chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2013US025055 is an initial spontaneous report received from a nurse received on 02 Dec 2013 and a follow up report from the health care professional on 03 Feb 2014. This report refers to a 15-month-old male patient. His vaccination history included FLUZONE (batch number: 49281-038815, other manufacturer) on 28 Oct 2013. He was vaccinated with FLUVIRIN (batch number: 131001; expiry date: not reported) at a dose of 0.25 ml intramuscularly on 02 Dec 2013. No adverse event was reported followed by this administration error. The event outcome, seriousness and causality were not reported. Follow up report from the health care professional received on 03 Feb 2014: Vaccination history was added.
a small amount or a couple of drops dripped back out from the injection site on the arm; 2 droplets that was about an inch dripped out before it stopped and it seemed to be less than 0.4mL; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE DISCHARGE (a small amount or a couple of drops dripped back out from the injection site on the arm) and INCORRECT DOSE ADMINISTERED (2 droplets that was about an inch dripped out before it stopped and it seemed to be less than 0.4mL) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE DISCHARGE (a small amount or a couple of drops dripped back out from the injection site on the arm) and INCORRECT DOSE ADMINISTERED (2 droplets that was about an inch dripped out before it stopped and it seemed to be less than 0.4mL). On 18-Mar-2021, VACCINATION SITE DISCHARGE (a small amount or a couple of drops dripped back out from the injection site on the arm) and INCORRECT DOSE ADMINISTERED (2 droplets that was about an inch dripped out before it stopped and it seemed to be less than 0.4mL) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
fever 103-105 started 2 hrs p/vax & fussiness 2 days later; congestion of ant pillars petechiae on palate;
Approximately 10 minutes after receipt of vaccine, patient appeared to be slumped over on chair she was directed to sit at for post observation period of 15 minutes, she was awakened and stated she felt nauseous and medical aid was offered to which she refused but she did accept water, she was also unsteady on her feet when she located to another chair. Her daughter was notified to pick her up and stated that she always has reactions following vaccines. When her daughter arrived she escorted her out to her vehicle along with another associate for assistance and the entire duration she was observed to be unsteady on her feet and ambulating slowly.
12 month old child brought in for vaccines. Mother elected to have child get HepA, MMR, and varicella. RN gave child HepA, varicella and MMRV (PROQUAD) in error; should have given MMR. Error identified when RN attempted to enter doses in system, and lot number discrepancy noted. Child got two doses of varicella vaccine. Child got combination vaccine which can cause increased risk of febrile seizures. Parent was informed, VIS for varicella and combo vaccine (MMR) given. Questions answered. No adverse reaction at this time; RN supervisor will follow up at 24 hr, 48 hr, 5d and 12d.
Drooping mouth, eye, facial muscles on right side of face; diagnosed as Bell's Palsy
Light headed; dizzy progressing to shaking chills; Given 1 Gm. of Tylenol at 6:45 PM. temp of 102.8 at highest measurement (7:30 PM).Hyperventilation; lower extremity weakness.  8:30 PM.  Taken to Hospital for evaluation on ERMD recommendation. Given Benadryl 25 mg, and Ibuprofen 600 mg.  Symptoms continue.  At 9:45 PM blood drawn for CBC and BMP.  Given Ativan 0.5mg for jerking body movements.   10:30 pm.  Resting more quietly with symptoms subsiding.  All lab results within normal limits.   11:00 PM.  Given 625 mg. Tylenol.  Released to Grandmother to take home.  Went right to bed and slept through until 7 am.   Oral temp at 7 am was 102.  Given 600 mg of ibuprofen.   08:00.  Feeling better; drinking juice and water. 09:00.  Oral temp 99.  Eating soup.   11:00 Taking shower 12:30 PM  C/O feeling cold.  Temp 99.9.  Given Tylenol 1 Gram.
Developed swelling of feet, eyes and rash on legs, 7/28/04. Rabies immunoglobulin 6/25, Rabies vaccine 6/28, 7/2, 7/9, 7/23.
Patient states he received the SHINGRIX vaccine in the morning and 8 hours later he became dizzy, developed a fever of 102, heart racing, states he is feeling better today, just feels "flush", temp 99, his arm at injection site is sore.
BAD FLU; FEELING LIKE CRAP; FEELING LIKE SLEEPING; HIGH FEVER; This spontaneous report received from a patient via a company representative 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced bad flu, feeling like crap, feeling like sleeping, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad flu, feeling like crap, feeling like sleeping, and high fever. This report was non-serious.
10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and flushed and experienced mild difficulty breathing. A rapid response was called, patient noted to have a swollen and red face and neck. 0.3mg IM Epinephrin given. HR 108, SpO2 98% on room air. Patient taken to the emergency department for follow-up. In the ED patient reported feeling anxious, nauseous,  and having a dry mouth. Notes that she had never had a reaction to a vaccine before. Diagnosed with an allergic reaction to the COVID-19 vaccine. Benadryl, pepcid, and Solumedrol given.
Right arm - rash, hot to touch. Measures 2 in. x 3 in. Symptoms were noticed at 5am on Thursday 8/19/10. Vomiting through the night (8/18/10) was given BENADRYL every 6 hrs. until improvement.
This case was reported by a pharmacist and described the occurrence of welt injection site in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. The pharmacist reported that "children" experienced welts at the injection site, however a specific number of subjects was not reported. On an unspecified date on or before 26 April 2007, the subject received unspecified dose of Infanrix in an unspecified thigh. At an unspecified time after vaccination with Infanrix, the subject experienced welt injection site. The pharmacist reported that, "A new nurse's injection technique was evaluated and there was a possibility that the nurse is injecting the subjects subcutaneously instead of intramuscularly." At the time of initial reporting the outcome of the events was unspecified. Follow-up information received on 11 May 2007 indicated that Infanrix was administered to the subject subcutaneously. The events resolved and according to the reporter, they were related to administration of Infanrix.
I initially developed a headache and arm soreness that began about 3 hours after the injection on 2/10/21..  That developed into low grade temp; body aches; chills; sweating; fatigue; nausea; vomiting; loss of appetite, inability to lift left arm above shoulder height and continuation of severe headache.  This continue into 2/11/2021.  Overnight on 2/11/21 I still had chills, sweating, headache and loss of appetite.  As I am reporting this on 02/12/21 I continue to have mild arm soreness and a mild headache along with fatigue.
All day feb 14 2021: fever up to 102 degrees, massive massive headache, some congestion, body ache, chills Started late night 2/14/21 rash on injection site at two places , one round circle  w 1 in diameter, second site was patch about 5in long and 2.5 in wide , rash continues through the present time.
JUL97 pt unable to straighten rt knee;pt seen by MD 7JUL97 rt leg shorter;PE revealed contracture rt knee;MD feels child has femoral nerve neuropathy;dx rt lower extremity paresis;a mass found found floating beneath muscle;
Pt received flu vaccine 10/22/01 and experienced a flu like syndrome for a short while he has had recurrent herpes simplex lesion on her buttocks. episodes went from being very infrequent to 1-2 events every month. Clearly related to menstrual cycle Lesions respond to Denavir (topical).
Received Anthrax, Rabies, and Typhoid vaccines as well as PPD. Within 1 hour of receiving vaccines, started having a headache. Anthrax and Rabies were first time vaccines.
No additional adverse effect reported; Expired vaccine used; Incorrect product storage; This spontaneous report has been received from a medical assistant, concerning a 14-year-old female patient. The patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 18-NOV-2019, the patient was vaccinated with an improperly stored (product storage error) dose of Hepatitis A Vaccine, Inactivated (VAQTA), Lot No. S009562 has been verified to be a valid lot number for (Hepatitis A Vaccine, Inactivated), expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019 (strength, dose, route of administration and anatomical location of vaccination were not reported)  for prophylaxis. Upon internal lot validation, the vaccine was administered after the expiration date (expired product administered).  The vaccine was stored at a temperature range above 47 Fahrenheit degrees (52.09 F) for the time frame of 1.39 hours. the previous temperature excursion was above 47 Fahrenheit degrees (64.83 F) for 13.35 hours and, the call was because of a data logger. No additional adverse effect was reported.
Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA209339, 2018SA209359 and 2018SA209360 (same reporter). This case involves a four years old female patient who received a 0.5 mL third dose of vaccine IPOL (lot N1G41, expiry date: 28-Jul-2019, route of administration was not reported) in the right deltoid on 30-Jul-2018, which was supposed to be discarded related to an excursion and incorrectly stored. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL for Immunisation; MMR for Immunisation and Varicella Vaccine for Immunisation. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered. It was reported that patient had a Polio vaccine from the same vial that was supposed to be discarded related to an excursion. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
This spontaneous case, was initially received from other health professional on 11-Oct-2017, concerning a 37-year-old, adult, male patient. The patient had no medical history and had not received any concomitant medications. On 06-Oct-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, batch number: 195212, expiry date: 30-Mar-2018, route of administration: intramuscular and anatomical location: left deltoid). On 08-Oct-2017 (reported as 2 days after receiving the vaccine), the patient experienced increasing soreness in jaw. It was reported that, the soreness had aggravated. The patient had not consulted any physician. It was also reported that, the patient had no other associated symptoms or other adverse event. At the time of this report, the patient had recovered from the event jaw pain. The reporter assessed the event as non-serious. Follow-up received on 18-Oct-2017: It was reported that the patient had no other associated symptoms and the outcome was changed from not recovered to recovering. Narrative amended accordingly. Follow-up report received on 24-Oct-2017: The outcome of the event was updated from recovering to recovered. It was reported that, the patient had no other adverse event. The narrative was amended accordingly. Significant case correction received with IRD 24-Oct-2017: No adverse event was deleted.
Administered Engerix-B instead of Pediarix; This case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old male patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th December 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 10th December 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The physician reported that, the nurse inadvertently administered Engerix-B to a patient instead of Pediarix instead of wrong vaccine administered. Lot number was from. The reporter did not consent to follow-up. The health care professional (HCP) said follow-up phone call from safety was okay (not postal or email).
Breakthrough case admission after 4 vaccines Moderna 2/9/21 Lot# 031L20A;  Moderna 3/9/21 Lot# 032M20A;  Moderna 10/27/21 Lot# 076C21A;  Moderna 7/19/22 Lot# 013B22A;
Patient came in for 2nd Hepatitis A, 2nd HPV & 2nd Varicella, Hep A, Varicella given left deltoid, HPV given (R) deltoid. Within 15 minutes of vaccination; patient was having systemic hive reaction. Pt given 25 mg 2 ml BENADRYL when pt discharged was much improved.
Information has been received from a health professional concerning an 8 year old male who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed mild breakthrough varicella. It was unknown if medical attention was sought. The patient's outcome was unknown. The patient was not hospitalized. There was no product quality complaint involved. Additional information has been requested.
Dizzy; Congested; Upset stomach; Beginning of a migraine that did not develop; Fatigue; Constipation; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration in the right arm on 06Apr2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included menopause and osteopenia. The patient did not have allergies to medications, food, or other products. Prior to the 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 included estrogens conjugated (PREMARIN) and ibandronate sodium (IBANDRONATE); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) via an unspecified route of administration in the left arm on 16Mar2021 at 10:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 06Apr2021 at 22:00, the patient felt dizzy, congested, upset stomach, beginning of a migraine that did not develop, fatigue and constipation. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, congested, upset stomach, beginning of a migraine that did not develop, fatigue and constipation was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
low blood pressure (99/71), low heart rate (40-70 bpm), fainting, palpitations
Left arm burning. And cramping in elbow tingling in fingers for over a month. Went to healthcare facility to check if should still get 2nd shot they told me I would need to see a neurologist. I got the 2nd shot 3 weeks after first shot and now issue spread into my neck muscles and leg cramps. Seems to be worse when it rains. Told me take anti-inflammatory but no help. My doctor gave me muscle relaxers neither has helped try ice and heat. Arm still burns. Took xrays. But I couldn?t get appointment with neurology til mid May.
Resident noted with a diffuse area of erythema (19x12cm) and warmth to right deltoid area. Venous distention noted to right lower arm. Denies pain or itching. No resp.distress, no hives, tongue WNL, handles secretions normally. No change in ROM or hand grips.  Physician notified, New order for Benadryl 25mg po q6hr prn.  11/13/05 Only slight pinkness remains to area.
Information has been received from a 75 year old female with high cholesterol, thyroid problems, allergy to MINOCIN and a history of knee replacement who in November 2007, was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included SYNTHROID. The patient had shingles twice since the vaccination. Once in January 2008 on her right side and again on 09-JUL-2009 the patient experienced shingles again beginning on her left side. She had extreme itching and pain that prevents her from sleeping. She had been prescribed prednisone, hydrocodone and a sleeping pill for the current shingles. Unspecified medical attention was sought. Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 17-OCT-2007 (previously reported November 2007), at pharmacist administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2008, the patient was treated by the patient's healthcare providers for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered not recovered. The causality of the events is related. Additional information has been requested.
Pt reports high fever - general body aches headache and difficulty breathing - denies feeling of throat closing - chest tight.
10 yo in for 1st Dose of Monovalent mistakenly given 5-11 Bivalent Booster. Primary onsite staff marked monovalent appt CR as false and created this new 5-11 Bivalent Booster appt for child in order to accurately report dose given. CDC rec in this case is not to administer monovalent 1st Dose. Child should return for a Monovalent 2nd Dose in 3 weeks.
Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site). On 16-Jan-2021, VACCINATION SITE RASH (Rash at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
reconstituted Shingrix with other non GSK diluent; reconstituted Shingrix with other non GSK diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number L55HS, expiry date 10th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional case details were reported as follows: The reporter was a medical assistant. The age at vaccination was not reported. The nurse reconstituted Shingrix with other non-GlaxoSmithKline diluent and gave it to the patient which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. There was no information about the patient involved at the moment of the reporting or day of occurrence. The reporter need time to gather all these details. The reporter consented to follow up by email.