chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had shot got 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that it was absolutely.  The patient had the shingles shot and two years later he/she got Shingles, the same week Covid lockdown started but no Covid vaccine. 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. The follow up would not possible as no contact details were available.
Slight fever (3/14/21) Fatigue (3/14 - 3/16/21) Headache (3/14 - 3/16/21) Significant arm pain ? more than injection pain (3/15-3/20/21) Itchy splotchy rash on left arm (3/22 - present)
Intense, irrational mood swing. Became increasingly emotionally unstable throughout early afternoon, and enraged around 4pm. Lasted only briefly, but felt very "off" all day leading up to the event, and after. Woke next morning and felt completely normal, with regular mood regulation and mental clarity.
Severe migraine lasting 10 hours Aches, chills, headache lasting 48 hours
Admitted to emergency room; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Admitted to emergency room) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HOSPITALISATION (Admitted to emergency room) (seriousness criterion hospitalization). The patient was hospitalized on 26-Mar-2021 due to HOSPITALISATION. At the time of the report, HOSPITALISATION (Admitted to emergency room) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Shots in left leg, leg swollen and red. Limping, falling a lot otherwise a good walker.
Patient began to feel unwell during the 15 minute post vaccination observation period. She reported feeling "very shaky-like when my blood sugar is going low". Was escorted to EMS area for further evaluation. The EMS evaluation determined the need for further evaluation and squad  transported patient for further hospital evaluation.
Patient was admitted to hospital for chest pain and was found to have a NSTEMI. Upon screening for hospital admission, was found to be COVID-19 positive. He was asymptomatic and was not treated for infection.
Notified by patient's mother that shortly after receiving vaccine, patient had "a short episode of seizure outside the clinic".  Mother notified health center 9 days after this occurred.  No notificiation to VAERS at that time.  In December 2007, while researching patient's file for a billing question, documentation showed that patient had received either a DTaP vaccine, or a Pediarix, at the age of 13 years.
On the next day the patient started to have fevers, headaches, couldn't stand up. In the second and third day after the vaccination the patient started to feel joint pain, tingling sensation.
Client was given his first dose of Hepatitis A and HPV on 11/05/2019. On 3/2/2020 Hepatitis A #2 and HPV #2 were given. Dose #2 of Hepatitis A was given too early and the ACIP minimum interval was not met. . Client was notified on 4/20/2020. No adverse reactions were reported from the client.
Information has been received from a physician concerning a female who was vaccinated with a single dose of ZOSTAVAX. After the patient received the dose of ZOSTAVAX, she developed a small knot on her arm. No other information was reported. This is one of several reports from the same source.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient who was also a co-worker of the reporter. On 08-NOV-2013 the patient was vaccinated with ZOSTAVAX vial of unknown dose, lot and expiry date via unknown route, in the arm for preventions of shingles. The patient had experienced not feeling well, feeling tired and a rash, oblong shaped, on back of the arm, around injections site, that was itchy, after vaccination at a pharmacy. The reported did not have any physician's information. Pharmacist gave permission for VZV packet to be faxed. VZVIP packet faxed. No treatment was given. Additional information has been requested.
This is spontaneous case, reported by other non-healthcare professional, initially received on 04-Feb-2018, concerns an unspecified age of female patient. On an unspecified date, the patient was administered with FLUVIRIN (route of administration: intramuscular, dose: unknown, anatomical site, manufacturer name, trade name, batch number and expiry date: not reported). On unspecified date, after 2 weeks of vaccination, the patient had headache and she got sick after eating. At this time of the report, the outcome was not reported. The reporter assessed this case as non-serious.
No adverse effects; a patient was administered an improperly stored ROTATEQ.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 22-AUG-2019, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (batch/lot# S010702 with expiration date 16-JAN-2021; dose, frequency, route of administration were not reported) for prophylaxis (Product storage error). The temperature and time frame were unknown (late shipment). Information of previous temperature excursion was not provided. No adverse effects were reported. Data logger was not involved.
Injection site swollen; Injection site itchy; Redness in her gums; Blisters in her gums; Painful injection site; Redness at the injection site which was circular (3in); This spontaneous case was reported by a physician and describes the occurrence of GINGIVAL ERYTHEMA (Redness in her gums), GINGIVAL BLISTER (Blisters in her gums), VACCINATION SITE PAIN (Painful injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site which was circular (3in)) and VACCINATION SITE SWELLING (Injection site swollen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Painful injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site which was circular (3in)). On 06-Jan-2021, the patient experienced GINGIVAL ERYTHEMA (Redness in her gums) and GINGIVAL BLISTER (Blisters in her gums). On 12-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site itchy). The patient was treated with BENZOCAINE (ORAJEL) at an unspecified dose and frequency and AZITHROMYCIN at a dose of 250 milligram twice a day. On 08-Jan-2021, VACCINATION SITE PAIN (Painful injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site which was circular (3in)) had resolved. At the time of the report, GINGIVAL ERYTHEMA (Redness in her gums) and GINGIVAL BLISTER (Blisters in her gums) was resolving and VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site itchy) had not resolved.        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.   Patient was treated with Orajel, unspecified antibiotic ointment and Azithromycin 250 mg (3 doses); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Slight swelling, tenderness, bright red rash Treatment is ongoing with a pain reliever of choice, hydrocortisone cream, ice, and anti-histamine(s)
2. Event Description: Facts; what, where, how it happened and what was going on:  Patient was ordered the Shingrix-Zoster vaccine by PA-C on 29Jan2020 while being seen during a routine visit. HS2 took the Zoster immunization order, provided Patient the zoster recombinant VIS and had him complete the immunization screening form. HS2 then reviewed the immunization screening form, confirmed this was going to be the patient?s first dose and asked the patient if he had any allergies and he stated he did not. The patient agreed to proceed with the immunization, HS2 then prepared the Zoster vaccine and administrered the Zoster vaccine IM into the patient?s Left deltoid. Afterwards, HS2 instructed the patient to wait a minimum of 15-20 mins. in the waiting room to ensure an adverse reaction does not occur. Patient contacted the duty HS, HS3 on 31Jan2020 regarding symptoms he believed were from the Zoster vaccine he received. The patient described how he developed 10/10 arm pain upon arriving home the day he was vaccinated. On 30Jan2020 he also, experienced arm pain and body aches that became present but then reduced. On 31Jan2020 the patient contacted HS3 stating he had hives all over his body. The patient was recommended to go to Urgent Care or ER by the duty HS, HS3 per PA instruction but the patient declined. The patient was then advised to go if symptom(s) worsened and to contact the duty HS again. The patient was instructed to take Benadryl.The patient was contacted on 2-1-2020 and all symptoms had resolved.
Labs were unremarkable except for positive COVID-19 test.  Chest  X-ray was negative for findings of COVID pneumonia, he did not have any hypoxia.  Symptom onset date is unclear with positive SARS-CoV-2 testing on 11/24/2021.  He had been in contact with known COVID-19 positive individual(s) prior to being hospitalized.
central nervous system is buzzing throughout her whole body; feels as she is having a consent orgasm in her private area; blisters surrounding her lip area; fever of 102.5; chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (central nervous system is buzzing throughout her whole body), FEMALE ORGASMIC DISORDER (feels as she is having a consent orgasm in her private area), LIP BLISTER (blisters surrounding her lip area), PYREXIA (fever of 102.5) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Trigeminal neuralgia, Drug allergy and Anesthesia. Concomitant products included LISINOPRIL from 15-Jan-2015 to an unknown date, METOPROLOL from 15-Jan-2015 to an unknown date and ALPRAZOLAM from 15-Jan-2015 to an unknown date for Blood pressure high, AMLODIPINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced LIP BLISTER (blisters surrounding her lip area), PYREXIA (fever of 102.5), CHILLS (chills) and VOMITING (vomiting). On 23-Mar-2021, the patient experienced NERVOUS SYSTEM DISORDER (central nervous system is buzzing throughout her whole body) and FEMALE ORGASMIC DISORDER (feels as she is having a consent orgasm in her private area). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. On 22-Mar-2021, LIP BLISTER (blisters surrounding her lip area), PYREXIA (fever of 102.5), CHILLS (chills) and VOMITING (vomiting) had resolved. At the time of the report, NERVOUS SYSTEM DISORDER (central nervous system is buzzing throughout her whole body) had not resolved and FEMALE ORGASMIC DISORDER (feels as she is having a consent orgasm in her private area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 (High) 102.5 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Patient demographics, medical history added. Events, concomitant medication  updated.
after recv vax pt presented with a fever 101, irritability & tiny red bumps which appeared below the knees to the feet & were from the elbow to hands. no blistering
Recurring episodes of stomach pain similar to a gas pain but located on the left side in the stomach area--it occurred upon waking the day after the shot, later in the afternoon, and most severely at 1 am that night (31 hrs. after the shot).  I took an Advil for the 1 am episode and fell back asleep.
Hives began on day 9 post Monderna vaccination. Resemble chigger bites and has several with cause itching  & discomfort.  Also had fatigue and a low grade fever which resolved within 2 days but the hives/rash has persisted for 2 weeks.
pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter.  No treatment information provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Reporter's informations were added.
Information has been received from a physician concerning a 26 year old female who on 15-AUG-2008 was vaccinated with the first dose of GARDASIL, Lot # 660389/1968U.  It was reported that a "couple of weeks later", the patient developed a lump at the injection site.  The patient was seen by a surgeon and the lump was removed.  The surgeon stated that the lump was due to GARDASIL vaccine.  Additional information has been requested.
Pt had a vasovagal episode with pt passing out few seconds. Pt received juice and crackers and felt better as well  Pt vitals stable was watched 30 minutes
8 hours after vx on 1/13/21 felt very hot in night to early morning, heart was racing thru night and checked that morning to be in 160bpm range and fever of 101.6, this resolved with ibuprofen medication OTC 2 tabs. Had chills and everything resolved by 36hrs. 2 weeks later strted feeling heart palpitations at night but heartbeat normal 85bpm. Then as of 01/28/21 4am felt palpitations stronger and heartbeat was in 160's and traveled down to 135 then 120 and would go up/down between 80's to 125 for 30 mins-1hour. Resolved at ER, ekg normal there and normal day before in clinic office.
Starting in April she wasn't feeling well and had a bladder infection. She couldn't eat got nauseous, dehydrated and we had to take her into the emergency room. She was treated for the bladder infection and given fluids intravenously. They sent her home with antibiotics. By the end of June, we had to take her back to the emergency room as she was still not eating well, the bladder infection was not clearing up and she was still nauseous. Her PCP sent her to a urologist who has sent off cultures to help get the bladder infection cleared but the pain is persistent. They have checked her for interstitial cystitis but it was very mild and not enough to be causing all of this pain. The gynecologist is checking her for possible endometriosis.
Presented to the ED with difficulty closing the R eye with notable R-sided facial droop that began on Saturday, March 27th. On physical exam, cranial nerves 2-12 intact, but notable R-sided facial droop and 7th nerve lesion in the peripheral distribution. VFF, PERRLA, 4/4 strength in the biceps/triceps/hand grip/hamstrings/quads/plantar/dorsiflexion. SILT UE/LE. No pronator drift. Normal finger-nose-finger. Normal rapid alternating movements. Reflexes 2+ in the patella bilaterally. Normal gait. BP on the presentation was 226/111, pulse was 78, respiratory rate was 20, oral temperature was 36.8 degrees Celsius, and SpO2 was 99%. Denied COVID-19 symptoms, activity change, chills, fever, congestion or dental problems, discharge or itching of the eye, chest tightness, shortness of breath, stridor, chest pain, leg swelling, abdominal distention or pain, dysuria, frequency, arthralgias, joint swelling, color change or rash, dizziness, syncope, back or neck pain, weakness, N/V, HA, vision changes, confusion, bowel changes, behavioral problems or confusion. Has been taking medications as prescribed, no prior history of CVA. PMH of DM and HTN.
This spontaneous report as received from a medical assistant refers to a 68 year old female patient. It was reported that the patient did not have any pertinent medical history and drug reactions or allergies. On 27-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # M005286), (route: intramuscular). The patient was not taking any medications concomitantly. On an unknown date in September 2016, the patient developed pain, redness, swelling and skin warm to touch. On 28-SEP-2016 (also reported as the next day), the patient said that in addition to the other symptoms, that she couldn't move her arm and that it was immobile. On 29-SEP-2016, the patient had a rash which was not there previously. On an unknown date approximately in September 2016 the patient was diagnosed as having cellulitis. It was reported that cellulitis is not related to the adverse event reported from the vaccine. The patient sought medical attention and received treatment for the events. The patient was able to move the arm then hence the outcome of the event she couldn't move her arm was considered to be recovered. The outcome of the events pain, redness, swelling, skin warm to touch and cellulitis was unknown. The causality of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
About 5 min after getting immunization the patient started to stand to tell an associate that he was having a reaction. He got light headed and started to pass out.  A pharmacy technician was able to get to him in time and guide him to the ground. He was unresponsive for 10-30 seconds. Before we could take further action he regain consciousness. After a couple minutes he wanted to go back to chair. Within a minute he lost color and passed back out. This time he came back sooner and stayed on the ground till EMSA arrived. Only BP we got was several minutes into the event 124/82 HR 54. Paramedics did not transport the pt.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  In 2006, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
Since having my second Pfizer Covid vaccination I have been experiencing heart palpitations.  I was seen by my PCP regarding this.  I wore a 24 hour halter monitor and did not have any palpitations while wearing the monitor. I have not had any further testing and have not been evaluation by a cardiologist but I do continue to have palpitations.
This spontaneous case, initially received from other non-health professional on 07-Oct-2018, concerning a 67-year-old, elderly, male patient. The patient's historical conditions included aortic aneurysm, transient ischaemic attack (TIA) and bicuspid valve. The historical procedures included pig valve replacement and Dacron aorta (on unspecified dates). The concomitant medications included COUMADIN, Metoprolol, lisinopril, levothyroxine sodium and AMBIEN. On 03-Oct-2018, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid (deltoid left arm as reported), batch number and expiry date: not reported]. On the same day at night, after vaccination, the patient felt difficult to lay on left side. On 04-Oct-2018, at noon, the patient felt discomfort in left quadrant, by 05:00 pm it much worsened and the patient took simethicone, then he felt stabbing cramp in left pectoral when breathing accompanied by the cough. The patient also experienced fatigue. At 08:30 pm, the patient went to the emergency room (ER) and electrocardiogram (EKG), blood tests and chest X-ray was performed, and then the patient was diagnosed with pleurisy. The treatment medications included IV steroids and FLEXERIL. On the next day, the patient felt much better. At the time of this report, the patient was recovering from the events pleurisy and fatigue. The reporter assessed the case as non-serious.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 27 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 30/JUN/2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210606143.