chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An expired dose of Pentacel was given to a consumer, no AE; Initial information was received on 28-Apr-2021 regarding an unsolicited valid non-serious case from a Nurse.  This case involves a patient (demographics unknown) who was administered dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ225AAA, expiry date: 23-Apr-2021) via unknown route in unknown administration site on an unknown date for prophylactic vaccination (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  The nurse called for recommendation after an expired dose of Pentacel was given to a consumer.  At the time of report, 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 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.
Rash on body. Had MMR #2 on 8/15/07 - HBV #1 on 8/15/07.
Febrile seizure x 2 - seen in ER x 2 7/28 & 7/29.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other= Moderna; dose 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 28Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Apr2022, outcome "unknown", described as "vaccine brand other= Moderna; dose 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested Covid positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medication in 2 weeks. Covid-19 treated with paxlovid, treatment start date was on 09Apr2023 and Treatment stop date was on 14Apr2023. Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
10 x 5cm redness on left thigh (DTaP site) 5 x 5cm induration swelling (no itch/ pain/ fever/ fussiness) observation 48 hours.
Patients guardian falsified DOB when registering for vaccination, stating the minor's DOB. Guardian, consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB which made the vaccine a contraindication.  No known adverse reactions noted.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 16-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
The PT was given lessor dose of covid vaccine. Administered was the .2cc VS .3cc for their age
Patient displayed yellow/blue bruise at site of injection. Stated his arm was sore for a few days after injection but did not notice bruise until 10/21
Approx 30 hours after ZOSTAVAX injection pt experienced swelling and extreme itching around injection site enveloping almost completely around upper left arm continuing to swell for up to 48 hrs then beginning to subside at 96 hrs at which pt returned to normal. No permanent issue appears to have occurred.
On August 13 patient went to a concert and experienced chills; headache; shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 28Mar2021 (Lot number: EP6955) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 13Aug2021, outcome "recovered" (Aug2021), described as "On August 13 patient went to a concert and experienced chills"; HEADACHE (non-serious) with onset 13Aug2021, outcome "recovered" (Aug2021), described as "headache"; DYSPNOEA (non-serious) with onset 13Aug2021, outcome "recovered" (Aug2021), described as "shortness of breath". The events "on august 13 patient went to a concert and experienced chills", "headache" and "shortness of breath" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, headache, dyspnoea.  Additional information:Testing for PCR done in that day and EKG on 16th. All test results normal. Found out she has high glucose linked to stress.The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was Unknown. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown. Since the vaccination, has the patient been tested for COVID-19 was Unknown.  Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine EUA:   Patient reported today 11/12/2021 and has a large, hot, red swollen area on left arm, measuring 8.0cm wide X 7.0 cm long and is located 12.0cm down from scapular/humeral joint.  Patient states that reaction started 11/12/2021 @ 2000, and by Saturday she had red streaks down to near elbow.  She saw a physician yesterday, 11/11/2021, who stated that the injection was given too low.  Provider prescribed Prednisone for the patient and she is taking Motrin.  Red streaks are not present at this time, and large red area is as described below.
On 10/26/2022 the patient above received the Moderna Monovalent vaccine instead of the Moderna Bivalent vaccine. She received .5 ml. She waited 15 minutes in the lobby after the administration of the vaccine without in side affects or reactions.
Patient states pain in arm increased throughout the evening until quite painful. Patient took 2 motrin and pain is better.  Patient is still sore and has some swelling at site. No signs o rash or anyphylaxis.  Recommended patient notifies pcp of reaction to determine if will get second dose in series.
gave 15 patients expired Flublok vaccine with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp. Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received by consumer via non healthcare professional (under Medical Information Inquiry Number- 00814633).  This case involves a 28 years old female patient who experienced gave 15 patients expired flublok vaccine with no reported adverse event (expired product administered) while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 03-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE unknown (lot QFAA2017, expiry 30-jun-2021) via intramuscular route in unknown administration site.  On 03-SEP-2021 the patient reported a gave 15 patients expired flublok vaccine with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "There were 16 patients that were administered the /expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."  Relevant lab data was not reported.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the 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 set out in the 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.
Injection site swelling and redness and achiness starting at day 1 and persisting through day 2
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had sore arms.  No other details were provided. This case linked with US2019AMR206161, US2019AMR206160 and US2019205719, reported by same reporter.
appx 6 hours after immunization given, patient started to feel swelling and itching in eyes which proceeded over the next few hours into high fever (105), chills, disorientation, and other frightening symptoms. Patient will never receive a vaccine again. He is not allergic to eggs.
pregnant female patient received another FLUZONE QIV NP in error with no reported adverse event; pregnant female patient received FLUZONE QIV NP with no reported adverse event; Initial information received on 21-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 20 years old female patient who is pregnant and received Influenza Quadrival A-B Vaccine [FLUZONE QIV] and another Influenza Quadrival A-B Vaccine in error with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The pregnant female patient received Influenza Quadrival A-B Vaccine [FLUZONE QIV] with no reported adverse event occurred at 10 weeks of pregnancy and another Influenza Quadrival A-B Vaccine in error with no reported adverse event occurred at 13 weeks of pregnancy and the patient was exposed to Influenza Quadrival A-B Vaccine at 10 weeks of pregnancy, during first pregnancy trimester for Influenza Quadrival A-B Vaccine.  The date of last menstrual period was reported as 03-Aug-2022. The estimated due date is 10-May-2023.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 25-Oct-2022, the patient received second dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection at a dose of 0.5 ml total (lot number: UT76781MA, expiry date: 30-Jun-2023, Strength: Standard) via intramuscular route in the left deltoid for immunisation. On 29-Sep-2022, she also received a dose 1 of the same vaccine (lot number: UT76781MA, Expiry date: 30-Jun-2023) (Drug Treatment Duration: Once) via intramuscular route in the left deltoid for immunisation  On 29-Sep-2022, the pregnant female patient received Influenza Quadrival A-B Vaccine with no reported adverse event (exposure during pregnancy) (latency: same day) following the administration of Influenza Quadrival A-B Vaccine.  On 25-Oct-2022, the pregnant female patient received another Influenza Quadrival A-B Vaccine in error with no reported adverse event (extra dose administered) latency: 27 days following the administration of Influenza Quadrival A-B Vaccine.  Action taken: not applicable.  Outcome: Unknown   Additionally, at time of reporting, the pregnancy is still ongoing.  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 the 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.
No rash at injection site; however, patient has rash (hives) on forearms, back, behind the left ear, around neck. After taking two diphenhydramine capsules, rash has improved. Patient has been advised to follow up with urgent care as soon as possible.
Per Patient: 3 days after the vaccine she start developing rashes. They look round (ring form) with lighter color inside and little rough around the edges of the rings. It is itching and primarily are all over trunk and neck and some on hands. Pt advised to see doctor for further clinical evauation and recommendation. For itching, anti itch medication was recommended.
pt recv vax 23SEP96 4PM & w/in 10min pt felt shaky;felt muscles contracting when recv vax & started shaking;hands extremely cold & pale, fingernails blue;pt taken to ER w/02;c/o near syncopal episode, chills, diaphoretic;exp hot flash
I contracted COVID-19, I did a telehealth visit with my doctor and was prescribed the antiviral medication Paxlovid; I am currently still taking it. The first night of my symptoms were very intense. I had chills and a high fever. I felt as if a train ran over my chest and very fatigued. I'm currently experiencing a deep level cough, it hurts when I cough and feeling very fatigued. My fever and chills have subsided, I am experiencing a metallic taste in my mouth that goes away when I eat or drink something; then returns.
Chronic migraine, chronic fatigue, dizziness, tingling in body, tinnitus, oversensitivity to sounds and lights, deep thinking leads to extreme mental and physical fatigue, overstimulation of senses. I have been to numerous doctors, currently seeing a neurologist, symptoms have improved somewhat since the beginning, but have not been resolved. I have taken many courses of steroids, trying different migraine medicines, had an occipital nerve block, taken many over the counter pain relievers, valium, meclizine.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 09-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 expiration date: 16-AUG-2015 (route, lot#, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Baby is inconsolably fussy - crying and screaming more than she ever has in her life, for longer periods of time. Will not eat for long periods (only 10 min then screams) and struggles to sleep (wakes screaming or takes extra long to fall asleep).
rigors, fever body aches muscle and joints, awful headache,Back pain diarrhea last from 03/03/2021 0130 am  ending 0715 am 03/05/2021
Given intramuscular instead of oral. Assessed child for adverse reactions for about 30 min. Child had no adverse reactions. No distress noted. Mom advised to come back or visit er if she did notice any other symptoms or reactions.
Received dt on11/11/02 and within a few days she developed pain redness and pruritis in the right upper arm, she also developed a frontal HA. I prescribed Benadryl 50 mg PO QID for the Pruritis . Cool compresses and recheck in two days sooner if necessary.
swollen, itchy lips, some small bumps around the outer border of lip tissue, bumps were also itchy.  top lip was more swollen than the bottom.; swollen, itchy lips, some small bumps around the outer border of lip tissue, bumps were also itchy.  top lip was more swollen than the bottom.; some small bumps around the outer border of lip tissue; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration in arm left on 30Apr2021 at 15:00 (at the age of 17-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no known allergies. The patient's concomitant medications received within 2 weeks of vaccination included bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10), taken for an unspecified indication and multivitamin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0153), via an unspecified route of administration in arm left on 08Apr2021 at 10:45 AM (at the age of 17-year-old) as a dose 1, single for COVID-19 immunisation. It was reported that, the patient was not pregnant at time of vaccination. 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, has the patient been tested for COVID-19 was reported as yes, (COVID test type post vaccination was nasal swab). On 08May2021, the patient experienced swollen, itchy lips, some small bumps around the outer border of lip tissue, bumps were also itchy, top lip was more swollen than the bottom. Treatment received for the events was reported as yes, self-administered over the counter antihistamine. The device date was on 23May2021. The patient underwent lab tests and procedures which included nasal swab, resulted as negative on 19Apr2021, nasal swab, resulted as negative on 26Apr2021, nasal swab, resulted as negative on 03May2021, nasal swab, resulted as negative on 10May2021 and nasal swab, resulted as negative on 17May2021. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Patient presented to the ER on 4/10 with complaints of SOB.  She has been SOB for a few days prior to admission.  She is on 4L of oxygen at home.  In the ED, WBC was 36.9, lactate 2.4.  Admitted for acute on chronic respiratory failure with hypoxia.  Possible trigger of COPD exacerbation could be COVID vaccine.  patient also positive for 3/4 SIRS criteria on admission. She did test positive for COVID in February but did not require hospitalization.  On 4/11, CTA showed tiny LLL PE.  Eliquis began.  Possible adverse event r/t clotting disorders after JJ vaccine?
Maternal exposure during pregnancy; Maternal exposure during breast feeding; No Adverse event; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No Adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No Adverse event). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications was not reported. Patient had a 3 year old and a 2 month old child.  No treatment medications were reported.  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.  Company Comment: This Spontaneous case describes the occurrence of maternal exposure during breastfeeding and maternal exposure during pregnancy in a female patient of unknown age, with no medical history reported, who experienced no adverse event. The exposure occurred after vaccination with an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: No New information received.; Sender's Comments: This Spontaneous case describes the occurrence of maternal exposure during breastfeeding and maternal exposure during pregnancy in a female patient of unknown age, with no medical history reported, who experienced no adverse event. The exposure occurred after vaccination with an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This is a spontaneous report from a contactable healthcare professional received via a sales representative. An 18-year-old male patient received TRUMENBA at 0.5 ml, single and HPV9, both via an unspecified route of administration, on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient almost passed out on an unspecified date after vaccinations. He elevated his legs and felt better. The event was resolving at time of report.