chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccinated twice, STILL get shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided are as follows: The patient self-reported the case. The age at vaccination was not reported. The patient was vaccinated twice and still get shingles. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Muscle aching started around 10am and progressed throughout the day turning into muscle cramping with electrical shock feelings. Left arm  injection site is swollen, hot and very large red area with pain and slight itching
2/3 of rear of arm inflamed-large (3cm) raised area with appearance of several potential "Pox resembling" lesions within last 48hrs.
Petechiae noted on trunk and extremities onset 1/12 per patient 5 am bruise noted on forearm states also has one on thigh but refused to display, afebrile denies blood in stool or urine referred to local ER then transferred to hospital.  02/22/2007 MR received from public health dept for  teenager who moved from another country in September 2006.  He developed petechiae on 01/12/2007 and some bruising on the arm and thigh.  Admitted to hospital on 01/17/2007.  Txd with IVGG with resulting increase in platelet count.  INH stopped.  D/C on 01/19/2007 INH started again 01/26/2007 Multiple vaccines received 01/05/2007.  03/05/2007 Hospital MR received for a 2 night ER admission for a finding of thrombocytopenia at another facility, accompanied by bruising, gingival bleeding, and epistaxis.  Platelet transfusion given as well as IVIG.   PE reveals (+) gingival bleeding.  Scattered petechiae on face, chest, and abdomen.  Scattered bruising bilaterally on lower extremities. Discharged with outpatient F/U.  Discharge DX: Idiopathic Thrombocytopenia Purpura.  Latent Tuberculosis.
On 09/20/2022 it started in the morning, I was fatigue. I felt like I had the flu. I did not have a fever. I just slept for four days afterwards. My arm was tender. My lymph nodes under my breast felt swollen. I had a headache. I did not feel good at all. The symptoms eased off at about two weeks. I went to see my nurse practitioner because I had a rash on my stomach that was itchy, and my breast were tender. The rash appeared about two weeks after the vaccine. The NP gave me a steroid shot and a steroid pack for 5 or 7 days. I am still in the recovering stage. The rash goes away and then flares up again. I had an appointment to see my allergist on 10/20/2022.
received on August 15th 2023 a dose of lyophilized Menveo reconstituted with sterile water.; received on August 15th 2023 a dose of lyophilized Menveo reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA733A, expiry date 31-MAR-2024) for prophylaxis.   On 15-AUG-2023, the patient received Menveo. On 15-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: received on August 15th 2023 a dose of lyophilized Menveo reconstituted with sterile water.) and inappropriate dose of vaccine administered (Verbatim: received on August 15th 2023 a dose of lyophilized Menveo reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 16 August 2023: The nurse reported the patient received a dose of lyophilized Menveo reconstituted with sterile water. The reporter asked how to proceed?  The reporter did not consent to follow-up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received a dose of lyophilized Menveo reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Heplisav-B and Twinrix administered on same day; Twinrix 1st dose in 2017, 2nd on 27Dec2022; This case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 46-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22nd September 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2017).   On 27th December 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 27th December 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced accidental overdose and drug dose administration interval too long. On an unknown date, the outcome of the accidental overdose and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27 DEC 2022 Reporters comment: This case was reported by the pharmacist. The pharmacist reported that another pharmacist administered a dose of Twinrix to a patient on 27th December 2022 and instead of pulling a flu vaccine to also gave the patient, inadvertently administered Heplisav-B. This was the patient's second dose of Twinrix, however pharmacist stated the patient was off schedule because the first dose was back in 2017.   Additional supportive information: As patient received Twinrix and Heplisav B which contained Hepatitis B in both vaccine which led to accidental overdose of hepatitis B component and received 2nd dose lately which led to drug dose administration interval too long. The reporter consented to follow up.
Severe Vertigo for 2 days.  Then Dizziness and occasional vertigo for over 22 days.
Was informed tonight by personnel about 8:10 pm tonight that I accidentally got 5x the recommended Pfizer vaccine booster dose due to failure of dilution with saline by vaccine administrator.  This error happened allegedly to everyone who got the covid vaccine (? only Pfizer) dose today starting from am till about 2 pm. Experiencing neck pain, intermittent headaches, body aches, some nausea and pain at injection site.
Information has been received from a nurse concerning a 21 year old male with no known allergies and autism and a history of previous hepatitis B vaccination series (manufacturer unknown) and previous nonreactive hepatitis B antibody test who on July 2006, August 2006 (Lot#652712/0039F) (2nd dose), January 2007 (Lot#652881/0105F) (3rd dose)was vaccinated with RECOMBIVAX HB. Subsequently the patient again tested nonreactive. Additional information has been requested.
In 1988 pt recvd 3 doses of Engerix-B; titers were checked in JUL91 post exposure & pt was found to be non responsive; booster of Engerix-B in JUL91 & pt now is protected;
TRANSIENT CEREBRAL ISCHEMIA 2/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This consumer report from the internet (initial receipt 15-Jan-2014) concerns a 10 month old female patient. On an unspecified date, (approximately six to seven years ago) the patient received the flu shot (manufacturer and batch number not reported) first dose of a series of two. On an unspecified date, roughly one or two weeks after receiving the flu shot, the patient developed a high fever and the doctors concluded she had neutropenia. Her neutrophil levels were so low that she was hospitalised for a couple of days. It took five months for her count to return to a normal level. She has not had an episode since. The doctor's thought it was autoimmune. Outcome was not reported.
Pt was without adverse event, but did have administration error.  was given a 2nd dose of PCV 20 6 mo following his first dose.
Information has been received from a registered nurse concerning an 18 month old male with no pertinent medical history and no drug reactions/allergies who on 03-FEB-2006 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (Lot # 652555/1023R). There was no concomitant medication. On 14-FEB-2006 the patient was diagnosed with chickenpox. However, on 15-FEB-2006, he presented to the office and the physician deemed that the patient did not have chickenpox. The patient was diagnosed with viral exanthem. The outcome was reported as not recovered. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Maderna booster shot received 11/03/21 and I had severe muscle and joint pain all over my body. Felt very sick and leg pains made it difficult to even sit at table to eat. I started a barking cough the next day and have continued to do so to this day 12/29/21. I also coughed for weeks after my first maderna shot as well. I also on the fifth day after my booster shot started to have severe pain in my neck, popping and clicking and dagger sharp pains up the side of my neck up to my right ear. I could not turn my head right. On day 15 after my booster shot my joint in my back right below my neck swelled up. I iced it. I have had to see an orthopedic doctor for my chronic cough and neck. I am very discouraged to receive any future vaccine shots after this experience. How do I proceed if unable to feel safe to take shot and demands of mandates that may be given to people to live their lives in the public environment.
Shingles and I was vaccinated last year/Suspected Vaccination Failure; Painful case of shingles; Painful, still have pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was just getting over a very painful case of shingles and he/she was vaccinated last year. The patient was luckily put on antiviral right away.  The patient still had pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Started with body aches, low grade fever, chills, night sweats. Exactly the same as when I had covid last month.
chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 43-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medications were reported. No treatment medications were reported.
Patient given pneumococcal vaccine at 11:30.  Patient went to check out of office and started to become very anxious complained of being hot and right ear became red and warm, stated heat moved through neck and down back and then complained of severe lower back pain and difficulty breathing.  Patient was taken back to exam room and given 25mg Benadryl, started on Oxygen 2 liters.
Pt states he iced it and tried anti-inflammatory, did not help. Pt presented to the ER with redness, swelling at injection site and afebrile.
Severe arm pain upper arm, can't lift arm without significant pain. TD vaccine given 1/21/2009 10:30 AM. Saw doctor following week 1/28/2009. Pain still exists.
Patient was given adult pneumo vaccinine 9/7/04. Mother of child reported he started running high fever with redness and swelling in left deltoid area where Pneumo immunization was given IM.
This spontaneous report was received from a nurse reporting on a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 18-AUG-2015, the patient was vaccinated with MMR II (dose, route, lot # and expiration date were not reported) and (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not reported). On the same date, the patient had tuberculosis (TB) skin test performed. On an unknown date in 2015, the patient developed a flat, red rash bilaterally on his arms, anterior thighs, neck and trunk. The nurse reported that the patient was in her office at the time of the report, but she could not provide the details about his adverse events as "he needed to go back to work". The outcome of rash was reported as not recovered. The relatedness between the event and MMR II (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Within 20 minutes of vaccination, deltoid large amount swelling, induration and moderate pain.  Staff pediatrician evaluated the individual and noted the reaction was likely a local systemic reaction.  Pt was treated with ice pack for swelling and released.
This spontaneous report was received from a healthcare worker (quality assurance coordinator) regarding a 42 year old patient(gender unknown). The healthcare worker reported that her facility had administered 9 doses of RECOMBIVAX HB, lot # J001183. On 07-MAY-2013, the one of the patient's was vaccinated with dose 1 of RECOMBIVAX HB (lot # J001183, expiry: 08-SEP-2014). At the time of this report(01-JUL-2013), the patient had not yet received dose 2 of RECOMBIVAX HB. No adverse effects reported. This is 1 of 6 reports received from the same reporter. Additional information has been requested.
She woke up with a burst blood vessel in her eye; This is a spontaneous report from a contactable other healthcare professional (hcp) (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date in 2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving the Covid-19 vaccine in 2020, she woke up with a burst blood vessel in her eye. There was blood throughout the white portion of her left eye. The outcome of event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for the reported event of eye hemorrhage due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including including eye examination at baseline and during subject drug therapy, Head CT/MRI, chemistry panel, CBC and coagulation panel, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient received both Influenza and PCV13 on 12/3/2019.  Returned to clinic on 12/5/2019 with cellulites of the upper left arm. Treated with doxycycline
4/18/12 (day after rec vaccines) patient felt cold achy, feverish, T 99.6. Went to Urgent Care (T 100.7). That evening she noted swelling, redness & Rt arm tenderness. 4/19/12 T 99, but arm sore ("like it was on fire") with redness spreading distally - was seen at ER on 4/19 evening. Ret to UCC on 4/20 as Rt arm inflamed & tender. Bld wk done. Cephalexin started 4/21. Pt arm began to feel better after 1st dose & improvement has continued.
Have had trouble with loose bowels since the 2nd injection on 4/22/2021.  The injection appears to have triggered a relapse of ulcerative colitis from over 10 years ago. Also still having aching sensation at injection site in upper left arm during  physical activity.
An immediate red welt and red rash formed just below the MMR Chickenpox vaccine site.  She has a low grade fever 99.7 degrees.  We have given her benadryl, but it doesn't seem to be doing anything.  The rash is no better and it is no worse.  It is warm to the touch and slightly raised.  I drew around the rash so I would know it is got any better or worse and it hasn't changed in 3 days.
One case of anaphylaxis, after an individual received Moderna's vaccine; A spontaneous report was received from other manufacturer Pfizer concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced one case of anaphylaxis, after an individual received Moderna's vaccine.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an undisclosed date, the patient received their dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   Other manufacturer forwarded article posted via social media regarding COVID-19 vaccines. The article contained a brief statement from the Center for Disease Control (CDC) that stated, they also noted one case of anaphylaxis, which can cause throat swelling and breathing difficulty, after individual received Moderna's vaccine'. No further information was provided regarding Moderna's COVID-19 Vaccine (mRNA-1273).  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
pt recvd vax & leg was extremely swollen & pt had n/v all day; pt had fever w/ t 102; MD notified DT ordered for future immun;
Patient was given FLUARIX QUAD. Procedure was followed according to pharmacy SOP. Upon withdrawal of needle, the patient had significant flash of blood. Within seconds, the patient began to complain of itching at the site of injection and continued to bleed. The Bandaid was pulled off and the site was wiped down with clean cotton ball. In order to determine whether the redness was blood or residue or a histamine reaction. We then wiped the arm with a little water on a cotton ball. The site of injection continued to be red and warm to the touch. Following store guidelines, we applied a cold pack to the site for 15 minutes. The site of injection then started to decrease in redness and slowly back to normal skin tone. The patient never complained of any problems with breathing or any other systemic reactions.
accidentally injected the contents of 1 Arexvy adjuvant vial into another Arexvy adjuvant vial; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number HL594, expiry date 19-OCT-2024) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product preparation error (Verbatim: accidentally injected the contents of 1 Arexvy adjuvant vial into another Arexvy adjuvant vial).  The outcome of the intercepted product preparation error was unknown.   Additional Information: GSK receipt date: 6-Sept-2023 The pharmacist called to report that there was no patient involvement with this event. The reporter consented to follow-up with health care professional/ pharmacy was obtained. The pharmacist accidentally injected the contents of 1 Arexvy adjuvant vial into another Arexvy adjuvant vial one day prior to the reporting date, which led to intercepted product preparation error.
A rash on upper arms that spread to trunk and upper thighs/rash was red and itchy, but without any raised bumps; A rash on upper arms that spread to trunk and upper thighs/rash was red and itchy, but without any raised bumps; This spontaneous case was received on 06-Apr-2021 from other non-health professional (consumer) via Communication (reference number: SEQW21-01134) and concerned a female patient of unknown age.  The patient's medical history and concomitant medications were not reported. The patient's vaccination history included other flu vaccine, but had never had a reaction like this to any.  On 05-Dec-2019, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 261234.  On 07-Dec-2019, within two days after receiving Flucelvax Quadrivalent, the patient developed a rash on upper arms that spread to trunk and upper thighs. The rash was red and itchy, but without any raised bumps.   On an unknown date, the patient saw a doctor who prescribed unspecified steroids for the rash. The first course of steroids did not resolve the rash and the patient was prescribed other unspecified medications, which after completing those, did resolve the rash.  On an unknown date, the patient recovered from the events of 'rash pruritic' and 'rash erythematous'.  The reporter assessed the events as related to Flucelvax Quadrivalent. The patient had never had a reaction like this to any other flu vaccine she had had.  Company comment: The events 'rash pruritic' and 'rash erythematous' are assessed as related to Flucelvax Quadrivalent.; Reporter's Comments: The patient had never had a reaction like this to any other flu vaccine she had had.; Sender's Comments: The events 'rash pruritic' and 'rash erythematous' are assessed as related to Flucelvax Quadrivalent.
On 5-8-2022, I started having a cough, stuffy/runny nose and fatigue. On 5-10, I took a home Covid test and it was positive. I went and got a rapid test/PCR Covid test at local Covid testing Center in my neighborhood. The rapid antigen was positive. My PCR was negative but I still quarantined. On 5-11, I had a telehealth visit with my PCP and they performed another Covid test on me in their parking lot that day with positive results. They prescribed a cough suppressant, Vit D, Vit C and Zinc. I am feeling better but still have a lingering cough. I am also having irregular menses cycles.  I am reporting my breakthru case of Covid.