chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GRAVES' DISEASE; This spontaneous report received from a parent via social media via company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s Janssen series 1 (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient was diagnosed with graves' disease. The parent reported that patient on life time medication and had bought encyclopedia of herbs to try first and sea moss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of graves' disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20211230855-covid-19 vaccine ad26.cov2.s -Graves' disease. This event(s) is considered unassessable. The event(s) 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(s).
15 MINS AFTER RECEIVED FLU SHOT, PT PASS OUT IN FRONT OF PARENT. DAD DID HOLD HER BODY. WE CALL EMS, SHOWUP IN 10 MINUTES AND TAKE VITAL SIGN, BP AND BS. EVRY THING BACK TO NORMAL (BP 83/60, BS 113). PARENT FEEL COMFORTABLE AND PARAMEDIC RELEASE PT BACK HOME AROUND 4PM
became very cold although indoors and well dressed; decided to go to bed with hot water bottle because was shivering with cold - while preparing that, had period of a minute or two of yawning; each yawn triggered violent shaking of hands and arms but could voluntarily shop the shaking  (THIS was very strange to me); went to bed and chills stopped as HWB took effect; then after a while, became uncomfortably warm, threw off all covers, pj's, and turned on ceiling fan; could not sleep all night as if I had coffee late in the evening; I had take one Alleve tablet at approx 8:30 pm because arm was uncomfortably sore and I thought it would disturb my sleep; chills started about 9pm; next day felt a little weak but none of the side effects except arm was still sore but much less
The morning after shot itching in the arm pits and anus area.  Has started to get better but still have itching.
Tactile temperature with unconsolable persistant crying irritability poor sleep 8-12 hours
pt received prime moderna vaccine, minutes later developed witnessed emesis and complained of gi upset and nausea.  Glucose was 98, bp 180s/90s.  (Baseline bp 140s-150/80s from what i saw in record).  Repeat BP 194/116 and pt still with nausea and emesis.  Given limitations at our facility during vaccine clinic she was sent to ER
2 weeks after MMR/Varicella vaccines received patient developed diffuse maculopapular rash over trunk & arm, runny eyes, runny nose, crankiness.
2 days p/vax pt started to have low grade fever & always cranky & irritable, eating in small amounts & frequently;
I had my vaccination 05/08/2022. On 10/18/2022 I started to experience a sore throat achiness fatigue no fever. On 10/20/2022 I had night sweats and I had tested COVID-19 positive. I was prescribed PAXLOVID for 5 days. Currently on 11/08/2022 I am still experiencing fatigue and congestion.
Flu like symptoms. Muscle aches, tiredness, chills, fever for 24 hours
Hospitalized; Unable to receive second dose of vaccine; Case reference number MOD-2021-014001 is a spontaneous case report sent by a Non-Health Professional on 15-FEB-2021 00:00:00 .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. After vaccination she was hospitalized and she was unable to receive the second dose of the vaccine.  Action taken with mRNA-1273 was not provided.  Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Non-Health Professional,  Age-  ,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- hospitalized  - unknown; unable to receive the second dose of the vaccine - resolved.; Reporter's Comments: This case concerns a female of unknown age who experienced a serious unexpected event of Hospitalisation and nonserious unexpected event of Inappropriate schedule of product administration, in that she "unable to receive the second dose of the vaccine".  The events occurred with unknown latency after the first dose of mRNA-1273. Very limited information regarding these events has been provided at this time.  Further information has been requested.
Painful Acne like rash around the Lower half of my face. With redness and pus filled bumps Possible perioral dermatitis.
1 of 5 adults immunized from the same lot# who exp redness & swelling surrounding the immunization site;No further clinical details provided
This spontaneous report was received from a physician and an office manager via a company representative and refers to a 16-yer-old female patient with no pre-existing physician-diagnosed allergies, birth defects, medical conditions. The patient had no illness at the vaccination time. Her current condition included anxiety. On 01-JUN-2018, the patient was inadvertently vaccinated with the fourth dose of GARDASIL 9 intramuscularly in the left arm (exact dose was not reported; lot # N028092, expiration date: 28-MAY-2020) for prophylaxis. On the same date, the patient was also vaccinated with the second dose of MENACTRA, intramuscularly in the right deltoid. The administered doses of vaccines were stored properly. On an unknown date in June 2018, the patient experienced increased anxiety due to receiving two vaccines instead of one. The outcome of increased anxiety was unknown. The relatedness between anxiety and suspect vaccines was not reported.
This spontaneous report was received from a healthcare worker (registered radiologist assistant) refers to a patient of unknown age and gender. On an unknown date in September 2012, the patient was vaccinated with dose 1 GARDASIL (lot #, expiry not reported). On 18-JUL-2013, the patient was in the office to receive the second dose of GARDASIL (lot # H009746, expiry 11-JAN-2015). No adverse effects reported. Additional information has been requested.
Patient developed erythema, swelling, vesicular erythema in left arm at the site of injection; with itching, no other symptom.  Erythema started within 24 hours of vaccination.
No additional AE filed; PROQUAD was involved in a temperature excursion on Jan 20, 2022. PROQUAD has been administered to multiple patients since the temperature excursion; This spontaneous report was received from a medical assistant referring to a 5-year-old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications      On 20-JAN-2022, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) was involved in a temperature excursion and on 21-JAN-2022, the patient was vaccinated with this improperly stored vaccine once at right thigh for prophylaxis (lot # U010745 with an expiration date on 03-OCT-2022; dose and route of administration, were not reported).   The freezer had a lot of ice, while it was being cleaned, the door was open for 15 minutes, and there was temperature excursion. The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) was exposed to a temperature excursion of 21.1 degrees Fahrenheit (°F) during a time frame of 2 hours 34 minutes. The temperature excursion occurred as a result of a reading from a Digital Data Logger. There was no prior temperature excursion and no adverse event was reported.  This is one of two reports received from the same reporter.
Narrative:  65yo female patient with the following problem list: 18 Active Problems PROBLEM LAST MOD PROVIDER Full care by hospice (SCT 170935008) (ICD-10-CM 11/29/2021 Z76.89), Onset 11/09/2021 Seen by palliative care medicine service (SCT 11/04/2021 305824005) (ICD-10-CM Z51.5) Severe recurrent major depression (SCT 04/18/2017 281000119103) (ICD-10-CM F34.1) Skin ulcer of toe due to diabetes mellitus type 09/29/2016 2 (SCT 10656271000119102) (ICD-10-CM E11.622) Obstructive sleep apnea syndrome (SCT 78275009) 10/17/2018 (ICD-10-CM G47.33) Cellulitis (SCT 128045006) (ICD-10-CM L03.032) 07/18/2016 Bilateral carpal tunnel syndrome (SCT 02/01/2016 12265501000119101) (ICD-10-CM G56.01) Peripheral neuropathic pain (SCT 279981003) 12/07/2015 (ICD-10-CM M79.676) Solitary nodule of lung (SCT 427359005) 10/09/2015 (ICD-10-CM R91.1) Endometrioid carcinoma ovary (SCT 254852002) 01/11/2016 (ICD-10-CM Z85.43) Joint pain (SCT 57676002) (ICD-9-CM 719.40) 03/18/2015 Low back pain (SCT 279039007) (ICD-10-CM M54.5) 01/26/2017 Diabetic retinopathy associated with type 2 12/17/2014 diabetes mellitus (SCT 422034002) (ICD-9-CM 250.50/362.01) Diabetes mellitus (SCT 73211009) (ICD-10-CM 12/07/2015 E11.40) Benign hypertension (SCT 10725009) (ICD-10-CM 02/26/2016 I10.) Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.5) 01/11/2016 Movement disorder (SCT 60342002) (ICD-9-CM 12/17/2014 333.90) Psoriasis (SCT 9014002) (ICD-10-CM L40.9) 09/23/2016 0 On 11/19/21 patient was discharged from skilled home health on 11/8 and admitted to hospice services. Pt died on 12/7/2021 at home. Pt had received covid vaccines on 4/1/21 & 5/1/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Vomiting, dizziness, nausea, fever 103.2, muscle aches and headache for over 24 hours.
Severe Headaches, Grand Mall Seizure, vomited, fell into vomit, inhaled vomit, ended up with pneumonia due to aspiration
Patient reported the right side of her face swelled up as if her lymph node was inflamed. It started right after receiving the shot and receded after several days.
11/23/04 Had Fluzone around 9:30AM. Noticed whelp like blisters on left forearm within 6-9 hrs in left arm, with itching which has spread upward and downward through the night and the next day. 11/29/04 pt into clinic, rash had worsened progressing to left hand and back with inflamed pustular areas, saw PMD and was treated with Valtrex which was successful.
This spontaneous report was received from a pharmacist, a 45 year old female patient refers to herself. The patient's concurrent conditions and medical history were not reported. On 25-AUG-2015 (today), while drawing up a dose of ZOSTAVAX (lot # L006392 expiry date of 25-MAY-2016) in a syringe for an unspecified patient a small amount of the vaccine may have gotten into her eye. Concomitant medications were not reported. The patient did receive a full dose of vaccine and a small amount may have gotten into the pharmacist's eye. The pharmacist flushed her affected eye with water. The pharmacist's affected eye was sore. The outcome of the event was unknown. The pharmacist was not sure if her eye was sore from the ZOSTAVAX getting into her eye or from the water she had flushed it out with. There was no product quality complaint involved. This is one of the two reports from the same reporter. Additional information has been requested.
Vasovagal response: nausea first followed by light headed, then cold and hot flashes within the first ten minutes of shot.
1/15- I felt like I swallowed glass and my whole body ached, chills, flu-like symptoms. 1/18- Went to urgent care and took a rapid Covid-19 test (positive). Advised to manage with OTC and asked for Z-pack 5 day to ward off any possible lung infection. Took an additional test for Covid-19 on 1/30 just to be sure I was clear. Most everything went back to normal but I still have a nagging cough and fatigued. 2/18.
Did not feel well; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Did not feel well) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Vitamin B12 deficiency, Hypothyroidism, Joint pain and Vitamin D deficiency. Concurrent medical conditions included Multiple sclerosis. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Did not feel well). At the time of the report, MALAISE (Did not feel well) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Treatment information was not reported.
has them now, had the Shingrix/suspected vaccination failure; has them now; rash; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. The patient was treated with dermatologicals nos (Cream (Nos)) and medication unknown. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 26-MAR-2022 Reporter's comment: This case was reported via interactive digital media. The case was reported by the patient's wife. The patient had shingles now but had the 2 shot of Shingrix vaccine when it came out. The patient had the rash but never blistered. The patient was on medicine and creams. Additional supportive information: The case describe the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR056675(invalid):Same reporter
patient felt her heart race. she has no past medical history. states back in december 2020 she had covid-19 and did experience rapid heart rate at that time. since then, however, she has not had any issues with heart rate. she denies chest pain, lightheadedness, sob. no nausea or vomiting. no headache, no blurred vision.
Fever, chills, rigors, T > 102 developed 2 days after vaccination, then neutropenia down to WBC = 1.3 and absolute neutrophil count 500 by 11/08/07, AST = 265; ALT = 106.  12/11/07 Reviewed hospital medical records which reveal patient experienced fever of unknown origin intermittently x 3 weeks of 102-103 with sweats & chills, HA, sinus congestion, sore throat, semi-productive cough, malaise, swollen tender submandibular lymph glands, fatigue & arthralgia when febrile. Seen by pcp multiple times & had ID & hematology outpatient consults prior to admission.  Admitted 11/8-11/13/2007 for antibiotic & further eval .  ID, heme & rheumatology consults obtained while hospitalized.  Tx w/IV antibiotics.  Fever gradually resolved. FINAL DX: pancytopenia, possibly related to underlying viral illness or autoimmune disorder; Fever of unknown origin, possibly related to viral syndrome, collagen vascular disease or reaction to flu vaccine.
Information has been received from a physician who mentioned one of her patient's knew someone who developed palpitations after getting a dose of GARDASIL (Lot number not reported). Subsequently on an unspecified date the patient experienced palpitations. This patient's physician attributed the symptoms to GARDASIL. Physician did not have any other information since it was not her patient. At the time of reporting the patient's status was unknown. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Heart palpitations began 6 hrs after vaccination. Last 2-3 hrs/day for two days. Sore arm 4 days; fatigue several days.
Information has been received from a 78 year old male consumer with type 2 diabetes, blood pressure, penicillin and BIAXIN allergies who on 24-FEB-2011 "Last Thursday" around 15:30 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included insulin, JANUVIA, MICARDIS and metformin. The consumer stated that on 24-FEB-2011 he took his blood sugar around 7:30 and the next morning on 25-FEB-2011 it was in the 200 range. The consumer also stated that normally his sugar levels are between 108-112. The consumer mentioned that "everyday" after the shot was administered his levels had remained elevated. His numbers had been 203, 205, 208, and on 28-FEB-2011 were 269. The consumer stated that he was thinking that since it was a live vaccine that it elevated his levels a bit just like a cold would. The consumer stated that normally when he gets a cold or something his levels get elevated, but he stated that his no 100% sure if this is the case or not. The consumer spoke to the pharmacist and they did no have information about sugar levels raised after a vaccine administration. There was no treatment given for the events. At the time of the report the patient had not recovered from the symptoms. This is one of two reports received from the same source. Additional information has been requested.
Very Elevated blood pressure.  The same for my husband who got shot at the same time.  Also a friend.
Initial unsolicited misuse report received from a nurse (registered) on 31 August 2016. This case involves a 53-year-old female patient, who was vaccinated with ADACEL via intramuscular route (batch number: U5271AA, expiry date: 10 February 2018) (dose, dose in series were not reported) at the right thigh on 23 August 2016. The patient's medical history was reported as none. Illness at the time of vaccination and allergies were also reported as none. Concomitant medications was not reported. On 23 August 2016, within 10 minutes following the vaccination, the patient developed anxiety, felt like patient was going to pass out, felt heart was racing, had intermittent elevated pulse rate, cool, clammy, and had decrease in oxygen saturation and palpitation (as diagnosed in ER visit). This was a case of drug administered at inappropriate site and product use issue. Reportedly, the patient required ER visit. The events' outcome was reported as unknown. List of documents held by sender: none.
I developed a severe rash over entire body about 3-4 weeks after receiving 2nd dose of Pfizer vaccine in Feb 2021. This required systemic antibiotics and dermatology consultation as well as high potency topical steroids. Skin biopsy was done, and revealed the lesion as allergic reaction in nature.  The skin rash got better after several weeks, but even after one year, the skin eczema reaction is still present, requiring the topical steroid medication.
arm is still sore; disrupts his sleep; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 23rd June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 24th June 2021, 1 day after receiving Shingrix, the patient experienced pain in arm and sleep disturbance. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the pain in arm and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and sleep disturbance to be related to Shingrix.  Additional details were provided are as follows: The patient received 2nd dose of Shingrix in left arm and still had left arm sore at the top part of his arm and the pain disrupted his sleep. The patient tried Aleve for a couple off days and that helped with the pain but when he stopped the Aleve the pain came right back. The patient did not want to take Aleve everyday. Referred to health care professional. Did not gave permission to contact health care professional. Did not consent to follow-up.
the expiration date of the box was different than the vials inside; Based on the expiration date on the box, it was not expired at the time, however the vials did; received an expired dose of Menveo which expired on Nov 30, 2020; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA207A, expiry date 30th November 2020) for prophylaxis. This case was associated with a product complaint.   On 16th May 2021, the patient received Menveo. On 16th May 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the patient experienced product packaging confusion and product expiration date issue. On an unknown date, the outcome of the expired vaccine used, product packaging confusion and product expiration date issue were unknown.  Additional details were provided as follows: The patient received expired dose of Menveo which expired on 30th November 2020 which led to expired vaccine used.  Healthcare professional mentioned that, the expiration date of the box was different than the vials inside which led to product packaging confusion.  Based on the expiration date on the box, it was not expired at the time, however the vials did, which led to product expiration date issue. The reporter consented to follow up.  This was 1 of 3 linked cases reported by the same reporter.  Note: Date of vaccination was captured as 16th May 2021, as the clarification was raised for the same but no response was received yet.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152087:Same reporter US-GLAXOSMITHKLINE-US2021152086:Same reporter
No additional AE; Nurse reported AE related to improperly stored and administered PROQUAD.         ?; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.     On 17-JUL-2023 the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X002292 and expiration date 21-JUL-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product storage error and no adverse event). The temperature excursion was 6.93 degrees Fahrenheit and lasted for 1 Hour 13 Minutes 0 Seconds. There was previous excursion 52.01 degrees Fahrenheit that lasted for 2 hours 6 minutes 0 seconds and 9.74 degrees Fahrenheit  that lasted for 4 hours 34 minutes 0 seconds.
Freezing  cold  shivering  temp 92.2  nauseated , horrible pain in hands shoulders and ankles  stuffy nose headache lasted 5 hours  (just like my last second shot).   Next day woke up better but at 2pm got a fever of 100.6 felt achy and awful.  Woke up today no temp and feel good but hands still hurt and shoulders
blue & red bruises all over body about 10 days p/vax;observation only;