chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inside part of her lip is red; lips inside part of her lip and tip of the tongue feel numb; This is a spontaneous report from a contactable pharmacist.  A 43-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the right arm on 22Dec2020 11:30 at single dose for COVID-19 immunisation.  The patient had no medical history. The patient's concomitant medications were not reported.  The patient stated, "since that night her lips, the inside part of her lip and tip of the tongue feel numb on 22Dec2020. Added she just looked at the inside and it is also red on 24Dec2020. She started to feel the numbness on the inside part of her lips and on the tip of her tongue later that night. The feeling is still the same today. Restates she just looked today and noticed it is red at the place where it feels numb". The outcome of the events were not recovered.
shoulder and neck tightness and soreness, tiredness lasting to the present date, weak arms, tingling in hands, poorer short term memory and speech, pain below directly below lower sternum
Pt recv vax on 9/18/98; on 9/21/98 pt exp fever, body aches, swelling at site &redness, cellulitis; pt tx= 1gm of Rocephin.
had a stroke 3 days after receiving a 5th dose of Comirnaty; Inappropriate dose of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An 85-year-old patient received BNT162b2 (COMIRNATY), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "at a long-term care facility, nursing home" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (dose 3 (booster), manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 4 (booster), manufacturer unknown), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "unknown", described as "had a stroke 3 days after receiving a 5th dose of Comirnaty"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Inappropriate dose of vaccine administered". Event took place after use of product.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Cerebrovascular accident. 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.
pt recvd vax & had inc t 102; pt eyes rolled backward; extremities were limp &  flaccid; resp were rapid; shallow & labored; duration 3-4 hrs; tx w/ apap;
R arm red hair reddened hot swollen approximately 10? x 8?   Nausea vomiting shivering muscle pain upset stomach pain lasting 3 days Swelling lasting 5 days weakness dizziness
Itching; Redness; Hives; Tingling sensation; itching eye; eye pain; a cluster of bumps came up on my head; shingles; woke up with a whole swollen face and eye; severe sinusitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles), SWELLING FACE (woke up with a whole swollen face and eye), SINUSITIS (severe sinusitis), PRURITUS (Itching) and ERYTHEMA (Redness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 15-Feb-2014, Hashimoto's disease since 12-Apr-2006, Increased blood pressure and High cholesterol. Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]) for Blood pressure increased, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, CARVEDILOL, LINAGLIPTIN, METFORMIN HYDROCHLORIDE (JENTADUETO) and ATORVASTATIN for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced SWELLING FACE (woke up with a whole swollen face and eye) and SINUSITIS (severe sinusitis). On 25-Mar-2021, the patient experienced HERPES ZOSTER (shingles) and RASH (a cluster of bumps came up on my head). On an unknown date, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness), URTICARIA (Hives), PARAESTHESIA (Tingling sensation), EYE PRURITUS (itching eye) and EYE PAIN (eye pain). The patient was treated with CEPHALEXIN [CEFALEXIN] at an unspecified dose and frequency; ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles), SWELLING FACE (woke up with a whole swollen face and eye), SINUSITIS (severe sinusitis) and RASH (a cluster of bumps came up on my head) outcome was unknown and PRURITUS (Itching), ERYTHEMA (Redness), URTICARIA (Hives), PARAESTHESIA (Tingling sensation), EYE PRURITUS (itching eye) and EYE PAIN (eye pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of events was with Rocephin (ceftriaxone sodium) shot and prednisone shot on 21-Mar-2021. On 23-Mar-2021 she was started on cephalexin and acyclovir and continued with oral prednisone.  No Concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2021: significant Follow-up appended
discomfort at the site of injection for short period of time; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort at the site of injection for short period of time) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included PREDNISONE, LISINOPRIL, ALLOPURINOL, CLOTRIMAZOLE and HYDROCHLOROTHIAZIDE, TRIAMTERENE (HYDROCHLOROTHIAZIDE WITH TRIAMTERENE) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (discomfort at the site of injection for short period of time). At the time of the report, VACCINATION SITE DISCOMFORT (discomfort at the site of injection for short period of time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include Paradoxical. No treatment was reported for the events.   This case was linked to MOD-2021-244832 (Patient Link).
rash on her left arm, a rash on her neck; weakness; itchiness on her neck; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on 01-OCT-2019) and scalp pain (developed pain on her scalp because of the Shingles).   In JAN-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: rash on her left arm, a rash on her neck), weakness (Verbatim: weakness) and pruritus (Verbatim: itchiness on her neck). The outcome of the rash and weakness were resolved and the outcome of the pruritus was not resolved.   It was unknown if the reporter considered the rash, weakness and pruritus to be related to Shingrix.     It was unknown if the company considered the rash, weakness and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUN-2023 The patient self-reported this case. The patient received first dose of Shingrix in late January 2023. The patient stated that after receiving the vaccine, she developed a rash on her left arm, a rash on her neck and itchiness on her neck.  The patient also experienced weakness.  All the symptoms were resolved except for itchiness. The reporter did not consent to follow-up.
Slight increase the white cell; The neutrophils 0.5 below 70 mark; Eosinophils 7 to 8 tenths below 0-5 percentage; His cholesterol increased; This is a spontaneous report from Pfizer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient took historical Vaccine BNT162B2 Dose 1 COVID-19 immunization. On 30Mar2021 Caller mentions that he got the 2 doses of the Pfizer covid vaccine. He received the second dose like a month and a half ago and today he had the results of his latest bloodwork and he noted a slight increase the white cell: the neutrophils 0.5 below 70 mark and the eosinophils 7 to 8 tenths below 0-5 percentage. He wants to know if this could be caused by the vaccine.  He mentioned also that his cholesterol increased. Caller wanted to know if the vaccine could increase his cholesterol. The patient underwent lab tests and procedures which included blood test: slight increase the white cell   on 2021 Slight increases the white cell: the neutrophils 0.5 below 70 mark and the eosinophils 7 to 8 tenths below 0-5 percentage, Cholesterol increased. Outcome of events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The vial was initially stored in refrigerator on 21-JUN-2023 and administred to patient on 26-JUL-0223; No adverse event; Vaccine past the expiration date administered to adult patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine past the expiration date administered to adult patient), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-JUN-2023 and administred to patient on 26-JUL-0223) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine past the expiration date administered to adult patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-JUN-2023 and administred to patient on 26-JUL-0223) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine past the expiration date administered to adult patient), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-JUN-2023 and administred to patient on 26-JUL-0223) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine past the expiration date administered to adult patient) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-JUN-2023 and administred to patient on 26-JUL-0223).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 Vaccine. No concomitant medication was reported.  The vial was initially stored in refrigerator on 21-JUN-2023. The vial did not undergo any temperature excursions. No treatment information was reported.  This case contains information for patient 1 out of 3.   This case was linked to US-MODERNATX, INC.-MOD-2023-735313, US-MODERNATX, INC.-MOD-2023-735317 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735313:Patient 2 US-MODERNATX, INC.-MOD-2023-735317:Patient 3
Patient stated that night he had a rash appear on his arm. He then developed difficulty breathing and was sent to the ER. He was given diphenydramine and a steroid shot and his symptoms subsided.
PATIENT SEEN FOR SOB X 2-3 WEEKS IN ED, CT SCAN SHOWED MULTIPLE PULMONARY EMBOLI.  HEMODYNAMICALLY STABLE WITH NO EVIDENCE OF HEART STRAIN, D/C HOME ON XARELTO
Information has been received from a physician and a medical assistant concerning a 10 week female patient with no pertinent medical history and no drug reactions or allergies, who on 23-JAN-2012, was vaccinated with ROTATEQ (lot number 671724/1543AA; exp. date 06-DEC-2013, dose and route not reported) and RECOMBIVAX HB (lot number 669599/0231AA, exp. date 04-OCT-2013, dose and route not reported). Concomitant therapy included PREVENAR (lot number F65442) and PENTACEL (lot number lot# C4074AA). Physician reported that on 23-JAN-2012, three hours after receiving ROTATEQ, RECOMBIVAX HB, PREVENAR, and PENTACEL the patient was lethargic, became extremely pale and was unresponsive. It was reported that "adverse event was congenital anomaly" (no otherwise specified). The patient sought medical attention. The patient was hospitalized from 23-JAN-2012 to 24-JAN-2012. Treatment therapy for adverse events included unspecified antibiotics as a precautionary measure. Performed lab studies included: urine culture test, blood culture test, electrolyte test, oxygen monitoring and a CRP test. On 24-JAN-2012 the patient's outcome was recovered. The patient's adverse events were considered to be life-threatening and disabling. Priority LOT check has been initiated. Additional information has been requested. It was reported that the patient was hospitalized for approximately one-day as a precautionary measure.
Onset of tingling and numbness to face 18 minutes following vaccine injection, interfered with speaking.  Seen at Hospital Emergency Department one hour following vaccine receipt.  Reported no anxiety until started on Benadryl drip.  Resolution of 90-95% of symptoms following 2.5 hours at ED.  Next morning facial muscles were fatigued and sensation of numbness and tingling was completely resolved by day 2.
This case was reported by a nurse via sales rep and described the occurrence of general body pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received on an unknown date. For tolerance, refer case US2018GSK140288.). On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain and polymyalgia. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the general body pain and polymyalgia were not recovered/not resolved. The reporter considered the general body pain and polymyalgia to be related to SHINGRIX. Additional information was reported as follows: The nurse thought, the patient did not had any other concomitant vaccines. The patient received the 2nd dose of SHINGRIX at a pharmacy. The patient had general pain and myalgia all over his body for 11 days so far, at the time of reporting. The patient would wait for 1 more week to see if the pain resolves and see a doctor if it had not. The nurse thought that, the pain was due to the vaccine. The patient felt, the pain with the 2nd dose was worse than expected with the 1st dose of SHINGRIX. The reporter could not remember any other details at the time of reporting. The nurse agreed to be followed up.
Pt. states that after receiving the 2nd dose of Phizer 05/05/2021, started experiencing symptoms 05/19/2021 of hole in the Makala and Cataracts in both eyes. Surgery for hole in the Makala in 07/2021, scheduled surgery for Cataracts in both eyes 01/2022. Still continuing to experience symptoms.
I felt a little slow; sleepy; It felt like someone slugged me really hard in the arm for 3-4 days; kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (I felt a little slow), SOMNOLENCE (sleepy), FEELING ABNORMAL (It felt like someone slugged me really hard in the arm for 3-4 days) and FATIGUE (kind of tired) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced MOBILITY DECREASED (I felt a little slow), SOMNOLENCE (sleepy), FEELING ABNORMAL (It felt like someone slugged me really hard in the arm for 3-4 days) and FATIGUE (kind of tired). In January 2021, FEELING ABNORMAL (It felt like someone slugged me really hard in the arm for 3-4 days) had resolved. At the time of the report, MOBILITY DECREASED (I felt a little slow), SOMNOLENCE (sleepy) and FATIGUE (kind of tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that dose was full dose Total, patient had taken 4 full doses of Moderna COVID-19 vaccine. AE had not caused patient to seek medical care office visit, Urgent care, ER or hospitalized  No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2022-482921, MOD-2022-482916 (Patient Link).
Irregular period- one period two weeks apart, other times without period for over 6 weeks. No irregular periods were had prior
Initial misuse report received from a healthcare professional on 20 November 2013. The cases were received on 21 March 2014. A '2-week-old' patient's (no information was provided regarding the patient's) had received a dose of FLUZONE and no adverse event was reported, i.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Swelling, redness, pain, tx is warm compresses prn, if worse call to schedule appt.
Chest pain; tachycardia; could not move; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), TACHYCARDIA (tachycardia) and HYPOKINESIA (could not move) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 immunisation.     Previously administered products included for COVID-19 immunisation: Pfizer BioNTech COVID-19 vaccine (dose 1; chest pains for 9 months) on 13-Mar-2021, Pfizer BioNTech COVID-19 vaccine (dose 1) on 13-Mar-2021, Pfizer BioNTech COVID-19 vaccine (dose 1) on 13-Mar-2021, Pfizer BioNTech COVID-19 vaccine (dose 2) on 16-Aug-2021 and Pfizer BioNTech COVID-19 vaccine (dose 2) on 16-Aug-2021. Past adverse reactions to the above products included Chest pain with Pfizer BioNTech COVID-19 vaccine; Chills with Pfizer BioNTech COVID-19 vaccine; Costochondritis with Pfizer BioNTech COVID-19 vaccine; Myocarditis with Pfizer BioNTech COVID-19 vaccine; and Tachycardia with Pfizer BioNTech COVID-19 vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), TACHYCARDIA (tachycardia) (seriousness criterion hospitalization) and HYPOKINESIA (could not move) (seriousness criterion hospitalization). The patient was hospitalized on 03-Jun-2022 due to CHEST PAIN, HYPOKINESIA and TACHYCARDIA. At the time of the report, CHEST PAIN (Chest pain), TACHYCARDIA (tachycardia) and HYPOKINESIA (could not move) outcome was unknown.            No concomitant drug was reported.  On 03-Jun-2022, the patient was hospitalized overnight.  No treatment drug was reported.  Company Comment: This is a Spontaneous case concerning a 64-year-old female patient with medical history of interchange of vaccine administration, COVID-19 vaccine, Pfizer BioNTech COVID-19 vaccine 1st and 2nd dose with adverse events of chest pains for 9 months, tachycardia, and myocarditis. The patient received 3rd dose with mRNA-1273 and on an unknown date and latency experienced the serious (per hospitalization) unexpected events of Chest pain, Tachycardia and Hypokinesia. The mentioned medical history of adverse reactions after first and second dose with Pfizer BioNTech remains a confounder. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
DTaP and IPV administered to left upper arm on 7/13/04. On 7/14/04, localized erythema and swelling which on 7/15/04 had spread to circumferential swelling, erythema, induration of upper arm. Mildly tender; no systemic symptoms. Patient was moving extremity with no limitations.
Badly soar arm two days after the injection. Continued dull soarness at the vaccination site on the arm and tingling up and down the arm for the following three weeks.
AFTER ADMINISTERED RSV AREXVY ABOUT 5 MINUTES, PATIENT WAS SHAKING UNCONTROLLY AND COULDN'T STOP. PATIENT'S HUSBAND CONCERNED ABOUT IT AND ASKED TO CALL EMS WHEN PARAMEDIC ARRIVED THEY CHECKED HER AND TRANSPORTED HER TO HOSPITAL NEARBY.
Nausea after receiving vaccines. Arm pain, unable to move the next day. Dry heaving. Treated with ice and MOTRIN.
Pt received Moderna vaccine 1/12/21.  No adverse reactions.  Moderna vaccine #2 2/19/21.  ED visit 2/21/21 for acute pancreatitis
swelling of the lips and forearms  on 2/22/2021 (6 days after vaccination)
Erythema and induration at site. Indurated area 2cmx2.5cm. Lymphadenopathy left axilla. Follow up report received on 01/31/2005 states adverse event:  swelling, redness, and pain.
Reported by physician's office: red, swollen injection site with possible cellulitis having a red streak towards the axillary (armpit).
This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 13-AUG-2014, the patient was vaccinated with the first dose of an improperly stored GARDASIL (Lot No. J010668 Expiration date: 29-APR-2016). Then, on 15-OCT-2014 received the second dose of an improperly stored GARDASIL (lot no. J010668 Expiration date: 29-APR-2016) (doses, routes and anatomical locations of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient experienced swelling and redness that extended down her upper arm. Painful as well. Patient took TYLENOL on a scheduled basis and used cold packs TID to help with swelling. Symptoms lasted approx 10 days.
2nd pregnancy, at date of first dose (1/10/2021), 12 weeks 3 days gestation. on 2/2/2021 patient developed light vaginal bleeding. Ultrasound exam revealed no fetal heartbeat. Measurements showed gestational size 14 weeks 1 day (1/22/2021).