop date were not reported. The previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) also via an unknown route of administration at 32-years, at single dose in right arm on 09Mar2021 at 08:30 for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with Bell's Palsy on right side of his face on 06Apr2021 06:00. The adverse event resulted in "Doctor or other healthcare professional office/clinic visit". And the patient received treatment with prednisone and valacyclovir for it. The patient was not diagnosed with COVID-19 prior to vaccination. He had Covid test (IDNOW COVID-19 rapid diagnostic test (nucleic acid amplification test NAAT)) post vaccination with type of Nasal Swab on 30Mar2021 with a result of negative. Event outcome was recovering.  Information on the lot/batch number has been requested.
This spontaneous report as received from a consumer refers to his cousin, a now 9 year old patient. On an unknown date in the patient's 3 year old, the patient was vaccinated with a dose of MMR II (lot#, expiration date, dose, route, indication not reported). On an unknown date after receiving the MMR II the patient experienced autism. The outcome of the event was unknown. Additional information is not expected due to caller did not wish to provide his demographic information.
Child came to the facility with history of Bruton's disease. Child was seen by primary care provider on 11/3/2021 for initial medical exam and ordered child to have a full vaccination by Clinic medical staff. No side effects or complications have presented at this time.
A few minutes after booster administration patient start feeling nauseas, dizzy, cold. She was very pale but didn't loose consciousness. By the time paramedics came in about 10 minutes she start feeling better. Paramedics checked her vital signs, everything was normal. Patient left pharmacy on her own with a companion.
Covid positive after full vaccination series; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive after full vaccination series) in a 100-year-old female patient 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 03-Jan-2021, the patient experienced COVID-19 (Covid positive after full vaccination series). At the time of the report, COVID-19 (Covid positive after full vaccination series) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: positive (Positive) Tested positive.   No concomitant medications were provided by reporter.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a 100 year-old, female patient with no reported medical history, who experienced the non-serious unexpected, according CCDS, AESI of COVID-19. The event occurred after the second dose of mRNA-1273 vaccine, dose date and events date not provided. The outcome of the event was reported as unknown. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 100 year-old, female patient with no reported medical history, who experienced the non-serious unexpected, according CCDS, AESI of COVID-19. The event occurred after the second dose of mRNA-1273 vaccine, dose date and events date not provided. The outcome of the event was reported as unknown. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.