chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of passed out in a 64-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included type ii diabetes mellitus. On 10th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th September 2018, 4 days after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant) and intestinal functional disorder. On an unknown date, the outcome of the passed out and intestinal functional disorder were recovered/resolved. It was unknown if the reporter considered the passed out and intestinal functional disorder to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX in the right arm. The patient experienced loss of bowel function. The patient reported that she was seen by urgent care and was sent home. The patient did not want to provide her physician's name and contact information, but was willing to be contacted by safety depertment (GCSP). The patient reported that her husand might have called to report the adverse events listed above, but was unable to locate the patient's husband name in database.
CDC reports: 2 yo child developed fever to 104 & local rxn following DTP/OPV/HIB immunization.
Headache, Myalgia, shakey, "disconnected and unable to concentrate:  Narrative:
Pain, swelling, redness at injection site.  Chills, fever, gastrointestinal discomfort.
I woke up a week after vaccine with a hot painful feeling at injection site and noticed it was swollen and red . I tried ice throughout the day but actually got bigger and redder the last 24 hours.  Prior to day 7 I  had no symptoms accept a little pain at injection sote for 48 hours .
Patient claimed got sore at the injection site the first day and next day red and inflamed and it kept on increasing the size. The patient called me on Sunday evening, recommended take Benadryl and if still no relief to go the Prescriber
I have had multiple diverse reactions, and I will report each one as a separate entry (based on time of onset).   Immediately upon receiving the first immunization, my entire left arm began tingling and then turned numb. This lasted for 2 days (partial feeling, partial numbness/tingling) down arm and also hand and fingers.   About two hours after the shot, neck and face turned dark red and began burning. This lasted for that evening. Allegra taken.
Extreme dizziness upon waking (could not stand up).  Recovery: <4 hrs.
Information has been received from an unspecified reporter referring to a female patient of unknown age. The patient's medical history, concomitant medications, and laboratory values are unknown. The patient received the ZOSTAVAX at an unknown dose, route, and frequency on an unknown date, lot # M010472, expiration date: 01-JUN-2017, for an unknown indication from the pharmacy to be dispensed unreconstituted for administration by a health care professional at the hospital where she worked. On 08-FEB-2017, the patient's pharmacy delivered the ZOSTAVAX vial without the diluent to the patient and provided a pharmacy label on the product instructing her to store it in the refrigerator, which was considered a dispensing error. It was not known if the patient was instructed to use within 72 hours after refrigeration. On 12-FEB-2017, the patient brought the vial to the hospital where she worked for a nurse to reconstitute and administer to her. At this time, on 12-FEB-2017, it was discovered that the diluent was not provided with the ZOSTAVAX vial, and the patient stated that she was concerned that the vaccine may no longer be okay to use since she had stored it in the refrigerator since 08-FEB-2017. On 12-FEB-2017, the patient's nurse contacted the Merck National Service Center and decided to not administer the ZOSTAVAX in question to the patient. As of 12-FEB-2017, the patient had not received the ZOSTAVAX and the outcome of the ZOSTAVAX dispensing error and the concern experienced by the patient was unknown. Additional information has been requested.
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant medications details were not reported by the reporter.  Reportedly, pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
"Tingling" all over body, slight reddening of the neck and chest area, kept shaking left hand
Pt recv vax on 2/16/98; on 2/17/98 pt exp swollen lips &hands, itchiness, congestion &hoarseness; dx=allergic rx to vax; tx=Benadryl
No adverse effects; Improperly stored; This spontaneous report was received from a physician, referring to a patient of unknown age and gender: The patient's pertinent medical history, drug reactions, allergies, current conditions and concomitant medication were not reported.  On 12-JUN-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (Schedule, route and anatomical location of vaccination were not reported; lot # R035223, expiration date: 04-DEC-2019), as prophylaxis; concomitantly administered with one dose of Merck sterile diluent solution for injection.  According to the physician, the varicella virus vaccine live (oka/merck)(VARIVAX) underwent a temperature excursion of -9 to 8 degrees Celsius (°C) for 15 minutes and from -14 to -10 °C for 4 hours and 45 minutes on that day, which was detected by a digital data logger. No previous temperature excursions were reported. No adverse effects reported.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2012 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider at hospital for the long-term prevention of shingles and/or zoster-related conditions. At the time of vaccination, patient relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live(ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated. Subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation, patient was treated by a doctor for shingles. As a direct and proximate result of patient use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will 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 shingles was not provided. The lawyer considered the event to be related to zoster vaccine live(ZOSTAVAX).
Per client: "Immediately after getting meningitis shot [MENVEO] 2 in red circle at injection site. 1 day after injection redness, itching w/ hard center. 5 days after 4 x 2 circle no pain or itching.
Information has been received from a medical assistant concerning an 8 weeks female with no drug allergy and no medical history who on 10-AUG-2011 was vaccinated orally with her first dose of ROTATEQ, 2ml. There was no concomitant medication. The reporter stated that immediately following administration, the patient vomited on 10-AUG-2011. The reporter was unsure whether or not the patient got the full dose. No treatment was given for AE. The patient did not undergo any lab diagnostics studies. The patient was in office to seek medical attention. The patient recovered on 10-AUG-2011. Additional information has been requested.
pt recv vax & changed personality & exp staring spells & body jerks;mom told pediatrician but MD felt it was nl;
On September 19, 2021, 2 days post vaccine, I developed a sizeable red, itchy, tender rash in my left upper arm from the site of the vaccination in my deltoid muscle that wrapped in toward my inner upper arm. On Monday, September 21, 2021, I took 1 pill of Xyzal to manage the itch I felt at the site. As of today, September 22, 2021, the redness, itchiness and tenderness have decreased but are still minimally present.
Adverse effects began with severe headache and chills from early Sunday morning through Monday morning. I used Tylenol to treat symptoms. Sunday evening a knot appeared at the injection site. Monday morning I noticed a tenderness in my left armpit and my upper arm began to show red blotches. The blotches spread around my arm and almost to my elbow. By Tuesday, the redness continued and the lymph nodes in the left armpit were so sore I had to prop my arm. I took Benadryl and Tylenol. I informed my primary care provider and sent photos of the arm. It is mostly gone as of 4/1/2021.
Myalgias, rigors, fever, sore throat which lasted approximately 24 hours before decreasing.. Acetaminophen helped slightly.
Fever, unusual weakness & tiredness, chills, shortness of breath, severe chest & stomach pain, muscle weakness, nausea, headache, bad stomach ache. Trip to ER on 1/28/2012. Possible 4 shot of a 3 shot series.
A report has been received from a Physician concerning an 8 year old, Female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 31-DEC-2014. The reporter stated that the patient experienced inadvertently administered expired FLUMIST Quadrivalent to four patients which started on 31-DEC-2014. The outcome of the event of inadvertently administered expired FLUMIST Quadrivalent to four patients is unknown. The report was considered to be non-serious.
Immediately stung, felt like bees stinging arm over and over which continued that evening. then that night there was a big knot, itched really bad, and looked red. It was not hot to the touch but it was sore and itched very badly. Her lip also developed a blister. Symptoms continued Friday-sunday and then started to subside.
shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 67-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in September 2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis at a pharmacy/drug store. On 12-DEC-2012, the patient suffered shingles (herpes zoster). As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient caused to suffer serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physician pain and mental anguish including diminished enjoyment of life, the needed for lifelong medical treatment, monitoring and /or medication.  At the time of the report, the outcome of shingles (herpes zoster) was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).
Pt. is a 2 mo infant that recived his immunizations on 10/25/06 (pediarix, HiB, PCV and Rotateq).  He had 2 days with reported fever, improved by day 3, on day 5 his parents noticed irritability, decreased appetite and also reported 2 emesis and one epysode of diarrhea with blood and mucus.  They presented to our office where I found a sick looking infant, lethargic and mildly dehydrated.  On physical exam he had abdominal pain.  Abdominal films revealed several air-fluid levels and distention.  Pt was admitted to hospital, I ordered an abdominal CT which was suggestive of intussusception, this was confirmed with gastrographin enema which also reduced it.  Pt did well after intervention, recovered and was discharged the following day.  11/01/2006: MR received from PCP revealing well baby exam of October 25, 2006 where infant received Pediarix, pneumococcal vaccine, and Rotateq./pc 11/3/2006: MR received from overnight hospital stay documenting fever for several days post vax which resolved, and infant was doing well. Five days post vax infant became irritable and lethargic, with poor appetite, and was noted to have had one episode of bloody stool the day prior, and continued to have mucus in his stool.  Infant was admitted to the hospital at this time to R/O intussusception. Gastrographin enema was performed which reduced the intussusception, and was confirmed by Abdominal X-ray the next day.  Infant was discharged. No d/C summary dictated./pc  Report received from pediatrician revealing F/U exam for intussusception on 11/2/2006: no fever, no vomiting, increased appetite. Stool to be sent to CDC for analysis/pc
Shoulder pain causing loss of sleep and discomfort. Patient stated stiffness, pain and "knots" in shoulder/neck/back area following administration.
This spontaneous report was received from an Office Manager regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 23-AUG-2016 the patient was vaccinated with expired dose of VAQTA 25/0.5 (units unknown), lot # K007791/expiration date-22-AUG-2016, 0.5 ml, intramuscular. No concomitant medication was reported. No adverse event was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Can't sleep or stay sleep; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old, non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 29Jul2021 at 16:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. Concomitant medications included paracetamol (TYLENOL) for unknown indication from an unknown date. The patient previously received morphine (MANUFACTURER UNKNOWN) and linaclotide (LINZESS) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jul2021, the patient could not sleep or stay sleep. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event could not sleep or stay sleep was unknown at the time of this report.   The lot number for BNT162b2, were not provided and will be requested during follow up.
After administration of vaccines pt became unresponsive with heart rate in 40's. EMS was called and pt transported to ER.
Digestive issues; inflamation; diahrrea; abdominal pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jul2021 (Lot number: EW0177) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D; FISH OIL. Vaccination history included: Bnt162b2 (Dose 1, lot number: EW0176, vaccine location: Left arm), administration date: 01Jul2021, when the patient was 40 years old, for COVID-19 immunisation, reaction(s): "Gastric pain". The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset 20Aug2021, outcome "not recovered", described as "Digestive issues"; INFLAMMATION (non-serious) with onset 20Aug2021, outcome "not recovered", described as "inflamation"; DIARRHOEA (non-serious) with onset 20Aug2021, outcome "not recovered", described as "diahrrea"; ABDOMINAL PAIN (non-serious) with onset 20Aug2021, outcome "not recovered", described as "abdominal pain". The events "digestive issues", "inflamation", "diahrrea" and "abdominal pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of gastrointestinal disorder, inflammation, diarrhoea, abdominal pain.  Additional information: The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received following medication within 2 weeks of vaccination as Multivitamin, vitamin D, fish oil. The adverse event result in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The healthcare professional considered the suspect vaccine had a no causal effect to the adverse event.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Although the attending Physician has assessed as events as no causal effect from BNT162B2,Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Hives and itching all over. Went to ED. Fluids, benadryl, solumedrol.
father reported pt had bruising all over, fatigue lasting one month;pt has Factor V Deficiency;
Red itchy patches on torso; Red itchy patches on torso; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 16Apr2021 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm left on 26Mar2021 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. 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 other vaccines within four weeks prior to the vaccination. On 18Apr2021, two days after the second shot, the patient experienced red itchy patches on torso which started to fade two weeks later. The clinical outcome of the event red itchy patches on torso was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of swelling in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). On 13 August 2014, the subject received unspecified dose of KINRIX (.5 ml, unknown route, batch number and injection site). On 13 August 2014, less than one day after vaccination with KINRIX, the subject experienced pronounced swelling and erythema. At the time of reporting, the outcome of the events was unspecified. This is one of the 2 case reported by the same reporter and for the same events.
deceased 1-22-2023;   resident of a nursing home and transferred to hospital on 1-17-23 with 2 days of shortness of breath  and then transferred to Med Center where she passed away.   had covid pneumonia apparently a year prior per records that did not require hosp admisssion.  This admission had covid pneumonia.     Was placed on inpatient hospice.
c/o itching that started 15mins after vaccine, pt completed observation period then advised RN of itching. Red diffuse hives obs. on pts abd, hands, and chest Vitals: @526 BP 144/99, HR 70, RR 14, O2SAT 98% @534P BP 130/92 HR 68, RR 14, O2SAT 98% @540 BP 11/96, HR 67, RR 14, O2SAT 97% @545 BP 132/94 HR 64, RR 14, O2SAT 99% pt declined benadryl po, did not have anyone to drive her home. Pt. observed until itching and hives resolved. Spontaneous resolution of Itching. Pt discharged to self, alert oriented. Recommended, follow up with primary care provider.