chrisvoncsefalvay/vaers-outcomes huggingface dataset:
during administration, half of the medication appeared to be running down her arm with no A/E; during administration, half of the medication appeared to be running down her arm with no A/E; Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious case received via a pharmacist via consumer (under Medical Information  Inquiry Number: 00819363) in a specific country.  This case involves an 18 years old female patient, while administering INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] half of the medication appeared to be running down her arm (underdose) and during administration, half of the medication appeared to be running down her arm (exposure via skin contact) with no reported adverse event.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 19-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  It was case of an actual medication error due to vaccine underdose and exposure via skin contact (latency: same day).  It was reported "However, the patient reported to the pharmacist that during administration, half of the medication appeared to be running down her arm and was not administered correctly. The Pharmacist would like to know if the dose should be counted as valid or if it should be repeated."  At the time of reporting, no adverse event was reported.  There will be no information on lot number for this case.  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.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 63 year old male patient who received 0.5 ml dose of FLUZONE HIGH DOSE (batch number, expiry date, site of administration were not reported) in left arm on 03 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration as Pharmacist reported a dose of FLUZONE HIGH DOSE given to a patient under 65 years of age. No known reported side effects 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 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 sender: none.
Pt developed large painful lump (approximately 2 in diameter) and bruising where flu shot given; took BENADRYL and acetaminophen to help with symptoms.
It was reported in a published article, that an 18 month old pt who in approximately March 1996 was vaccinated with a first dose of MMR II (no Thimerosal). Prior vaccinations included a first dose of hep B vaccine recombinant (manuf unk) (parenteral Mercury dosage 12.5mg HG as Thimerosal) on approximately 12/15/94, a second dose in approximately February 1995 and a third dose in approximately June 1995. The pt also received the frist dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid (manuf unk) (parenteral Mercury dosage 25mg Hg) and HIB conjugate vaccine (manuf unk) (parenteral Mercury dosage 25mg Hg) in approximately February 1995, the second dose in approximately April 1995 and the third doses in approximately June 1995. The pt received a fourth dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid (manuf unk) parenteral Mercury dosage 25mg Hg) in approximately June 1996 at the age of 18 months. It was reported that this was a "regressed autistic child with normal development until 18-20 months of age, then loss of speech, eye contact, social interaction and attentiveness." It was also reported that the pt exceeded the concern level for total mercury exposure. Upon internal review, autism was considered to be an important medical event (OMIC). Additional info has been requested. It was also reported that a second pt developed necrotizing measles lymphadenitis after being treated with MMR II (WAES0304USA00946).
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
was diagnosed with cellullitis at the injection site; This spontaneous report was received from an office manager via a company representative, referring to a 69-year-old female patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were unknown by reporter.  On 03-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, frequency, route of administration, and anatomical location were not reported, lot number and expiration date were unknown by reporter).  On 06-FEB-2020, the patient returned to the office and was diagnosed with cellulitis at the injection site. The patient sought medical attention and was given an unspecified treatment for the adverse event. It was unknown if laboratory diagnostics or studies were performed. The outcome of injection site cellulitis was reported as not recovered.  The causality assessment between the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the occurrence of the aforementioned event was not reported.
Patient came to a school wide vaccine clinic. Parent filled out her form and wrote child's birthday as 04/16/2016 making the child 5 years old and eligible for the vaccine. When entering her info into system we could not find a previous account for the child, so we created a new one with the birthday of 4/16/2016. Upon entering the vaccine into our pharmacy system and running the patients insurance for a administration fee, we discovered the patients birthday is actually 4/16/2017 making her 4 years old. We contacted her mom and mom stated that she "did not know the vaccine was only for 5 year olds". When questioned about the inaccurate birthday on the form, she was not able to respond why she wrote 2016. I advised her that the child would not be able to receive her second vaccine until she was in fact 5 years old and to follow up with the pediatrician for information on vaccine series at that time.
Case number PHEH2013US023615 is an initial spontaneous report received from a pharmacist on 08 NOV 2013. This report refers to an 8-years-old male patient. His medical history and concomitant medications were not reported. The pharmacist reported that this patient under 18 years of age received FLUCELVAX 2013/2014 (batch number: 006031A) intramuscularly on 08 NOV 2013. No adverse event was reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 08 NOV 2013. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Patient was given first bivalent booster earlier than recommended time frame between last booster and bivalent booster.  Provider did not inform staff that patient had received a regular pfizer booster on 09/07 from another pharmacy.  We administered bivalent booster on 10/05/22.  Guidelines state at least 2 months should pass before the bivalent booster is given.  Both patient and provider were notified.  No adverse reaction was noted per provider.
Vaccines administered after more than 1 temperature excursion; Vaccines administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 11:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 11:34 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.44 for dose administered on 03-Mar-2021 and 67.52 for dose administered on 31-Mar-2021.  No concomitant product use was reported.   It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    On 03-Mar-2021, excursion temperature at 9 am was 51, total doses given for the day was 200, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021. 20 vial was moved to clinic. Vaccine BUD date was 26-Mar-2021 for batch number 014M20A.    On 31-Mar-2021, Excursion temperature at 09 am was 32, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were moved to clinic. Vaccine BUD date was 29-Apr-2021 for batch number 030B21A.  Temperature recordings were taken by a traceable temperature monitor at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
On day 5 after receiving second vaccination, the arm that my vaccination was administered developed red itchy small rash. Maybe headaches, but not certain of cause. Just wanted to report this to help your database.
Spoke to RPh at pharmacy who felt symptoms matched vaccine side effects. Patient had a severe headache and loss of vision and went to the E.R.
Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 57 years old female patient who received 0.5 mL booster dose of vaccine ADACEL lot U5563AA, expiry date-28/02/2019 via unknown route in the left deltoid on 11-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was a case of actual medication error due to Expired vaccine used. No side effects. 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. Documents held by sender: none.
Shingrix shot left me in bed and fever and Asleep for 2 days. Shot left me in bed for 2 days sick.
Redness on right side of neck and of right side of back; Blood pressure was measured at 140/70 and in 30 min it went down to 120/70; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received BNT162B2 (COMIRNATY, Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 at 15:15 as 1st dose, SINGLE for covid-19 immunisation at workplace clinic (30 year at time of vaccination). The patient medical history and concomitant medications were not reported. On 08Feb2021, the patient had his blood pressure checked which shows 140/70 and in the next 30 min it went down to 120/70. The patient also experienced redness on right side of neck and of right side of back. The patient reports about receiving shot of intervenors Benadryl as a therapeutic measure. The outcome of the events was reported as recovered at the time of report on 08Feb2021 (as reported).  No follow-up attempts are needed. No information about batch/lot number cannot be obtained.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 expiry: 11-SEP-2021) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Night of tetanus shot cramps in both legs and arms, then weeks later rash at tetanus area of liver of liver right below left rib, much worse.
vaccine did not protect patient from getting covid as covid test positive with CREON (PANCREATIN)/vaccine did not protect patient from getting covid as covid test positive.; COVID-19 virus test positive; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from AbbVie, (Mfr. Control No.: 21K-163-3804517-00). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on an unspecified date (Batch/Lot number unknown, expiration date unknown) as SINGLE DOSE for covid-19 immunisation; pancreatin (CREON), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. This was a social media report by a consumer of a female with an event of non-serious COVID-19 vaccine did not protect patient from getting covid as covid test positive with CREON (PANCREATIN). There was no reported medical history. In 2021, the patient experienced covid-19 vaccine did not protect patient from getting covid (drug ineffective) as COVID test was positive on 28Feb2021. Thus, COVID-19 VACCINE was also considered suspect. Reporter causality not provided. The action taken in response to the event for pancreatin was unknown. The outcome of the events was unknown.  The reporter's causality for the event(s) of COVID-19 VACCINE DID NOT PROTECT PATIENT FROM GETTING COVID AS COVID TEST POSITIVE onset in 2021 and COVID-19 VACCINE DID NOT PROTECT PATIENT FROM GETTING COVID AS COVID TEST POSITIVE onset 28 Feb2021 was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling of lower lip starting one day after vaccine administration, and lasting a week and a half. Patient reported lip also appeared to look like a chemical burn. Symptoms went away by themselves after a week and a half.
Exposed to Covid on the same date as vaccination, tested positive 4 days later -- recovered from that and in March diagnosed with sinus infection that turned into bronchitis... still coughing
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: She passed out for a brief moment a few minutes after the vaccine.  We called 911.  Fire Dept checked her and all vital signs are normal. The paramedic think that she had a brief panic and her blood pressure went down. She was with her mom and mom said this kind of event happened before and she was not concerned.
Pt. felt achy, stayed in bed for about day. 1 day later developed a spreading rash near site of injection.
Information has been received from a pharmacist concerning a 74 year old male patient who on 03-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663894/0129Y) SQ. On 05-MAR-2009 or 06-MAR-2009, 2 to 3 days after administration of ZOSTAVAX (Merck), the patient experienced injection site reactions. The patient experienced erythema, swelling, induration, pruritus, bruising and redness at the injection site. The pharmacist reported that most patients reported redness and itchiness immediately after administration. The patient had sought unspecified medical attention via telephone. At the time of reporting the patient's adverse events persisted. This is one of several reports from the same source. Additional information has been requested.
Had a fever; Chills; Headache; Had major vomiting 8 times; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207), via an unspecified route of administration in the left arm on 29Mar2021 at 11:00 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis, arthritis, shellfish allergy and allergy to bee stings. Concomitant medications included prednisone (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ), calcium (MANUFACTURER UNKNOWN) and ergocalciferol (VITAMIN D); all for unknown indications from unknown date. The patient previously took erythromycin (MANUFACTURER UNKNOWN) for an unspecified indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6203), via an unspecified route of administration in the left arm on 08Mar2021 at 11:00 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks of vaccination. On 29Mar2021 at 23:00, 12 hours post vaccination, the patient experienced fever, chills, headache, and major vomiting 8 times within short period of time. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events fever, chills, headache and vomiting was recovering.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning an approximately 7 or 8 year old who was vaccinated with a dose of Varivax (Oka/Merck). subsequently, the patient developed a full blown case of chickenpox. Lesions count was not available. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
30AUG red rash (entire body), sl fever, body aches;2SEP saw MD w/above sx & itching;11SEP large lump behind ear, large red raised (1cm in diameter) vesicles around waist & between shoulder blades & inner thighs;painful, weak,n,shingles;
Chest pain, irregular breathing, heart rate skipping, fast heart rate and fatigue.  The time course was from 8pm on 12/13/2021 until now at 3:41pm on 12/14/2021.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 38-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 20-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medication was not reported. Patient ID was reported as 8813324.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Reportedly, in this report the patient was not Eligible. Breakdown of doses were reported as 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B.  Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-689946 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689946:
Felt like I was getting a cold, took a COVID-19 test and it was positive. Didn't go to the doctor.
Fever to 104.0 and irritability starting about 12 hours after multiple immunizations (Vaqta, Fluzone, Comvax, Prevnar).  No other symptoms.  Exam unremarkable, urinanalysis normal.  All symptoms resolved in <24 hours.