chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired dose given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Date moved to refrigeration on 13-Oct-2021 and Use by date on 13-Oct-2021.   This case was linked to MOD-2021-357519 (Patient Link).
This case is a cluster of ten unidentified patients who experienced similar adverse events following vaccination with ADACEL. Initial report received from a health care professional on 01 April 2011. A group of ten unidentified patients received from the same nurse a tricep injection (route not provided) of ADACEL, sanofi pasteur lot number C3838BA, on 28 March 2011. Ten employees out of 12 who received ADACEL had local reactions. One individual immediately reported to Employee Health (EH) after being injection complaining of itching at the site but no other complaints. As the week progressed the arm became very red, swollen and warm to touch. The injections were given in the tricep area rather than the deltoid. In all ten of those with reactions, all ten of them were administered in the tricep area rather than the deltoid. The reactions have ranged from small (no larger than a 50 cent piece) to engulfing the entire back of the arm and all ten had redness, warmth, and knots to varying degrees. Three individuals complained of flu like symptoms with headache, malaise, and low grade temperature (99.2 to 99.8). Two individuals have complained of neurologic type symptoms such as numbness in the shoulder and/or hand. Five patients have been sent to a physician for evaluation and treatment of the sites. There were two individuals given the vaccine that same day with the same nurse and same anatomical location but had no reaction. Two patients received the ADACEL vaccine with the same lot number on a different day and given by another EH staff in the deltoid and neither had a reaction. The outcomes were not reported. Documents held by sender: None.
presented with dyspnea, cough with green sputum and hemoptysis.  In the ED patient was noted to be hypoxic, D-dimer 2.14, creatinine 1.34, LFTs elevated, lactic acid 2.2 to.  There his stay patient has progressed to needing 100% BiPAP.  Patient had difficulty maintaining sats and was fighting the BiPAP.  Discussion was held with patient's daughter and wife regarding patient's current status.  They have agreed to make him comfort care only.
Numbness to Lips. Raised bumps (pinwheel) to head, neck,back and anticubital spaces.  Swelling to facial region.  Pt given epi 1:1000 1cc IM R deltoid.  Pt continued and still continues to have adverse reactions with above symptoms, dispite current treatment of Singular, Allegria, Pepcid and Prednisone.
Got rash 3 days after the vaccine; This spontaneous case was reported by a patient and describes the occurrence of RASH (Got rash 3 days after the vaccine) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Got rash 3 days after the vaccine). At the time of the report, RASH (Got rash 3 days after the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
patient got a second dose of Daptacel instead of HIB with no AE; Initial information regarding an unsolicited valid non-serious case was received from Consumer/non-hcp (healthcare professional) via Medical Information (Reference number- 00582667).  This case involves a patient with unknown demography who experienced received a second dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date was not reported) instead of HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiry date was not reported) via unknown route at an unknown administration site (wrong product administered) for prophylactic vaccination on 29-Apr-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   It was an actual medication error case due to wrong vaccine administered (latency: same day).   It was reported that patient received a 0.5 mL dose DAPTACEL (lot C5643CA and expiry date: 17-Jul-2021) via unknown route at an unknown administration site on 14-Apr-2021 for prophylactic vaccination and was supposed to get HIB on 29-Apr-2021 but got a second dose of DAPTACEL. The reporter wanted to know for appropriate follow-up side effects.  At the time of reporting, the patient experienced no specific adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. 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.
Dizziness, heaviness -- stress management education provided. Given water, drank 8 oz. Dizziness resolved, stable, released from vaccination site.
Information has been received fro a physician concerning a 3 year old child who in approximately August 2004 was vaccinated with a dose of varicella virus vaccine live. The physician reported that in approximately August 2004, one week after being vaccinated, the patient developed a mild case of breakthrough chicken pox. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Loss of sense of taste; Loss of sense of smell; Stuffy nose; Congestion; Dry nose; Fatigue; General malaise; Feeling sleepy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of AGEUSIA (Loss of sense of taste), ANOSMIA (Loss of sense of smell), MALAISE (General malaise), SOMNOLENCE (Feeling sleepy) and NASAL OEDEMA (Stuffy nose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MALAISE (General malaise), SOMNOLENCE (Feeling sleepy) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced NASAL OEDEMA (Stuffy nose), NASAL CONGESTION (Congestion) and NASAL DRYNESS (Dry nose). On 01-Feb-2021, the patient experienced AGEUSIA (Loss of sense of taste) and ANOSMIA (Loss of sense of smell). On 14-Jan-2021, MALAISE (General malaise), SOMNOLENCE (Feeling sleepy) and FATIGUE (Fatigue) had resolved. At the time of the report, AGEUSIA (Loss of sense of taste), ANOSMIA (Loss of sense of smell), NASAL OEDEMA (Stuffy nose), NASAL CONGESTION (Congestion) and NASAL DRYNESS (Dry nose) outcome was unknown.        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.   No concomitant medications was reported. No treatment details were provided.  Company comment Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Information has been received from a nurse practitioner concerning a female who was vaccinated SC with a 0.5 ml dose of PROQUAD. It was reported that the patient developed rash after vaccination. The patient's rash looked like chickenpox and appeared on her abdomen. Unspecified medical attention was sought. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown gender who had shingles. Among the patient, some were as young as 48 years old. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the reporter vaccinated the patients with ZOSTAVAX (dose, route, lot# and expiration date were not reported) (inappropriate schedule of drug administration). Concomitant drug was not reported. No adverse effects were reported. Additional information has been requested.
Patient developed severe Bacterial Cellulitis at the injection site 12-24 hours post injection. Patient was counseled by the nurse giving the injection that it would be sore which delayed the patient getting treatment until a septic state set in.
This is a spontaneous report from a contactable physician. A 18-year-old female patient of an unspecified race received TRUMENBA (Batch/Lot # and expiration date: M95617, Exp date:Jul2017), via intramuscular route on 18Jul2016, at 0.5 ml in the right arm for immunization. The patient medical history and the patient concomitant medication was none. On the same date the patient also received the second dose of GARDASIL (Manufacturer: Merck, lot M014929, exp.date 27May2017) via intramuscular route in the arm left at 0.5ml single dose for immunization. The patient had received the first dose of human papilloma vaccine on unknown date. The patient experienced the next day of the shots, dizziness, low back pain, headache and pain in the right hand joints all with outcome unknown. The events required a physician visit. A Full blood count was performed on unknown date and was normal. Follow-up (16SEP2016):  Follow-up attempts are completed.  No further information is expected. Follow-up (23Sep2016): additional information received from the same physician includes gender of the patient, lot and expiration date of the vaccines, dosage regimen and anatomical location of the administration of the vaccine, route of administration, date of vaccination. Headache added as adverse event.; Sender's Comments: Linked Report(s) : 2016356581 Legacy paper report number.
COAGULOPATHY, UNSPECIFIED TYPE 2/16/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Three day history of uper lip swelling and redness, angle redness, and entire inner lip swelling plus itching.
flu like symptoms after the second dose; fatigue after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms after the second dose) and FATIGUE (fatigue after the second dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A21B) for COVID-19 vaccination.     Concomitant products included SALINE [SODIUM CHLORIDE] for an unknown indication.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms after the second dose) and FATIGUE (fatigue after the second dose). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms after the second dose) and FATIGUE (fatigue after the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included anti emetic medication. Treatment medication were not provided. The patient received her second dose in her left arm shoulder deltoid muscle. anti emetic medication   This case was linked to MOD-2021-401280, MOD-2021-401418 (Patient Link).
hurts too bad to sit/has a bad back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 17Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Surgery" (unspecified if ongoing), notes: She had undergone 17 surgeries and has different diseases. clarified all the surgeries were years ago. The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "hurts too bad to sit/has a bad back".  Additional information: Caller on the line and stated she and her husband both completed the 1st and 2nd doses of the Pfizer COVID Vaccine on 11Mar2021 and is asking when she could receive the booster shot; caller mentioned prior to the 1st dose of the vaccine she had undergone 17 surgeries and has different diseases. Caller clarified the information provided by the transferring agent and states that their 1st doses of the vaccine was on 17Feb2021, and the 2nd doses of the vaccine were on 11Mar2021 and clarified all the surgeries were years ago and she had quite a few and will be age 77. Caller states she wanted to go back to the same place regarding the facility where she had the vaccine and is aware that Pfizer unable to schedule appointments and referred caller back to the facility. Reporter details: Caller provided a different address than was provided by the transferring agent and states she has a lot of different doctors there and she had the vaccine in. Caller states they have to wait 8 months after the 2nd dose for the booster which would be November 10th and then states she had the 2nd dose of the vaccine on 10Mar2021 despite stating earlier the 2nd dose was on 11Mar2021; captured as stated by the caller.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I tested positive for COVID on 1/30/22 even though I had 2 doses of Pfizer and the booster.  I was in bed for a week with fever, sweats, but didn't need to go to the doctor's or hospital.
Fever less than a day. Headache x2 days, L Axilla w/slight edema and L armpit pains 2 days
Red spot on the injection site for 6 days after booster; Expired vaccine received for booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot on the injection site for 6 days after booster) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine received for booster dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 013A21A and 00M20A) for COVID-19 vaccination. Concurrent medical conditions included COPD.On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot on the injection site for 6 days after booster) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine received for booster dose). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received for booster dose) had resolved. On 16-Nov-2021, VACCINATION SITE ERYTHEMA (Red spot on the injection site for 6 days after booster) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter.
I experienced fatigue, queasiness, loss of appetite, and I was diagnosed with Bradycardia as well. I went to the doctor on the 06/21/2022  where I had a stress test, wore a Holter monitor for 24 hours, and had an echo done. I have an appointment on 07/06/2022 to go over my results and discuss treatment which could possibly include a pacemaker. I am still experiencing intermittent shortness of breathe and Bradycardia.
Information has been received form a consumer concerning her son who on an unspecified date was vaccinated with PEDVAXHIB (OMPC). Concomitant therapy included PREVNAR. It was reported that the patient had a "similar reaction" like her other son. The consumer reported previously that her other son had adverse experiences while vaccinated with ATTENUVAX (Enders-Edmonston) (MSD) (WAES # 0902USA04542) and VARIVAX (Merck) (MSD) WAES # 0903USA00002). No further information is available.
tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I had always have low blood pressure my whole life" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B [VITAMIN B COMPLEX]. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Had the first vaccine and did okay I was tired but I did okay and finally after 2 weeks I started feeling better. Consumer stated, I take B vitamin (further not clarified) and just the other thing I wanted to tell you. I had always have low blood pressure my whole life (further not clarified). Just after the vaccine I went to see my doctor to get the regular checkup, my blood pressure was (incomplete sentence), and she put me on a very low dose of blood pressure medication (Not clarified) for the first time in my life. So, you know this is not going to work for me, I can't live like this. I mean I am not going to, I don't do, when I say I can't live like this. I mean I am not going to get another vaccine unless totally improved they offer me, just to help me a little. Patient did not receive any other vaccine previously.   Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101721403 similar report from same reporter;US-PFIZER INC-202101721495 similar report from same reporter
Red, raised rash under arms and on buttock. Appeared approximately 1 pm on 11-18-08, almost 24 hours after Rash itching resolved within 12 hours after taking baking soda bath.
Swelling developed under the arm in the armpit area, accompanied by soreness, lasting about 3-4 days.
Excessively tired; Pain at vaccination site; This case was reported by a consumer and described the occurrence of tiredness in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   On 15th September 2020, the patient received Fluarix Tetra 2020-2021 season. On 17th September 2020, 2 days after receiving Fluarix Tetra 2020-2021 season, the patient experienced tiredness and injection site pain. On an unknown date, the outcome of the tiredness and injection site pain were not recovered/not resolved.   The reporter considered the tiredness and injection site pain to be possibly related to Fluarix Tetra 2020-2021 season.  Additional information was provided as follows: The case was reported by the spouse of the patient. The age at vaccination was not reported. The patient complained of being excessively tired and pain at vaccination site, assumed both are due to vaccine. The reporter consented to follow up.
PRURITIC PAPULAR RASH ON DORSUM OF BOTH FEET 2-3 WEEKS AFTER 2ND VACCINE
Next day post vax, the pt experienced loud ringing in her ear. It was noted that the pt has seen several physicians regarding her symptom.
This case was reported by a nurse via call center representative and described the occurrence of shingles in a 59-year-old male patient who received SHINGRIX for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were received as follows: After vaccination with SHINGRIX, the patient developed shingles within two weeks following the vaccination. The patient was inquiring what the recommendation was and whether she should get the second dose.
Pain at injection site requiring naproxen  200 mg nightly at about 4 A.M. Pain has not resolved as of 12/13/2019.
localized redness and swelling of the left upper arm (6cm circumference). perfectly round skin nodule
Developed a small itchy rash at the site of the injection. No other symptom. Never experienced this with flu shot or anything.
Patient was highly anxious and sweating profusely prior to vaccine, voicing anxiety about vaccination. Patient received injection, sat down in observation, 1 minute later was becoming unresponsive and went limp. Proceeded to lay patient on ground where he stiffened for less than 10 seconds and became responsive (alert and oriented x3), smiled and said "I passed out didn't I?" Patient was given a juice box and a bottle of Gatorade as he was sat up. Vitals were taken as follows: BP 125/90, HR 90, O2 93. Patient reported a history of syncope after injections once he was sitting up again. Patient was offered EMS services and declined. Kept patient in observation for 45 minutes. Has been alert and oriented and walking around ever since.
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 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GJ2824) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 at 12:00 as dose 1, single (Lot number: EN9581), in left arm, on 08Feb2021 at 12:00 as dose 2, single (Lot number: EL9267), in left arm, on 21Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 03Mar2022 at 12:00 as dose 4 (booster), single (Lot number: PK9894), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
5 minutes after giving vaccines in RLT leg from injection site to toes turned bright red lasted for 30 min. Observed. No treatment given.