chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Morning after the vaccine and into the evening hours - Vaccine was 1/26 @ 11:30am and side effects still prominent on 1/27/2021 @ 8:30pm. Muscle pain in and around the upper arm where the vaccine was administered, still hurts and is tender to touch. Feels like someone punched the area numerous times also pain in upper shoulder and neck. Later in the morning @ around 10:30a throughout the day and into the-night, a headache that comes and goes-located in a strange area, in the lower back portion of the head where the head and neck meet.  In addition, low back pain and tired.
Persistent paresthesia and sometimes dysesthesia in limbs (upper and lower) that is one sided, but shifts from side to side.
So I was a week or two into in it and it started feeling like inflamed in my arms and my chest and my lymph node on my left side on my neck and arm pit felt big that was feeling like on the inside. I had COVID a month prior and I had lost my smell and I started to smell smoke after my vaccination. Those were the things that were happening and I had a weird sense of smell. It was distorted. This was very mentally taxing because the vaccine was stopped the next day after I took it and I was really worried and it brought on a lot of anxiety. Basically this went on for 6 to 8 months. I was on my period before the shot and ended up not having a period for several months after the vaccine.
headache,  pain in shoulders and lower back (earlier am), fatigue, sleepy all day long from about 11:00 am; next morning everything was gone.
Fever; Site injection pain,; Felt terrible; This is a spontaneous report from a non-contactable consumer. A 41-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021, the patient experienced fever, site injection pain and felt terrible for about 24-48 hours post injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, site injection pain and felt terrible was resolved on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician and refers to unspecified female patients of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with GARDASIL 9 (route, dose, lot # and frequency not reported) for prophylaxis. On unknown dates, the patient experienced cervical cancer. The outcome of the cervical cancer and the causality assessment were not provided.
The vaccine area is itchy, swollen, warm and redness. This started around 7:00 pm on 4/3/2021. Redness has increase and still warm and itchy.
Redness and swelling the size of a fist under injection site on right deltoid, warm to touch and painful with movement reported by patient and daughter. Clinic nurse advised daughter to take patient to Urgent Care on 7/11/17. Urgent care prescribed cephalexin 500mg 3 times a day x 10days. Urgent Care advised patient to see primary care MD on 7/12/17. Patient went to Primary Care MD on 7/12/17 for further evaluation. MD found patient was afebrile, swelling subsided, some erythema further down the arm possible due to gravity, cellulitis but could not rule out allergic reaction. Addition prescription for cephalexin to continue 7 days after first 10 days. Acetaminophen recommended for discomfort.
Vaccine was expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 18-Apr-2022; Expired vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 18-Apr-2022) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 18-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The vial was initially stored in refrigerator on 04-Apr-2022. The vial did not under go any temperature excursions. Treatment information was not provided.
Pt has increased cough and wheezing and called EMS due to worsening shortness of breath.  Pt does have COPD and diabetes.
Severe swelling around the eye area; Redness around the eye area; Itching around the eye area; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 09Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced severe swelling, redness, and itching around the eye area. The events resulted in emergency room/department visits or urgent care. The events resulted in doctor or other healthcare professional office/clinic visits. Therapeutic measures were taken as a result of the events included treatment with unspecified steroid. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe swelling, redness, and itching around the eye area were resolved on an unknown date in Apr2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Strep Throat  like symptoms; Can not eat and bothers him; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PHARYNGITIS (non-serious), outcome "unknown", described as "Strep Throat like symptoms"; EATING DISORDER (non-serious), outcome "unknown", described as "Can not eat and bothers him".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Began having itchy skin on 11/ 24/21. Hives began on 11/25/21. Throat tightening began on 11/29/21 Unsure of reason for hives/ itching/ throat closure. Vaccine booster administered on 11/10/21. Unsure if allergic reaction is due to vaccine booster or exposure to other environmental allergens.   Addendum on 12/17/21: Followed up with Allergist/Immunologist and ENT both decided the symptoms were an inflammatory response to the COVID vaccine booster. Will have to continue to follow up with Allergist with hives/ itching and throat swelling anticipated to dissipate within the next 4 weeks.   Hives primarily on trunk, but also some on limbs beginning on 11/24/21. Overall skin itchiness and welts continue. Issues with throat tightening beginning on 11/29/21. Hives and throat tightening has continued despite medication from doctors office. Pursuing allergy testing at this time.
Sat (4/17): severe chills for two hours starting at 11:55 pm Sun (4/18): woke and could not walk across the room without falling down due to dizziness, was nauseated, strong headache, fever of 102 all day, bedridden Mon (4/19): Fever was reduced but nausea, headache still persisted all day, continued chills. Right middle finger began to swell and turn purple Tues (4/20): Lost feeling/sensation in right middle finger, head feels off, nausea still persists, stomach pains.  Called doctor and had televisit with nurse practitioner
Myopericarditis, troponin 7.4. Pt admitted to hospital 4/30/2021-5/3/2021. Slightly reduced EF initially, started on heparin drop for c/f LV thrombus. EF normal, c/f LV thrombus resolved at time of discharge. Pt discharged on cochicine x 3 months, to f/u with cardiology.
Arm Pain - onset 6h post injection Body aches - 24h post injection Arm pit pain & swelling - 34h post injection Headache -34h post injection  Injection site swelling/lump - 38h post injection Lightheaded - 44h post injection
1315PM VS 165/98 -78. PATIENT STATES THAT HE IS FEELING LIGHT HEADED AND DIZZY 15 MINS AFTER HE RECEIVED  THE 2ND MODERNA VACCINE. LOT # 022M20A EXP 8/8/21 TO THE LEFT DELTOID @1300. MONITORED PATIENT FOR 40 MINS TOTAL. OFFERED PATIENT A BOTTLE OF WATER RECHECKED VITALS BP 144/95-69. PATIENTS STATES THAT HE IS FEELING BETTER AT 1345. NO OTHER COMPLAINTS VOICED AT DEPARTURE.
Gardasil (#1: 08/17/07) (#2 10-20-07) Dizziness (1) 09/17/07 Coldness (2) 01/17/08 Slurred speech with Headache.  04/07/2008 MR received from PCP beginning with WCC 5/2/2007 and including vax record and 2 ER records with DX: Vasovagal Syncope (9/19/2007) and Vasovagal episode, r/o seizure (1/16/2008). On 9//19/2007 pt presented to ER after near syncopal episode while running.  Pt felt dizzy and almost passed out.  Transported by EMS to ER.  PE WNL. Seen again 1/16/08 after a fall/shaking episode. Pt reported feeling cold and being unable to speak. Suttering upon arrival to ED.  PE WNL. D/C home to f/u as outpt. Seen by PCP 2/7/08 with c/o dizziness and pallor on 2/5/08. Under work-up
Information has been received from a physician concerning a 10 year old male with no pertinent medical history or drug reactions/allergies, who on 11-SEP-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot # 06044 - not valid) IM into his right "ARL". Concomitant vaccination included a second dose of HAVRIX (lot # AHAVB282BH) IM into her left arm. There was no illness at time of vaccination. On 11-SEP-2008 the patient experienced severe dermatitis over entire body with swelling of legs. The patient was treated with 4 mg of dexamethasone and 0.25 unspecified therapy for symptoms described. On 11-SEP-2008 the patient was recovered. No lab tests or diagnostic studies were performed. Further information is not expected.
25 hours post vaccine I had a hive on my lip that started swelling up and what felt like an itchy throat. I took a benedryl and then after about an hour it subsided.  I had not had anything but but usually coffee this morning prior to that reaction.
having a problem with his lower back/ sharp pain in his back; if he coughs the pain goes right to the spine in lower back; if he coughs the pain goes right to the spine in lower back; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, on 06Apr2021 at 10:45 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number not reported) in Mar2021 (3 weeks ago), as SINGLE DOSE for COVID-19 immunization. On 06Apr2021, the patient was having a problem with his lower back. An hour and 15 minutes or an hour and 20 minutes later of the second dose, on the same day of 06Apr2021, he had a sharp pain in his back and as he coughed the pain went right to the spine in lower back.  The patient wanted to know what he could do to relieve this. The patient had been taking Tylenol every 4 hours and took 8 on 06Apr2021 and it was not working on it. The patient never had back problems before. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The patient is a 65 yr/o male with a history of Afib on Xarelto and HTN presents via EMS for evaluation of AMS that was noted by wife this am. The wife states as soon as the pt woke up he was altered mainly acting confused and not speaking normally. She also states that his side of the bed was wet this am but is unsure if it was sweat or urine. LKW 2200 last night before the pt went to bed. Upon EMS arrival the pt was sitting on the floor, playing with a toilet brush, and speaking non-sense. While en route to the ED the pt reportedly had convulsive seizure like activity and was non-responsive 15-20min following the activity. He is now awake but not verbally responsive and still acting confused. No hx of seizures per wife. Hx otherwise limited as pt is non-verbal at this time
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients received improperly stored doses of GARDASIL 9 lot # L037554 with expiration date 25-DEC-2017 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
The pharmacy sent Moderna COVID-19 vaccines on 10-Jun-2022 but the patient received the vaccine on 12-Jul-2022.; Patient recived vaccine after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient recived vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (The pharmacy sent Moderna COVID-19 vaccines on 10-Jun-2022 but the patient received the vaccine on 12-Jul-2022.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient recived vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The pharmacy sent Moderna COVID-19 vaccines on 10-Jun-2022 but the patient received the vaccine on 12-Jul-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient recived vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (The pharmacy sent Moderna COVID-19 vaccines on 10-Jun-2022 but the patient received the vaccine on 12-Jul-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, the pharmacy has sent Moderna COVID-19 vaccines on 10-Jun-2022 and on the same day the vials were initially stored in refrigerator, but vaccine was given to the patient on 12-Jul-2022. The patient administered vaccine after the 30 days use date.  The vials did not undergo any temperature excursions. No adverse event reported by the patient.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-607720 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-607720:
injection site brusing; This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE BRUISING (injection site brusing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, emulsion for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult CROHN'S  DISEASe).   In 2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE BRUISING (injection site brusing). At the time of the report, INJECTION SITE BRUISING (injection site brusing) had resolved.            no treatment products included
Woke up to strong and painful diarrhea - almost passed out while sitting on the toilet. Had an odd white noise in my ears - not "ringing" but buzzing kind of sound. Lasted for about 3-5 minutes and I ended up lying on the floor for about 15 minutes before I could get back up. Felt like I may blackout. It's three hours later and I'm ok now.
Initial report received from a healthcare professional on 05 November 2013.  A 10 year old male child received dose of FLUZONE at left deltoid on 03 November 2013. On the same day, patient experienced nausea and fever, patient had sever does of FLUZONE previously. It ws reported that, evens lasted for 24 hours. List od documents held by sender: none.
Moderate headache requiring Advil for relief. Severe dizziness and mild nausea throughout the day. Dizziness is at its worst when sitting upright from lying down.
"covid arm" - raised, red, itchy rash at the site of the immunization 7 days after receiving the shot.
Severe dizziness, weakness, and loss of focus about 3 hours after injection and continuously for the last 24 hours so far.
Pain down arm that is spreading and pain in joints as well and it seems to be getting worse.    Pain Management doctor > rec NSAID and f/u with PMD
Arm where PNEUMOVAX 23 was injected was red, swollen, and painful.
Right upper arm 2 days post vaccine redness, erythema, induration and tenderness at injection site (5 cm diameter sign of erythema/ induration) treatment  - Clindamycin
Patient stated it felt as the pharmacist hurt her when administering the vaccination/ she stated it hurt as it entered arm and was extremely sore for a few days after the vaccine. The pharmacist on duty who took the information on 11/1/2022 examined her arm and dud not see any redness or bruising and explained that it is a common reaction to have soreness at the vaccination site.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, cold, shivering, flushed, tired Narrative:
first dose of the vaccine in August 2020, the second dose in May 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (Received 1st dose of shingrix in August 2020).   In May 2022, the patient received the 2nd dose of Shingrix. In May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK receipt date - 09th June 2022 Reporters comment: The reporter did not consent for follow-up. Additional Supportive information: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule.
Child immunized with Hep-A No. 1 and within 10 minutes, developed (B) petechia cheeks. No edema or respiratory s/s.
This spontaneous report as received from a pharmacist via a company representative refers to a 89 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 1 shot, lot # N022703, expiration date 27-FEB-2019 (route was not reported) for prophylaxis. On an unknown date, the patient experienced swelling after receiving PNEUMOVAX 23. The patient received an unspecified treatment. The outcome of swelling, and the causal relationship between the event and PNEUMOVAX 23 were not reported.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unknown number of patients of unknown gender and age. On an unknown date, the patients were vaccinated with an unkown number of doses of GARDASIL injection (lot/batch number, expiration date, route, dose, dose number and frequency were not reported) that were exposed to temperatures of 0 Celsius (C) for 15 minutes. No adverse effect were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Chest attention; Chest pain; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, 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 experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant) and CHEST DISCOMFORT (Chest attention). At the time of the report, CHEST PAIN (Chest pain) and CHEST DISCOMFORT (Chest attention) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was provided.  Reporter mentioned that patient had two dose of vaccine in April and May. The patient experiencing chest pain and chest attention.  Company Comment - This case concerns a 21-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of chest pain and chest discomfort. The date of onset was not reported, neither vaccination date. The events occurred after the second dose of Spikevax. The rechallenge was not applicable as the outcome of the events is unknown. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 21-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of chest pain and chest discomfort. The date of onset was not reported, neither vaccination date. The events occurred after the second dose of Spikevax. The rechallenge was not applicable as the outcome of the events is unknown. The benefit-risk relationship of Spikevax is not affected by this report.