chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chronic Fatigue, Brain Fog, SOB on exertion, headaches, backaches, body aches, chronic cough, constipation/ diarrhea, appetite varies, large leg blotches when standing, difficulty sleeping. Had a  Bone Marrow Transplant in Nov 2020 and was in remission.Was taking Ninlaro as a maintenance therapy to prevent recurrance of Multiple Myeloma before and after taking Moderna Bivalance dose in November of 2022. Symptoms started with fever, headaches, nausea/vomiting which subsided within 3 days but I felt very tired and unable to do my Activities of Daily living, wanted to stay in bed. Symptoms persisted for months and I  returned to Oncologist to run standard cancer and other tests,  to rule out recurrance of cancer.
Adverse Events: Fever, Back Pain, Nausea, Dizziness (for about 2 days)   Treatment: Rest and Tylenol PM  Outcome: Feel Better
feeling cold; shaking; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), TREMOR (shaking), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M2DA) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (feeling cold), TREMOR (shaking), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, FEELING COLD (feeling cold), TREMOR (shaking), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Five days post first injection I woke up at 2am with a severe headache which lasted approximately 3 hours. This happened for 4 nights the same way, then stopped for several days then reoccurred  for several days then stopped.  The night of the second injection (2/3/2021) I woke up with severe head pain which lasted approximately 5 hours. This happened again the next two nights. The third night was not a severe as the first two.
Moderna vaccine administered was  beyond the manufacturer recommended use time of 30 days at the refrigerated temperature.
Sick; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has missed the window for the second dose of covid-19 vaccine due to being sick. Caller is asking when it would be safe for the patient to get it. Outcome of the event was unknown. Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.
There were NO adverse events other than that Moderna vaccine was given to this person when they were 15 years old.  We did NOT know this because the person gave us an incorrect birthdate which would have made them 18years old.  We only found this out when our registry alerted us that this person has  a different date of birth making them 15.
A report has been receiving from a Study Investigator concerning a 44 year old, female subject, Height: 5.2 inches; Weight: 133.0 Pounds, enrolled in study MA-VA-MEDI3250-1115; A Postmarketing Safety Study of Q/LAV in Subjects 2 Through 49 years of age. FLUMIST (intranasal) started on 01-Oct-2013. The patient experienced PREGNANCY which started on 28-Sep-2013. The patient recovered from the event of PREGNANCY on 06-Jun-2014. The outcome of the pregnancy was reported to be a Healthy baby both on 08-Jun-2014. The report was considered to be non-serious. The investigator considered that there was no causal relationship between PREGNANCY and FLUMIST.
Patient collapsed directly after vaccine. Unsure if fainted or seizing.  Pharmacist on duty called 911 to respond. Patient came back to and was evaluated by EMS, not taken to hospital and went home with father.
Headache, cough, burning lungs, aching all over, tired, burning eyes. Taking TYLENOL, DAYQUIL, NYQUIL and Cough Suppressant.
scratchy throat; heavy congestion or cold; lot of phlegm production; sleepy; productive cough; soreness on side; fever; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of THROAT IRRITATION (scratchy throat), NASOPHARYNGITIS (heavy congestion or cold), PRODUCTIVE COUGH (lot of phlegm production), SOMNOLENCE (sleepy) and PRODUCTIVE COUGH (productive cough) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinusitis.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced THROAT IRRITATION (scratchy throat), NASOPHARYNGITIS (heavy congestion or cold), PRODUCTIVE COUGH (lot of phlegm production), SOMNOLENCE (sleepy), PRODUCTIVE COUGH (productive cough), MYALGIA (soreness on side), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, THROAT IRRITATION (scratchy throat), NASOPHARYNGITIS (heavy congestion or cold), PRODUCTIVE COUGH (lot of phlegm production), SOMNOLENCE (sleepy), PRODUCTIVE COUGH (productive cough), MYALGIA (soreness on side), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        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.   treatment information were not provided
17SEP91 515PM mom contacted nurse & stated pt was "very hot", had hives over the entire body; No difficulty w/respirations; Advised to go to ER -hlth ctr was closed; mom states seen @ ER doing fine 18SEP91;
The patient fainted about 5 minutes after administration of the vaccine. He mentioned before the vaccine that this also happened before his last vaccine (M-M-R) and said it was related to anxiety associated with getting vaccines/needlephobia. I asked him if he felt comfortable getting the vaccine today and he said to go ahead and give him the shot. At the time of injection he started breathing a little heavier but looked relatively well. After about 5 minutes in our waiting area, he started to look pale and fainted. The pharmacy manager and technician went to check on him. He was not responsive for about 30 minutes before he came to.
Pain at injection site that migrated to back and underside of arm. Pain increased when lifting arm up. 3" red area around injection site. Extreme tiredness night of vaccination. Severe Body aches day after injection that would have prevented going to work had TYLENOL not eased the body aches. Ice helps with injection site.
Three days 1st dose of  Pfizer vaccine I developed moderate headache and malaise. Six days later  I developed a maculo-vesicular itchy, non painful rash on my R forehead.  I visited an Immediate Care office (started valacyclovir) and I was seen the same day by a retina specialist ophthalmologist (started prednisone 60 mg/day). I'm doing much better.
Patient had the 4th dose of Moderna on 6/28/22 and then Patient started experiencing parosmia (unusal / strange smell) the day after on 6/29/22.  He states that he could smell other things normally, but there would be a strong chemical like smell lingering and it wouldnt go away.  Only until about 7/2/22 that strong chemical smell started fading away.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-MAY-2016, the patient was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot # J006587, expiry date: 04-DEC-2015). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient reported headache, increasing heart rate and generally not feeling well @ 45 minutes post injection. She reported she took OTC Benadryl  which she carries with her, and called her PCP, Dr. who provided a prescription for Prednisone which she filled at the retail pharmacy at this hospital.
SQ site on L arm with approx 2 1/2 in by 1 1/4 in red, puffy slightly firm to touch raised area.  Stings.  Pt reports started burning/stinging a few hrs after inj.  Pt instructed to start BENADRYL q 8 hours x24-48 hours.  Topical hydrocortisone, cool compresses x15 min q 2-4 hours.
A report has been received from a Physician concerning a, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 04-DEC-2014. It was reported that the pregnant patient inadvertently given FLUMIST on 04-DEC-2014. The outcome of the event of inadvertently gave FLUMIST to a pregnant patient and inadvertently gave FLUMIST to pregnant patient is unknown. The report was considered to be non-serious.
The vial was initially stored in the refrigerator: 09Jun2022. The vial was first punctured: 9:30 AM on 14Jul2022.; Doses administered more than 12 hours after post puncture. patient had received an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered more than 12 hours after post puncture. patient had received an expired dose) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator: 09Jun2022. The vial was first punctured: 9:30 AM on 14Jul2022.) in an 85-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049L21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Jan-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Feb-2021, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jul-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered more than 12 hours after post puncture. patient had received an expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator: 09Jun2022. The vial was first punctured: 9:30 AM on 14Jul2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered more than 12 hours after post puncture. patient had received an expired dose) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator: 09Jun2022. The vial was first punctured: 9:30 AM on 14Jul2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. The vial was initially stored in the refrigerator: 09Jun2022. The vial was first punctured: 9:30 AM on 14Jul2022. The vaccine administration of a total of 3 doses were all given on 14JUL2022 sometime after 9:30. The vial was stored in refrigerator post puncture. The vial did not undergo any temperature excursions. The  vial of Moderna COVID-19 vaccine was punctured and a dose was withdrawn and given to a patient. The punctured vial was then placed in a bag in the refrigerator. A few days later the bag was removed from the refrigerator and a dose was given to a second patient more than 12 hours after the vial had been punctured No treatment medication was provided by reporter.
inadvertently administered the bexsero vaccine following a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adolescent female patient who received Men B NVS (Bexsero) (batch number 5YP3L, expiry date 31-JAN-2026) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero (right deltoid). On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: inadvertently administered the bexsero vaccine following a temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JUN-2023 The reporter consented to follow up. The reporter reported that patient was inadvertently administered the Bexsero vaccine following a temperature excursion, which led to incorrect storage of drug. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023088652:Same reporter
severe vomiting; diarrhea; very very sick; Tired; pain in hip/joint pain; This is a spontaneous report from a contactable consumer (patient). A 83-year-old female received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EN6199), via an unspecified route of administration on Wednesday, 03Mar2021 at 16:00 (at the age of 83-year-old), as dose 1, single in left arm for COVID-19 immunization Pharmacy/drug store. The patient's medical history included asthma which was not ongoing, and hip surgery 5-6 years prior to the first dose. Patient had allergy, can't take aspirin and Codeine by injection. She can only take Tylenol. Concomitant medication unspecified medicine at 06:00 AM every morning, which she has taken it for years, and has taken nothing new. On 03Mar2021, after first dose of vaccine, the patient experienced pain in hip/joint pain. Patient thought it was from her Hip surgery on the left side. But she read from papers that the vaccine causes joint pain and used heat pad. On 04Mar2021, post first dose, the patient was "very very sick" and tired. At 13:00 noon, the patient experienced severe vomiting and diarrhea. Patient has not eaten anything and was only been drinking water. The clinical outcome of the event hip/joint pain was resolving and clinical outcome of the event diarrhea was resolved on an unspecified date in Mar2021. The clinical outcome of all other events was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
The next morning, I woke up and felt unwell, but nothing out of the ordinary. I was extremely tired and went to bed in the afternoon and slept until the next day.  The next day I woke up fine. 3-4 days later I developed a feeling of swelling in axilla that was a pressure/discomfort, and it was unusual and uncomfortable enough for me to take Tylenol, which helped. It persisted and you could see the axilla was swollen. After a week I went to my PCP and they saw there was swelling but less than to the effect of being overly concerned and they advised me to take Tylenol. It waxed and waned and by early December I noticed a discomfort inside of upper arm.
This spontaneous report was received from a physician and pharmacist refers to a 69-year-old female patient. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain and a completed form was received on 10-SEP-2012. The patient's medical history included chickenpox and shingles. On 28-AUG-2012 (also reported as 31-AUG-2012) the patient was vaccinated with, 0.65 millilitre (ml) ZOSTAVAX lot number 0421AE (validation request sent), expiration date 21-MAR-2013 subcutaneously. Concomitant medications included VERAMYST, Methyltestosterone, cyanocobalamin (reported as B12) and ZANTAC. The pharmacist reported that on an unknown date in 2012 the patient developed painful shingles after receiving ZOSTAVAX. She developed rash under her arms, breasts, chest and back. Itching and blisters were associated with Herpes Zoster (event). Treatment was not given for the event. Medical attention was sought for the event, the patient called the pharmacist. On 07-SEP-2012 a nasal swab specimen was collected and was sent to the laboratory on 10-SEP-2012 for Varicella Zoster Virus (VZV) Strain Identification Polymerase Chain Reaction (PCR). Results were pending at the time of this report. The event did not resolve at the time of this report. Additional information has been requested.
Information was received from a lawyer regarding a case in litigation concerning a patient of unknown gender and age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 08-NOV-2013, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles, or herpes zoster. On or about 21-NOV-2013, the patient was treated by a Family Nurse Practitioner for the onset of a painful and pruritic rash, which was diagnosed as shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine and/or because of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  Further, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
I got the shot on the top of my right arm but on my right elbow area was really painful it was like a broken arm because I couldn't use it I couldn't do anything with it but it got better after 4 days.   Seen doctor on  12/24/2020.
27JUN91 pt awakened screaming, temp 104 given APAP; By 8AM t104 & eyes rolled back; started shaking, turned pale, limp, stiffened ahd convuls; Taken to ER advised had rxn to vaccine & to give APAP q4h until temp is down;
Patient has redness and faint ecchymosis type appearance and mild gross swelling to affected areas. Raised, itchy, patchy/hive-like appearance to her left deltoid and left upper thigh.
Significant skin reaction at site of injection. Started 24 to 36 hours after receiving injection. 3 inch circumference site with raised hardened red skin. Appears to be self limiting and resolving when reported to pharmacy on 08/15/2009.
No additional AE; a patient received improperly stored vaccine; This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided   On 15-FEB-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U020239, expiration date 28-JUN-2023 for prophylaxis (strength, and route of administration were not provided). The vaccine underwent a temperature excursion of 6.4 degree Fahrenheit (F) for a period of 30 minutes (Product storage error). The vaccine did not undergo a previous temperature excursion. The patient did not experience any adverse event.
Employee received her COVID (Pfizer) booster. She became flushed - complained of feeling hot all over - diaphoretic, dizzy, feet became tingly and had a headache. Employee was taken to Urgent Care for evaluation.
8 days post vaccine dose I had an itch on my arm @ the vaccine site and upon scratching it noticed it was red and a little swollen. Did not require any treatment as it was super itchy.  Redness and swelling disappeared w/in 36 hours of onset.
Fever, light-headedness, chest pain, arm soreness, headaches; started about 15 hours after 3rd dose of Pfizer, the symptoms have been lasting about 8 hrs now
Administration of Kinrix instead of Infanrix; Kinrix administered to a 20-month-old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 20-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 11th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: The medical assistant called to ask for information about the administration of Kinrix instead of Infanrix. The reporter asked for safety information and recommendations about patient vaccination. The reporter consented to follow-up. Additional supportive information: The patient received Kinrix instead of Infanrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Initial unsolicited report received from a Nurse on 16-Jan-2018. This case involves a female patient (age not reported) who was removing cap from DTaP component (batch number: C5230AA) vial of PENTACEL (batch number: C5420AA and expiry date was not reported) and the top of the vial broke off at the neck. The patient's medical history and concomitant medications were not reported. On an unknown date, during vaccination, the patient was sustained a small laceration to her right thumb when top of vial broke off. It was also a case of product container issue. Relevant lab investigation was not reported. Laceration was covered with Band-Aid as corrective treatment. The patient was recovered from the event (lasted for couple days). List of documents held by sender: none.
On day 8th after my vaccine I developed redness, induration,  itching,  measuring about 3 inches at the site of the vaccine and weakness of the arm  with swollen lymph nodes in axila