chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT BECAME VERY LIGHTHEADED MOMENTS AFTER GETTING VACCINATED. SHE HAD A HARD FALL OUT OF A CHAIR IN THE WAITING AREA. SHE WAS OFFERED COLD WATER AND COLD COMPRESS  FOR NECK AND FORHEAD IN WHICH SHE DENIED THE COLD COMPRESS. SHE ALSO DENIED LAYING FLAT ON BACK ON A BENCH IN THE WAITING AREA AS WELL. I ALSO CHECKED BLOOD PRESSURE AND PULSE VALUES WHICH WERE LOW. SHE SAT IN THE WAITING AREA FOR APPROX 45 MINS. A STORE MANAGER WAS CALLED PER PROTOCOL AS WELL
Huge painful lump in left armpit. Maybe 2 inches in diameter on the morning of the 4th day. Easily visible in a mirror. Not 100% certain of the letters in the lot number, but numbers are correct.
15 minutes after administration of vaccines, pt c/o feeling dizzy, nausea and right eye pain. She was placed on supine position for 10 minutes and responded well. Patient was sent home after 30 minutes of observation. Followed up with patient by phone later in the day.
Could barely walk; Back and legs aching; Back and legs hurt really bad; Feels like she pulled a muscle; Pain returns with exertion; little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little tired), GAIT INABILITY (Could barely walk), BACK PAIN (Back and legs aching), PAIN IN EXTREMITY (Back and legs hurt really bad) and FEELING ABNORMAL (Feels like she pulled a muscle) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LAMOTRIGINE, MIRTAZAPINE (MIRTAZEPINE TEVA), ZOLPIDEM, SERTRALINE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), ONDANSETRON and ACETYLSALICYLIC ACID, CARISOPRODOL (SOMA CMPD) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced FATIGUE (little tired). On 01-May-2021, the patient experienced GAIT INABILITY (Could barely walk), BACK PAIN (Back and legs aching), PAIN IN EXTREMITY (Back and legs hurt really bad), FEELING ABNORMAL (Feels like she pulled a muscle) and PAIN (Pain returns with exertion). At the time of the report, FATIGUE (little tired), GAIT INABILITY (Could barely walk), BACK PAIN (Back and legs aching), PAIN IN EXTREMITY (Back and legs hurt really bad), FEELING ABNORMAL (Feels like she pulled a muscle) and PAIN (Pain returns with exertion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-106692 (Patient Link).
FEVER, SWEATS, CHILLS, FATIGUE, HEADACHE, REDUCED APPETITE, COUGH, AND BODY ACHES
Case number PHEH2014US000645 is an initial spontaneous report received from a pharmacist on 06 Jan 2014 with the follow-up received on 21 Feb 2014. This report refers to a 17-year-old female patient who was inadvertently vaccinated with one dose of FLUCELVAX (batch number: 010031A) into left deltoid at 0.5 ml, intramuscularly on 02 Jan 2014. No adverse event was reported following this administration error. Follow-up received from a pharmacist on 21 Feb 2014: Site of vaccination and batch number updated. Following an internal review on 18 Aug 2014 of the data received on 21 Feb 2014, it was identified that the labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with VAQTA lot # N008823 for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA.; Sender's Comments: US-009507513-1708USA011923: US-009507513-1708USA013475: US-009507513-1708USA013473:
Fever, body aches, diarrhea x 1 wk following vax;
Headache, myalgias - present about 12 hours after vaccine was given, resolved after one day without problems. R sided supra clavicular lymph node - tender, enlarged, started 3 days after vaccine, still present
WIFE CALLED AT 5 P.M. 11/30 STATING HE HAS A LARGE EGG SIZE RED AREA WHERE VACCINE WAS GIVEN. ALSO COMPLAINS OF WARM FEELING AROUND NECK AND CHEST. SHE GAVE BENADRYL AND APPLIED ICE. AT 7 P.M. WIFE CALLED TO SAY FEELING BETTER AND 12/1 PUBLIC HEALTH NURSE CALLED WIFE STATED TEMPATURE IS GOOD AND FEELING FINE, DID NOT SEEK MEDICAL ATTENTION.
Patient complained of strong arm pain after administration of Shingrix vaccine. Patient came back to pharmacy 9/20/2022 complaining that arm was still hurting from the shot.  Patient said taking tylenol helped but did not get rid of the pain
Body aches; Chills; Headache; Diarrhea; Nausea; Loss of appetite; Fatigue; Abdominal pain.
Patient received vaccine. He preceded to wait area. Within minutes he slid out of his chair and hit his head on the floor. He appeared to be unconscious and possibly seizing. He came to. We asked him his name, date, and where he was. He was able to answer all questions. Said his head hurt. Medics arrived and took over
first dose of Shingrix on 18-FEB-2023 and second dose on 8-Mar-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 9372K, expiry date 05-AUG-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 08-MAR-2023, the patient received the 2nd dose of Shingrix. On 08-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first dose of Shingrix on 18-FEB-2023 and second dose on 8-Mar-2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The patient received 1st dose of Shingrix on 18th February 2023. The reporter declined permission to collect her contact details but did give permission to follow up via email which was listed in adverse event form. The reporter consented to follow up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Chills; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage #1. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) outcome was unknown.            This case was linked to MOD-2021-017264 (Patient Link).
Pt recvd 3 doses of Engerix-B & was determined to be a non-responder by repeat tests; pt recvd booster or 1st dose of second series 12AUG91 & still was determined to be a non-responder 6NOV91; recvd booster dose on 7NOV91;
Pt states she has bruising redness, firmness bump at the injection site  it as dime size and has been going down little by little  10/4/2022, no respiratory issues fever n/v or chills .
Patient received the Covid-19 vaccine and within 1 minute  started to slump over with weakness and immobility. He had dizziness and was lightheaded. He complained of blurred vision. His mother was by his side. Pharmacist called 911 and paramedics arrived in about 5 minutes. Patient started feeling better but was pale and his vision was bad. Mom said he was dehydrated and at the lake all weekend. Paramedics took him out on stretcher to emergency room.
On April 10th, 12 days after vaccination, at approximately 6pm, patient started having explosive diarrhea and uncontrollable gas. This subsided by the morning of the 11th. On the 11th, patient experienced extreme fatigue, sensitivity to light and sound, and nausea. Monday the 12th, at 3am, patient was woken up to severe migraines (patient has no prior history of migraines or headaches). She described her pain as radiating-- like a bright, light house was being shined directly into her eyes in her sleep. This was combined with a pounding, pulsating feeling in the frontal lobe. Patient reported hypertension, nausea, and tingles in the tips of her fingers. These symptoms persisted throughout the day. On Tuesday the 13th, the same symptoms persisted. Patient heard the new CDC warnings about the Janssen vaccine, and concerned for her well-being, called her physician. Her physician directed her to go to the emergency room as soon as possible.
Weakness, pain, numbness in left leg. Spread up leg into groin; diagnosed by neurologist as Guillian Barre. Treatment: IVIG 400mg/kg/day for 4 days, then plasmaphoresis for 6 treatments, Neurontin, Tegretol, Narcotic pain control. The discharge summary states Staphylococcus sepsis.
The knuckle on the middle finger of my right hand has become swollen and painful. It has been this way since shortly after receiving my second dose of the vaccine.
Cough, after first vaccine/ Cough, after first vaccine was reported as worsened; Pain in back of neck, and over to the right shoulder, after first vaccine; Pain in back of neck, and over to the right shoulder, after first vaccine; Sensation in the shoulder blade, extending to middle of the back, feels like a sunburn sensation, after first vaccine; Congestion in sinuses, after first vaccine; Diarrhea, after first vaccine; Bad chills, after first vaccine; Low grade fever, 100.2, after first vaccine; Headache, after first vaccine; Eyes sore with pressure, after first vaccine; Eyes sore with pressure, after first vaccine; Soreness in left arm, after first vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0179, Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 16Jul2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history not reported. No prior vaccinations, no relevant tests, no other products, no prior vaccinations (within 4 weeks) and other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There were no concomitant medications. On 17Jul2021 06:00, the patient experienced bad chills, after first vaccine. On 16Jul2021 22:00, the patient experienced soreness in left arm, after first vaccine. On 17Jul2021 07:00, the patient experienced pain in back of neck and over to the right shoulder, sensation in the shoulder blade, extending to middle of the back, feels like a sunburn sensation, congestion in sinuses and diarrhea after first vaccine. On 17Jul2021 18:00, the patient experienced cough and in Jul2021, after first vaccine was reported as worsened. On 17Jul2021, the patient experienced headache and eyes sore with pressure after first vaccine. On 17Jul2021 06:00, the patient experienced low grade fever, 100.2, after first vaccine. The patient underwent lab tests and procedures which included body temperature: 100.2 on 17Jul2021 and weight: maybe 190 or 195 lbs on. Therapeutic measures were taken as a result of bad chills, soreness in left arm, pain in back of neck, and over to the right shoulder, sensation in the shoulder blade, extending to middle of the back, feels like a sunburn sensation, congestion in sinuses, diarrhea, after first vaccine, cough, cough, after first vaccine was reported as worsened, headache, eyes sore with pressure and low grade fever, 100.2. The outcome of bad chills, diarrhea and headache was recovering. The patient has taken generic Tylenol for some of her symptoms. On 20Jul2021, the outcome of the events soreness in left arm and low grade fever, 100.2 was recovered. The outcome of bad chills, diarrhea and headache was recovering. The outcome of pain in back of neck and over to the right shoulder, sensation in the shoulder blade, extending to middle of the back, feels like a sunburn sensation, congestion in sinuses, cough, after first vaccine was reported as worsened and eyes sore with pressure was not recovered.
The pt experienced a fever of 102, and was given Tylenol. Fever decreased to 101 and then increased back to 104.
4 day h/o lethargy, irritability, fever, cough, thick rhinorrhea & diarrhea 1wk p/vax;
This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included back surgery (in 2003). On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized pruritus and injection site erythema. On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the generalized pruritus and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 74 or 75 year old. The patient received SHINGRIX on left arm. The patient experienced itching. The itching was associated all throughout the body. The itching occurred on different parts of the body such as arms, legs, shoulders, and face. At the time of reporting, the patient experienced itching from her right arm and down to elbow and the wrist. She felt like spiders crawling on it. She visited her doctor and had been prescribed anti-itch medication. The patient also experienced wide pink area measuring 6 inches long and 2 to 3 inches wide at the injection site that lasted for about 2 weeks. The reporter did not consent to follow-up and no further details were provided. The patient was referred her to healthcare professional. For tolerance to 2nd dose, refer case US2019GSK030779.
Momentary numbness of hand/left arm/left cheek. Dizziness. Both passed after 1-2 minutes. Took pt's BP=164/104. Pt stopped atenolol 2 wks earlier AMA. Asked pt to sit some more to retake BP. 5 min later he said he was ok. Referred to MD for BP check and advised to restart B.P. med.
mom reports that w/in 4hr of vax pt had sudden onset of fever to 105 & a rash on the rt arm;sx lasted <24hr & they did not contact office until pt was in w/a sibling about 2mo later 6/21/99;
Shingles; This case was reported by a pharmacist via other manufacturer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient experienced shingles after vaccination.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            No concomitant products were reported.  On an unknown date, the patient experienced fatigued. Moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On unknown date, patient received covid-19 booster vaccine manufactured by moderna.  Causality for humira (adalimumab) The reporter's causality for the event(s) of fatigued with humira(adalimumab) was no reasonable possibility.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
PATIENT RECIEVED INMMUNIZATION AT GROUP FLU INJ SESSION. 50MINS AFER RECEIVING INJECTION AFTER BACK IN BARRACKS FELT SHORT OF BREATH, FAINT, AND HAD COUGH. PT DID NOT SEEK MEDICAL ATTENTION UNTIL 4 DAYS LATER WITH COMPLAINTS OF COUGH. GIVEN ALBUTEROL TX IN CLINIC AND INHALER. 2 DAYS AFTER TX PT STATED THAT THE FELT BETTER. NO HX OF ASTHMA.
PATIENT REPORTS COUGHING UP BLOOD CLOTS  FOR THE PAST 3 DAYS AND SENT PICTURE OF 1 THAT WAS COUGHED UP
Fever; hives on b/l legs; non-stop screaming; congestion, runny nose; left eye watery.
Narrative: Myalgia, Fever, CoughWheeze, Nausea
In the afternoon I started getting a burning and stinging pain in my shoulder blade area. This was the same side where I got the vaccine. I had a Telehealth with my doctor, who prescribed some medication that was not helpful. Valacyclovir was the medication, but it made the sensation into an itch rather than burn. The sensation diminished on its own after about 4 weeks. Did not take full course of medication. Sensation is gone as of time of report.
sick with COVID-19 after getting fully vaccinated with the Pfizer COVID-19 vaccine; sick with COVID-19 after getting fully vaccinated with the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. The consumer reported same events for 2 patients. This is the 1st of 2 reports. A 64-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single; dose 1 via an unspecified route of administration on an unspecified date as dose 1, single  for covid-19 immunization. The patient's medical history and concomitant medications were not reported. According to the reporter the patient was sick with covid-19 after getting fully vaccinated with the Pfizer covid-19 vaccine on an unspecified date. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101129857 Same reporter/ drug/ event for different patients
Urticaria/itchy hives; flu-like symptoms; itchy rash from my neck, arms, chest & back to my upper thighs; itchy rash from my neck, arms, chest & back to my upper thighs; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9264), via an unspecified route of administration on 22Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 01Feb2021 as dose 1, single for COVID-19 immunization. The patient experienced itchy rash from my neck, arms, chest & back to my upper thighs on an unspecified date in Feb2021, flu-like symptoms on 23Feb2021 and urticaria/itchy hives on 24Feb2021. Verbatim: Patient had the second dose of the vaccine on Monday 22nd. Today I am covered in an itchy rash from my neck, arms, chest and back to my upper thighs. The vaccine hotline told me to go to Urgent care as I do not have a PCP. Patient went to hospital and was told to take Benadryl and given a Rx for prednisone. However the visit was (amount) out of pocket. Patient was extremely upset. With the meds today I paid (amount) I have all of my receipts and documentation and am seeking a reimbursement from Pfizer for this amount. On 22Feb2021 patient received the second dose of the Pfizer COVID-19 vaccine. The following day patient experienced flu-like symptoms which patient had anticipated could be as possible a side effect and was not concerned. However, on the following day (24Feb2021) patient body became covered in itchy hives from my neck, entire back, torso, arms, and upper thighs. Patient was very worried called the vaccine hotline though (facility name) (where patient received the doses) and they advised me to go to urgent care. The hotline representative called the urgent care facility to let them know I was on my way. At the urgent care facility I paid (amount) just to be seen. I was then prescribed prednisone and given a prescription to fill at the local (store name) and was told to take Benadryl and Pepcid which I also purchased at (store name) when picking up the prednisone prescription. The hives subsided over the course of two days with medication. The patient underwent lab tests and procedures which included blood pressure was 125/88, temperature was 98.1 degree fahrenheit, pulse was 76, oxygen saturation was 98 %, respiration was 16, weight was 148 lbs. The patient received Prednisone (DELTASONE) 20 mg tablet, take 2 tablets by mouth daily for 5 days; Benadryl and Pepcid as a treatment medication for the events. Outcome of the events itchy rash from my neck, arms, chest and back to my upper thighs, flu-like symptoms was unknown; urticaria/itchy hives was recovered on an unspecified date in 2021.
03/22/2021, severe right back pain. 03/23/2021 visited Urgent Care (severe right back pain).  03/26/2021 visited  Emergency Care (severe lower right side pain).
Info has been received from a relative of a 13 year old female who was vaccinated with a 4th dose of Hep-B. Subsequently, the pt developed a little bit of swelling around the injection site. The pt had not sought medical attention for her experience. Additional info has been requested.
My daughter had UTI symptoms starting in March of 2016. Had third dose of GARDASIL in June of 2016. Doctor kept treating her with antibiotics even though no bacteria showed up in urine. She was better until July of 2016 when she thought she had another UTI and was given more antibiotics. Was ok until Dec of  2016 when the symptoms came roaring back. More antibiotics to no avail and GP told her to see a urologist. Urologist paid basically no attention to her but gave her more antibiotics even though no bacteria and also URIBEL. The pain and frequency was so horrendous that she went to her GP for something for her anxiety. The mixture of the URIBEL and PROZAC sent her into serotonin syndrome causing seizures and possible death. She was hospitalized for 6 days and had an EF fraction of 30. As soon as I got her out of hospital I took her to Clinic for heart and bladder. Her heart function is still low and she was diagnosed with interstitial cystitis. The doctor could not believe that a 19 year old would have this condition.