chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DTaP-IPV component of Pentacel was administered seperately from Hib component/ No AE; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 2 months old male patient who was vaccinated with 0.5 ml first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number: C5324AC and expiry date: 09-May-2019) via intramuscular route in the right thigh on 23-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) ; PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) on an unknown date.  It was a case of actual medication error due to inappropriate reconstitution technique.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.   Documents held by the sender: none.
erythema & tenderness-lt deltoid area;measuring 6x6 cm-still present 96 hr p/vax
Swelling, Red rash size, 2 " in diameter started Sat. AM some soreness. 2 days later still bright red, rash itching. No swelling. Dx localized reaction. Patient advised to use OTC cortisone.
Pt recvd 1st dose Hep B vax 5FEB91 & that evening pt devel asthenia, fever, somnolence, & sweating; pt missed 5 days of work; pt elected to discontinue the remaining vax; pt recovered;
stomach pain after 3 week's of hot first dose; hot first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain after 3 week's of hot first dose) and FEELING HOT (hot first dose) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain after 3 week's of hot first dose) and FEELING HOT (hot first dose). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain after 3 week's of hot first dose) and FEELING HOT (hot first dose) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Med Info Agent: AE submitted via virtual assistant I have stomach pain after 3 week's of hot first dose.   Reporter did not allow further contact
8/1/08 90 mm diameter area of induration and edema, very tender. Central 10 min area of bruising (bled after the shot). Warm to touch but not erythematous.
About an hour after the vaccine I developed the same jolting pain in my lower body, but this time on both sides but more so on the left side. I developing weakness, shaking and weeks of intermittent paralysis mainly to the left leg with trouble moving it also. The jolting pain moved to my upper body and was so bad resulting in significant SOB. I was afraid of falling asleep because I would wake up with severe breathing issue and SOB. Still to date I still experience the SOB while sleeping. I went to the ER about 2 or 3 times for this issue over the next few months. I went to the ER who referred me to see an Urologist and currently I am awaiting an appointment to see them. In July I was still experiencing these issues and various other issues so I went to a Medical Center where I was admitted for 4 day and additional testing was done. Some symptoms has improved but I am still experiencing various different symptoms to date.
Initial unsolicited case received from a consumer on 27 Sep 2017. This case involves 90-year-old male patient who was vaccinated with 0.5 ml one dose of FLUZONE HD (Batch number, expiry date, dose in series were not reported) intramuscularly at the very top of the arm at the shoulder on 23 Sep 2017. Patient medical history was not reported. The patient had never had a vaccine related reactions in the past. Concomitant medications were not reported. On 23 Sep 2017 in the afternoon, few hours after the vaccination, the patient developed itching and redness with swelling to 2 times the arm size. It was also a case of actual medication error due to Wrong injection technique. Relevant lab tests and corrective treatment were not reported. The outcome of the events were reported as not recovered. 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 set out in Good Pharmacovigilance 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. List of documents held by sender: none.
Sought treatment on June 5th for drooping right side of mouth and inability to independently operate right eye (unable to close/blink)
Following a Moderna booster shot, (I had already completed a first round of 1 Pfizer vaccine and 1 Pfizer booster), I experienced chest pain 2 days after receiving this second booster shot.
pt recv vax 10AM since 10:00 pt has been crying;screaming in pain;parents not able to console pt;pt refusing bottle;tried walking, car ride, cuddling, pacifier, pt still cries; MD stated no pertussis next time;
Patient received her HD flu vaccine and 6 hrs later had sharp shooting pain that began in her lower back and radiated up to her neck. She states that it started happening when she turned 65 and got the HD vaccines. She says that it happens every year around this time and that this was the first year that she associated it with her flu vaccine. She says that the pain is so bad that she has seen multiple doctors and gone to the ER in the past and no one can ever do anything for the pain. She states it lasts a few days after her flu vaccine is given.
vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.
Booster vaccination; Booster vaccination; Mouth sore- lasted 2 days; Dry mouth; Absolutely no energy; Exhausted; This is a spontaneous report from a contactable Nurse. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 1 single and second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 2 single for COVID-19 immunization for COVID-19 immunization. Patient had no known allergies. The patient reports mouth sore- lasted 2 days and gets one every once in a while and goes away comes back for a day- it comes and goes with a dry mouth, after covid booster vaccination. Patient said that knocked her out the next day, just exhausted and absolutely no energy on an unspecified date in May2021. The outcome of events was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Patient diagnsoed with aplastic anemia and treated with ATG+CSA+eltrombopaq starting 5/25/2022.  His counts had recovered with persistent improvement and "normal" blood counts lasting up until July 2023.  CBC dated July 3, 2023 shows WBC 6,400/mcL, ANC 2,700/mcL, hemoglobin 13.2 g.dL, and platelet count 161,000/mcL.  He recieved Covid-19 vaccine on July 7, 2023.   CBC dated July 10, 2023 shows WBC 7,200/mcL, ANC 2,700/mcL, hemoglobin 13.7 g.dL, and platelet count 116,000/mcL. His counts continued to trend down from there.  CBC dated August 8, 2023 shows WBC 4,200/mcL, ANC 1000/mcL, hemoglobin 10.4 g.dL, and platelet count 8,000/mcL.  He was admitted August 8, 2023 with concern for recurrence of aplastic anemia.
1 of 3 pts recvd vax from the same lot# who exp an inj sit rxn;pt devel red, swollen, indurated area-size of an egg following vax;required MD visit;tx prescribed included cool compresses, topical steroid cream & DPH;
2am in the morning she experience numbness and tingling in her right foot which progress to her leg and her head. Lost sensation and couldn't move or feel the right side of her body. Went to ER and while in the ER she begin to have stroke like symptoms which she went paralyze for about 5hrs on her right side.
Patient developed generalized urticaria three days after receiving DTaP #3, HiB#3, Prevnar #3. Given Benadryl with resolution.
Rash started on (L) leg and rapidly progressed-Parent took patient to  urgent care center-patient was given steroid injection and Benadryl. Also given 1 tsp of prednisolone x 2 doses Q 6 hr after visit. Patient also with temp 101 deg last noc. seen in office today-Dx with urticaria and prescribed Orapred 15 mg/5 ml-3ml BID x 5 days and Benadryl
Likely Giillain-Barre syndrome. Trouble swallowing, shortness of breath, pins and needles starting in extremities the moving to torso then to face over weeks, vision issues (blurring/double vision), confusion and some motor movement challenges, lack of energy/weakness.
Tingling in cheeks and face which progressed to bells palsy on right side of face.; Tingling in cheeks and face which progressed to bells palsy on right side of face.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN0175) via an unspecified route of administration, administered in arm left on 06May2021 15:30 (age at the time of vaccination was 45-year-old) as dose 2, single for COVID-19 immunization. Medical history included food allergy (Shellfish). The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN0151) via an unspecified route of administration, administered in arm left on 15Apr2021 15:15 (age at the time of vaccination was 45-year-old) as dose 1, single for COVID-19 immunization. On 07May2021 12:15, the patient experienced tingling in cheeks and face which progressed to bells palsy on right side of face. The patient received treatment for AEs as Antiviral Medication, Head MRI, antibiotic. The adverse event result in physician office visit and emergency room visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient underwent lab tests and procedures which included Head MRI: result unknown on an unknown date. The outcome of the events was unknown.
Patient noted a couple days after vaccination noted redness and swelling around shot area. Had itching - so used hydrocortisone. Saw PCP on 9/15 told her to watch. Today noted hives around injection site and up and under arm. Rash resolving.
HAVING UNDERLYING PNEUMONIA; This spontaneous report received from a health care professional concerned a 60 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: pulmonary arterial hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, Expiry: Unknown) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. Concomitant medications included Macitentan for pulmonary arterial hypertension. The batch number was not reported and has been requested. The patient was hospitalized (date unspecified) and having underlying pneumonia. She was unaware that having underlying pneumonia. She stated that had no side effects from the medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of having underlying pneumonia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211015035-covid-19 vaccine ad26.cov2.s-having underlying pneumonia. This event(s) is considered unassessable. 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).
pt recvd vax 10AM; temp shot up to 104 R @ 4PM w/bodily jerking; contacted MD who suggested alternating advil & ASA; temp went down & pt was back to nl by afternoon of 23FEB95; pt had a similar jerking episode w/ high fever 2 wks earlier;
Ache at injection site; Body aches; Chills; Massive headache; Aggravation of allergy; Hives; Itching; Puffy eyes; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 at 14:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) for unspecified indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021 at 23:00, the patient experienced ache at injection site, body aches, chills, massive headache, aggravation of allergy causing hives/itching, puffy eyes and all started late night/ overnight after injection. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the reported events. The clinical outcome of the event ache at injection site, body aches, chills, massive headache, aggravation of allergy causing hives/itching, puffy eyes was resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Weakness-Mild
Fever, chills, myalgias, astenia, general malaise which lasted for about 24 hours. No treatment or medical care needed
Covid infection after vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid infection after vaccine.) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid infection after vaccine.). At the time of the report, COVID-19 (Covid infection after vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drugs were reported. no treatment medication were reported,   Reporter did not allow further contact
Pt is an 17 year old male who presents with a history of left shoulder pain since 3/25. He has recently been vaccinated for SARS Co-V2 (First dose on March 5th with second dose on March 27). He is currently hospitalized for elevated troponin and working up for myocarditis.
Patients left arm was swollen, red, hot and painful to touch from shoulder down to elbow
Vomiting, Chills, Sweats, achy all over entire body, excruciating headache
Five minutes p moderna vaccine was given pt. c/o itching around injection site. Pt. has had anaphalactic reaction to toradol. Benadryl 50mg given IM  to Rt. detoid. Pt. talkative. No diff. breathing. VSS.   3/2/21 1428   Client has a h/o severe allergic  reaction to antibiotics. five minutes  after Moderna vaccine given to O Deltoid. Pt. c/o of itching of area area vaccine. Benadryle 50mg given IM to  (R) deltoid. Client talkative. Requests water mouth was getting dry. 122/64 , 78, 20 1502 Client used restroom and  left accompanied by 2 friends. Client instructed not to drive. Verbalized understanding. Instructed pt to take PO Benadryl 50mg before coming in for next vaccine for March 30th.
Burst blood vessels in the left eye extending from iris to the outer edge of the eye ball; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HYPERAEMIA (Burst blood vessels in the left eye extending from iris to the outer edge of the eye ball) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced CONJUNCTIVAL HYPERAEMIA (Burst blood vessels in the left eye extending from iris to the outer edge of the eye ball) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, CONJUNCTIVAL HYPERAEMIA (Burst blood vessels in the left eye extending from iris to the outer edge of the eye ball) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medications were not reported.  The patient reported that she experienced the adverse event in the left eye, 12 hours after  the administration of the second dose of the vaccine. The right eye was completely fine.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Treatment medication included Tylenol (acetaminophen).   This case was linked to US-MODERNATX, INC.-MOD-2021-102880 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
HANDS AND WRIST JOINT PAIN WHEN FIRST WAKING UP; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (HANDS AND WRIST JOINT PAIN WHEN FIRST WAKING UP) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (HANDS AND WRIST JOINT PAIN WHEN FIRST WAKING UP). At the time of the report, ARTHRALGIA (HANDS AND WRIST JOINT PAIN WHEN FIRST WAKING UP) had resolved.            No concomitant products were reported.  On unknown dates, the patient experienced hands and wrist joint pain when first waking up and after third covid vaccine shot pain and wrist was worst. On an unknown date, hands and wrist joint pain when first waking up resolved. Moderna covid-19 vaccine (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. Patient received 1st dose covid-19 vaccine manufactured by moderna. Patient received 2nd dose covid-19 vaccine manufactured by moderna. Patient received 3rd dose covid-19 vaccine manufactured by moderna.  Causality for humira(adalimumab) The reporter's causality for the event(s) of hands and wrist joint pain when first waking up and after third covid vaccine shot pain and wrist was worst was not provided.  No treatment information was reported by the reporter.  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.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Injection site appeared red, warm to touch and was still painful for patient
pt recv vax & devel mild adenopathy of the groin & throat, sore throat, & malaise; 29JAN95 pt presented to MD w/rash which began as a papular eruption on lower facial area and spread;
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Pateint was revaccinated 03/19/21 and has since received her second vaccine 04/09/21.
Symptoms: Fever, chills, joint pain, muscle aches, fatigue, headache  Treatment: Acetaminophen  Outcome: Reduced fever and pain after 15 minutes of 1000mg acetaminophen  Time Course: all day 2021-05-06