chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2020 as dose 1, single (Lot number: EL0142), in left arm, on 21Jan2021 as dose 2, single (Lot number: EL9261), in left arm, on 21Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 56 years, in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Restless leg syndrome" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included (Other medication in 2weeks): HORIZANT oral; ALENDRONATE oral; PRILOSEC [OMEPRAZOLE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (24Jul2022) Positive. Tested positive Antigen tests for Covid 6 days after finishing full dose, symptoms returned 5 days after finishing dose and after 2 negative antigen tests. Therapeutic measures were taken as a result of vaccination failure, covid-19 and treatment included Paxlovid from 13Jul2022 to 18Jul2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure and COVID-19 cannot be ruled out.
The vaccine made her feel like she was on cloud; When she went to lay down it felt like an after birth like a big blob; Little blisters on her arm; This is a spontaneous report received from a Pfizer sponsored program via a contactable consumer (patient, self-reported).  A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), 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 reported that on an unspecified date she had the vaccine made her feel like she was on cloud, when she went to lay down it felt like an after birth like a big blob, and little blisters on her arm. The patient wanted to know if there was a third dose- Relayed FAQ. The vaccine made her feel like she was on cloud 9 like she could go for a run When she went to lay down it felt like an after birth like a big blob Little blisters on her arm-Cold. Her doctor thought she probably caught a whiff of something that affected her breathing but it was in no way covid again. Those two shots have been awesome and have helped her COPD and her immune system. When you have COPD you were always catching colds and infections and stuff. When you have COPD and you leave the house, you weren't sure you were coming home. If I could, I'd get a booster every day. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
2 days -ecchymosis all over body. Idiopathic thrombocytopenia purpura.
Blood Iron Increased; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 22-MAR-2021, Laboratory data included: Blood iron (NR: not provided) High. On an unspecified date, the subject experienced blood iron increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood iron increased was not reported. This report was non-serious.
Itching in her throat; Myalgia; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in her throat), MYALGIA (Myalgia) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PRURITUS (Itching in her throat), MYALGIA (Myalgia) and FATIGUE (Tiredness). On 26-Apr-2021, PRURITUS (Itching in her throat), MYALGIA (Myalgia) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.
Information has been received from a nurse at a physician's office concerning a female patient with a history of hepatitis C who on 11-Dec-2006 was vaccinated with Gardasil vaccine (yeast). On 12-Dec-2006 the patient reported that she had developed swelling of her hands. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information is not expected.
Pain; Localised erythema, arm was red; Fatigue; Sickness; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sickness), PAIN (Pain), ERYTHEMA (Localised erythema, arm was red) and FATIGUE (Fatigue) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) Citrate free. In April 2022, the patient experienced ILLNESS (Sickness). On an unknown date, the patient experienced PAIN (Pain), ERYTHEMA (Localised erythema, arm was red) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Sickness), PAIN (Pain) and FATIGUE (Fatigue) had not resolved and ERYTHEMA (Localised erythema, arm was red) had resolved.            No concomitant medications were reported. No treatment information was provided.   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.
Woke up with a nickel size red spot where the vaccine was administered; Was a rash up my arm/6 days after shingles; Rash warm to the touch/ 6 days after shingles; I had a sore arm for a couple days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th April 2022, the patient received Shingles vaccine. On 10th April 2022, 6 days after receiving Shingles vaccine, the patient experienced injection site erythema, injection site rash and injection site warmth. In April 2022, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the injection site erythema, injection site rash and injection site warmth were unknown.   It was unknown if the reporter considered the pain in arm, injection site erythema, injection site rash and injection site warmth to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced a sore arm for a couple days and then on Sunday (10th April 2022) woke up with a nickel size red spot where the vaccine was administered. Later that night it was a rash up his/her arm which was warm to the touch. The patient asked what could he/she do. Additional supportive information: The follow-up would not possible, as no contact details were available. Note: The event injection site rash and injection site warmth coded as it seems as per description that, the rash and warmth is on the same place where there was red spot.
3PM following vax pt was being bathed when drew up in a ball, eyes rolled up, started jerking lasted 7-10mins; t107.5 taken to ER told was febrile sz;
25OCT97 had runny nose 26OCT97 temp inc to 103 R;loss stool;fever had poss febrile seizure 1PM p/vax;dx ?viral vs rxn to MMR;also noted red spots on torso for first time;T103 aural;seen by MD for eczema & nasal congestion;
Contract pharmacist, administered dose of Moderna after the 6 hour punctured expiration time.  This vial was left over from the previous day she administered doses and she used the same vial the next calendar day to do the first 8 doses for the day.    Pt is being offered 2nd dose again, will schedule asap if pt agrees
Patient received her second Meningococcal B (Bexero) vaccine today, 9/10/19, at 8:20 am.   The first dose was given on 7/30/19. The vaccine was given properly in the left deltoid after the patient passed the nursing protocol for administration.  When patient left, she was feeling well and had no complaints.  Her mother called our nurse triage line at 11:05 am stating that she was having left arm pain, numbness and weakness and that she was unable to make a fist or raise her arm above her head.  She arrived to our clinic at 12:45 to be seen by a provider.  She was having chills, left arm pain 6/10 and generalized body aches/pain 8/10 and felt shaky. Her vitals were as follows: temperature 39 degrees Celsius, blood pressures were 72/38 initially and then 90/38, pulse 89, and 99% oxygen saturation.  The patient was given something to eat as she had only a small breakfast and no lunch.  After further discussion with the provider, the mother stated that the symptoms started an hour and a half after she received the vaccine.  There was no swelling, redness or warmth at the injection site.  Patient?s repeat blood pressure thirty minutes later was 98/61 and pulse was 89, she was not flush-appearing and was starting to feel better.  The arm weakness had improved prior to being seen in clinic, and was completely resolved prior to her leaving the clinic.  She was observed for over an hour in clinic and was sent home with instructions to return should symptoms reappear.
Patient present to ED due to concerns with shortness of breath for past 10 days. Patient denies chest pain.
Info has been received from a mother concerning her approx. 15 year old son who in approx. 1996 was vaccinated with the 3rd dose of Hep-B. Following vaccination, in approx. 1996, the pt developed flu-like symptoms which were dx'd as infectious mononucleosis. Every 2 weeks since his vaccination, the pt has had allergy symptoms including difficulty breathing. It was recently found that the pt has an allergy to yeast. The pt sought unspecified medical attention. Additional info has been requested.
Headache Under arm lymph node pain in left arm, chills low grade fever on 12/24/21 Narrative:
At the close of business on 11/23, a vial of moderna bivalent booster was left on the counter instead of disposed of in the sharps container. In the morning on 11/25, upon administering my first shot of the day I grabbed a new vial and put it on the counter. When I went to draw up the vaccine, I grabbed what I thought was the new vial and drew the vaccine then gave it to my technician to administer. Later in the day, I realized I had two vials on my counter and that I had drawn my first vaccine of the day from the old vial from 11/23.
I first got a cold (tested negative for COVID twice through a rapid test and then a PCR test). After a few days of recovery, I suffered what was presumably a severe allergic reaction to black mold exposure that triggered my asthma. As a result, I was prescribed prednisone and to go back on a daily Flonase inhaler. While I do not imagine in any way that these incidents were related to either COVID-19 or the vaccine, the CDC called me after my v-safe check-in and directed me to report them, so I am doing so accordingly.
Uncontrollable Vaginal bleeding; anemia; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Aug2021 at 12:00 as dose 2, single (Lot number: FF2588) at the age of 34 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies:onion" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Omnicef, reaction(s): "known allergies: omnicef". Vaccination history included: BNT162b2 (Dose Number: 1; Batch/Lot No: EW0172; Location of injection: Arm Left), administration date: 06Aug2021, when the patient was 34-year-old, for COVID-19 immunization. The patient did not receive any other vaccines in four weeks and was not diagnosed with COVID-19 prior vaccination. The following information was reported: VAGINAL HAEMORRHAGE (medically significant) with onset 05Sep2021, outcome "recovered", described as "Uncontrollable Vaginal bleeding"; ANAEMIA (medically significant) with onset 05Sep2021, outcome "recovered", described as "anemia". The events "uncontrollable vaginal bleeding" and "anemia" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: if covid tested post vaccination: Yes. Therapeutic measures were taken as a result of vaginal haemorrhage, anaemia (IV iron, procedure d&c).; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events vaginal hemorrhage, anemia and the use of suspect product cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 3:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 3:24 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Had 12 mth vaccines on 4/23/08. Received Varivax and DTaP in (L) thigh. Came to clinic on May 2, 2008 with redness and swelling noted to left thigh at injection site. Approx 25mm round raised area, warm to touch. Dr examined pt localized reaction. Instructed to return to clinic if it gets worse. Cold compresses, Tylenol and Motrin for discomfort.
On exam today 10/7/02 before giving vaccine, grandmother was advised about reactions. She complained of baby being limp and not easily aroused for a few seconds. Today, only DT was given and baby discharged in stable condition after half hour after injections. Returned back 15 hours later complaining of limpness and pale on lips and hard to arouse. On re-evaluation was stable in office.
This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. Pharmacist reported with PREVNAR 13 there is more pain than other vaccinations. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
4-2-21 TC: PT STATES SHE HAS A RASH TO HER LT ARM AT THE INJECTION SITE. NO HEAT, NO PAIN, NO SWELLING.  NO SOB, NO  DIFFIUCLTY SWALLOWING. WILL SELF MONITOR AND F/U WITH PCP PRN.
Pt recvd vax & exp discomfort & a large, reddened area st the inject site;
Swelling, redness, hot to touch in area of shot in the form of a 5" by 4" itchy oval. Applied light application of pink BENADRYL lotion occasionally to site over the one week period of the event. Area started out pink then increased to red over the course of the week until it started to subside near the end of the event. It seemed also that a skin spot that had cleared previously in my scalp reoccurred at this time (Oct 5, 2018). I do have an appt. Nov 29 to check this out.
BRIEF RESOLVED UNEXPLAINED EVENT; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male 5 months old infant. The patient was enrolled in a non-company sponsored study. The patient's weight was 3.32 kilograms, and height was 51 centimeters. No past medical history or concurrent conditions were reported. The patient's mother had a medical history of Anxiety, Asthma, Attention deficit disorder (ADD), Attention deficit hyperactive disorder (ADHD), Depression, Endometriosis and polycystic ovary syndrome (PCOS). The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: 0421A211A, expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 for covid-19 immunization. Concomitant medications included buspirone hydrochloride for drug used for unknown indication, escitalopram for drug used for unknown indication, ibuprofen for drug used for unknown indication, prenatal vitamins for drug used for unknown indication, omeprazole for drug used for unknown indication, and salbutamol for drug used for unknown indication. On 05-APR-2021, the patient had fetal exposure during pregnancy. In SEP-2021, Laboratory data included: Cardiac function test (NR: not provided) not reported, and Hearing test (NR: not provided) not reported. On an unspecified date, the patient had brief resolved unexplained event. On 16-NOV-2021, the patient was hospitalized. Number of days hospitalized and discharge information were not reported. No birth defects, genetic or inherited disorders had been identified since birth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 26-SEP-2021, and the outcome of brief resolved unexplained event was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and brief resolved unexplained event was related, and between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20210761824.; Sender's Comments: V0: 20220221367-COVID-19 VACCINE AD26.COV2.S-brief resolved unexplained event. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20220221367-COVID-19 VACCINE AD26.COV2.S-fetal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
R57.1 HYPOVOLEMIC SHOCK 10/6/2022 LIVER MASS
Red rash wrapping around arm, painful.... has been taking motrin otc and icing. Symptoms improving.
Third shot he fainted 12 hours after the vaccine was administered; In May 2023 the patient had a third shot of Shingrix (due to a medical clerical error); This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on February 16, 2018 received 1st shot) and Shingrix (on August 06, 2018 received 2nd shot).   In MAY-2023, the patient received the 3rd dose of Shingrix. In MAY-2023, 12 hrs after receiving Shingrix, the patient experienced fainting (Verbatim: Third shot he fainted 12 hours after the vaccine was administered) (serious criteria GSK medically significant) and extra dose administered (Verbatim: In May 2023 the patient had a third shot of Shingrix (due to a medical clerical error)). In MAY-2023, the outcome of the fainting was resolved. The outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the fainting to be related to Shingrix.     It was unknown if the company considered the fainting to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-MAY-2023 and 22-MAY-2023 In 2018 the patient received 2 doses of vaccine On an unspecified day in May 2023 the patient had a third shot of Shingrix (due to a medical clerical error), which led to extra dose administered. The patient stated that he had a stronger reaction to the third shot than the first or second. He stated that first and second shots did not bother him but the third shot he fainted 12 hours after the vaccine was administered.  The patient reported that fainting was the low point.  He said he had no problems after that, after recovering from fainting. The patient asked if there any need to complete 2 shot series of the new dosages and do the vaccine lasted for lifetime The reporter consented to follow up via email or regular mail.   Upon internal review the case was updated on 25-May-2023. summary of changes: Following internal review it was determined initial GSK receipt date was 20-May-2023, which was later than initially reported.
Chills, headache, body ache, fever. Recovered in 1 day.