chrisvoncsefalvay/vaers-outcomes huggingface dataset:
uncomfortable with PHN.; received two doses of Shingrix/ Last episode/ suspected Vaccination failure; Last episode; This case was reported by a pharmacist and described the occurrence of suspected vaccination failure in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included immunoglobulin therapy, shingles (had 7 breakthrough, refer linked case US2021AMR216523) and pneumonia bacterial. Previously administered products included Pneumovax with an associated reaction of pneumonia viral (received as late as July 2015 yet has had viral pneumonia twice and bacterial pneumonia once), Hizentra and valacyclovir (a maintenance dose of 500 mg valacyclovir qd, increasing to bid and tid if improvement not seen in shingles). Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In October 2021, more than 2 years after receiving Shingrix and Shingrix and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced post herpetic neuralgia. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and prednisone. On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient was having immunodeficiency. The patient received 2 doses of Shingrix in the fall of 2018. Since the vaccination, she had 7 breakthrough Shingles infections.  The patient's physician had her on a maintenance dose of 500mg Valacyclovir QD, increasing to BID and TID if improvement not seen. Last episode of shingles was about two weeks before the date of reporting, she had to use Valacyclovir 1g TID x1 week, then 500mg TID along with Prednisone. Given that these were happening so often, she wondered if a third dose of Shingrix would be advisable. She was quite uncomfortable with post-herpetic neuralgia. Her physician said the usual 2 shots was the maximum. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR216523:same reporter
Tongue/throat swollen with white spots, hurt to swallow, migraine worst ever had,nausea,vomiting,chills, runny nose this happened 7 days after 2nd shot. They days up until today I barely had any side effects, my arm wasn?t even sore.
Information has been received from a 79 year old female consumer with a history of "low immune system" who on 15-MAR-2007 was vaccinated with a dose of Zostavax (Merck). Concomitant therapy included "Lutrizone Cream" (therapy unspecified), "Dosaphine" (therapy unspecified), cyproheptadine hydrochloride, clonazepam, "Meglozine" (therapy unspecified) and "Thyroid medications" (therapy unspecified). Subsequently the patient "being very itchy all over her body", vaginal itch, burning, tingling and nerve pain. Unspecified medical attention was sought. An unspecified "liver test" was performed (results not reported). The patient is currently not recovered. No product quality complaint was involved. No further information is available.
Itching, red and raised skin injection site 3-4 days after vaccination. Also clogged sinuses, right ear and tinnitus 13 days after injection. Clogged ear, sinus issues and tinnitus gone after approx 24 hours. Has not ye t returned. Itching, raised and red skin gone after 1 weeks.
Patient is a 74 y.o. male patient of DO pmh copd, htn, schizophrenia who presents to ED with increasing shortness of breath and cough.   Acute respiratory failure with hypoxia Pneumonia of right lower lobe due to infectious organism Acute exacerbation of COPD On presentation?hypoxic to 80%, tachypneic with respiratory rate to 26  WBC 13.79 CT PA with mild tree-in-bud nodules in the right middle and right lower lobes which may be infectious or inflammatory. Continue with dexamethasone, scheduled inhaler, omnicef and zithromax  On 1 L of oxygen.  To wean to RA Wean oxygen as tolerated, encourage incentive spirometry WBC up to 16 < 10, today, down to 13 Patient feels better, SOB improved so will DC home once fully weaned off oxygen. Patient advised to follow-up with his PCP.   Covid-19 Date of onset of symptoms: 11/16/22 Symptoms present on admission: shortness of breath, cough Date of covid positive test: 11/18/2 Vaccination status: fully vaccinated per patient and received 4 total vaccinations Imaging: ct as above Oxygen requirements on admission: 3 to 4LNC Current oxygen requirements: 1 L Medical therapy: dexamethasone started 11/28/2022.   S/p Paxlovid therapy for 5 days Consultants following: None Special isolation DC'd   Essential hypertension  BP elevated 140's to 170's Continue lisinopril 40 mg p.o. daily Hydrochlorothiazide 12.5 mg p.o daily increased to 25 mg daily BP better controlled   Schizophrenia On invega q28 days, continue depakote and loxapine   Family Contact Information    Code Status: Full Code   Quality Measures ? DVT Prophylaxis: Lovenox ? Foley Catheter: Absent   Disposition ? Discharge Location: Home ? Estimated Discharge Date: 12/2/2022 ? Outpatient Testing: None
12/5 Patient was vomiting all day (no eating) and experiencing paralysis. Wife found husband on the floor several times. Tried to pick up bag from nightstand but couldn't move his arm and arm was hanging. Couldn't move body or legs and was slipping out of bed. Felt very weak and couldn't move to use the bathroom. Hit his head on the nightstand and injured his ear. Wife called ambulance to come take him to emergency. Was admitted on 12/5. Found diverticulitis, dehydration, pain, viral infection, and stomach pain. Hospital ruling out sepsis.
FEVER, BODY PAIN, FINGER PAIN, WHOLE BODY IN PAIN.
12-19-10 Patient noted to have eye rolling and staring episodes approximately 5 hours apart. Admitted to hospital 12-17-10 - discharge 12-20-10. Patient has had subsequent similar behaviors and evaluation continues.
Hurt; Got shingles vaccine had shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In OCT-2022, the patient received Shingles vaccine. In FEB-2023, between 3 and 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles vaccine had shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). On an unknown date, the patient experienced pain (Verbatim: Hurt). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported he or she received Shingles vaccine and experienced shingles while he or she is on vacation. The patient stated that it was not fun and it really hurts. The physician stated that it would have been worse without vaccine. It was bad enough. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Pt received vaccine at approx. 16:00-17:00 on Thursday, 1/2/03. At 12:01 AM, Saturday, 1/4/03, she developed nausea, dizziness and vomiting every hour. She also developed headache, back ache and blurred vision and chest pressure.
On 6/5/01, the pt received her 1st 0.5cc IM dose of Engerix-B and a 0.5cc IM dose of diphtheria-tetanus vaccine. On 6/8/01, the pt developed a "minor" red spot at the injection site. No drugs were used to treat the adverse event. The reporting physician stated that the adverse event was mild in intensity and was possibly related to Engerix-B. The adverse event resolved on 6/10/01. As of 7/2/01, the adverse event had resolved.
Shortness of breath, joint aches, vertigo, brain fog, general malaise, weakness, fever. Lasted 1-1/2 days.
Patient developed symptoms of COVID-19, then tested positive starting around 11/16/2021. Symptoms include abdominal pain, nausea, cough, fatigue and low-grade fever.
swollen lymph node; This is a spontaneous report from a lay media report reporting events for 3 patients. This is patient 1 of 3. This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced swollen lymph node on an unspecified date. She described one patient with a newly diagnosed breast tumor who had swollen lymph nodes on the same side and had recently received a Covid shot in the arm on that side. A biopsy was performed, an important step to determine whether there were malignant cells in the nodes that would then help decide a course of treatment. It was negative for cancer. The vaccine had most likely caused the swelling. The patient underwent lab tests and procedures which included biopsy: negative for cancer on unspecified date. Outcome of the event was unknown.; Sender's Comments: Linked Report(s) : Same article/same event/different patient
I started off with headache, congestion and sneezing. Then I had fatigue, fever loss of taste and smell. I felt like I was overheating, I had brain fog and shortness of breath. I went to ER, they gave me an infusion of antibodies.
Fainted after receiving vaccine. Legs elevated, sternal rub, oxygen at 2 liters applied. Pt given supplement after becoming alert. Time frame 8 minutes. Pt ambulated out of clinic with steady gait alert and oriented x 3. Mother states patient has vasovagal response with vaccines in past.
(R) arm swollen warm to touch from shoulder 2/3 down upper arm. Taking 1 OTC ALEVE q 12 hours.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:42 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 64.04 years. No concomitant products were provided. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Vaccine was stored in Cooler 1 on 03-Apr-2021.  The excursion time on initial supply was at 9AM, temperature was 34 degree F, total 210 doses were given for the day, vaccine was not frozen prior to administration. Vaccine moved to fridge on 30-Mar-2021 and moved to clinic on 03-Apr-2021. 20 vials were sent to the clinic. Vaccine BUD date was 29-Apr-2021. Vials only punctured right before administration.  Treatment medications were not reported.
Began to feel hot.; Upper extremities became to feel tingly or prickly internally/ tingling traveled to my legs; Antsy, fidgety and felt like bouncing off the walls.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP7534) via an unspecified route of administration in left arm on 16Mar2021 at 07:15 (at an age of 61-years-old) as a single dose for COVID-19 vaccination. Medical history included allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 16Mar2021 at 07:30, approximately 10 minutes after the vaccination the patient had upper extremities felt tingly or prickly internally and began to feel hot. Then the tingling travelled to his legs, almost like the feeling when legs fall asleep. About an hour later felt like drank a pot of coffee, the patient was antsy, fidgety and felt like was bouncing off the walls. The clinical outcome of upper extremities felt tingly or prickly internally and began to feel hot, tingling travelled to the legs, almost like the feeling when legs fall asleep was recovered on an unknown date; while for the event antsy, fidgety and felt like was bouncing off the walls were recovered on 16Mar2021.   No follow-up attempts are needed. No further information is expected.
fever; stomach upset; injection site pain; chills; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2020, the patient received the 1st dose of Shingrix. On 17th September 2020, less than a day after receiving Shingrix, the patient experienced upset stomach, injection site pain, chills and fever. On an unknown date, the outcome of the upset stomach, injection site pain and chills were recovered/resolved and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the upset stomach, injection site pain, chills and fever to be related to Shingrix.  Additional details were reported as follows: Reporter was patient's wife. The patient received 1st dose of Shingrix and later on same day, experienced fever, chills, injection site pain, and stomach upset. Reporter stated that the chills, injection site pain, and stomach upset lasted 3 to 4 days and then resolved, but patient currently still had a fever. The reporter consented to follow-up but did not for healthcare professional.
Client received Pfizer Covid 19 vaccines on 4/13 and 5/4  2021  at  in .  Client was admitted to same hospital on 7/6/2021 with pain and infection of unknown origin and at that time tested positive with PCR for Covid 19.  No Covid symptoms per nursing staff on floor where client was admitted.  Client is in isolation x 10 days.  VAERS report submitted because client tested positive for Covid and had completed vaccine series.
24 hr post vaccine: fever, headache, chest pain 48 hr post vaccination: tingling sensation in arms and legs (bilateral), rash on chest, face, back
No noticeable reaction to vaccine other than, I noticed nine days after the injection a hot, hard, red swollen painful lump (dime size) developed at the injection site.  I put on ice and it feels better.  I've never had a reaction to a vaccine before.  Did not contact my doctor. I still plan on getting my booster shot on July 30th in the other arm.
Pt recv vax on 10/28/98; on same day pt exp firm/swollen/ hot/ painful LA; tx=Zyrtec
Adverse effect has been an inability to get aroused. Sexual dysfunction. Started within two weeks after receiving second vaccine shot.
(L) arm swollen, red, hot from shoulder to elbow (13 cm x 10 cm), mildly tender to touch (deltoid area). (R) deltoid area 2 x 3 cm area pink, non-swollen, non-tender skin.
Patient had tingling in the mount and felt like her tongue was swelling about two hours after vaccination. Paramedics were called who took her to the ER
Approx. 11 hours after receiving vaccine I developed racing heart, dizziness nausea.  Next day still experienced elevated heart rate and also headache.  Both of these events lasted for 3 days until Thurs., March 11th.
I contracted Covid had fever chills, can't smell or taste congestion and Cough lost voice, chest is sore from coughing.
severe shivering all night long; couldn't sleep; too cold to get up; i guess i had fever; bad headache; feeling exhausted the entire next day; This case was reported by a consumer via sales rep and described the occurrence of shivering in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shivering, sleeplessness, feeling cold, fever, headache and exhaustion. On an unknown date, the outcome of the shivering, sleeplessness, feeling cold, fever, headache and exhaustion were unknown.   It was unknown if the reporter considered the shivering, sleeplessness, feeling cold, fever, headache and exhaustion to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got the first Shingrix shot and had pretty horrible side effects severe shivering all night long and could not sleep and too cold to get up and take temperature but had fever, bad headache the next morning, and felt exhausted the entire next day after vaccination. The patient stated that had a due for the second shot and was really dreading the side effects. The patient was wondering if waiting longer after the first shot (6 months) or shorter (3 months) to get the second shot effects how severe the side effects are the second time. The patient asked if you have severe side effects the first time, are they likely to be as severe the second time or could they be even worse. The patient realize everyone reacts differently but would like to know what the odds are.      Lab Comments: On an unknown date body temperature was recorded
headache; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache After vaccination. The patient asked she received the second dose of the Pfizer-BioNTech COVID-19 vaccine yesterday. she reported a headache to DSU agent, if she could take Aspirin for his symptoms after vaccination. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
C/o dizziness post-vaccination.  VS@12:55  BP 137/91, pulse 66, RR 16.  Referred to EMT:  systolic BP 124; EKG showed irregular heartbeat, unspecified.  Recommended further assessment by participant's cardiologist.  Bottled water given.    Client reported feeling better.  Stood up and walked a few steps.  Coherent, pleasant, answered questions appropriately, appropriate eye contact.
Severe seizure, (including convulsions, gutteral moaning, eyes rolling into back of head, and eventually stopped breathing and turned blue) 911 was called, transported to ER by ambulance. Lab work, chest xrays done. Dr's diagnosed as febrile seizure, though no instance of fever BEFORE seizure onset, no after release from ER. Max temp was 101.5 at ER.
Elder females do get diarrhea with the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (Elder females do get diarrhea with the Moderna vaccine   ) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Elder females do get diarrhea with the Moderna vaccine   ). At the time of the report, DIARRHOEA (Elder females do get diarrhea with the Moderna vaccine   ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.
On 3/21/02, telephone call from parent, noticed an area on left arm at area of MMR, today, an irregular rash area and slight swelling. Advised it may be a localized reaction. Can apply cool compresses but if it does not subside in a few days, to consult PMD. On 3/29/02, telephone call. She states that the rash-type redness on left arm lasted to about 3/23/02 and then subsided.
Approximately 10 minutes after receiving the Moderna COVID-19 vaccine dose #2, Patient began experiencing left arm itching/shaking/tingling followed by nausea and vomiting.  Later in the day, Patient experienced a headache and back pain.  The next day, Patient experienced headache, congestion, and body aches.
general itchy rash on arms, legs, and body. Short term blisters on skin lasting approximately one hour.
At 12:26 PM, the patient's parent alerted the nurses station that the patient was "not feeling well," and complaining of nausea. Initial blood pressure at 12:26 PM was 85/50, pulse 81. Patient alert, oriented, and responsive. Patient was immediately positioned supine on the exam table and patient's feet were elevated. Patient was given a granola bar and a cup of water. At 12:28 PM, blood pressure was 85/59, patient complained of nausea.  At 12:30 PM, blood pressure was 104/70, pulse 79. At 12:32 patient's blood pressure was 100/63. Patient was monitored for several minutes. Patient stated she "felt better." At 12:40 blood pressure was 93/63. At 12:56, blood pressure was 97/62. Patient denied complaints of nausea, dizziness, numbness, shortness of breath. Patient discharged. Follow up call placed at 6:00PM, no answer.