chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A rash has developed that I have been unable to get rid of. It started in the middle of my upper torso and has gradually spread up my neck. I have not changed any of my products prior to developing the rash. I have since tried to switch to hypoallergenic laundry detergent, but it is not helping. I had a cousin develop a similar rash months ago after she took the Pfizer Vaccine, and she has now been told that this will be a chronic issue and that the vaccine has caused her to develop an immune disorder.
Right hypothenar eminence (thumb) started aching approximately 24 hours after shot administered, then the right wrist ached badly (i.e arthralgia).  No other etiology of pain identified.  Anaprox DS (Naproxen) and split provided.
dry component was administered to patients by reconstitution with sterile water with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 4 months old female patient who was given dry portion (ACTHIB) reconstituted with sterile water and separated from the liquid portion (DTAP-IPV) with no reported adverse event while receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and rotavirus vaccine live reassort oral 5V (Rotateq) for Prophylactic vaccination.  On 01-Aug-2023, the patient received standard 0.5 ml (total) dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot: UJ791AA, expiry date: 10-Oct-2023) via intramuscular route in the right thigh for Immunization.  On 01-Aug-2023, the patients had dry portion (ACTHIB) reconstituted with sterile water and separated from the liquid portion (DTAP-IPV) with no reported adverse event (product preparation error) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  Reportedly, Medical assistant asked if it is okay to administer only the liquid portion of the vaccine because the dry component was administered to 2 patients by reconstitution with sterile water  Action taken-not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sometime post vax (date not specified) pt complained of redness and swelling at the site of injection. Further info is requested.
itches; warm at injection site; keeping her up at night; arm hurt/couldn't raise arm above head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt/couldn't raise arm above head), VACCINATION SITE PRURITUS (itches), VACCINATION SITE WARMTH (warm at injection site) and INSOMNIA (keeping her up at night) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt/couldn't raise arm above head). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itches), VACCINATION SITE WARMTH (warm at injection site) and INSOMNIA (keeping her up at night). The patient was treated with Benadryl cream at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm hurt/couldn't raise arm above head) had not resolved and VACCINATION SITE PRURITUS (itches), VACCINATION SITE WARMTH (warm at injection site) and INSOMNIA (keeping her up at night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
By night arm sore and movement was limited. Pain extends from fingerprints to neck/chin. Was in agony at night from the pain; took ADVIL/TYLENOL. Called in doctor in the doctor who recommended to continue ADVIL/TYLENOL, hot packs and give it 48 hours for AES to resolve. Went to doctor on 3/24 who prescribed antibiotics, ALEVE and to continue applying heat. Shoulder is leaning in because pt in so much pain. Doctor will schedule MRI if symptoms don't resolve in next couple of days.
the vaccine made them "sick as hell,"; like they had the flu for 3 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (the vaccine made them "sick as hell,") and INFLUENZA LIKE ILLNESS (like they had the flu for 3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (the vaccine made them "sick as hell,") and INFLUENZA LIKE ILLNESS (like they had the flu for 3 days). At the time of the report, VACCINATION COMPLICATION (the vaccine made them "sick as hell,") outcome was unknown and INFLUENZA LIKE ILLNESS (like they had the flu for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drug reported. No Treatment drug reported.
The patient was fully immunized in February with the Moderna vaccine. Today, he inadvertently received a dose of the Pfizer vaccine. The patient does not report any ill effect, but because the dose is in excess of protocol, I am filing a VAERS report.  Patient also contacted his PCP who said he should be fine but if he suddenly felt very unwell he should head to the emergency room. He was feeling well with my follow up call this evening. I will follow up again tomorrow to see how he is feeling.
This case was reported by a nurse via call center representative and described the occurrence of adverse event in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse who was reporting for herself stated that the pharmacist who administered the SHINGRIX vaccine to her told her that he had 2 patients who had to go to the Emergency room after receiving the vaccine. She stated they were not admitted and they did not die. This was all the information she provided. This case was linked to the case US2018071812 and US2018GSK075873, reported by the same reporter.
Product administered to patient of inappropriate age; Rash; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 6-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EP6955) at the age of 6 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown"; RASH (non-serious), outcome "unknown". The event "rash" required physician office visit.  Additional information: Caller reported that her granddaughter was also a Pfizer recipient and had a little rash. Caller reported that her granddaughter has been to see a pediatrician, and she doesn't want to weigh in on it.
Could not walk; Feet hurt; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number, expiry date and NDC number were not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history, investigation assessment, concomitant medications and other products were not reported. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. As per the description, the caller mentioned that a friend, who has a sister living in another state received the second shot of Pfizer Covid-19 vaccine and experienced feet hurt and she couldn't walk. Caller confirmed that the effects lasted a couple of days. The outcome of all events was recoveredon an unspecified date.  Information about batch/lot number has been requested.
Ache; Trembles; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), TREMOR (Trembles) and FATIGUE (Fatigue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Feb-2021, the patient experienced PAIN (Ache), TREMOR (Trembles) and FATIGUE (Fatigue). On 15-Feb-2021, PAIN (Ache) outcome was unknown and TREMOR (Trembles) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information and concomitant medications are not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue is consistent with the product safety profile
Hot flashes and chills- lasted for 24hrs Headache - lasted 48hrs Tired - lasted 48hrs Swollen lymp node in left armpit - lasted 96hrs Sore neck left side - lasted 96hrs
4-17-09 9:10 AM Pt. c/o ears tingling, L side of shoulder, face (L side) feeling slightly numb - No c/o difficulty in breathing, No c/o throat tingling, No c/o injection site re: pain or tenderness, BP 130/72 Temp. 97, Pulse 96, Resp. 18, FNP assessed pt. and ordered 50mg p.o. BENADRYL. Pt. given meds @ 0915. At 0930 pt. stated "I feel as if I had novocaine to the L side of my face. BP 126/80 Pulse 68 Resp. 18 Pt. alert, No slurring of speech. 0950 Pt. stated numbness sensation to face is going away. No c/o itchiness, no noted erythema, has been encouraged to hydrate with water. 1015 BP 118/80 P 60 Resp. 18. Very little numbness noted. FNP assessed pt. 1050 Pt. left clinic without complaints, BP 118/78 - P-60- Resp 18.
Case number PHEH2014US003848 is an initial spontaneous report received from a consumer on 23 Feb 2014: This report refers to a 17-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscular at a dose of 0.5 ml on an undetermined date. The vaccine was reported to be from the 2013/2014 season. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 23 Feb 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Fever, couldn't barely move the next day, Arm swollen, hard, Red the size of an orange, breathing was hard.
About 7 days after vaccination, patient developed subjective fevers, fatigue, body aches, headache, blurred vision, shortness of breath, nausea, neck pain, dizziness, and confusion.  He also demonstrated hemi neglect, hemianopsia and hemiparesis. He was admitted to the hospital and worked up for CVA and infectious etiology. Neurology was consulted. Lumbar puncture performed. CSF with 170 WBCs, 20 RBCs, negative culture, negative viral meningitis panel. HIV viral load and CD4 were checked upon admission to the hospital. Viral load elevated at 11,500 but CD4 was 436. At this point, he admitted to not taking ARV medication since January 2022. Neuroimaging ruled out CVA.  Neurology insisted on checking CSF VDRL which was negative. Serum syphilis antibody was also non-reactive.  Working diagnosis was aseptic meningitis. Treated symptomatically. Patient clinically improved over 3 days and was discharged home.
face turned bright red; face turned bright red and swollen the next day.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 14:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included charcot-marie-tooth disease. Patient had no known allergies. Concomitant medications included cyclobenzaprine (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. 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 09Apr2021 at 08:00, the patient experienced face turned bright red and swollen the next day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events face turned bright red and swollen the next day was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
The vaccine was found expired by cold chain, and even so was applied at a 9:30 am appointment. At 12:49 they contacted us to inform us of what happened they apologized and once again coordinated the application of the vaccine since the first one had no effect.  They informed us when we asked for an explanation that the vaccine could have been utilized until 11pm the day prior, Otherwise it expired by cold chain and therefore would have no effect when placed.   After asking for the necessary clarifications and with fear, we decided to give my daughter the vaccine once again. In the vaccination card I kept the annotation of what had occurred.
Post vax, the pt had constant crying with no consoling and increased temperature of 102.2F-103F.
28 patients affected *at our organization*:  The CDC publishes technical specifications recommendations that EHR vendors use to configure and test immunization schedule rules.  The CDC inadvertently omitted a key patient scenario from their system, which our EHR vendor followed. The resulting rule update was activated on April 27, 2022.  This rule error indicated that a patient aged 65 years or older with a specific list of comorbidities should receive a third dose of a pneumococcal vaccine instead of the actually recommended two doses.  An advisory based on this rule was displayed in a set of ambulatory encounters, and a third pneumococcal immunization was administered in some of these encounters.  We became aware of this when clinics contacted us about the inappropriate prompting for additional dose in patients that are not eligible.  We contacted EHR company, who reported this back to CDC.  This issue was corrected on May 6, 2022, and a query with chart review process identified 28 patients who received this *inappropriate* third pneumococcal immunization during the period of this inaccurate advisory.    Given the scope of the error, and the impact on multiple EHR vendors, it seems likely that thousands of patients could have been affected.  Variables that impact applicability include 1. EHR vendor use 2. Local institution speed of download/implementation.  The actual patient risk with inadvertent additional dose is unknown, though the potential for serious harm is assessed as low.    Note that the actual vaccine(s) listed is not exactly correct, I am selecting the most appropriate from what is available.
Fainted at 7:45am on 9/15/2021. She lost total control. I (husband)  happened to be near by and held her. After 45-60 seconds I took her to sofa and she lied down for about 10-15 mins. During the time she was sweating a lot. After that no issues so far. She does not remember 45-60 second period at all.
chest pain; Bronchitis; hissing in ear; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), BRONCHITIS (Bronchitis), TINNITUS (hissing in ear) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain), BRONCHITIS (Bronchitis), TINNITUS (hissing in ear) and HEADACHE (headache). At the time of the report, CHEST PAIN (chest pain), BRONCHITIS (Bronchitis), TINNITUS (hissing in ear) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller was warm transferred from Moderna Customer Care, case number 00132442. Caller was very angry and refused to answer any of the agents questions. She stated "you don't sound like you know anything and you are not a medical professional. You need to answer my questions, I don't need to answer yours!" Customer care stated that caller developed bronchitis, hissing in ear, chest pain and headache. Caller did not provide consent for safety follow up.
I had shingles; The blisters have yet to pop or crust with more rash beginning along L2 8 days after the initial outbreak; The blisters have yet to pop or crust with more rash beginning along L2 8 days after the initial outbreak; This is a spontaneous report from a contactable consumer or other non hcp. A 28-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8731) via an unspecified route of administration in Arm Left on 27Apr2021 12:00 (age at vaccination 28years old) as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder from an unknown date and un-known if ongoing Other medical history: Adult ADHD. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. The patient previously took bactrum t and experienced drug hypersensitivity, minocycline and experienced drug hypersensitivity, formaldehyde and experienced drug hypersensitivity. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8737) via an unspecified route of administration in Arm Left on 06Apr2021 at 02:00 (age at vaccination 28years old) as single dose for covid-19 immunisation and patient rash with first dose. On unspecified date in 2021 the patient experienced i had shingles, the blisters have yet to pop or crust with more rash beginning along l2 8 days after the initial outbreak. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
6 days after vaccine Pt suffered a seizure on April 12th. He had no prior history of seizures or epilepsy. He was found unconscious on the floor of his home office by his wife, laying on his stomach making a snoring sound and she was unable to wake up. The event lasted under 2 mins and he regained consciousness. He was taken to urgent care same day. He suffered two more events on April 25 & 26th. He was taken to the ER on the 26th for testing. On July 6th he suffered back to back seizures and on July 16th he suffered another. With no prior history he is being diagnosed with epilepsy post vaccination
Pulse changes; This non-serious case was reported by a consumer via call center representative and described the occurrence of pulse increased in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cardiac pacemaker insertion.   On 14-SEP-2023, the patient received the 1st dose of Shingrix (left arm). On 16-SEP-2023, 2 days after receiving Shingrix, the patient experienced pulse increased (Verbatim: Pulse changes).  The outcome of the pulse increased was not resolved.   It was unknown if the reporter considered the pulse increased to be related to Shingrix.     It was unknown if the company considered the pulse increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-OCT-2023 Reporter was a patient that reports that she received the 1st dose of Shingrix in her left arm and starting on, her pulse, which is normally in the 60's to low 70's, is all over the place, with readings of 100, 99, and 98 on the 16th of September 2023. Patient reports she was still having this problem as of last night, 5th October 2023, when her pulse went from 60's to 100, while she was sitting down. Patient reports she has a pace maker which she got November 2022 (pre existing Shingrix vaccine). Patient also reports her physician has put her on a low salt diet; but, if she eats something with salt, it does not seem to affect her pulse. Consent to follow up with HCP was obtained.
Pt reports that she only experienced fatigue with the 1st dose for a day. With 2nd dose on 5/4/2021 was when her dizzy like symptoms begun, pt described it as vertigo-like symptoms that comes and goes. Pt reports that she'll experience tinnitus first before the dizzy spells comes on. During weekend pt started she had full blown episode of dizziness with nystagmus. Pt reports that the dizziness usually occurs first thing in the morning, and when she takes the Meclizine it helps with the dizzy spells but she'll be in bed all day because she'll get dizzy when she walks. Pt reports she took Meclizine and Dramamine and these provides relief for ~36-42 hours. Pt also reports she stayed pretty hydrated. Pt also reports that 12 hours post her 2nd dose she had experienced chills and ache, she took 1 Advil and 1 Tylenol and slept, when she woke up the next day the chills and ache was gone but felt a little sluggish.