chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on her arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness on her arm). On 26-Feb-2021, VACCINATION SITE PAIN (Soreness on her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant Medication was provided. No treatment  was provided.  Description:25Feb2021 and 26Feb2021 she experienced soreness on her arm.   This case was linked to MOD-2021-100002 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30 Apr 2021:Updated event outcome to resolved.
Adverse event: severe very painful and dizzying headache. Treatment: ibuprofen (1 dose). Outcome: most of headache gone, but faint lingering headache (untreated) until past 50 hours from time of vaccination.
Fetal Demise 3 days after receiving seasonal influenza vaccine at 10 weeks pregnant.
The MCV4 and MCVB vaccines were administered on the right arm and then the HPV (GARDASIL 9) vaccine was administered on the left arm. Immediately, patient states that she felt nauseous and fainted, rigidity on the hands, cyanosis on the forehead, loss of consciousness, sweats, and a little difficulty breathing.
Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SAS092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA09512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092725 (same vaccine). Objective: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. Methods: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. Results: Since 2013, 7, 378 women who were offered the Tdap vaccine antenatally developed at our institution: 7, 152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.77 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4, 159). Conclusion: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of TDAP (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. Ad Tdap vaccine was exposure in utero, out of total 2, 093 number of neonate patients out of which 206 (3 percentage) patients birth weight was observed less than the third percentile, 364 (5 percentage) patients birth weight was observed less than the fifth percentile, 714 (10 percentage) patients birth weight was observed less than tenth percentile and 809 (11 percentage) patients birth weight was observed greater than the ninetieth percentile. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
No adverse event; Patient had dose 1 on 25 Apr 2023 and dose 2 on 03 Jun 2023; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 25 Apr 2023 and dose 2 on 03 Jun 2023) and NO ADVERSE EVENT (No adverse event) in a 10-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 03-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. On 03-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 25 Apr 2023 and dose 2 on 03 Jun 2023). In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 25 Apr 2023 and dose 2 on 03 Jun 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 25 Apr 2023 and dose 2 on 03 Jun 2023).    The route of administration of suspect Moderna bivalent was reported as BI. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Swelling; Rash; This is a spontaneous report from a contactable other hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced swelling, rash. The outcome of events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Following Paxlovid I tested negative; Following Paxlovid I tested negative; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 08Mar2021 as dose 2, single (Lot number: EN6204), in left arm, on 30Aug2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 14Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Gluten intolerance" (unspecified if ongoing); "Known allergies: Almonds" (unspecified if ongoing); "Known allergies: Maple products" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "not recovered" and all described as "Following Paxlovid I tested negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (unspecified date) Negative, notes: Following Paxlovid I tested negative; (04Aug2022) Positive, notes: Covid rebound. Asymptomatic. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Antiviral details: Paxlovid indicated for COVID 19 Treatment. Treatment start date was 22Jul2022 and treatment stop date was 27Jul2022. Following paxlovid, I tested negative, but 5 days later on 04Aug I tested positive again-Covid rebound. Asymptomatic. No other medication in 2 weeks.
13MAY91 mom described swelling in front under & behind ear; 14MAY91 TC to mom advised to call MD; Mom states bruise on face front of ear; Thought pt had fallen & got bumped;
the site was swollen and red, draining pus; the site was swollen and red, draining pus; the site was swollen and red, draining pus; This is a spontaneous report from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received the first does of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Mar2021 13:15 (Batch/Lot Number: EN6204) (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, spinal neuropathy and allergy to latex. Concomitant medication included atenolol taken for an unspecified indication, start and stop date were not reported. Past drug history included the patient had allergy to acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the site was swollen and red, draining pus and she cleansed the area and it was size of a walnut. The area opened on its own with a moderate amount pus. The patient had no fever. She had been cleansing and keeping the area clean and dry. She kept applying antibiotic and cove. It was red but no drainage. It had not spread. The patient had no other symptoms. The outcome of events, the site was swollen and red, draining pus was recovering.  No follow-up attempts are needed. No further information is expected.
The patient reports developing a painful itchy rash on right shoulder around 6/8/2020. Rash progressed up right side of her neck to her ear. The patient was evaluated by me with a televisit on 6/18/2020. Photos were taken of the rash and it was diagnosed as herpes zoster. The patient started treatment with valtrex.
Client  presented to the vaccination site on 11/04/2021. The client notified  RN that he received COVID vaccine on 04/29/2021.  RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the Janssen COVID vaccine. Per CDC guidance, approval to proceed with COVID vaccine Janssen was obtained from medical consult team. Client received COVID vaccine (Janssen, Lot# 1855194) on 11/04/2021 at 12:04 pm. The client did not report any symptoms during the 30 minute observation period.  RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 12:40 pm, walking with steady gait.
Red edematous rash around injection site and expanding down upper part of arm. Painful to touch and warm to touch.
Large site reaction. ~3-4 inch diameter red, swollen area. Hot to the touch, painful, itchy.
Pt. had rash on entire body, felt hot and lethargic for a few days.
Patient received COVID Moderna on 03/15/2021 by PCP office. On 04/09/2021, received a COVID Pfizer vaccine. Report created per RN, for documentation purposes in case of any future symptoms, due to different brands were administrated.
This spontaneous report was received from a physician refers to an elderly female patient of unknown age. On 31-JAN-2013 at 09:00 a.m. the patient was vaccinated with ZOSTAVAX (lot #, expiration date and route not reported). No concomitant medications were reported. Physician stated that he reconstituted ZOSTAVAX on 30-JAN-2013 at 8 PM, kept it on ice and administered the ZOSTAVAX to the patient on 31-JAN-2013 (reported as this morning at 9 AM. No adverse effects reported. Physician stated he had no other information for this patient. Additional information is not expected.
Pt recv vax on 10/12/98; on same day pt exp fainting; felt lightheaded x 1-1.5 hr, stiff limbs, jerky arm movements, nausea
A report was received from a health care professional on 2/16/04 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/31/03 and 12/3/03. On 10/31/03 and 12/3/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
29 hours after shot, had an allergic reaction; Throat did not close but the whole face swole up; Could not stop shaking; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Aug2021 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to tree nuts, anaphylactic. The patient always carried a epinephrine (EPIPEN). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 29Aug2021, 29 hours after the shot, the patient experienced an allergic reaction. The patient's throat did not close but whole face was swollen up and the patient could not stop shaking. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events allergic reaction, throat did not close but the whole face swole up and could not stop shaking were recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to our office 07/14/2016 with a localized 2cm erythema on the upper right arm warm to the touch and painful per patient.
This spontaneous report as received from a 36 year old female, non pregnant consumer with no drug reactions or allergies and no pertinent medical history, who is also the patient. On 01-JAN-2013 the patient was vaccinated with the first dose of GARDASIL (dose, route and site of administration) (lot number and expiration date were not reported). There was no concomitant medications.  The patient was due to receive her third dose on 01-JUL-2013, but she decided to postpone getting her final dose of GARDASIL, because she developed the flu "a couple of weeks ago" (exact date unspecified), in 2013. The patient did not seek medical attention. No lab tests were performed. She was given TYLENOL as a treatment of adverse event. At the time of the report the patient's condition was not improved and she did not recover from the flu. The relatedness between the vaccination with GARDASIL and flu was not reported. Additional information is not expected.
Started feeling ill the following day. She felt like she had the flu aching and sleeping all day. Area is swollen and red and in the middle a white area the size of a fist. It has now blistered and arm hurts.
Patient stated she was having some SOB after being vaccinated. She states she is Asthmatic and have not had her nebulizer treatment in over a week, because she had received a new one and had no idea how to set it up. Patient's VS was stable and Sat @ 95% - 97% on RA. Patient urged to take 2 puffs of her Xopenex treatment. Patient was then monitored for an additional 10 minutes after which she states felt well enough to go home. Patient accompanied by her husband to home in stable condition
fever; some chills; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) and CHILLS (some chills) in a 76-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (some chills). At the time of the report, PYREXIA (fever) and CHILLS (some chills) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.    This case was linked to MOD-2023-723031 (Patient Link).
At the time of the injection patient had immediate tingling and "electric" sensation. After 15 minutes, patient had reddness and soreness at the injection site. Left arm remained sore throughout the day. Patient ran 3 miles on a treadmill from 8:30-9:15.  At 10:20 p.m. the upper arm became painful to touch and uncomfortable to use. The patient took 2, 200 mg ibuprophen for pain and went to bed. In the morning the arm was still sore to touch, but much less painful than the night before. In the afternoon it continued to be sore and uncomfortable, but did not impede daily activities.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy", notes: like I did with my codeine allergy. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Caller states she had a reaction "like I did with my codeine allergy" to the 1st Pfizer vaccine dose". Additional information: Caller stated she was just speaking to "PRIVATE" regarding side effects. Caller states her 1st dose was 3 weeks ago this coming Saturday, 17Apr2021, and is scheduled to receive the 2nd dose on Saturday, 17Apr2021. Caller states she had a reaction "like I did with my codeine allergy" to the 1st Pfizer vaccine dose. Should I get my 2nd dose? How much protection do I have from taking one dose? No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Ipol vial that was exposed to a temperature excursion; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  It was linked with 2019SA130411, 2019SA130412 and 2019SA130410.  This case involves a 2 months old male patient who that was exposed to a temperature excursion, while he received 0.5 ml vaccine IPV (VERO) [IPOL] on 24-Apr-2019 (lot: P1A242M)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HIB VACCINE (HIB) for Immunisation; and ROTATEQ for Immunisation.  It was of actual medication error due to incorrect product storage. It was reported vaccine underwent the following elevated temperature excursion on 23 Apr 2019 at 1:05 pm the temperature was 46.4 degrees Fahrenheit, at 2:05 pm the temperature 46.7 degrees Fahrenheit , and by 2:35 pm it had returned to within range at 45.8 degrees Fahrenheit.  It was unknown whether adverse event was experienced.  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 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.  List of documents held by sender: none.
Hep B #1 given 1/23/04- outdated 1/11/04.
101 fever, severe chills (shaking), severe body aches, headache, fatigue from 7pm on 4/14 to 8:00am 4/16. Covid arm (red rash) under injection site appeared 4/16.
administered dose past the manufacture expiry date (2nd dose that was expired when administered on 15Oct2021 Lot#050E21A  Exp 13Oct2021); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date (2nd dose that was expired when administered on 15Oct2021 Lot#050E21A  Exp 13Oct2021)) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date (2nd dose that was expired when administered on 15Oct2021 Lot#050E21A  Exp 13Oct2021)). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date (2nd dose that was expired when administered on 15Oct2021 Lot#050E21A  Exp 13Oct2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided. 9 patients were administered dose past the manufacture expiry date along with patient. 3 doses administered on 15-Oct-2021 and 6 doses administered on 22-Oct-2021.