chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (recently testing positive for COVID), NASOPHARYNGITIS (Had a cold since end of November beginning of December.), DRUG INEFFECTIVE (lack of drug effect) and BRONCHITIS (bronchitis) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NASOPHARYNGITIS (Had a cold since end of November beginning of December.). On 15-Dec-2021, the patient experienced COVID-19 (recently testing positive for COVID) and DRUG INEFFECTIVE (lack of drug effect). On an unknown date, the patient experienced BRONCHITIS (bronchitis). At the time of the report, COVID-19 (recently testing positive for COVID), NASOPHARYNGITIS (Had a cold since end of November beginning of December.), DRUG INEFFECTIVE (lack of drug effect) and BRONCHITIS (bronchitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. On 15-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.  Patient Went to the ER / stopped at the ER (on the way home from work as patient was not feeling good at work) and got diagnosed patient thought it was bronchitis but Tested positive for COVID December 15th.  Company Comment:  This is a spontaneous case of drug ineffective concerning a 48-year-old, female patient with unknown medical history, who experienced the unexpected non-serious event of bronchitis and nasopharyngitis and the non-serious AESI event of COVID-19. The patient tested positive for COVID, 7 months after the second dose of mRNA-1273 vaccine.  The rechallenge was not applicable since the events have not been reported after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case of drug ineffective concerning a 48-year-old, female patient with unknown medical history, who experienced the unexpected non-serious event of bronchitis and nasopharyngitis and the non-serious AESI event of COVID-19. The patient tested positive for COVID, 7 months after the second dose of mRNA-1273 vaccine.  The rechallenge was not applicable since the events have not been reported after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
1st in 2019, hasn't received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked, did they need to restart the series. No further details on patient or vaccination. The reporter consented to follow up.
Injection site she found raised place on the arm, it seems to be going down; Right arm, below the injection site she found hardness; Right arm, below the injection site she found a little bit itchy; Right arm, below the injection site she found soreness; Right arm, below the injection site she found redness; A little tired; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Injection site she found raised place on the arm, it seems to be going down), VACCINATION SITE INDURATION (Right arm, below the injection site she found hardness), VACCINATION SITE PRURITUS (Right arm, below the injection site she found a little bit itchy), VACCINATION SITE PAIN (Right arm, below the injection site she found soreness) and VACCINATION SITE ERYTHEMA (Right arm, below the injection site she found redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FATIGUE (A little tired). On 23-Mar-2021, the patient experienced RASH PAPULAR (Injection site she found raised place on the arm, it seems to be going down), VACCINATION SITE INDURATION (Right arm, below the injection site she found hardness), VACCINATION SITE PRURITUS (Right arm, below the injection site she found a little bit itchy), VACCINATION SITE PAIN (Right arm, below the injection site she found soreness) and VACCINATION SITE ERYTHEMA (Right arm, below the injection site she found redness). On 16-Mar-2021, FATIGUE (A little tired) had resolved. At the time of the report, RASH PAPULAR (Injection site she found raised place on the arm, it seems to be going down), VACCINATION SITE INDURATION (Right arm, below the injection site she found hardness), VACCINATION SITE PRURITUS (Right arm, below the injection site she found a little bit itchy), VACCINATION SITE PAIN (Right arm, below the injection site she found soreness) and VACCINATION SITE ERYTHEMA (Right arm, below the injection site she found redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Narrative:  74yo patient at outside community hospital died Oct 4,2021@01:22 from heart attack he had on 9/23/2021 after was placed on life support and was in a coma in the ICU. Wife was considering hospice but pt died prior to transferring to hospice. Pt had received covid vaccines on 1/8/21 & 2/5/21. Likely this death is not related to covid vaccines given patient's age, heart attack, and long length of time between date of vaccines and date of death.
This spontaneous report as received from a nurse who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M000442, expiry date 31-MAR-2018 (dose, route of administration were not reported) for prophylaxis. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 38 minutes and from 47F to 77F for 3 hours and 14 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009203: US-009507513-1709USA010539: US-009507513-1709USA010541.
23JAN98 c/o congestion & cough seen later that day w/T102 R;nl exam;
A pharmacist reported that a female in her 40's received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined on 12/01/99. On 12/02/99, the patient developed an injection site reaction characterized by swelling and tenderness "more severe than usual". The patient was treated with Vioaxx and Claritin. She recovered on 12/09/99.
Case number PHEH2012US020208, is an initial spontaneous report received from a nurse on 12 Oct 2012. This report refers to an unknown aged female patient. She had no history of allergies to eggs, thimerosal etc. It was reported that, she was vaccinated with flu shot four years prior without any negative responses. She was vaccinated with FLUVIRIN (batch number: 123121) at a dose of 0.5 ml intramuscular, on 04 Oct 2012 at 7 am. On the same day at about 11.30 am she passed out. After an extensive work up they could not find any reason other than having vaccinated with flu shot earlier that day. Event outcome, seriousness and causality of the event was not reported.
3"  diameter round swelling and rash at injection site.  Itching.  I took Benadryl and put ice on the swelling on Sunday and  Monday .  It  is less annoying today but still red and hot.
7/28/2023 Vaccine Event    Pfizer 5-11 COVID vaccine bivalent dose was ordered for child (8yM) by MD. Past immunizations, history, and COVID-19 vaccine history was reviewed prior to meeting patient to confirm appropriateness of order. Plan, COVID questionnaire, and double identifications were confirmed with MoC using video interpreter. After obtaining informed consent, the immunization was prepared by myself.    MoC also requested that sibling, who accompanied child during this visit, receive COVID vaccine as well. Sibling is due for Moderna 6m-5 year bivalent dose or Pfizer 5-11 bivalent dose per CDC guidelines for age 5. Both sibs have completed their monovalent series. Records, CDC advice, and immunization history confirmed this plan. Sibling was added to nurse only IZ schedule.    Preparation - Each syringe was correctly labeled and vaccines/identifiers (I.e. vaccine cards, and immunization records), were separated, and 1 pink cap Moderna 6m-5yr dose and 1 orange cap Pfizer 5-11yr dose was brought to the room. Double verifiers again were performed with MoC and children in the room. MoC agreed to verifiers prior to immunization - however, when I confirmed sibling's name and birthdate and gestured to patient, MoC stated that this was correct. However, patient's identifiers were confirmed incorrectly to patient. Due to this confusion, patient (8yM) received pink cap Moderna bivalent for ages 6 months through 5 years, and sibling (5yM) received orange cap Pfizer bivalent for ages 5-11.    After this incident, I reviewed findings with vaccine RN coordinator and supervising MD Dr. Per CDC guidelines, sibling (5yM) received appropriate dose for age. However, patient (8yM received the younger age range for Moderna bivalent). Children have already left home in stable condition. However, I personally called MOC and notified her of error on my behalf. Relayed advice from vaccine supervising RN and MD that no adverse reactions are to be expected, reviewed again expected side effect from COVID vaccine (fever, soreness) versus s/s allergic reactions. MoC was understanding to explanation and verbalized understanding. Instructed MoC to call back should there be any new symptoms or concerns.  7/31/2023 follow up:   F/U with MoC over telephone using interpreter regarding child receiving incorrect COVID vaccine on Friday 7/28/2023. MoC reported that no adverse s/s were noted, and that children are their regular playful selves today. Both child and sibling reported sore arm and fever which resolved in first 1-2 days. Also spoke to CDC and Moderna manufacturing team over telephone, who provided information regarding next steps via online CDC resource for errors. Spoke with MD Medical Director Dr. regarding situation who advised that there are no dangerous consequences for the child, but child may not be fully protected and that another/repeat dose is not recommended at this time. Follow up instructions provided to MoC, who appreciated call.
Information has been received from a registered nurse concerning a 66 year old female with chronic fatigue syndrome, hyperthyroidism, arthritis, stress and incontinence and coeliac disease who in 1995 was vaccinated with PNEUMOVAX vaccine IM 0.5 ml. In 2003 the patient was vaccinated with PNEUMOVAX vaccine IM 0.5 ml. On 03-OCT-2008 the patient was vaccinated with PNEUMOVAX (lot # 662100/0742X) IM 0.5 ml on the right arm and FLUZONE vaccine on the left arm. Other concomitant therapy included LEVOXYL, aspirin, PREVACID, PLAQUENIL, estrogens, PREMARIN, vitamin E, calcium (unspecified) (+) vitamin D (unspecified) and omega-3 marine triglycerides. On 03-OCT-2008 the patient developed temperature of 103f, chills and body aches. On 04-OCT-2008 the patient experienced red raised bumps at injection site of the right arm. On 06-OCT-2008 the patient recovered from temperature of 103f, chill, body aches and red raised bumps at injection site. The patient sought medical attention and spoke with physician on 06-OCT-2008. This is one of several reports from the same source. Additional information has been requested.
enlarged lymph node on the left side of my neck; This case has been considered Invalid as Unspecified AE and Unspecified product. The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 27Jun2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EL1284) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "never smoked" (unspecified if ongoing); "have not drunk alcohol", stop date: 1975, notes: since 1975; "never used illegal recreational drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "enlarged lymph node on the left side of my neck".  The information on the batch/lot number for drug, unspecified has been requested and will be submitted if and when received.  Follow-up (27Jun2023): This is a spontaneous follow-up report from same contactable Consumer. Updated Information Included: Case processed as valid. New reporter, Patient information, Relevant Medical History added. Suspect vaccine information updated. Best doctor. Vaccine Facility Information and New event added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300234680 Same patient and similar event, different vaccine dose (Dose 4);US-PFIZER INC-202300234679 Same patient and similar event, different vaccine dose (Dose 3);US-PFIZER INC-202300234678 Same patient and similar event, different vaccine dose (Dose 2);
Diarrhea started 5 days after vaccination date: green, mucous,  no blood.
PENTACEL was given and noted that was outdated, after checking with state health, was advised to repeat- no adverse reactions at this time.
Pt seen 10:30am swelling and pain noted at day care brought in by grandmother, no history available as to when symptom accured. Rt upper arm swollen, erythematous indurated, tender area. Localized cellulitis 2 hours vaccines. TX with Keflex 250mg TID x 10 Days.
The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a Pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015 the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Pt vaccinated with DTP/OPV 2 hrs later lips turned blue, skin pale, questionable brief period of apnea, hyporesponsive, temp 100.6(R). Treated w/O2 & Tylenol. Quickly improved admitted to hosp for observation.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age with penicillin allergy, asthma, sinus congestion, sinus infection and hypothyroidism. The patient was vaccinated intramuscularly in the gluteus maximus, with a first dose of 0.5 ml of PNEUMOVAX23 (lot number reported as H016283, exp date 21-FEB-2014) on 07-DEC-2012. No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR, albuterol for nebulization, VENTOLIN, FLONASE, ZYRTEC, levothyroxine sodium and PRISTIQ. The nurse reported that a patient developed an injection site reaction described as a cellulitis following vaccination with PNEUMOVAX23 in December 2012. The injection site reaction was described as a swollen, tender, erythematous 5 by 3 inch area at the injection site. The exact development of the swollen, tender, erythematous 5 by 3 inch area at the injection site was unspecified, but the patient contacted the office on 10-DEC-2012. While at the office on 10-DEC-2012 the nurse noted that the patient had a slight limp from the swelling and cellulitis. The patient was given KEFLEX as treatment for the event. The patient also reported that she suffered from muscle cramps in her right knee, hip and buttock region and she also experienced nausea. No lab diagnostic tests were performed. The nurse asked for a lot check. The outcome of the event was unknown. The relatedness for developed an injection site reaction described as a cellulitis following vaccination was not provided for PNEUMOVAX23. The reporting nurse considered the event to be disabling, since the patient could not walk right and limped; she also considered cellulitis to be life threatening. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning an approximately 3 year old female, who on 29-JAN-2007 was vaccinated with the first dose of ROTATEQ (Lot # 656103/1166F), 2ml, orally; on 01-APR-2007, was vaccinated with the second dose of ROTATEQ (Lot # 656189/1239F), 2ml, orally and on 04-JUN-2007, was vaccinated with the third dose of ROTATEQ (Lot # 656392/0239U), 2ml, orally. The physician reported that the patient tested positive for rotavirus. She was hospitalized on 12-MAR-2009 and released on 12-MAR-2009. The patient had to be rehydrated at the hospital. The patient recovered on an unspecified date. Additional information has been requested.
Client reports that 5 minutes after her dose she felt lightheaded, palpitations, flushing of her face and feeling hot.
felt unusual; tiredness; soreness of the arm and hip; soreness of the arm and hip; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Mar2021 as Dose 1, single for Covid-19 immunization. The patient's medical history included asthma (she had asthma but did not feel shortness of breath). The patient's concomitant medications were not reported. She received her first dose yesterday. According to her, she has asthma but did not feel shortness of breath. However, she felt unusual, nothing severe. She felt tiredness, soreness of the arm and hip after the 1st dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Nausea, fatigue, dizziness, vertigo - spent so much time hunched over toilet puking i had to take a hot bath & lay on a heating pad for the back pain
lightheaded/dizzy; has ache in the right arm; loss in appetite; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded/dizzy), PAIN IN EXTREMITY (has ache in the right arm) and DECREASED APPETITE (loss in appetite) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (lightheaded/dizzy), PAIN IN EXTREMITY (has ache in the right arm) and DECREASED APPETITE (loss in appetite). At the time of the report, DIZZINESS (lightheaded/dizzy), PAIN IN EXTREMITY (has ache in the right arm) and DECREASED APPETITE (loss in appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: She doesn't have an email address. She stated she is fine now and had both shots.
TOOK ONE DOSE A WEEK AGO AND THEN FORGOT ABOUT THE REST; This spontaneous case report (PVX2019-2455) was received from a pharmacist on 27-Sep-2019. It described a male consumer who "took one dose a week ago and then forgot about the rest" (PT: Incomplete course of vaccination), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took only one dose of Vivotif a week ago and then forgot about the rest.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took one dose a week ago and then forgot about the rest" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose a week ago and then forgot about the rest" was considered as not applicable.
OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced out of specification product use. The action taken with covid-19 vaccine  was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.