chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; nausea; Occurred at same time as menstrual period, so probably not related but I figured; This is a spontaneous report from a non-contactable other health professional. A 28-year-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: solution for injection Batch/Lot number: EL3248, expiration date not provided), via unknown route of administration, administered in Arm Left on 05Feb2021 14:30, as DOSE 2, SINGLE (at the age of 28-year-old) for covid-19 immunisation. The patient medical history was not reported. Patient had not received any other vaccine within 4 weeks. Concomitant medications included spironolactone, sertraline HCL and amfetamine (ADZENYS XR ODT) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient reported that she had menstrual period on the same time so probably not related but she figured she might as well report it anyway on 05Feb2021. Beginning a couple days after second vaccine, the patient experienced persistent diarrhea and nausea on 07Feb2021. The patient underwent lab tests which included sars-cov-2 test: negative on 05Feb2021. The outcome of event menstrual period was unknown other events as recovered on 09Feb2021.   No follow-up attempts are possible. No further information is expected  .
COVID-19; This spontaneous report received from a company representative concerned multiple patients of unknown race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. It was reported that "529 people had died of COVID-19 since 01-APR-2021. According to the ADPH, this included twenty people who were vaccinated, who did their part in the fight against COVID-19". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210903589- JANSSEN COVID-19 VACCINE Ad26.COV2.S- COVID-19. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COVID-19
Marked swelling of right leg within 24 hrs of receiving a DPT in right thigh - treated for "presumptive cellulitis" - shot given on 6/23/14.
3.5 months and counting of Chronic Spontaneous Uticaria  Hives and itchiness all over body with, only slight, relief from antihistamines and creams.
pt recv vax 23MAY96 & 22NOV97 pt exp a mild case of chickenpox;
hives,generalized & intermittent since dose 3>2yrs ago;weight gain 20 lbs & colitis since the last dose of vax;states had Imovax according to MD notes but that it was duck embryo & blue color;7JUL94 f/u tx w/Atarax for itching;
Myalgia, Arthralgia, FATIGUE, TENDERNESS AT INJECTION SITE,, CHILL Narrative:
Patient reports mild neuropathic pain in the right foot about 6 weeks following administration of their second dose.
Tested positive for COVID on 4/24/2021 and hospitalized for 6 days; Tested positive for COVID on 4/24/2021 and hospitalized for 6 days; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration administered in left arm on 17Feb2021 (Lot Number: EN6201) (Lot number also reported as EL9262) (vaccination age was 63-year-old) as single dose for covid-19 immunisation. Medical history included ocular myasthenia gravis. There were no known allergies and no Covid prior vaccination. Concomitant medication in two weeks included prednisone. There was no other vaccine in four weeks. The patient had tested positive (Nasal swab) for COVID on 24Apr2021 and hospitalized for 6 days in 2021. The adverse event occurred on 22Apr2021. The event was considered as serious as results in emergency room/department or urgent care, hospitalization for 6 days. The patient had 5 days treatment of remdesivir for the event. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
After receiving the 2nd MMR vaccine, my daughter woke up 5 days later with an extremely swollen face and eyes. Her whole face was red and hot and she kept saying her eyes were hurting. We called our dr. who said to start benedryl. We also started cortisone cream the following day for her rash on her face and upper chest. Still working through it but  much better (3 days after rash began).
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates in 2017 (reported as between 01-MAR-2017 and 01-SEP-2017), the unspecified number of improperly stored doses of RECOMBIVAX HB lot number M046373, expiration date 04-NOV-2018 (doses, routes of administration and anatomical locations were not reported) were administered to the patients. The doses were stored in temperature of -59 degrees Fahrenheit for 6 months. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Product quality complaint was not involved. This was one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA011984.
Breakthrough COVID (partially vs fully vaccinated?).  Patient received one dose of Pfizer vaccine, but states he completed 2 shots of Pfizer in July.  Could not be confirmed.  Admitted for suicidal ideation with an incidental finding of COVID.  Patient is symptomatic with chills, body aches, diarrhea, nausea, but no respiratory symptoms.
Information has been received from a 25 year old female who was vaccinated on unspecified dates with the first and second doses of GARDASIL (lot #'s not reported) and experienced nausea, pain and itching at the injection.  About one month later she developed a "knot" at the injection site that lasted for about 2-3 months.  After getting the third dose of GARDASIL (lot # not reported) she did not have any adverse reactions.  The first two doses were given by the same nurse and the third dose was given by another nurse at the same office.  Subsequently, the patient recovered from nausea, pain, itching at the injection site and knot at the injection site.  Additional information has been requested.
The patient presented to hospital, l on 06/29/2022 and was found to have Covid-19 PNA.  The patient did not improve and was enrolled in hospice care on 07/01/2022.  The patient expired on 07/05/2022.
During my second dose of my last shot giving of the Moderna shot I received my last dose on December 10, 2021. The next day following I had a nose bleed after my second dose given. Later within the same month I experienced a breakthrough bleeding of my Menstrual cycle and I got my period on December 28 until January 2 of 2022. Prior to that I had a normal cycle on December 4 until the the 8th of December. I have been experiencing ever since my second dose of them are doing a shot two periods a month. It's now February and I last had my period February 4 until the 9 of February 2022, and I again am having bleeding February 22, 2022. I have now learned that there have been several reports of women having issues with their cycle as this I haven't known prior to getting the shot and now was told about such a thing. I am extremely worried as I now am having to have blood count down because of this stupid issue!!! I am extremely upset because of the unknown and the payments that this may cost of me is putting stress on me since this is now a following matter .
AFTER THE DAY OF AN INJECTION SHE STARTED HAVING RASH LIKE SYMPTOMS ALL OVER HER LEFT SHOULDER, CHEST, ABDOMEN, LOWER BACK. PATIENT STATES RASH LOOKS LIKE CHICKEN POX SYMPTOMS.
This spontaneous report as received from a pharmacist refers to a 71 year old male patient with diabetes and mushroom allergy On 24-JUL-2014 the patient was vaccinated with 0.65 ml of ZOSTAVAX (lot # J014812, expiration date: 20-FEB-2015) subcutaneously in the right arm. On 25-JUL-2014, the patient developed redness and swelling of his right arm at the injection site after receiving ZOSTAVAX. That area also itchy, "hot" and tender to touch. The affected area was about 3 inches in diameter. No treatment ws given for adverse event. None of lab diagnostics studies was performed. On 28-JUL-2014 the patient come back to the pharmacy for seeking medical attention. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
pain at injection site; Ten min after dose my arm felt cold. felt my hands to my cheeks, both hands felt same temp but injected entire arm felt a cold sensation like my nerves were cold throughout arm; ten min after dose, tingling also like it was colder than the other arm; This is a spontaneous report from a non-contactable Pharmacist (patient).  A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at 18:00 at single dose in arm for COVID-19 immunisation at the age of 37-year-old. Medical history included anxiety and depression. It was unknown if the patient was pregnant. Concomitant medications were unknown. The patient reported that on 20Jan2021, ten min after dose, arm felt cold; the patient felt her hands to her cheeks (as reported), both hands felt same temp but injected entire arm felt a cold sensation like nerves were cold throughout arm.; tingling also like it was colder than the other arm. It lasted about 30 min, then it got about 50% less intense. Intensity continued till the time of report. The morning of the report on 21Jan2021, the patient woke up with dull pain at injection site. The patient was not treated for the events. The patient did not have COVID prior vaccination, and she was not COVID tested post vaccination. The patient was recovering from the events.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information expected.
Mother reports at 11/8/2022 appointment for 2nd flu vaccine. "A couple of weeks after he got the vaccines he had red bumps on his outer right thigh. He scratched them. They lasted about a couple of weeks."
20 min after vaccine, patient reported hives to BL forearms; no airway concerns.  Benadryl 50 mg PO given one time only in clinic.   Transferred to ER immediately, handoff report given to charge RN; at this time patient in nad, A+OX3, breathing spontaneously and effortlessly.  Patient currently in ER at time of VAERS report.
Onset rash 11/13/06 on face and arms spread to legs 11/14/06. Few vesicular lesions Left buccal mucosa and lower Left gingival surface. Papular rash on forehead, around eyes,  chin, hands upper arms, lower legs. Slightly vesicular but no true vesicles. Plan = no aspirin. Calamine or Aveeno PRN.
fever 102 R lasting 20-22 hrs; high pitched crying for 4 days w/3-4 hrs breaks for sleep; assessed by MD 7JUL92; tx APAP; MD advised to administer ped DT;
PAIN IN THE JAW; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with amoxicillin/clavulanic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: janssen 1802070, and batch number: JANSSEN 1802070 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 01:19 to left arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced pain in the jaw. On 09-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the jaw, and headache on MAR-2021. This report was non-serious.
RESIDENT RECEIVED BIVALENT VACCINE IN ERROR FOR 2ND DOSE. ADVISED FACILITY THAT RESIDENT CAN BE ADMINISTERED ANOTHER BIVALENT VACCINE IN 2 MONTHS DEPENDING ON CLINICAL JUDGEMENT AND PATIENT PREFERENCE.
Headache behind the eyes, fatigue, body aches, chills, nausea. Headache and nausea started about 30minutes after vaccine.  Fatigue starting later the same day.  On  4/20 woke up with headache, nausea, body aches, and chills off and on.  Very mild headache on 4/22 with fatigue. Other symptoms improved.  Symptoms improved by afternoon on 4/22.
pt recvd vax 3MAR92 & on 16MAR92 devel a rash described as being diffuse erythema; also exp fever, inc lymphadenopathy, achiness & inc BP 140/90;
Left arm pain started the next day 3/6/21. Intense burning pain, aches, left arm weakness for several weeks, used ice/heat; got 2nd shot and still having left arm pain, using heat/ice, left arm weakness.
Sick for one or two days; Being unusually tired; Chills; Fever; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Sick for one or two days), FATIGUE (Being unusually tired), CHILLS (Chills) and PYREXIA (Fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for one or two days), FATIGUE (Being unusually tired), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, ILLNESS (Sick for one or two days), FATIGUE (Being unusually tired), CHILLS (Chills) and PYREXIA (Fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2022-438428, MOD-2022-438430 (Patient Link).
08/24/22 presents to ED for "SOB". PMHx of "breast cancer, COPD, asthma, bronchitis, hypertension, diabetes, OSA"
*Injection very high on shoulder, into rotator cuff and bursa. *Rotator cuff tendonitis, capsulitis, fluid surrounding biceps tendon. *Corticosteroid injections by orthopedic. *Continued physical therapy.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (STERILE DILUENT). No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46 F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6 F 14 F for 76 minutes and in between 15 F to 46 F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion.; Sender's Comments:  US-009507513-1711USA002012: Original Case : 1711USA002012.
Sore arm the first afternoon and night. Muscle aches and fatigue on Day 2. Took tylenol for treatment. Day 3 (48 hours after shot) I felt great.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. In 2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
returned approx 15mins p/vax; rt eye edema partly closed; taken to nearest ER;
lt leg swelled from hip to below knee cap-mom states would scream when touched-would not walk on it-called PMD @ clinic;24MAY97 & was told just to watch it-pt okay now;
Mom called clinic at approximately 16:50 on 09/14/00 stating just picked child up from sitter and noticed left leg extremely red and swollen. Instructions were given for mom to take child to ER. Upon calling to check on child on 9/15/00 AM, mom stated ER MD said it was an allergic reaction and told her to give Benadryl. Mom states his leg still has a red, raised area and still with swelling but that child is eating, playing and acting fine.
A few hours after receiving my 2nd dose vaccine I got sores on my tongue. The following day I felt very fatigued, had a low fever for a couple hours,  sore neck and shoulder to the injection site, sore throat, headache, light sensitivity and hazy/foggy feeling. I also had a finger feel sore and inflamed for about 5 days.  It has been 1 week now and I still have major fatigue, headaches, brain fog, morning sore throat and just a feeling of ?not well?. I try to workout, but after I get so fatigued I can?t perform regular daily tasks. I have been so foggy, I can?t help my kids with their school work.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 17-NOV-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 120, and 48 hours, with the lowest recorded temperature of 34, and 33 degrees Fahrenheit (1.11, and 0.55 degrees Celsius) respectively. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
UTI symptoms that began day after vaccination - urgency, frequency, dysuria. Chills. Axillary lymphadenopathy. Fatigue.
TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a pharmacist (PVX2019-447) on 18-Feb-2019.The report describes a 39-year-old female consumer who "took an unrefrigerated dose". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003241 and expiry date: Nov 2019) for typhoid fever prophylaxis.   It was reported that the consumer took the first unrefrigerated dose of Vivotif on 14-Feb-2019.  The action taken with Vivotif with respect to the event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.
Itchy arm; Spot size of a baseball on left upper arm which is red; She is reporting this as a COVID arm; Spot is swollen; Spot is painful; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy arm), RASH MACULAR (Spot size of a baseball on left upper arm which is red), VACCINATION SITE REACTION (She is reporting this as a COVID arm), VACCINATION SITE SWELLING (Spot is swollen) and VACCINATION SITE PAIN (Spot is painful) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A2JA) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (Itchy arm), RASH MACULAR (Spot size of a baseball on left upper arm which is red), VACCINATION SITE REACTION (She is reporting this as a COVID arm), VACCINATION SITE SWELLING (Spot is swollen) and VACCINATION SITE PAIN (Spot is painful). At the time of the report, PRURITUS (Itchy arm), RASH MACULAR (Spot size of a baseball on left upper arm which is red), VACCINATION SITE REACTION (She is reporting this as a COVID arm), VACCINATION SITE SWELLING (Spot is swollen) and VACCINATION SITE PAIN (Spot is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included Osteoporosis tablets, Cholesterol Medication, Multivitamins.  No treatment information was provided.
103 fever, chills, severe muscle pain, hypersensitive nerves, chest pain, headache, lightheaded
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-OCT-2007, the patient was inoculated with ZOSTAVAX at a healthcare facility as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUL-2016, the patient was treated by a physician at the healthcare facility for a vesicular outbreak, which was diagnosed as subclinical shingles. The patient was prescribed VALTREX, and hydrocodone for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long term prevention of shingles, 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Patient noted raised, red, mildly pruritic bumps on his hands. Some of the lesions are painful.
Dizziness, headache, nausea and vomiting, shaking.  Tylenol and Benadryl