chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED AFTER STORAGE OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 4-AUG-2022) dose was not reported, administered on 17-FEB-2022 for prophylactic vaccination. Age at time of vaccination 19 years old. No concomitant medications were reported. On 17-FEB-2022, the patient experienced vaccine administered after storage outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after storage outside of recommended storage conditions and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558390, 20220558439, 20220558451, 20220558455, 20220558511, 20220558598, 20220558638, 20220558340, 20220558343, 20220558345, 20220558349, 20220558378 and 20220558383.
Shingrix was given subcutaneous rather than intramuscularly on 1/10/23. Patient reports  on 1/11/23 arm swollen, red, itchy, nausea, fever, chills, headache.  On 1/12/23 symptoms mild  improving; fever now  < 100F but reports the swelling to arm continues and  is about 4 " in length. Patient goes to urgent care clinic and given antibiotics (doxycycline 100mg BID x 5 days) for cellulitis on 1/13/23. Follow up on 1/20/23, cellulitis resolved.
No masjor problems after 24 hrs. Days days after 2nd dose I started to get fever, headache, chills, overall aches/pains, sweats, lethargy, This started Tues evening 5/18 and I' still experiencing same reactions today 5/25. I've been to primary care provider twive 5/23. Additional tests were run and came back negative. Two Covid tests have also been performed and have come back neg.
Patient was admitted to the hospital with bilateral carotid artery stenosis and was in the ICU for one day. This is within 6 weeks of receiving COVID vaccination.
Loss of facial muscle control on right side of face lips, eyes etc approx 36 hrs after shot
This spontaneous report has been received from a medical assistant referring to a 10 patients of unknown age and gender. Information regarding medical history, drug reactions, allergies and concomitant therapies was not provided. On an unknown date, the patients were vaccinated with an improperly stored VAQTA, (dose, strength, route of administration and frequency were not provided), lot # M033611 and expiration date 02-MAR-2018 for prophylaxis. The reporter stated that the temperature range of the vaccine was 0 Celsius (C) and 2 Celsius (C), the time frame was 15 hours and 42 minutes, also stated that there was no previous temperature excursion, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA013142: US-009507513-1701USA007990.
Arm pain, red, raised "blotchy" 5" x 3" area. Benadryl/ice suggested.
whole left side of her face is swollen; Caller states her first dose of the Pfizer Vaccine was on 08Jun2021 and the 2nd dose was yesterday 30Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 30Aug2021 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Caller states her first dose of the Pfizer Vaccine was on 08Jun2021), administration date: 08Jun2021, when the patient was 44 years old, for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Aug2021, outcome "unknown", described as "Caller states her first dose of the Pfizer Vaccine was on 08Jun2021 and the 2nd dose was yesterday 30Aug2021"; SWELLING FACE (non-serious) with onset 31Aug2021, outcome "not recovered", described as "whole left side of her face is swollen".  Additional Information: Caller stated she was calling about the Pfizer Vaccine and stated she got the 2nd dose of the vaccine yesterday and the whole left side of her face is swollen and she was going to go to the hospital after this call, caller was asked if she needed urgent medical attention at this time and stated she was ok to complete the report but will call after the call is completed. Caller stated she does not have the HCP information with her to provide at this time. Caller stated her first dose of the Pfizer Vaccine was on 08Jun2021 and the 2nd dose was yesterday 30Aug2021 and she has a lab number for the vaccine to provide of 1451-7.2 but stated her patient card and lots, expiry dates or NDC numbers for the vaccine is not with her at this time. She Stated the facial swelling began when she woke up this morning at about 5:30 am and is ongoing and the same as when it began; stated she took the vaccine because she does not want to get sick and has two kids and takes care of them and can't afford to be sick. Caller asked if the shot was life threatening or would kill her if she does not go in; caller aware Pfizer cannot provide treatment recommendations or medical advice but was offered transfer to USMI if she has product questions; caller declined and stated she will go to the hospital.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a case in litigation via a case report concerning a male child patient who on approximately 06-JUN-2002 was vaccinated with a dose of MMR II (Lot number not reported). Subsequently, the patient experienced OMS. On 17-JUN-2002 approximately 11 days after the vaccination, the patient fell and cut his upper lip, according to the record. Twenty days after vaccination, his mother took him to the doctor because he had been falling frequently for the previous five days. A physician reported that the MMR vaccination triggered an autoimmune response in a child whose immune system was already under assault by a neuroblastoma and various infections. No further information is available.
Swelling occurred at the injection site. It then welted up and got larger the next few days. It was red and itches but also hurt. Couldn?t lift my arm past my shoulder. Not other symptoms occurred.
Per telephone call from pt. mother, pt became dizzy and nauseous "hours" after immunization. Mom states child was walking in store and complained of abdominal pain, dizziness & nausea. Mother took child to E. R. Physician noted symptoms stated were resolved.
GIVEN DILUTENT ONLY; GIVEN DILUTENT ONLY; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only diluent of Rotarix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No other information was reported.
Patient has bruising below injection site. Bruising is still present 2 weeks after immunization.
This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received TWINRIX (adult) (batch number MF3X3, expiry date July 2014). On an unknown date, the patient received TWINRIX adult. On an unknown date, an unknown time after receiving TWINRIX adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to TWINRIX adult. Additional information: The pharmacist administered an expired dose of TWINRIX which led to maladministration.
EXPIRED VACCINE ADMINISTERED (EXP 6/30/22). NO ADVERSE REACTIONS NOTED.
Onset over about 5 mins. Trouble breathing, dizziness, sudden headache with possible syncope event with sharp chest pain in left side of body. Went to bed assuming it was a random panic attack, but breathing did not get better and reported to local Urgent Care 8/08/2022. EKG came back normal and was recommended to go to local ER ASAP for further testing to ensure it wasn't a blood clot.   At ER got another EKG, a chest CT, and basic blood work done. EKG came back normal, blood work came back with low MPV. CT came back with no signs of acute pulmonary illness and no embolism, but did come back with "dependent atelectasis in the lungs posteriorly bilaterally". Receiving follow-up with PCP next week.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: sulfa and keflex. Past adverse reactions to the above products included Allergy with keflex and sulfa. Concurrent medical conditions included Type 2 diabetes mellitus and Hypertension.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-May-2022 to 11-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   It was unknown if the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  On 16-May-2022, the patient had reemergence of symptoms after finishing 5-day course of Paxlovid.  Company Comment: This is a spontaneous case concerning a 73-year-old male patient with a medical history of Type 2 diabetes and hypertension, who experienced the unexpected non-serious ADR COVID-19 which occurred approximately 6 months after receiving a dose of mRNA-1273 Vaccine, dose 3 in vaccine series. There is no available information regarding the first 2 doses in the COVID-19 vaccine series. As reported, symptom reemerged 5 days after finishing 5-day course of Paxlovid (Nirmatrelvir/Ritonavir). The patient's age and medical history of diabetes and hypertension, all of which weaken the immune system, remain as confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 73-year-old male patient with a medical history of Type 2 diabetes and hypertension, who experienced the unexpected non-serious ADR COVID-19 which occurred approximately 6 months after receiving a dose of mRNA-1273 Vaccine, dose 3 in vaccine series. There is no available information regarding the first 2 doses in the COVID-19 vaccine series. As reported, symptom reemerged 5 days after finishing 5-day course of Paxlovid (Nirmatrelvir/Ritonavir). The patient's age and medical history of diabetes and hypertension, all of which weaken the immune system, remain as confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
tested Covid positive; fever; Chills; feel funny/felt loopy; This is a spontaneous report received from a contactable consumer, the patient.  A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Arm Right on 26Mar2021 15:15 as dose 1, single for covid-19 immunisation (52 years age at vaccination). Medical history was reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other vaccine on the same date of Pfizer vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 26Mar2021, Patient felt funny/felt loopy, on 27Mar2021, she had fever, chills and on 30Mar2021, the patient tested covid positive. She got the first dose of the Pfizer Covid vaccine last Friday 26Mar2021 around 15:15 PM, states that she experienced side effects starting Saturday evening, 27Mar2021, states she had fever and chills, which were side effects that she read about and she took Tylenol to treat them and everything was fine, states that she noticed she went to school on Monday and talked to her principal and explained to her she got the shot and her principal said she did not look right and she decided to go home, states when she went home her husband was not feeling right so he decided to go get tested and she decided to get tested as well for Covid virus, states she tested positive for the virus on Tuesday, 30Mar2021. States it was a possibility she had it before and did not know, she had no symptoms prior to the vaccine. She stated she knew the vaccine can't give someone a Covid infection. She asked, if she need to wait 90 days before getting the second dose. The patient underwent lab tests and procedures which included Covid test: positive on 30Mar2021. Therapeutic measures Tylenol were taken as a result of fever and chills. Patient did not go to emergency room or physician's office due to adverse events. The event fever was resolved on 28Mar2021 and outcome of events covid-19 and chills was not recovered and for feeling funny and loopy the outcome was unknown.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 17Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 01Nov2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Apr2022 as dose 4 (booster), single (Lot number: 066K21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of lung collapse" (unspecified if ongoing), notes: History of lung collapse; "lung blebs removed", start date: 2020 (unspecified if ongoing), notes: lung blebs removed in 2020; "Endometriosis (thoracic, pelvic, and intestinal)" (unspecified if ongoing), notes: Endometriosis (thoracic, pelvic, and intestinal); "Endometriosis (thoracic, pelvic, and intestinal)" (unspecified if ongoing), notes: Endometriosis (thoracic, pelvic, and intestinal); "Endometriosis (thoracic, pelvic, and intestinal)" (unspecified if ongoing), notes: Endometriosis (thoracic, pelvic, and intestinal); "known allergies: Pineapple, apple, apricot" (unspecified if ongoing), notes: known allergies: Pineapple, apple, apricot; "known allergies: Beef" (unspecified if ongoing), notes: known allergies: Beef; "Ulcerative colitis" (unspecified if ongoing), notes: Ulcerative colitis. Concomitant medication(s) included: NORETHINDRONE [NORETHISTERONE ACETATE], start date: 01Aug2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: tested negative from day 7-12; (Jun2022) Positive, notes: symptoms return on day 13 and was sick again for 5 day. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: I got better after day 7. Felt fine and tested negative from day 7-12. I tested positive and had symptoms return on day 13 and was sick again for 5 day. When symptoms returned I had extreme chest pain, trouble breathing, congestion, and fever. It was just as bad as the first 5 days, with the exception of intestinal issues. The first 5 days intestinal issues were the worst for me, and only nausea returned with my rebound.Anti-Viral details: product=COVID 19 Treatment, brand=Pfizer Paxlovid, treatment start date=14Jun2022, treatment stop date=19Jun2022, indication=Treatment of COVID-19.
Two days after receiving the injection, patient complained of fever, itching, pain and swelling at the injection site, redness and what look like little blisters around site. 1/11/18 -patient reports no fever but continues to have pain, redness and swelling. Site was assessed by the provider and recommended treatment was KEFLEX 500 mg 1 po tid for 10 days #30, BENADRYL 25 mg use as directed for itching (over the counter), and either MOTRIN or TYLENOL for pain (over the counter).
1/23/22 I began experiencing red, itchy raised rash and irritation on various areas of my body - best described as hives. The hives would appear in a few locations and go away within 30-60 minutes, recurring in other areas.  Scratch marks from itching would also appear as red raised lines. I have also experienced inner ear throbbing while external ear it itchy, red and warm. The following day 1/24/22 I was seen at an urgent care and prescribed a 5-day course of Prednisone 50mg daily, which has since been completed as prescribed. The same day, i began taking Benadryl nightly, and Allegra daily. I also began using calamine lotion on irritated areas as needed. Since beginning these medications, the occurrence of hives and itching had become less frequent, but has remained the same in its intensity.
severe muscle pain on the left and right side of his neck; he cannot turn his head to the left or right; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-MAY-2023, the patient received the 1st dose of Shingrix (injection, right arm). On 24-MAY-2023, 5 days after receiving Shingrix, the patient experienced muscle pain (Verbatim: severe muscle pain on the left and right side of his neck) and mobility decreased (Verbatim: he cannot turn his head to the left or right). The outcome of the muscle pain was not resolved and the outcome of the mobility decreased was not reported.   It was unknown if the reporter considered the muscle pain and mobility decreased to be related to Shingrix.   It was unknown if the company considered the muscle pain and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAY-2023 The patient received Shingrix in his right arm and reported that the day before reporting, he started having severe muscle pain on the left and right side of his neck and he could not turn his head to the left or right. The patient reported that this pain was really severe last night and on the day of reporting. The patient did not have the lot for his dose. The reporter did not consent to follow-up.
The whole left side of my face has facial paralysis. Being treated as if it were Bell Palsy because we are not sure if this is a side effect from receiving the vaccination.
neither one of us ever had issues drawing blood out of our veins till ever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: POOR VENOUS ACCESS (non-serious), outcome "unknown", described as "neither one of us ever had issues drawing blood out of our veins till ever". Additional information: The reporter and the patient received the first and second shot of BNT162B2. The reporter and the patient have routine blood drawn for a routine check up and neither one of them ever had issues drawing blood out of their veins until they got the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264488 Same reporter/product/event, different patient
Experienced flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Experienced flu like symptoms) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition was reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Experienced flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Experienced flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech.
Information has been received from a physician concerning a 24 year old female patient who on unspecified dates was vaccinated with 0.5 ml all three does of GARDASIL injection (Lots# not reported). The physician stated that a year and a half after the patient received GARDASIL a pap smear was performed and the test showed a low grade HPV positive. At the time of the report the patient's outcome was not reported and the patient had no visible genital warts. The patient did not seek medical attention. Additional information has been requested.
Patient came to the hospital for shortness of breath, and was found to be COVID-positive.  She was vaccinated, but did not receive her booster.  She was also found to have superimposed Legionella pneumonia as well, and was seen by infectious disease.  She is maintained on steroid taper with Decadron, as well as Levaquin.  She will complete her Decadron over the next 5 days, as well as her Levaquin.  She did require high flow oxygen at 1 point, which was weaned down.  She is pending home O2 evaluation for possible home oxygen for short-term.  She will follow-up with her primary care physician within 1 week.  All questions and concerns were answered and addressed prior to discharge with patient/family.