chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; Shingles have never ended; This serious 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and SHINGLES VACCINE (NOS) (SHINGLES VACCINE) for prophylaxis.   On an unknown date, the patient received Shingrix, Shingrix and SHINGLES VACCINE. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles have never ended). 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 Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 31-Mar-2023. The patient reported this case via interactive digital media. The patient had the first shingles vaccine back in 2011 and both Shingrix vaccines but his/her shingles had never ended. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
pain in arm, both shoulders and neck; pain in arm, both shoulders and neck; pain in arm, both shoulders and neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in arm, both shoulders and neck), VACCINATION SITE PAIN (pain in arm, both shoulders and neck) and ARTHRALGIA (pain in arm, both shoulders and neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (high blood pressure), Diabetes and Asthma.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced NECK PAIN (pain in arm, both shoulders and neck), VACCINATION SITE PAIN (pain in arm, both shoulders and neck) and ARTHRALGIA (pain in arm, both shoulders and neck). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NECK PAIN (pain in arm, both shoulders and neck), VACCINATION SITE PAIN (pain in arm, both shoulders and neck) and ARTHRALGIA (pain in arm, both shoulders and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported.  Patient takes medications for all of those unrelated to the vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2022: Follow up received contains contains No New Information.
07/29/2011-BLOODY DIARRHEA/HEMATOCHEZIA 08/01/2011-EMESIS, SEIZURE-LIKE ACTIVITY 08/02/2011-HOSPITAL ADMISSION
first Shingrix shot in September / first week of September 2020 / second Shingrix shot in November 2020 around Thanksgiving / (starting around Feb 6 2021) she has a big shingles outbreak; severe shingles outbreak; ribs are hurting; red line around her belly / 2 red lines moving toward the front of her belly; there's a huge blister; very sick; left (injected) arm was painful; could not move it for 3 days; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix (intramuscular). In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th February 2021, between 2 and 3 months after receiving Shingrix and between 4 and 6 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rib pain, erythema and blister. On an unknown date, the patient experienced injection site pain, injected limb mobility decreased and sickness. On an unknown date, the outcome of the vaccination failure, shingles, erythema and blister were unknown and the outcome of the injection site pain, injected limb mobility decreased and sickness were recovered/resolved and the outcome of the rib pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, injected limb mobility decreased, rib pain, erythema, sickness and blister to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, rib pain, erythema, sickness and blister to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. In November 2020 around Thanksgiving, the patient received 2nd dose of Shingrix and less than 3 months after the 2nd dose, her left (injected) arm was painful and she could not move it for 3 days and less than 6 months after the 1st dose and less than 3 months after the 2nd dose, the patient was also very sick for 3 days. On 6th Feb 2021 (approximately), the patient had a big shingles outbreak, it's on her back right behind the ribcage and her ribs were hurting and there was a red line around her belly, there are 2 red lines moving toward the front of her belly and there was a huge blister and was unable to lay on her right side. The patient was sick, and she could not touch her ribs for 3 days now was shocked that this shingles outbreak was far worse than anything she was experienced before. The reporter did not consent to follow-up.
Patient started passing out after the vaccination. She was conscious, but had difficulty talking. Her face started breaking out with rashes. Administered EPIPEN JR and called 911.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer,  took out one to two vials and place in fridge each day as needed.  No treatment medication was provided to the patient.
Suspected vaccination failure/had the vaccine but came with shingles; Shingles; This 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.     Additional Information: GSK receipt date: 27-June-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine but still came down with shingles. The patient stated that be sure to get your shingles shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
I did have a small, round red, sore area about 2 days after the shot.  It last 3 days.  Then on March 10, my upper arm (down to my elbow) became very red all over, very sore and warm to the touch.  This went on for days.  I went to the doctor toward the end of that week.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Infection / Cellulitis (diagnosed by MD)-, Additional Details: Patient went to urgent care after noticing extensive redness and swelling at injection site. MD at urgent care told patient that it was not a reaction to the vaccine but cellulitis caused by something unsanitary at the pharmacy where he was vaccinated. Patient then returned to pharmacy today 4/7/22 to issue a complaint.
I started getting symptoms of sneezing. That night I felt flu like symptoms with a low grade fever of 101.1. The next day for 2 days I was lethargic and some coughing. I was feeling some better by 2/7/2022 and got tested at a clinic. I did a rapid and PCR test and both were positive. I felt brain fog and loss of energy which lingered for months.
Pt was given a pneumovax 23 shot yesterday and left pharmacy without issue. She called today to let me know about an hour after she received the shot, her arm was experiencing stiffness and pain that radiated down her arm. She described her arm as "hurting and am unable to lift it. I think you damaged my joint".  I apologized that she was experiencing discomfort and asked if she had tried to ice or treat it with otc Ibuprofen or any other type of pain remedy. She said her husband was an ER doctor and she had been icing it and took ibuprofen and something else her husband gave her last night to sleep since it was uncomfortable to lie on and affected her being able to sleep through the night. I thanked her for letting me know of her experience and assured her I would write up the incident and follow up with her in another day or so to see if her condition improved. I also asked her to contact me if anything worsened. At the time of our discussion, she stated the pain had not worsened since yesterday, but not improved either.
Erythema, warmth, swelling, pain, at the injection site.  Fever 101-102F for 2 days Parents giving Tylenol and Benadryl
My face began swelling around my chin, mouth, & cheeks around five hours after receiving vaccine.  I also felt flushed & appeared red.  My voice became raspy.  Mild GI pain/discomfort.
Possible vaccine failure. Varicella lesions appeared 1/6/05 and continued to erupt for 4 - 5 days. 50 plus lesions. Low grade fever 4 - 5 days.  (Another child in same school with possible vaccine failure.)
Patient has reported no adverse effects. Upon entering information into the vaccine registry is when the error was noticed. Patient received booster dose instead of full second dose.
Patient received his first dose of Pfizer (LOT#: FK5127) Exp: 1/12/22 on 11/08/21 at 1446. Vaccinator alerted RN that they had given the wrong dose to patient. Patient received Pediatric Pfizer dose instead of Adult Pfizer dose. RN educated mother of patient regarding her son receiving the wrong dose and that he would be receiving adult Pfizer when he returns in 3 weeks for his second dose. Mother verbalized understanding. RN educated patient and his mother on adverse reactions to COVID-19 vaccine and when to seek EMS. Patient and mother verbalized understanding. Patient stayed his full 15 minutes of observation. Patient did not report any adverse effects from COVID-19 vaccine. Patient left with his mother at 1505 unassisted and with a steady gait.
81 years old woman with PMH of Anemia, CAD s/p CABG, Carotid stenions, CHF with EF 30%, COPD, DM, HLD, HTN, who presented to the ED with chief complaint of increase SOB over the last 5-6 days. The SOB got worse with exertion. Pt stated that she was using O2 only at the weekend but now she required O2 all the time. The associated symptoms wheezing, SOB,  productive cough with yellow sputum, nausea, chills, fever, and diarrhea. Pt stated that she been having 6 episodes of diarrhea per days. Pt denied having any vomiting, chest pain, abd pain. Pt stated that she tested positive for Covid on 3/23/21.     Per chart review, patient had 1st COVID 19 vaccine on 03/04/2021, tested positive for COVID 19 on 03/24/2021.
The patient had a localized reaction 15 x 10 cm round reaction, red, hot, tender, well demarcated. This occurred today.
Pt states he had SOB, swelling of nose/lips the evening of getting vaccine. He went to ER for treatment. They ran test and didn't find anything, so they kept him for observation until he felt better.
pt recv vax & devel rigors, fever, chills, nausea, malaise;pt was recovered as of the date of this report;this is one of three pt from this site to report these adverse rxn;
I had minor symptoms right after the second vaccine. The following morning after the shot, I had no discomfort in the arm. Beginning the September, I was experiencing higher blood pressure. It was alarming. I called around Labor Day for an appt. I was seen by Nurse Practitioner on September 9 and I saw doctor on September 22. I am going to see a Cardiologist on October 25. The doctors lisinopril dosage, I was on 10 mg and right after the visit with the Practitioner visit, I started taking 20 mg for about a week and did not see any change. I increased to 30 mg. When I went to see the doctor, and the doctor said to go to 40 mg of lisinopril with 12.5 mg of hydrochlorothiazide. That seemed to have brought my high blood pressure down. I have started getting active, but then I started having a couple of bouts of low blood pressure. I haven't fainted or anything, but I am very conscious of this. Yesterday, there was a major incident, after I walked 30 min, I took a shower. I took an extended shower and when I got out I took my blood pressure was 93/67 with a pulse of 112. I took on the other arm, it was 106/72. About an hour after the shower, it was 96/61. My average now due to the low readings, 141/9 which is still above the recommended 120/80.
Vision issue, not clear; Colorful strobe light in eye; vision is not good at night time; irritates her right eye; This case was reported by a consumer via call center representative and described the occurrence of visual disturbance in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2021, the patient received the 1st dose of Shingrix. In November 2021, 3 days after receiving Shingrix, the patient experienced visual disturbance, flashing lights, decreased night vision and eye irritation. On an unknown date, the outcome of the visual disturbance was recovering/resolving and the outcome of the flashing lights, decreased night vision and eye irritation were not recovered/not resolved.   It was unknown if the reporter considered the visual disturbance, flashing lights, decreased night vision and eye irritation to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received first dose of Shingrix on the left arm from pharmacy. Three days after the vaccination, the patient had a vision issue, she described it as her vision in the right eye was not clear. The patient went to see her eye doctor to see if her retina was okay, the eye doctor informed that her retina was intact. Then the patient stated that the vision had gotten a little better, but still not back to how it was before the vaccination. Furthermore, the patient stated that the vision was not good at night time. The patient stated that at night, she felt like there was a strand of eye lash in the eye which irritates her right eye, also, she experienced a colorful strobe light effect in corner of right eye. The reporter did not have information about lot/expiry date, dose and route of administration. The reporter stated that she wrote a letter to GlaxoSmithKline via email which included the side effect she experienced. The reporter consented to follow-up with her healthcare professional; however, she did not have a fax number or email address to her healthcare professional. The reporter consented to follow up.
The vaccine that was given was not mixed with the lyophilized antigen so gave only the diluent there was not adverse reaction noted
Pt received vaccine this am. At 1:30pm pt complained of itching covering entire left arm. Treated with benadyl, ice.
Patient is an 84-year-old female with a history of hypertension who presents the emergency department with malaise.  She states she has not felt well the last couple of days.  She denies vomiting however states she is nauseous.  She has not been eating and drinking appropriately because she just does not feel like it.  No fever.  No sick contacts.  She is COVID vaccinated. Associated Symptoms: nausea, URI symptoms
Welt on arm that is raised, red, swollen, tender and large (circular 3 inches in diameter).  Back pain and sore throat.
pt recv vax 12MAY98 & 13MAY98 pt exp a mild sz for which med attention was sought;
Patient received more than the recommended vaccination schedule for COVID-19 vaccines. Total of 7 vaccines reported, from Pfizer and Moderna.
Info has been received from an investigator regarding a 12 mt old female who received Prevnar Hib-Titer, MMRII, Varivax, and IPV, vax's on 6/7/00 as part of a medical group's post-marketing surveillance trial. The next day, the child developed irritability, a fever of 103.2 and experienced a seizure. Unspecified lab results were negative. Febrile seizure is considered medically important. Both the medical monitor and the investigator agreed that these events were not related to vax administration. Follow-up info received on 1/25/02 indicated that the investigator has changed his assessment of the relatedness of febrile seizure (expected per package insert) to possibly related to Prevnar admin. Info regarding this event has been forwarded to manufacturers of the different vaccines administered. On 3/13/02 it was administered that there is a duplication of this report. Report #U200200177 is a duplicate of this report.  This case is closed.  (OMIC)
Legally blind; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Left on 14Apr2021 (Batch/Lot number was not reported) (at age of 68-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included type 2 diabetes.  The patient's concomitant medications were not reported.  The patient previously took the first dose of BNT162B2 on 24Mar2021 (at age of 68-year-old) for COVID-19 immunisation. The patient experienced legally blind on 30Apr2021. Consumer stated, 'I just wanted to know I have type 2 diabetes (Intent: History) and I wanted to know if anybody else has reported any adverse reaction to the vaccine? I have a very bad reaction (Clarification unknown) with Pfizer COVID Vaccine and I wondered if other people has same reaction, people with type 2 diabetes if they have a trouble with the Vaccine'. Date of adverse event: 30Apr (Consumer was unsure). LOT#: Consumer stated, 'I have no idea. There is no bar code. It was from (Pharmacy name). I am also legally blind so, this is very difficult to see it'. Due to network issue call handler voice did not get through to the consumer. Call back was done to gather more information but was not successful.  Limited information was available over the call. The outcome of event was unknown.  Information about lot/batch number has been requested.
Pain; Stiffness; Swelling around shoulder joint; Unable to move left arm; Headache; Chills; Vaccine was given too high stating it was 1/4 inch below the shoulder bone; This spontaneous case, was received on 07-Sep-2020 from a pharmacist via agency (reference number: SEQW20-01292) and concerned a patient of unknown age and gender.   The patient's medical history and concomitant medications were not reported.  On 06-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) for influenza prophylaxis. The patient reported the vaccine was given too high stating it was 1/4 inch below the shoulder bone (explicitly coded as 'Product administration error'). The batch number reported was P100227879, expiry date: 28-May-2021.  On the same day, after receiving Afluria Quadrivalent, the patient was unable to move left arm and had swelling around shoulder joint, pain, stiffness, headache and chills.  At the time of this report, the patient did not receive any treatment for the events.   At the time of initial reporting on 07-Sep-2020, the patient did not recover from the events.   The reporter did not provide causality assessment.    The reporter assessed the events as non-serious.  Company comment:The patient developed all events on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. Reportedly, vaccine was given too high stating it was 1/4 inch below the shoulder bone (explicitly coded as 'Product administration error'). No information regarding concomitant medication and medical history was provided. Based on provided information, causal relationship between the suspect product and the event of product administration error is assessed as not related per company conventions, while for all other events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed all events on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. Reportedly, vaccine was given too high stating it was 1/4 inch below the shoulder bone (explicitly coded as Product administration error'). No information regarding concomitant medication and medical history was provided. Based on provided information, causal relationship between the suspect product and the event of product administration error is assessed as not related per company conventions, while for all other events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
dizziness, hypotensive, nausea, tremors, muscle aches, light headed
Moderna Covid-19 Vaccine EUA.  2:00 am 1/28/2021- woke up feeling queasy, joints in legs were achy. My left  knee replacement felt like it was in a vise,  This  was a  short lived event with some residual feeling in the knee in the morning.   3 days after injection  10:00 pm 1/30/2021- I noticed a small rash on my left abdomen near the navel, this rash moved quickly to the left and soon covered entire left abdomen, moving to the groin area then down left inner thigh.  I took a Benazepril and went to bed. During the night I woke up several time with a strong pressure in left bowel area. Changing position seemed to help and went back to sleep. woke up about 5 am and checked the rash which was mostly gone except for the original spot where it began.  The rash and pressure seemed to be restricted to front left side below waist area. It is now 11:00 am 1/31/2021 and I am feeling fine, very little residual rash at initial site.   I had not read anything about delayed reactions as late as 3 1/2 days after the injection so wanted to report this event.
High fever, very achy, body aches and pains, felt lousy, didn't want to eat or drink