chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Short term memory loss; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Short term memory loss) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMNESIA (Short term memory loss). At the time of the report, AMNESIA (Short term memory loss) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact
No further adverse events/no product quality complaints.; Caller is nurse reporting administered dose of expired DILUENT. Caller reports no history of prior excursions on products. No additional details provided.; Caller is nurse reporting administered dose of expired DILUENT. Caller reports no history of prior excursions on products. No additional details provided. No further adverse events/no product quality complaints.; This spontaneous report was received from a nurse concerning a patient of an unknown age and gender. The information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 15-JUN-2022, the patient started was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U002399, expiration date 22-JAN-2023) which was reconstituted with a sterile diluent (MERCK STERILE DILUENT) (lot # S026378, expiration date 15-MAY-2022) (route of administration, anatomical location were not reported) for prophylaxis (product preparation issue and expired product administered).
received vaccines after a temperature excursion with no reported adverse event; Initial information received on 02-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves at 6 patients received vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] temperature excursion with no reported adverse event.  The patient's 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 Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection expiry date not reported lot UJ840AA via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious received vaccines after a temperature excursion with no reported adverse event (poor quality product administered) on the same day following the administration of IPV (VERO).  It was reported "The batteries went bad Max/low temperature reached: Negative 4.8C Human error? No Does extended stability data cover the excursion? No If negative advice, was the product administered to a patient? Yes".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event received vaccines after a temperature excursion with no reported adverse event.  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 the guidelines. 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.
Sore arm beginning 3-4 hours after vaccination and increasing in severity, peaking about 12 hours after vaccination.  Slight fever (99.5), chills, and body aches beginning morning after vaccination and persisting all day.  Extreme fatigue beginning several hours after vaccination and persisting until morning of the second day following vaccination.  Mild fatigue and mild stomach upset / diarrhea three days after vaccination.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 29-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L037339, 0.5 ml - 10 Pk SD PFS-Luer-Lok, expiry date 09-FEB-2018; route of administration was not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to three separate temperature excursion (dates unspecified): one lasting for 64 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.1 degrees Celsius), the second one lasting for 24 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the third one lasting for 24 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.1 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Red softball sized rash on left upper arm where vaccine was administered. Onset several hours after being discharged/vaccine administered.
Got a bad cough and each day is getting worse, as far as the coughing; Not a high fever but a 99.8 fever; Oxygen between 93 and 94; Very weak; This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in arm on 26Apr2021 (Monday), 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date, 1st dose, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced a bad cough and he was very weak. The reporter stated that each day was getting worse, as far as the coughing. The patient did not have a high fever but had a 99.8 fever. It was reported that the patient put the oxygen thing on his finger, and it flicked between 93 and 94. The reporter asked whether she should bring the patient to the emergency room, or minute clinic and was advised to contact health care provider if she thought it was necessary. The outcome of the event got a bad cough and each day was getting worse, as far as the coughing was not recovered. Outcome of other events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
11/23 - urticaria left shoulder. No treatments pursued. 11/24-11/27 - moderate urticaria spreading to torso (chest/low back and forearms), triggered by hot showers, exercise, friction lasting 2-4 hours. Some relief of itching with Benadryl. 11/28-11/30 - urticaria now involving scalp and neck circumferentially, constant. No relief with Benadryl, Claritin, topicals. Video visit with urgent care provider for further instruction on management (recommended above including antihistamine and cortisone creams). 12/1 - woke at 3 am with diffuse urticaria on arms, legs, torso, neck, face. Neck and face swelling, throat swelling. No improvement with Benadryl, Claritin, or Albuterol/Fluticasone. Contacted video visit urgent care for further instruction. Presented to ED, symptoms improved for approx. 2 hours after epinephrine injection. 12/2-12/12 - migrating urticaria involving face, chest, lower back, thighs/lower legs, and forearms. 3-4 hours relief with Claritin, Pepcid, Medrol Dosepak. No further neck/throat swelling. 12/13-present - mild, transient urticaria lasting up to 30 min on face, neck, chest, lower back, forearms after warm showers, exercise, or friction. Symptoms well managed with Claritin, Benadryl.
patient received a dose of Moderna from a vial that had been punctured for more than 12 hours; patient received a dose of Moderna from a vial that had been punctured for more than 12 hours; patient received a dose of Moderna from a vial that had been punctured for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours), PRODUCT STORAGE ERROR (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) and POOR QUALITY PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 043L20A, 014M20A and 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022 at 1:30 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) and POOR QUALITY PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours), PRODUCT STORAGE ERROR (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) and POOR QUALITY PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vial was initially stored in the refrigerator on 12-May-2022. Date(s) and time(S) vial was first punctured was 17-May-2022 at 2:16PM. The vial was stored post puncture in R/T FRIDGE.. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was probably 5 MINS, It was reported that just drawing up. It was never really left out at room temperature. No treatment medications were reported.   This case was linked to MOD-2022-570995.
The reporter is the patient. An 83-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), in Apr2022 as dose 1, single (lot number unknown) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "inclusion body myocitis" (unspecified if ongoing), notes: has her in a wheel chair; "in a wheel chair" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: penicillin family" (unspecified if ongoing). Concomitant medication included: PAXIL. Past drug history included: Codeine, reaction: "allergies". The following information was reported: FATIGUE (non-serious) with onset 06Apr2022 at 11:30, outcome "not recovered", described as "incredible fatigue/ terrible fatigue"; DECREASED APPETITE (non-serious) with onset 06Apr2022 at 11:30, outcome "not recovered", described as "no appetite"; SOMNOLENCE (non-serious) with onset 06Apr2022 at 11:30, outcome "not recovered", described as "sometimes sleeping all day"; PAIN (non-serious) with onset 06Apr2022 at 11:30, outcome "recovered" (08Apr2022 at 11:30), described as "terrible body pain"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2022, outcome "recovered" (2022), described as "flu like symptoms". Therapeutic measures were not taken as a result of fatigue, somnolence, decreased appetite, pain, influenza like illness. Additional Information: The COVID-19 vaccine was administered in doctor's office/urgent care. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. For four months the patient has had incredible fatigue. Sometimes sleeping all day. No appetite. Terrible body pain in the beginning for 48 hours. When that left, she had flu like symptoms for 3 weeks. Now down to terrible fatigue. The patient wanted to know how long she will deal with this. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 68 year old female who on 13-MAR-2007 was vaccinated SC with a first dose of Zostavax. Concomitant therapy included furosemide, potassium chloride, Tylenol, vitamins (unspecified), Norvasc and simvastatin (manufacturer unknown). On 15-MAR-2007, the patient developed a facial and truncal rash resembling varicella. No diagnostic laboratory tests were performed. Additional information is not expected.
About 24 hours after first Moderna Vaccine, on 3/3/21, pt developed fatigue, body aches and vaginal ulcerations/sores. These continued to worsen and spread to a lesser extent to face, upper chest and back on 3/4/21 at which time she was seen in my clinic. Lesions appeared consistent with HSV although was difficult to explain chest/back lesions. Swabs for herpes and shingles completed. Lesions continued to worsen and pt soon developed oral sores. She was admitted to hospital on 3/6/21 and tested for mono, herpes, etc. White count was elevated but no infectious source identified. Treated with rocephin and azithromycin although GC/CT negative. Lesions resolved on their own. Fatigue and body aches have slowly improved.
This non-serious medically confirmed spontaneous report (initial receipt 08-Oct-2015) concerns a 62 year-old male patient who had tolerated AFLURIA in the past. On 08-Oct-2015, the patient received AFLURIA vaccine (batch number U59208) 0.5 mL via the intramuscular route in the left arm. The patient received excursioned AFLURIA, which was kept at 63 F sometime overnight, and reported that he seemed fine. Action taken was reported as 'maintained'. The outcome was unknown. Reporter's comments: The reporter assessed the case as non-serious, causality s unlikely in relation to AFLURIA and reported the term of 'Off-label use - not stored correctly for short period of time'.
I experienced angina lasting ~ 15-20  seconds. I've never experienced anything like this and have no cardiac illness or involvement. I was at work and just stood there until it passed. It felt like someone was squeezing my chest from front and back very hard, would categorize pain as about 7 or 8 out of 10. I hadn't eaten anything that morning and only a few sips of black coffee 4 hrs prior. Could this have been a reaction to the covid vaccine?
2 days after injection patient came to pharmacy. Had red raised red rash size of a quarter 2 inches below injection site. No itch or pain. Called Merck. They opened VZV ID program case # 1-5097362976 and faxed to me. Gave to patient. She took it to dr to check out rash.
Very fatigue, fever , back pain ( like I was beat up), & dizzy From 6 p.m. Friday 4-23-21 to Sunday 4- 25-21 8:30 a.m.
Redness, itching, lump at vaccination site. Noticed about 8 pm 2/4/21
Redness at site of vaccine. In days 1-4. Stopped. Reappeared day 7, to-date. Hot to the touch.
Flare up of colitis symptoms for 4.5 months.  Also had flare ups after 1st and 2nd doses that lasted 3 months.
A report was received from a health care professional on 24 October 2003 concerning an octogenarian female who experienced rash and hives on her face and back of her neck 2 days after receiving Fluvirin on 20 October 2003. On 22 October 2003 the vaccinee experienced rash and hives on her face and back of her neck. On 24 October 2003 the vaccinee presented to a doctor's office and was prescribed loratadine, diphenhydramine hydrochloride, and prednisone (if condition worsened). The vaccinee had no known drug allergies and received the influenza vaccine in the past with out any problems. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 27 November 2003: Follow-up information received from a health care professional indicated the the 75 year old vaccinee recovered after three weeks.
Stuffy nose; low-grade headache; low-grade stiffness/pain in neck muscles and shoulder muscles. Fever, 1 - 1.5 degrees. Duration - approx. 18 hours. It wore off while I was sleeping that night.  No residual effects the next day.
Severe throbbing headaches with feeling of burns at the top of my head, intermittent chest pain, sinus pain, blurry vision, sensitivity to sun, generalized body tightness, aches and pains, heard of hearing (hearing was fuzzy, and muffled for more than two months). All these symptoms lingers for more than two months (from 31st May to 29th August 2021 as I was on my way to the Airport early in the morning and suddenly felt a relief. I could see clearly again, could hear clearly again and the headache released and my body felt lighter
Myalgia, Fever, Diarrhea, NauseaVomiting, chills, body aches, nausea, temp 100.9, loose stools, lump at injection site, Narrative:  Other Relevant History:
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2023AMR034747   Additional Information: GSK Receipt Date: 01-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that the patient had the Shingles shot a couple of weeks ago from reporting and stated it was like a flu shot arm a little sore the next day. The case had been linked to US2023AMR034747, reported by the same reporter, for a different product. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR034747:Same reporter
On 11/11/2022 I developed a scratchy throat; headache; vomiting and diarrhea. On 11/12/2022 I started feeling upper respiratory issues; chills; fever 101.4 and fatigue.
death Narrative:  Patient received Moderna COVID #1 on 2/4/21 and #2 on 3/4/21. He was seen by his PCP via telephone visit on 3/2/21 for a routine follow up, no acute issues noted and follow up was planned for 6 months. On 3/12/21, he passed away, no notes in medical records or scanned records to indicate what happened. No autopsy results available. 8 days from date of last vaccine and date of death.
This case was reported by a physician via call center representative and described the occurrence of general body pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hiatal hernia and esophageal acid reflux. Previously administered products included SHINGRIX with an associated reaction of injection site pain and flu vaccine with an associated reaction of injection site pain (1st dose of SHINGRIX and Flu vaccine, refer case US2019GSK038438). Concurrent medical conditions included rheumatoid factor positive. On 26th February 2019, the patient received the 2nd dose of SHINGRIX. On 27th February 2019, 1 days after receiving SHINGRIX, the patient experienced general body pain, bone pain, headache, chills, pain of skin and feeling bad. On an unknown date, the outcome of the general body pain, bone pain, headache and chills were not recovered/not resolved and the outcome of the pain of skin and feeling bad were unknown. It was unknown if the reporter considered the general body pain, pain of skin and feeling bad to be related to SHINGRIX. The reporter considered the bone pain, headache and chills to be related to SHINGRIX. Additional details were reported as follows: The reporting dentist was the concerned patient. The day of reporting, the patient was experiencing pain all over her body, headache, and chills. The patient stated that every bone hurts. The patient's skin hurt and she felt like she was on her death bed. The reporter consented to follow up.
Client returned 1 1/2 hours after shot with hives on arms, back, face, chest and ears were quite red and hot to touch. Eyes very blood shot. Recommended client take Benadryl STAT then follow directions on box.
The patient presented with an episode of syncope within 2 minutes after getting the HPV vaccine. The patient remained in the chair provided with an ice pack, HR 75, and BP 85/60. At 12:43 patient was relieved of syncope, and vitals were reassessed BP 90/65, HR 75. Patient and patients mother re-educated about normal side effects of HPV vaccine. 12:45 patient walked to her car.
first dose > 35 days ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041D21A or 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) had resolved.            No concomitant medications reported. No treatment medications reported.