chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 64-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis at a physician office. On an unspecified date in June 2015, the patient suffered shingles (herpes zoster). As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient caused to suffer serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physician pain and mental anguish including diminished enjoyment of life, the needed for lifelong medical treatment, monitoring and /or medication.  At the time of the report, the outcome of shingles (herpes zoster) was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).
Pt stated it felt itchy the next day of injection (Saturday) or Sunday (2 days after injection) She noticed a bump & redness around the area, it got as big as 7cm, pt iced area for 20mins 3x a day for 1 day. Area is now (as of 8/14/19) 4cm, still itchy and bump is smaller.
Administered a booster dose of Pfizer COVID-19 vaccine that had expired 5 days prior.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 23-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Patient had a sore arm after the administration. This was a dose given outside of recommendations due to an error reporting on the patients behalf.
Information has been received from a 26 year old consumer concerning herself, with no pertinent medical history and no known drug allergies/drug reactions who on 15-DEC-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication reported. It was reported that after third vaccine of GARDASIL, "a week later", she experienced a medium sized lump that had not gone away. It was also reported that she did experience some pain after injection but that had gone away. There were no laboratory diagnostic tests performed. The patient sought unspecified medical attention. Additional information has been requested.
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Feb-2022; Dose administered after 30-day Use By Date/ inadvertently administered expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/ inadvertently administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Feb-2022) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 008C21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/ inadvertently administered expired dose of the Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/ inadvertently administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. Patient did not reported any adverse reactions.  Treatment information was not provided by the reporter.
tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive). At the time of the report, COVID-19 (tested positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 53-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.  Number of doses/vials:173 doses Date the vial was initially stored in the refrigerator was unknown.  The vial did not undergo any temperature excursions.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information
Started itching and I got a rash around it like circular rash one below it one above it and it feels warm to touch and it itches like crazy; Started itching and I got a rash around it like circular rash one below it one above it and it feels warm to touch and it itches like crazy; Hold my hand on the spot it felt warm; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6205, and Expiration date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 73-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included Osteoporosis. The concomitant medications for patient were not reported. It was reported that, on 24Feb (the patient did not know how long it was) she had a bone density test (result unknown). The patient reported that, she received the first COVID Vaccine on 04Mar2021, which was a week ago and (yesterday) on an unspecified date in Mar2021, she noticed she "started itching and I got a rash around it (Clarification unknown) like circular rash one below it one above it and it feels warm to touch and it itches like crazy". The patient stated, "I did not have a fever generally but when I hold my hand on the spot it felt warm" and she was wondering if that was something she needed to be concerned about. At the time of report, the patient was scheduled for second dose on 25Mar2021. No treatment was given for the events. The patient reported that, she had not done anything in response to events, she was just worried about it or something else was happening or maybe they should not get the second one she was not sure. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt came to the hospital related to increase amount and frequent urination and fatigue. She was admitted for hyperosmolar state and started on short and long acting insulin. Pt also asymptomatic for covid. Pt discharged home.   Updated Information VAERS ID: 2267405, Contact info for vaccine administration unknown. Vaccine given on 3/17/2021 and 04/26/2021
HIGH FEVER; CHILLS; SEVERE HEADACHE; PRESSURE IN EYES; COUGH. 2 ASPIRIN TWO TIMES OVER 8 HOURS.
A 12 year old patient was inadvertently administered a dose of the pediatric Pfizer (ages 5-11) vaccine
Information has been received from a physician concerning a 25 year old female (weight 106#, height 60") who on 01-OCT-2007 at 17:00 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot #0530U), IM in the left deltoid. Concomitant medication was not reported. No illness was noted at the time of vaccination. The physician said that the GARDASIL vaccine (yeast) plunger would not push down on the syringe and the needle would not retract. On 01-OCT-2007, two minutes after the injection the patient became unresponsive and her body became stiff. The patient was administered one ammonia inhalant and she became alert and oriented. The patient complained of nausea. Her blood pressure at that time was 120/70. on 01-OCT-2007, the patient recovered from the events. Additional information is not expected.
hives on toes; itching ankles/; rash at vaccination site; bruise on the injection site with a rash on my right arm about an 1 inch above the injection site; hands swollen; my tongue was swollen and my lower lip was swollen; itching hands; hives/hives on my right butt cheek/hives on feet/hives on ankles/hives on hands; hands itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/hives on my right butt cheek/hives on feet/hives on ankles/hives on hands), PRURITUS (hands itching), MOUTH SWELLING (my tongue was swollen and my lower lip was swollen), VACCINATION SITE BRUISING (bruise on the injection site with a rash on my right arm about an 1 inch above the injection site) and PERIPHERAL SWELLING (hands swollen) in a 42-year-old female patient 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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 25-Feb-2021, the patient experienced URTICARIA (hives/hives on my right butt cheek/hives on feet/hives on ankles/hives on hands) and PRURITUS (hands itching). On 26-Feb-2021, the patient experienced MOUTH SWELLING (my tongue was swollen and my lower lip was swollen) and PRURITUS (itching hands). On 27-Feb-2021, the patient experienced VACCINATION SITE BRUISING (bruise on the injection site with a rash on my right arm about an 1 inch above the injection site), PERIPHERAL SWELLING (hands swollen), PRURITUS (itching ankles/) and INJECTION SITE RASH (rash at vaccination site). On 28-Feb-2021, the patient experienced URTICARIA (hives on toes). On 27-Feb-2021, URTICARIA (hives/hives on my right butt cheek/hives on feet/hives on ankles/hives on hands) and PRURITUS (itching hands) outcome was unknown. At the time of the report, PRURITUS (hands itching), MOUTH SWELLING (my tongue was swollen and my lower lip was swollen), VACCINATION SITE BRUISING (bruise on the injection site with a rash on my right arm about an 1 inch above the injection site), PERIPHERAL SWELLING (hands swollen), URTICARIA (hives on toes), PRURITUS (itching ankles/) and INJECTION SITE RASH (rash at vaccination site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: follow up received on 12-mar-2021 no  significant followup received
Pain at injection site beginning at about 6:00 pm 2/6, by 10:00 severe chills began resulting in uncontrollable shivering that caused my entire body to shake.  By about 10:30 pm severe muscle pain began. The pain was so severe I was unable to sleep much that night. despite also experiencing fatigue. Severe muscle pain, severe fatigue,  and intermittent severe chills continued throughout the next day, 2/7.  Today is 2/8 and I have only mild muscle pain and injection site pain remaining, as well some mild fatigue.  I treated it by taking Aleve, 2 tablets at 10:30 pm 2/6, 1 tablet 10:30 am on 2/7, and 1 tablet 10:30 pm on 2/7.
day after recieving shot got little blisters pop up on chest. was very fatigued and severe joint pain. no treatment
had first shingrix vaccine on 09 march 2022 and missed his second shot; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 09 March 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: had first shingrix vaccine on 09 march 2022 and missed his second shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023 The healthcare professional (HCP) stated patient who administered the first dose of shingrix on 09 March 2022 and had missed his second shot. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The healthcare professional (HCP) wanted to know if they need to start the series over. No additional information was provided. The reporter consented to followup.
Mother dx with herpes zoster 2 weeks prior by family doctor. Pt dx with chicken pox at college infirmary. 3 siblings also got varicella at this time as well.
26 Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) in a 72-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 007J21-2a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 20-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient did not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  No concomitant medications were reported. No treatment medications were reported.
Case number PHEH2014US003763 is an initial spontaneous report received from a pharmacist on 20 Feb 2014. This report refers to a patient whose age was not reported. The patient's medical history and concomitant medications were not reported. This patient over 55-years of age was vaccinated with a dose of MENVEO (batch number: not reported) intramuscularly on an unknown date. No adverse events were reported following the maladministration.
Patient states intermittent fevers and body aches and pains starting to occur Tuesday morning and most pronounced by noon-time 9/18. States intermittent fevers lasted throughout Wed. night 9/19 and reported to be as high as 104 degrees F. She was sick enough with body aches and pains and high fever to miss work for three days. No fever reported 9/20 but patient was still taking TYLENOL for a sore arm. She had erythema surrounding the site of injection as well as projecting down her left deltoid, but not expandiing past the elbow joint. It was warm to the touch and possibly slightly raised.
Slight fever and chills, swelling at injection site, supraclavicular lymphadenopathy, right
5 minutes after injection had internal thickening of throat and difficulty swallowing. After a couple of minutes swallowing improved but throat thickening continued for another approximately 15 minutes. At 50 minutes after the injection had faint tingling around the mouth and mild throat internal throat thickening again. Took 25 mg of Benadryl. No further s/s.
HCP states they provided patient with Moderna Covid19 Bivalent as primary series instead of Monovalent Moderna Covid 19 vaccine.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP states they provided patient with Moderna Covid19 Bivalent as primary series instead of Monovalent Moderna Covid 19 vaccine.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (HCP states they provided patient with Moderna Covid19 Bivalent as primary series instead of Monovalent Moderna Covid 19 vaccine.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP states they provided patient with Moderna Covid19 Bivalent as primary series instead of Monovalent Moderna Covid 19 vaccine.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP states they provided patient with Moderna Covid19 Bivalent as primary series instead of Monovalent Moderna Covid 19 vaccine.).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
This study case was received from the investigator in a trial on 16 August 2012. A 19-year-old male subject, with a past medical history of psoriasis, experienced a dry cough 10 days after the subject received the following vaccines on 25 July 2012: smallpox (vaccinia) vaccine (manufacturer, lot number, route and site of administration not reported). The subject had a dry cough mostly in the morning with sinus drainage. Subject denied shortness of breath (SOB), chest pain, chest pressure or palpitations. The subject had no other complaints and normal troponin and ECG on 06 August 2012. It was very unlikely that the event was cardiac in nature. No further treatment or follow-up was required. No further information was available at the time of the report. The subject's outcome was not recovered. Follow-up information was received from the investigator on 11 February 2013. Mucous sinus drainage began on 06 August 2012. No additional information was provided. Felt not to represent potential myopericarditis. Nothing more to follow. Outcome remained not recovered. The subject was lost to follow-up. Follow-up information was received from the investigator on 02 January 2014. Concomitant medication included Motrin 800mg orally three times a day beginning on 23 July 2012 for past medical history of right rib pain. Rapid troponin I was within normal limits (negative) and central troponin I was <0.10 ng/ml on 06 August 2012. Dry cough and sinus drainage with mucous were ongoing. The subject was an alcohol and tobacco user. Documents held by sender: Medical records.
Within 1st 24 hours pain edema, erythema about 10-15 cm around injection site. 18-36 hours fever, chills, malaise, lethargy, headache, macular papular rash throughout body.
Initial report was received from a health care professional through another manufacturer on 13 June 2012 under service request number 1-5196539672. A patient, who was 66-years-old at the time of the report, had received an injection of Td  (manufacturer, lot number, route, site and date of administration not reported) about 40 years ago" and an unspecified amount of time later experienced an anaphylactic reaction. Medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: None.
Child had 2-3 minute episodes of unresponsiveness approximately 6 hours after vaccination. EEG with non-focal slowing; MRI NL. Follow up:  This is an 18 day old male with no significant medical history, who was seen in ER last night after having an episode of unresponsiveness times 1 to 2 minutes. The pt was in mother's arms after being fed 15 minutes prior. Mother was holding the pt as he had his eyes open and just looking around. Then suddenly the pt closed his eyes and mother felt he became unresponsive. Mother was not able to get the pt to respond. Mother was touching pt face and rubbing his cheek, but he did not seem to respond by opening his eyes. Mother denies any cyanosis. Mother also states that she grabbed the pt's hand and was trying to get him to respond, but felt he did not respond by grabbing her hand. Mother also states that she did not see any chest movement and could not hear the pt breathing. Mother denies any jerking activity. The pt then awoke within 2 minutes per mother on his own and was acting as he normally does and was acting appropriately thereafter. Mother states that the pt returned to normal activity without any fatigue or drowsiness. The pt did not have any fecal or urinary incontinence. The pt was then seen in the clinic today for follow up of his ER visit from last night, and was admitted by his PCM for prolonged monitoring for this event. Mother states that the pt has had normal PO intake with atleast 8 wet diapers today, with no change in his bowel movements. The pt normal has frequent BMS during the day and stool are yellow in color. No fever, vomiting or diarrhea. There has been a sick contact with the pt's father who has a cough and sister who has rhinorrhea. However, the pt does not have any URI symptoms. Mother also denies any rash or lesions on the skin.  The pt was a term baby born via SVD with no complications. Mother was positive for GBS but treated with antibiotics during her labor. the pt was in the hospital for 24 hrs and then was able to go home thereafter.
N/A, Patient received vaccine 2 days and 6 hours past BUD. Supported by Pfizer. Patient did not have an adverse reaction, vaccine was used after BUD but before expiration.