chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; Information has been received regarding a case in litigation from a lawyer referring to a currently 85 years old elderly patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) at a Medical Center for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider (HCP) for the following injury resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of the event was unknown.
2am woke up to violent shaking and my teeth chattering. My temp was 101.4 I got dressed put ice on my swollen arm put layers of clothes on to keep warm. I shook & shook uncontrollably.  My sister had done this same thing after her first shot so I thought it was just a reaction to the shot I was scared but 4- 6 hours my temp has come down it's sticking at 100.4 so am taking tylenol. I thought someone might want to know that not only I had this side effect but so did my sister several months ago. I have included my cell phone and home phone my husband is very ill so if I skipped around here a bit I am overworked and no staff but please feel free to text or email me. I didn't die but it was pretty uncomfortable.
can't remember nothing; 12 hours later caller was bad sick; diarrhea ever since starting about two hours after getting the vaccine; shivering; whole body was hurting; running a fever; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (can't remember nothing), ILLNESS (12 hours later caller was bad sick), DIARRHOEA (diarrhea ever since starting about two hours after getting the vaccine), CHILLS (shivering) and MYALGIA (whole body was hurting) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021 and Memory loss (memory loss was from the shot but from having Covid.). Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine in March 2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   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 ILLNESS (12 hours later caller was bad sick), DIARRHOEA (diarrhea ever since starting about two hours after getting the vaccine), CHILLS (shivering), MYALGIA (whole body was hurting) and PYREXIA (running a fever). On an unknown date, the patient experienced AMNESIA (can't remember nothing). In November 2021, ILLNESS (12 hours later caller was bad sick) had resolved. At the time of the report, AMNESIA (can't remember nothing), DIARRHOEA (diarrhea ever since starting about two hours after getting the vaccine), CHILLS (shivering), MYALGIA (whole body was hurting) and PYREXIA (running a fever) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included beta blocker, and antidepressant medication. Patient was sick for 72 hours. No treatment medication were reported.
Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves five patients (age and gender not reported) who experienced a knot at injection site, redness at injection site, itching at injection site and burning at injection site, while he/she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Exp. Date not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious a knot at injection site (vaccination site nodule), redness at injection site (vaccination site erythema), itching at injection site (vaccination site pruritus) and burning at injection site (vaccination site pain) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that, she has photos of some of these site reactions and thought it was unusual that several patients reported this; she wondered if the formula or strain was "more acidic" this year. No information about relevant test reported. Final diagnosis was burning, itching, redness and a knot at injection site. The patient was treated with HYDROCORTISONE (HYDROCORTISONE) and LORATADINE (CLARITINE) for Injection site reaction. The patient recovered for all events within a few days of injection on an unknown date. List of documents held by sender: none.
Patient received only the adjuvant and not the antigen portion; Patient received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2023, the patient received Shingrix (intramuscular). On 6th February 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 7-Feb-2023 Reporter's comment: Transferred to medical information to address her questions as what should happen next. The reporter consented to follow-up. Additional supportive information: The patient was given the adjuvant only and not the antigen portion of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This case was reported by a nurse and described the occurrence of anaphylaxis in an adult male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine. The pt reported a history of anaphylaxis with DTP in the past, as well as anaphylactic reactions to bee stings. Concomitant immunization included influenza vaccine. On an unspecified date, the pt received a dose of diphtheria and tetanus toxoids and acellular pertussis vaccine and influenza vaccine. At an unspecified time following administration of diphtheria and tetanus toxoids and acellular pertussis vaccine and influenza vaccine, the pt experienced anaphylaxis. The outcome of the event is unknown. DTPa vaccine is contraindicated in pt's with a history of anaphylaxis following administration of DTP. DTPa vaccine is also not recommended for immunizing individuals seven years of age or older. Anaphylaxis was assessed as medically serious. (OMIC)
Patient reports an adverse event related to his Pfizer COVID Vaccine.  Patient reports feeling like he forgot how to walk.  Most noticeable when he first wakes up in the morning, but also happens throughout the day.  When he stands up, he is off balance and has to actually think about the process of walking before he can move without falling.  He thought it was related to other medical conditions he has but he spoke to a nurse friend of his and she said he needed to report this as an adverse reaction.  Patient reports he has fallen several times due to this adverse reaction.  Patient has received no treatment for the adverse reaction.
Information has been received from a registered nurse concerning female patient with no pertinent medical history who on approximately 22-JUN-2007 was vaccinated with a dose of the Gardasil. There was no concomitant medication. Five minutes after receiving the vaccination, the patient became dizzy, nauseous and diaphoretic. The symptoms lasted for 10 minutes. Unspecified medical attention was sought. The patient recovered from the
Within two hours Swelling on the left arm - upper part and it was painful. The first dose of the vaccine, the pain started the second day and the injection site got swollen. But this second dose was within 2 hours of my vaccine even more and overwhelming fatigue.  - aches, chills, muscle cramps, coughing, sweating - those lasted three days; headache - ever present and felt like head was in a vice; breathing was an issue - asthma was triggered on Sunday  - I started prednisone  - informal dr consultation with a friend - on Tuesday because of the asthma and by Friday I was feeling halfway better again and by the following Sunday about 75% better. 9 days later I was back at work. It took that week back at work though to get back out of the funk and by the following weekend I was close to 90%. Pain in the shoulder lasted about two weeks - it was quite tender for that long.
pain / shoulder to elbow, left arm/Injection site shoulder pain; Pain at injection site, radiating from shoulder to elbow; arm is still slightly swollen; This case was reported by a consumer via call center representative and described the occurrence of injection site joint pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 19th March 2021, for tolerance refer case US2021182206).   On 31st July 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 31st July 2021, 5 hrs after receiving Shingrix, the patient experienced injection site joint pain, pain in elbow and swelling arm. On an unknown date, the outcome of the injection site joint pain, pain in elbow and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site joint pain, pain in elbow and swelling arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient received the 2nd dose of Shingrix in left arm and patient experienced pain which was from shoulder to elbow in left arm. The patient also had slightly swelling on arm. The reporter stated that, she was still having pain since then and also still slightly swollen. The reporter referred her to HCP (Health care professional). The reporter consented to follow up. This case was linked with US2021182206 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021182206:Same reporter
intermittent Hives/urticaria; raised red rash that would disappear after a few minutes; Itchy; felt washed out; mild sore throat; low grade fever of 100 degrees Farenheight; slight nausea; sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (intermittent Hives/urticaria), OROPHARYNGEAL PAIN (mild sore throat), PYREXIA (low grade fever of 100 degrees Farenheight), NAUSEA (slight nausea) and FATIGUE (felt washed out) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0020A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (codeine,monistat,robaxin). Concomitant products included VACCINIUM SPP. (CRANBERRY [VACCINIUM SPP.]) for UTI, COLECALCIFEROL (VIT D3) and PYRIDOXINE HYDROCHLORIDE (VIT B6) for an unknown indication.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). On 02-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (mild sore throat), PYREXIA (low grade fever of 100 degrees Farenheight) and NAUSEA (slight nausea). On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (felt washed out). On 25-Apr-2021, the patient experienced RASH ERYTHEMATOUS (raised red rash that would disappear after a few minutes) and PRURITUS (Itchy). In May 2021, the patient experienced URTICARIA (intermittent Hives/urticaria). On 05-Feb-2021, VACCINATION SITE PAIN (sore injection site arm) had resolved. On 03-Mar-2021, OROPHARYNGEAL PAIN (mild sore throat), PYREXIA (low grade fever of 100 degrees Farenheight) and NAUSEA (slight nausea) had resolved. On 04-Mar-2021, FATIGUE (felt washed out) had resolved. On 25-Apr-2021, RASH ERYTHEMATOUS (raised red rash that would disappear after a few minutes) and PRURITUS (Itchy) had resolved. At the time of the report, URTICARIA (intermittent Hives/urticaria) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100 (High) Low grade Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took Multi vitamin gummy.  No treatment medications were provided.   This case was linked to MOD-2021-238997.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up report is Non significant report include reporter email information were added. On 18-Aug-2021: Follow up report received on 18-AUG-2021 with new medical history added. new concomitant medication added. new events added.
Patient had 2nd dose of COVID-19 shot on 05/22/2021. She developed skin problem the same day after the 2nd shot. Her skin was hot to touch and feeling itch underneath around the injection site. She took Tylenol, put ice pack and drank a lot of water. After 2 to 3 days of the 2nd dose, her left arm around the injection site had a mass that was red/purple with sharp pain and itch. No fever was reported during this time. She contacted CDC and was told to see a doctor. Her doctor prescribed Bactrim DS and diagnosed for skin infection on 05/28/2021. Pharmacist found out when doing consultation on her Bactrim DS.
Extreme vertigo for 2 days, unable to get out of bed. Milder vertigo throughout the day still occurring for 4 days. Able to walk and get up but need to be careful as balance is compromised
Information has been received from a woman in a physician's office concerning a 7 yr old white male student with no medical history who on 11Aug98 was vaccinated in the left leg with the first dose of varicella virus vaccine live (lot 626956/0837H). There was no illness at the time of vaccination. The woman reported that on 19Jun04. The pt developed vesicles on his trunk, legs and arms. The pt was not seen in the office and no lab/diagnostic tests were performed. Subsequently, the pt recovered with no problems. Additional information is not expected.
This spontaneous report as received from a healthcare worker refers to a 14 years old female patient. The patient was vaccinated with the first and the second dose of GARDASIL (dose, route, lot number and expt. date were not reported) on 05-DEC-2011 and 20-SEP-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse effect has been observed or reported. Additional information has been requested.
The patient felt like there was "hair in her throat". The patient stated that she feels this way when she has issues with allergies. This occurred around 20 minutes after vaccination. 25mg of Benadryl was administered orally. The patient was feeling good and released. She was instructed to take another 25mg of Benadryl at home in 4-6 hours if she needed. She was also instructed to tell provider about this reaction before receiving her second dose of the Pfizer vaccine.
This spontaneous report as received from a physician and nurse via company representative refers to a female patient of unknown age. The reporter learned of 3 patients that have developed a rash after receiving ZOSTAVAX. The reporter stated that at least one of the 3 patients was a female and two with unspecified demographics. Patients concurrent conditions and medical history were unspecified. It was reported that in between 27-JAN-2014 and 07-FEB-2014, each patient was vaccinated with ZOSTAVAX Subcutaneous Injection, (Lot number: J008433, expiry date: 11-OCT-2014), (dose was unspecified). Approximately in 2014 (reported as sometime after 27-JAN-2014), the patient had developed a rash after receiving ZOSTAVAX. It was reported that the most severe rash reported may have also been previously reported through the vaccine adverse experience report number (VAERS) reporting system and included a rash that was 8-10 millimeters or centimeters in diameter. The other 2 rashes reported were less severe (it was unspecified out of three patients which patient had developed the most severe rash). Lot Number for the diluents of 2 out of the 3 vials were reported as J012748 for both vials. All three patients came in for follow up visits with the physician for unspecified reasons. No product quality complaint was involved. The outcome of event rash was unknown. The reporter's causality for the event with the therapy of ZOSTAVAX was not reported. This case is linked with case 1402USA004472 as same reporter link. Additional information has been requested.
Developed SOB and tachycardia after the first vaccine, but resolved over time, then after second vaccine I started to experience the SOB and the tachycardias were more frequent and stronger higher 171. Contacted my healthcare provider who recommended to see go to the ER. ct angio confirmed PE, receiving treatment, but still experiencing tachycardia,
a patient was given two injections of Menactra by mistake, in the right deltoid and in the left deltoid on the same day,No AE; Initial information received on 17-Jul-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 12 years old female patient who received two doses of 0.5 mL of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] Injection (lot number: U6596AA expiry date 24-May-2021) via an intramuscular route in the right deltoid and the other dose in the left deltoid by mistake for prophylactic vaccination on 17-Jul-2020 respectively.  Concomitant therapy received by patient was a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot and expiry date was not reported) via an unknown route in the right deltoid and also received a dose of HPV VACCINE (lot and expiry date was not reported) via an unknown route in the left deltoid for prophylactic vaccination on an unknown date respectively.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  It was an a case of an actual medication error case due to extra dose administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a healthcare professional and refers to a currently 18 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 18-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
This spontaneous report as received from a nurse refers to multiple patients of unknown demographics. The reporter stated that the patients received improperly stored ROTATEQ (lot number/expiry date unknown) on unknown dates (incorrect product storage). No adverse effects reported. The outcome was unknown. Excursion information for the vaccine: High temperature: 30 Minutes at 11.2 degree Celsius. Lowest temperature cumulative: 3 Hours and 17 Minutes at 0.4 degree Celsius. It was confirmed that the vaccines that were incorrectly stored were administered. There were no previous temperature excursions. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Small induration; Coordinator reports improperly stored vaccine products were administered to patients on unknown dates. Names of vaccines involved; VAXELIS. Temperature ABOVE 47F (58.1F); This spontaneous safety report, with reference number 02365662 (Interaction # 02365635) was received by the partner on 04-APR-2023 and forwarded to agency on 05-APR-2023, from a health professional.    This case was considered non-valid due to no patient identifiers (Temperature excursion only).  Due to the nature of the event, the causality between the event "coordinator reports improperly stored vaccine products were administered to patients on unknown dates. Names of vaccines involved; VAXELIS. Temperature ABOVE 47F" and Vaxelis was not applicable.   Further information is expected.  FOLLOW-UP INFORMATION was received on 18-APR-2023, from a HCP. The case is maintained as non-serious and non-valid.   Due to the nature of the event, the causality between the event "coordinator reports improperly stored vaccine products were administered to patients on unknown dates. Names of vaccines involved; VAXELIS. Temperature ABOVE 47F" and Vaxelis remained not applicable.  FOLLOW-UP INFORMATION was received on 09-MAY-2023 from an HCP and additional information was received by the partner on 10-MAY2023 and forwarded to agency on 11-May-2023 from an HCP.  This case is now considered valid due to patient identifiers being provided.   The reporter did not provide an assessment of the causal relationship between VAXELIS and the event of "Small induration."   Due to the nature of the event, the causality between the event "Coordinator reports improperly stored vaccine products were administered to patients on unknown dates. Names of vaccines involved; VAXELIS. Temperature ABOVE 47F" and Vaxelis remained not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received on 25-MAY-2023, from a HCP. The case is maintained as non-serious and upgraded to valid (patient identifiers were provided on the follow-up received on 09-MAY-2023, from the HCP).   The reporter did not provide an assessment of the causal relationship between VAXELIS and the event of "Small induration."   Due to the nature of the event, the causality between the event "Coordinator reports improperly stored vaccine products were administered to patients on unknown dates. Names of vaccines involved; VAXELIS. Temperature ABOVE 47F" and Vaxelis remained not applicable.  No further information is expected given that the reporter replied to all our queries.