chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingrix knocked her out; This case was reported by a consumer via other manufacturer and described the occurrence of loss of consciousness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 7th November 2020).   On 20th February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced loss of consciousness (serious criteria GSK medically significant). On an unknown date, the outcome of the loss of consciousness was unknown.   It was unknown if the reporter considered the loss of consciousness to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient's boyfriend. The age at vaccination was not reported. The patient got the Shingrix shot a month prior to having the Pfizer COVID vaccine and the Shingrix affected patient in terms of side effects and Shingrix knocked her out. On an unknown date patient received Pfizer COVID19 Vaccine, lot no: EN6207, expiry date: unknown. The reporter consented to follow up. This case has been linked with US2021AMR069448, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR069448:same reporter - reporter´s case
Initial and follow up information has been received from a physician and a registered nurse in the physicians office concerning a pt (age and gender not reported) who on an unspecified date was vaccinated with  HPV rL1 6 11 16 18 VLP vaccine yeast. The physician reported that the pt experienced soreness, pain at injection site after receiving HPV. The registered nurse reported that she had spoken with the physician who felt that the soreness was not really a reaction or a problem. It was reported that the physician did not feel it was an adverse effect, just soreness at the injection site. At the time of this report, the outcome of the event was unk. Additional information has been requested.
On October 17 & 18 had 5 episodes where my knees went weak & felt like jelly causing me to fall to the ground. Only lasted a few seconds & there was no numbness at all. Just felt like jelly and gave out. Called local hospital (I was out of town) and talked to Doc on call. Told me if it got worse to come to ED otherwise report the employer as possible reaction to H1N1 vaccine.
This spontaneous report as received from a Registered Nurse regarding a 4 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 06-AUG-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. Sender's Comments: US-009507513-1807USA011693; US-009507513-1902USA001123; US-009507513-1902USA001140; US-009507513-1902USA001126; US-009507513-1902USA001137; US-009507513-1902USA001119; US-009507513-1902USA001124; US-009507513-1902USA001133; US-009507513-1902USA001132; US-009507513-1902USA001135; US-009507513-1902USA001136; US-009507513-1902USA001125; US-009507513-1902USA001129; US-009507513-1902USA001134; US-009507513-1902USA001139; US-009507513-1902USA001138; US-009507513-1902USA001120; US-009507513-1902USA001127; US-009507513-1902USA001131; US-009507513-1902USA001122; US-009507513-1902USA001121; US-009507513-1902USA001142; US-009507513-1902USA001130; US-009507513-1902USA001141.
POST VACCINE FELT DIZZY AND FAINT, BROUGHT TO HOSPITAL, TRENDELENBERG ON STRETCHER, VSS THROUGHOUT OBSERVATION. S/S RELIEVED AFTER ABOUT 20 MINS. ESCORTED TO EXIT WITH NO ISSUES AT 1602. 1547 INITIAL BP 154/79 HR 74 SATS 97% RA 1559 BP 144/80 HR 71 SATS 97% RA 1601 BP 146/80 HR 73 SATS 98% RA
Sick as a dog 14 Hours after the first monovalent booster; Body aches 14 Hours after the first monovalent booster; Fatigue 14 Hours after the first monovalent booster; Fever 101.4F 14 Hours after the first monovalent booster; Chills 14 Hours after the first monovalent booster; Nausea 14 Hours after the first monovalent booster; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick as a dog 14 Hours after the first monovalent booster), MYALGIA (Body aches 14 Hours after the first monovalent booster), FATIGUE (Fatigue 14 Hours after the first monovalent booster), PYREXIA (Fever 101.4F 14 Hours after the first monovalent booster) and CHILLS (Chills 14 Hours after the first monovalent booster) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced ILLNESS (Sick as a dog 14 Hours after the first monovalent booster), MYALGIA (Body aches 14 Hours after the first monovalent booster), FATIGUE (Fatigue 14 Hours after the first monovalent booster), PYREXIA (Fever 101.4F 14 Hours after the first monovalent booster), CHILLS (Chills 14 Hours after the first monovalent booster) and NAUSEA (Nausea 14 Hours after the first monovalent booster). On 14-Nov-2021, ILLNESS (Sick as a dog 14 Hours after the first monovalent booster), MYALGIA (Body aches 14 Hours after the first monovalent booster), FATIGUE (Fatigue 14 Hours after the first monovalent booster), PYREXIA (Fever 101.4F 14 Hours after the first monovalent booster), CHILLS (Chills 14 Hours after the first monovalent booster) and NAUSEA (Nausea 14 Hours after the first monovalent booster) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, Body temperature: 101.4 F.         No concomitant medications were reported. After shot, patient had events for 30 hours. No treatment information was provided.   This case was linked to MOD-2022-669096, MOD-2022-669098 (Patient Link).
Redness and swelling over both arms where she recieved vaccines. Treated with ice pack and Benadryl by weight.
3 days p/receiving vax, pt presented to ER as a probable SIDS;
Patient received vaccine - waited 15 minutes seated and then had fainted when exiting store. Elevated patients legs and rested on floor for 15 minutes and patient then exited store upon recovery
pt recvd vax;went limp; twitching motion;purple color;to er; T of 103; tx w/ cefzil, albuterol for resolving bronchitis;
the administration of an expired dose of Shingrix.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 5592T, expiry date 12-OCT-2023) for prophylaxis.   On 03-NOV-2023, the patient received the 1st dose of Shingrix. On 03-NOV-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: the administration of an expired dose of Shingrix.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-NOV-2023 A LVN contacted GSK via phone to inquiring about Shingrix and what information was available about the administration of an expired dose of Shingrix.  They gave partial information about vaccine, patient and event. The vaccine administration facility was the same as primary reporter. The patient received vaccine which was expired on 12th October 2023, which led to expired vaccine used. The reporter consented to follow up.
Pt recv vax on 10/16/97; post vax pt exp dizziness, abdominal pain, diarrhea, joint aches, fatigue; 10/24 pt test showed elevated liver function.  Pt imp 11/3/97
Pt has redness, swelling and elevated skin temperature at injection site of PNEUMOVAX - (R) deltoid - redness goes from lateral anterior upper arm shoulder to elbow.
Redness, swelling on left arm post flu vaccine. Localized reaction. Started 24 hours post injection. Worse following day. Itching. Patient given prednisolone to treat and symptoms resolved.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pruritus (itching on left arm), vaccination site erythema (red rash spreading 4-5 inches down the arm) and vaccination site rash (red rash spreading 4-5 inches down the arm) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included many types of unspecified allergies. On Apr 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 16, 2021, patient experienced vaccination site pruritus (itching on left arm), vaccination site erythema (red rash spreading 4-5 inches down the arm) and vaccination site rash (red rash spreading 4-5 inches down the arm). At the time of the report, vaccination site pruritus (itching on left arm), vaccination site erythema (red rash spreading 4-5 inches down the arm) and vaccination site rash (red rash spreading 4-5 inches down the arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications reported. Treatment included, a disinfectant, organic apple cider vinegar and hydrogen peroxide.
Narrative:  62 year old obese male admitted 8/19/2021 for the treatment of atrial fibrillation w/ RVR and HF exacerbation. He was found to have COVID symptoms 8/26/2021, including a fever and cough. COVID test returned positive 8/26/2021 despite being fully vaccinated with Moderna COVID vaccine on 1/8/2021 and 2/5/2021. PMH: HTN, CAD, PTSD, severe depression, ETOH dependence, hiatal hernia, barret's esophagus, GIST tumor (on Gleevec,) h/o GI bleed, gout, AF with prior MAZE 2018 & AF ablation 10/2017 and numerous prior cardioversions, mitraclip 2018, CAD s/p 3vCABG 2018, HF (EF 59%, but previously as low as 39%). Typically monoclonal antibodies are reserved for outpatients, but patient is hospitalized for a reason not related to COVID-19 and meets criteria for infusion at this time. Patient is eligible to receive an COVID-19 monoclonal antibody infusion to prevent progression of condition. Patient is considered at high risk for progression to severe disease based on risk factors identified above. Patient was offered a monoclonal antibody infusion and accepted. The Regeneron product was given 8/26/201. Given increasing O2 requirement and fever and elevated d-Dimer, patient also began remdesivir on 8/28/2021. Anticoagulation with enoxaparin 1 mg/kg q12h was also begun. He was discharged in stable condition on 9/11/2021.
Red, Swelling, Painful: over injection site, 2.5 x 5 cm.
Patient had an asthma attack about 10 minutes after the dose was given while waiting in the post-vaccination area.
Hot/cold flushes, body aches, temperature 101.5F and nausea.
fever and chills developed, then later on hand tremors, leg numbness. numbness on arms on inside from elbow to wrist
Coughing and felt like throat was closing.  Around 1 am woke wheezing and felt pressure on her chest, difficulty breathing.
Information has been received from a registered nurse concerning her husband who in December 2008, was vaccinated with the first dose of PNEUMOVAX 23 (lot number not reported) with no reactions. On 09-JUL-2009 the patient received his second dose of PNEUMOVAX 23 (lot number not reported) (unspecified if this was the right or left arm). Concomitant therapy included cyanocobalamin. In July 2009, the patient experienced swelling from the elbow to the shoulder in the arm where the vaccine was given. The registered nurse stated her husband was not able to move his arm and he also had a fever of 101F. The nurse stated her husband was given another dose, because the physician did not have the correct medical records and did not know that he was already given a dose. The registered nurse reported on 09-JUL-2009 night she took her husband to the Emergency room but he was not admitted. The emergency room reported he had a "hematoma" and he was also treated with antibiotics. Subsequently, the patient recovered from swelling from the elbow to the shoulder, not able to move his arm, fever of 101 degrees F and hematoma. Follow up information has been received from a medical assistant concerning a 57 year old male patient with a history of coronary artery disease (CAD) in December 2008, allergy to LIPITOR (myalgia) and iodine solution (Hives), who in December 2008 was vaccinated with the first dose of PMEUMOVAX 23. On 09-JUL-2009 at 8:30 AM, the patient received a second dose of PNEUMOVAX 23 (Lot: 661527/0122Y) intramuscularly in the left deltoid (The physician's office did not know of the previous vaccination). On 09-JUL-2009, the patient experienced swelling, fever and hematoma which required an emergency room visit. Additional information is not expected.
Patient states that arm hurt from the shot and has continued to hurt for 3 weeks.  She sought physician treatment and was told she had bursitis from the shot being administered too high on her arm. Patient is currently being treated with naproxen and tramadol for pain and still cannot lay on her left arm due to pain.
At this state there have not been any adverse outcomes. We administered the vaccine incorrectly. The patient received her 3rd Pfizer vaccine without the diluent and received 0.5ml rather than the 0.3mls.
Very Dizzy the morning after shot; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: 6199) via an unspecified route of administration in the right arm on 09Mar2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunization. The patient's medical history included breast cancer. The patient did not have any allergies to medications, food, or other products. 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 therapy included radiation treatment for breast cancer. On 10Mar2021 at 06:00, the patient was very dizzy the morning after shot. The patient was in radiation treatment for breast cancer. The patient stated that she never felt dizzy from this treatment. The patient did not receive treatment for very dizzy. The clinical outcome of very dizzy was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Missed 2nd dose on recommended interval.; Soreness of arm after first dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on recommended interval.) and VACCINATION SITE PAIN (Soreness of arm after first dose) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on recommended interval.) and VACCINATION SITE PAIN (Soreness of arm after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on recommended interval.) had resolved and VACCINATION SITE PAIN (Soreness of arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: No new information was provided.
Hives on face and neck developed 3-4 hours (roughly, possibly earlier) after 2nd dose of vaccine I called the nurse hotline for my insurance and also spoke with a nurse from the Health Dept.  who both recommended Benadryl and monitoring of symptoms
Patient received second dose of Moderna vaccine on 1.22.2021. Patient had no side effects with the first vaccine. Patient received 2nd vaccine 25 days later. Patient experienced flu-like symptoms for the first 24 hours. On 1.23, the patient began to notice a "chicken pox" type rash develop on his arms and spread across the upper part of his body. Patient was seen by employee health on 1.26 and diagnosed "exanthem, most likely vaccine related." Patient was instructed to take benadryl and return to clinic with worsening symptoms.
Had the shots, get a mild form of shingles every year; Shingles mild case every year; Shooting pain; Entire body is itchy; 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 (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got mild form of shingles every year around February).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shots, get a mild form of shingles every year) (serious criteria GSK medically significant), shingles (Verbatim: Shingles mild case every year), shooting pain (Verbatim: Shooting pain) and pruritus (Verbatim: Entire body is itchy). The outcome of the vaccination failure was unknown and the outcome of the shingles, shooting pain and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, shooting pain and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, shooting pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient got a mild form of shingles every year around February first comes like clockwork. The patient had the shots did not prevent it.  It was horrible he/she got shooting pain his/her entire body was itchy. 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.
Ever since receiving the shot I get dizzy spells sometimes 6 times a day to where I have to throw up.; Ever since receiving the shot I get dizzy spells sometimes 6 times a day to where I have to throw up.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 14:30 (Lot number: 301308A) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "bipolar adhd" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: known_allergies Yes. Concomitant medication(s) included: CELEXA; LITHIUM; VESI Q. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 310308A, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 09Sep2021, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), VOMITING (non-serious) all with onset 02Oct2021 17:00, outcome "not recovered" and all described as "Ever since receiving the shot I get dizzy spells sometimes 6 times a day to where I have to throw up.". Therapeutic measures were not taken as a result of dizziness, vomiting.  Additional information: The patient have any known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store.  Follow-Up (15Nov2021): Follow-up attempts are completed. No further information is expected. No follow-up attempts are possible. No further information is expected.
A rash began on his arms and traveled to the entire body. No hives or blisters. No other symptoms.
This spontaneous report as received from a nurse via other company letter Pfizer, refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. Approximately in 2012 (reported as four years ago), the patient had a reaction, respiratory issues. The outcome of respiratory issues was unknown. The causality of the event was not reported. Additional information has been requested.
The nurse inadvertently administered 1ml instead of 0.5ml; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (The nurse inadvertently administered 1ml instead of 0.5ml) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (The nurse inadvertently administered 1ml instead of 0.5ml). On 27-Apr-2021, ACCIDENTAL OVERDOSE (The nurse inadvertently administered 1ml instead of 0.5ml) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2021-092554, MOD-2021-092190 (Patient Link).
Full body rash and wheezing/minor difficulty breathing. Similar to my experience with sulfa drugs. I only experience asthma related wheezing during allergy season and this was January. Started ~30 min after vaccination. Full recovery was ~3 days.
This spontaneous report as received from a registered nurse refers to a 6 month old patient. On 04-SEP-2013, 6 month old patient was accidentally vaccinated with VAQTA, 0.5 ml, intramuscular instead of RECOMBIVAX. No adverse effect reported. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Medium
Dizziness; Afraid to drive; Experienced some issues with the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FEAR (Afraid to drive) and VACCINATION COMPLICATION (Experienced some issues with the vaccine) 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 DIZZINESS (Dizziness), FEAR (Afraid to drive) and VACCINATION COMPLICATION (Experienced some issues with the vaccine). At the time of the report, DIZZINESS (Dizziness), FEAR (Afraid to drive) and VACCINATION COMPLICATION (Experienced some issues with the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.