chrisvoncsefalvay/vaers-outcomes huggingface dataset:
white cell count is up; might have an infection I am fighting; This is a spontaneous report from a contactable consumer (reporting himself) or other non hcp. A 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number : ER8734, Expiry date: unknown), via an unspecified route of administration in left arm on 15Mar2021 (age at the time of vaccination was 63-year-old) as dose single for COVID-19 immunization. The patient's medical history included blood cholesterol increased and hypertension (take medication so its fine for both), blood triglycerides, Simvastatin for Triglyceride, benign prostatic hyperplasia  and Tamsulosin for Prostate. The patient's concomitant medications included lisinopril taken for hypertension, simvastatin taken for blood triglycerides and tamsulosin  taken for benign prostatic hyperplasia. On an unspecified date, the patient experienced white cell count was up and might have an infection that the patient fighting. The high was 10.8. The caller enquired stated my wife and got second dose of Pfizer today. Is there a difference in the first dose and the second dose. Has this been seen after getting the vaccine. Transferring agent stated, the patient had received both doses of Pfizer COVID-19 vaccine and  the patient had some blood work done last week and the patient's white blood count was up to 11.1 on 30Mar2021. On paraphrasing concern, consumer stated, correct. When probed for the date of both vaccination: The patient got the second dose than go back to, the patient was assuming, that the patient got the first dose on 15Mar2021. When probed for the date of laboratory investigation, consumer stated, the patient thought it was last Tuesday so that would have been 30Mar2021. When probed for the name of facility, consumer stated, actually it was a headquarter. The patient thought first and second shot at the same site. When probed for the expiration date, consumer stated, its just says 2nd dose COVID-19 date which was yesterday, Manufacture Pfizer LOT number that the patient just gave, the patient can peel the sticker off that the patient's wife put on. When probed if the consumer was HCP, Consumer stated, that the patient was retired. When probed for the Unit of lab result : consumer stated, no the patient did not have that information. When probed for the any other further Lab test: consumer stated, no but they want me to back in 3 months and do it again, Its not high, There high was 10.8 and the patient was 11.1 which was very minimal but that was the high 10.8 want the patient to down about 9 or something the patient thought 9 point something. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Injection site has bruise; swelling in upper arm; redness appeared at base of swelling about 4 inches below injection; injection site tender; injection site is swollen; This is a spontaneous report from a contactable consumer (patient). A 49-years-old non-pregnant female patient received second dose BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot/batch no: EN6208) as a single dose on an unspecified route of administrated in right arm on 12Mar2021 at 12:30 PM for COVID-19 vaccination. Medical history included diabetes and Polycystic ovary syndrome (PCOS). The patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot/batch no: EN6201) as a single dose on an unspecified route of administrated in right arm on 19Feb2021 at 12:15 PM for COVID-19 vaccination. Concomitant medication includes atenolol (MANUFACTURER UNKNOWN), metformin  (MANUFACTURER UNKNOWN), spironolactone l(MANUFACTURER UNKNOWN), humalog (MANUFACTURER UNKNOWN) and lant(MANUFACTURER UNKNOWN). Patient was allergic to penicilin, vicodin, moraphine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 13Mar2021 patient experienced Injection site has bruise, swelling in upper arm, redness appeared at base of swelling about 4 inches below injection site, injection site was swollen and tender. The patient reported that Injection site has bruise. Day two noticed swelling in upper arm.  Day three redness appeared at base of swelling about 4 inches below injection site. Day 4 redness has more than doubled and tenderness has increased at the area of redness. The entire upper arm below injection site was swollen and tender. The events resulted in Doctor or other healthcare professional office/clinic visit, however it was unknown if treatment received for the adverse event. The clinical outcomes for Injection site has bruise, swelling in upper arm, redness appeared at base of swelling about 4 inches below injection site, injection site is swollen and tender was Not recovered. No follow-up attempts are needed. No further information is expected.
sickness; body aches; chills; bad headache; nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness), PAIN (body aches), CHILLS (chills), HEADACHE (bad headache) and NAUSEA (nausea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included albuterol Inhaler and ALPRAZOLAM for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (bad headache), NAUSEA (nausea) and FATIGUE (Fatigue). On 12-Mar-2021, the patient experienced ILLNESS (sickness), PAIN (body aches) and CHILLS (chills). On 14-Mar-2021, PAIN (body aches) and CHILLS (chills) had resolved. At the time of the report, ILLNESS (sickness) outcome was unknown and HEADACHE (bad headache), NAUSEA (nausea) and FATIGUE (Fatigue) had not resolved.        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 medication include Ibuprofen, aspirin, zofran, ginger ale beverage   This case was linked to US-MODERNATX, INC.-MOD-2021-079168 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079168:2nd dose
tender arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (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: TENDERNESS (non-serious), outcome "unknown", described as "tender arms". It was unknown if therapeutic measures were taken as a result of tenderness.  Additional information: Patient took the 1st dose on 25Mar2021 and was experiencing tender arms. Patient wants to know if it was possible to experience adverse events over a week after taking the vaccine. Attempted to transfer to MI but call got disconnected. AE form created.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approx. 11 am on 4/2- begin to unbearable chills, headache, lost appetite, sleeping, lost of energy .  4/4, starting having diaherra, lasting until 4/6.    On 4/8,  begin to start feeling better.
fatigue began about 8 pm day one- dragged myself to the bed and difficult to pick head up until 11 pm same day dull headache began about 10 pm day one - and became quite intense the next morning - Sudafed reduced headache somewhat, very slight remaining headache at 1:30 day 2 - completely gone by 2:30 day 2. Sore arm for a few days
patient received an expired Dapacel vaccine, No AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to 2020SA058732 and 2020SA057112 (same reporter)  This case involves a 19 months old male patient who was vaccinated with a third dose of 0.5 ml of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5367AA and expiry date: 30-Jan-2020) via intramuscular route in the left arm on 31-Jan-2020 for prophylactic vaccination (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) for Immunisation.  It was actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 NASAL CONGESTION (Congestion). At the time of the report, NASAL CONGESTION (Congestion) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
1/9/21 Fever 100.4, fatigue, and mild body aches lasting 1 day. 1/17/21 Began developing red areas on left arm, which eventually blistered and extended from upper arm to thumb tip. Also associated with pain in the arm and hand. Physician diagnosed  shingles on 1/20/21. Treated with valacyclovir.
Patient had a rash and fever a few days later. He was diagnosed with Diabetes Type 1 on 7/11/05, just 5 months after his sister was diagnosed with Diabetes Type 1. She had the same vaccination at the same time. 8/27/08 Labs received from hospital unable to locate rest of chart.
accidentally got the Shingrix vaccine instead of varicella; accidentally got the Shingrix vaccine / I'm 24 years old.; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of wrong vaccine administered in a 24-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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.  Additional details were provided as follows: The patient self-reported this case. The age at the vaccination was not reported.  However could be 23 years or 24 years old at the time of vaccination. The patient accidentally got the Shingrix vaccine instead of varicella, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The patient was contacting the company to see what were the side effects and what had to be done.
Day of shot (PNEUMOVAX 23 and FLUZONE HD) 8-28-14 redness, soreness and pain. Progressively got red and swollen from elbow to shoulder of inoculated arm. Pt saw urgent care provider and was given antibiotic which redness and pain decreased significantly.
PT RECEIVED THE MODERNA VACCINE FOR COVID19 ON MONDAY FEBRUARY 22. SHE STATED THAT AT NIGHT SHE STARTED WITH NAUSEA AND HEADACHES. TUESDAY MORNING AROUND 3:00AM SHE STARTED WITH RASH THAT STARTED AT FEET AND STARTED GOING UPWARDS THE ENTIRE BODY BY WEDNESDAY.
headache; nausea; mild flu-like symptoms; shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknonw date 3 months before day of reporting).   On 9th March 2020 10:00, the patient received the 2nd dose of Shingrix (intramuscular). On 9th March 2020, less than a day after receiving Shingrix, the patient experienced headache, nausea, influenza-like symptoms and shivering. On an unknown date, the outcome of the headache, nausea, influenza-like symptoms and shivering were recovering/resolving.   It was unknown if the reporter considered the headache, nausea, influenza-like symptoms and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at 10 AM the day before reporting and experienced headache, nausea, influenza-like symptoms and shivering in the middle of the night.   The patient never had a response like this from a vaccine before.  Till the time of reporting she was still experiencing some mild flu-like symptoms. The reporter consented to follow up.
BUD date 04/07/2022 administered on 4/13/2022. Pfizer could not provide stability data beyond 04/09/2022 and recommended revaccination
napping more often; Head fog; Decrease ability to imitate a task/Decrease ability to stay on task; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Head fog), MOBILITY DECREASED (Decrease ability to imitate a task/Decrease ability to stay on task), FATIGUE (Fatigue) and SOMNOLENCE (napping more often) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Ritalin                                                        ADHD, Methylphenidate                                                ADHD, Escitalopram                                                   Bipolar Depression, Lexapro                                                        Bipolar depression  and Lemotrigine                                                    Bipolar depression for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced FEELING ABNORMAL (Head fog), MOBILITY DECREASED (Decrease ability to imitate a task/Decrease ability to stay on task) and FATIGUE (Fatigue). On an unknown date, the patient experienced SOMNOLENCE (napping more often). At the time of the report, FEELING ABNORMAL (Head fog), MOBILITY DECREASED (Decrease ability to imitate a task/Decrease ability to stay on task), FATIGUE (Fatigue) and SOMNOLENCE (napping more often) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was not provided.
Nausea in less than 10 minutes after first shot was administered.  Shortness of breath followed around 20 minutes or so after receiving the first dose.
Patient said he started having lung pain 3 days after getting his flu shot. He had pain in left lung, it got worse, then he started having pain in right lung also. He also had pain in his left arm. He described the pain as an ache. He did consult a dr and got a chest xray which was clear. Lung pain is gone now, 11/16/2019, but his arm is hurting again today.
DAPTACEL given to 7 YO. Age of patient at time of event: 7 years.
Pt became very ill within 2 hours of her vaccine. She had nausea, was weak, feverish, cold, clammy, headache and chills. She also has been bothered by a headache and a poor appetite and she did have slight discomfort in the left upper quadrant of her abdomen. She was bedridden for 10 days. The doctors denied that the shot had anything to do with her illness, so I foolishly subjected my child to the rest of the shots. We watched her continue to get sick. The doctor suggested ibuprofen or Tylenol and diet as tolerated, but he suspected it is more of a nonspecific viral illness.  We have been treating her for over a year now for CFS. We travel to another state for treatment. She is still recovering. The 60 day follow-up states that the pt is much more functional; however, she periodically complains of pain, having chiils. There will be more info a year from now as to her residual symptoms. Doc 215768 states the following:"patient suffers from chronic fatique, joint pain, arthritis symptoms + depression. She is under many doctors care. All thanks to this shot. She is failing in school, misses more days than is present. This vaccine has ruined  patient's life. She is a fraction of the young person she was before receiving this shot. It is travisty that this vaccine is promoted onto infants now. Why are we supporting this action? Where is the risk benefit ratio to children? If you only knew what our life has been like due to this shot, you'd work to make change, but hopefully, you'll never experience what we have gone through.
This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 25th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and product supply issue. On an unknown date, the outcome of the injection site pain and product supply issue were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient asked that could GlaxoSmithKline (GSK) provide any guidance on how the get the second dose of SHINGRIX. The patient received first shot on 25th October 2018 and was told by there pharmacy the second shot would be put aside for the patient for an appointment scheduled for 4th january 2019 (well within the 2 to 6 month window). However, the patient just found out last minute the pharmacy gave other dose away and at the time of reporting, the patient left hanging as to and asked how to get the second dose within the necessary timeframe. And, said the only option that pharmacy offer them was for to call the patient every week to have them look for inventory within a 50 to100 miles radius. The patient asked that was there anything GSK can do to help someone who has had the initial dose already so that the did not have to go through both shots again, Especially since the patient had the typical soreness from the first shot.
This non-serious initial spontaneous case was received from Other Health Professional on 13-Sep-2017, concerns a 58-year-old adult female patient. The patient's current condition included: hypertension and hypothyroid, concomitant medication included: ROBAXIN and loratadine for unknown indication. On 13-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, lot number: 178501 (as reported), expiry date: April-2018, route of administration, anatomical location: not reported). It was reported that the FLUAD was administered to the patient under age 65 and no adverse effects were noted. The patient did not receive any treatment associated with event. The outcome of the event was not reported. The reporter assessed the event as non-serious.
Patient stated she felt dizzy once standing after first dose of vaccine.  I had her stay in the same chair she received the vaccine in for her post-vaccination wait time.  She immediately felt dizzy and described her vision as pixilated.  She also stated she could not hear out of her right ear.  She wanted to stay seated with her eyes closed.  Everything resolved within 13 minutes with no treatment.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient who had allergy to "sulfa antibiotics". The patient had no pertinent medical history. On 23-FEB-2016 the patient was vaccinated with ZOSTAVAX (lot # reported as L034727, expiration date 09-DEC-2016, subcutaneous, 0.65 ml). Concomitant therapies included LIPITOR, lisinopril (manufacturer unknown) (reported as "lisinipril"), FLONASE and trazodone (manufacturer unknown). On 24-FEB-2016, the patient began to experience "pain, warmth, redness, and swelling the size of a golf ball" at the injection site. On the same day, the patient called the pharmacy for medical attention and the pharmacist instructed the patient to "ice the area" as treatment. No lab diagnostics studies were performed. On 25-FEB-2016 (the reporting day), the pharmacy spoke with the patient and the symptoms had not improved. Additional information has been requested.
Sicker than a dog; Laid in bed for 36 hours; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Laid in bed for 36 hours), ILLNESS (Sicker than a dog) and MYALGIA (Arm was sore) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concomitant products included MELATONIN and ALLOPURINOL for an unknown indication.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION COMPLICATION (Laid in bed for 36 hours). In April 2021, the patient experienced MYALGIA (Arm was sore). On an unknown date, the patient experienced ILLNESS (Sicker than a dog). In April 2021, VACCINATION COMPLICATION (Laid in bed for 36 hours), ILLNESS (Sicker than a dog) and MYALGIA (Arm was sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.
extremely sore arm; Acute body ache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extremely sore arm), PAIN (Acute body ache), NAUSEA (Nausea) and PYREXIA (Fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Nasal Swab test) on 20-Jun-2020. Concurrent medical conditions included Sinus disorder (Severe sinus) since 07-Dec-2020, Fever since 07-Dec-2020, COPD, Thyroid disorder NOS (Thyroid), Gastrointestinal disorder NOS (Esophagus), Gastrointestinal disorder NOS (Stomach), Sinus congestion (Congested everyday), Contrast media allergy (Contrast dye) and Drug allergy (Prednisone). Concomitant products included LEVOTHYROXINE and OMEPRAZOLE for an unknown indication.   On 10-Feb-2021 at 9:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (extremely sore arm), PAIN (Acute body ache), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (extremely sore arm), PAIN (Acute body ache), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2020, SARS-CoV-2 test: positive Nasal Swab.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-033001 (Patient Link).