chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient never received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd May 2018 with batch number 5NY3B).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: The pharmacist enquired if they should repeat the dose or would the patient had to start over since it had been over 6 months. The registered pharmacist (RPH) reported that, the patient never received the second dose. The registered pharmacist mentioned patient was coming to get the second dose. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
COVID-19 vaccine to a 16 year old; A spontaneous report was received from a nurse concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, COVID-19 vaccine to a 16 year old.  The patient's medical history was not provided. Concomitant medications were not reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported. The reporter stated, the patient would like to receive dose two to complete the vaccine series.    The event, COVID-19 vaccine to a 16 year old, was considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a 16-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of drug administered to patient of inappropriate age. The event is assessed as not related to Moderna COVID-19 Vaccine.
Patient Had 2nd Covid shot on Friday Feb 5th started having diarrhea on 2/7/21 and then on 2/8/21 continued dairrhea. in am and then 2/8 pm patient began getting short of breath, low grade fever, cough and wheezing
I started feeling sick that night after I went to an early dinner. I thought I feel a little funny so I took my temp it was 99 low grade, it was slowly rising the highest it went was 100.1. I started having chills so I notified the people I had dinner with. I had congestion. I did lose taste and smell. I lost my appetite completely for about 2 days. I tested positive August 9 two days after I started feeling sick. I got the antibody infusion August the 11th at Hospital. The next morning I started feeling better. I stayed home for 10 days though I was already feeling better.
Redness, induration of injection site 45 mm-tightness of throat, fever 101F, chills, localized pain, nausea, vomiting, diarrhea.
Rash on body-mom will try Benadryl-if doesn't improve will be seen. Mom also put child in polyester last night and thinks that might have caused rash. Will use different clothing.
fever 101, soreness, red dot; 2 1/2 days w/fever on 13DEC95 fever was 103;
I immediately had a metallic taste in my mouth and became lightheaded. Arm became very sore as the day went on. Metallic taste lasted about 12 hours. Stomachache and feeling generally unwell came on about 4 hours after administration. Also felt like of "out of it" and sickly. Felt better after about 12 hours. Arm was sore for about 48 hours.
(L) upper arm localized swelling - tightness - pain.  Shot was not given in the deltoid (visible shot mark close to shoulder).
Immun given 12AUG91; pt began to exhibit fever 1-2 hrs post vax; t100 R; given APAP; pt taken to ER 13AUG91 around 1030 next day rectal temp high when entered ER; pt had sz & lifeless w/odd color; pt ill but sx began to resolve;
TESTED + FOR COVID ON   2-2-22 AT HOSPITAL DECEASED 2-22-22
Woke up eight days after my first dose with a large red welt at the injection site. It feel warm but otherwise doesn?t seem to hurt or itch. It is just unsightly and weird.
Mild soreness at injection site 8 days after injection, then developed swelling, pain, redness in both axillas as well as his groin. He also had tightness of his chest and wheezing with profuse sweating. Taken to ER. WBC elevated to 17,000, was given Pepcid and Benadryl. Admitted for observation; symptoms resolved next morning and patient was discharged.  8/29/08 Reviewed hospital medical records of 8/16-8/17/2008. FINAL DX: allergic reaction Records reveal chest pain, SOB, pain of right axilla & left groin, myalgias.  About a week after vaccination, developed swelling, pain, redness bilateral armpits & goin, wheezing, chest/neck tightness & diaphoresis.  No reaction from previous vaccinations.  ER exam revealed tenderness of right axilla but no adenopathy.  Had shotty lymphadenopathy left groin.
Swollen right arm pit and right neck Arm pain at vaccine location Lower back pain  Leg numbness Groin pain General malaise
Day one sore arm. Day two sore arm, extreme tiredness, extreme pain in arm when trying to use it. Day three tiredness gone. Day four and five arm still has shooting pain when using. Day nine rash breaks out on forearms, both arms. Day ten rash spreads to shoulders and back of neck. Like chicken pox. Starts off small and begins to blister. Extremely itchy and uncomfortable. See Dr and he prescribes natural herbal remedies with  water, rash begins to go away after five days of treatment. Pain in upper arm remains through to June 16. Return to Dr and he noticed swelling still in the upper arm muscle. Pain is not as severe but moving the arm certain ways causes a high level of pain.
pt fussy 9SEP90, crying, collapsed loss color, no breathing cyanosis rt side; convuls, erratic heart rate; called 911 slept all afternoon; later another sz;
fatigue and sudden throbbing pain radiating from left side of neck to shoulder, down to arm and back area that progressed to opposite side of vaccination site.
Shortness of Breath,  dry cough began approximately a month later.  I have sought treatment from my allergist , assuming it was asthma,  but the symptoms have been non-responsive to medications.
Pediatric patients be given Havrix Adult Dose; Pediatric patients be given Havrix Adult Dose; This case was reported by a other health professional via sales rep and described the occurrence of overdose in a 18-year-old male patient who received HAV (Havrix adult) (batch number EK59B, expiry date 20th November 2020) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were 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 were provided as follows: The age at vaccination was not reported. The reporter stated that, the pediatric patient received Havrix adult dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This was 3 of 4 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR159012:Same reporter US-GLAXOSMITHKLINE-US2021AMR159011:Same reporter US-GLAXOSMITHKLINE-US2021AMR158998:Same reporter
Skin over r/deltoid warm to touch, tender to touch and erythema is present and 50mm of edematous skin of the deltoid area.Montored over the course of three days.  Area resolved at the end of three days.
Massive saddle block pulmonary embolism occurred approximately 0800hrs.  06/24/2021
Information has been received from a medical assistant concerning a 14 year old female patient who on 28-AUG-2009 was vaccinated with a first dose of GARDASIL (Lot# 1129F) and on unspecified date was vaccinated with a second dose of GARDASIL (Lot# 663454/0672Y) and on approximately September of 2010 was vaccinated with a third dose of GARDASIL (Lot# 663454/0672Y). Concomitant therapy included MENACTRA and Tdap, "the same day of her last injection". The medical assistant stated that the patient experienced changes in her menstrual cycle after being administered GARDASIL. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient was upset/e patient was not happy about this; first dose of Moderna but a 0.25 mL,Two boosters given as a primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ANXIETY (Patient was upset/e patient was not happy about this) and INCORRECT DOSE ADMINISTERED (first dose of Moderna but a 0.25 mL,Two boosters given as a primary dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A and 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced ANXIETY (Patient was upset/e patient was not happy about this) and INCORRECT DOSE ADMINISTERED (first dose of Moderna but a 0.25 mL,Two boosters given as a primary dose). At the time of the report, ANXIETY (Patient was upset/e patient was not happy about this) outcome was unknown and INCORRECT DOSE ADMINISTERED (first dose of Moderna but a 0.25 mL,Two boosters given as a primary dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient came in to get the first dose of Moderna but a 0.25 mL booster dose and HCP again give a second 0.25 mL booster dose was given to make a total 0.5 mL and patient was not happy about this, but was not experiencing any side effects.   No Concomitant product use was reported. No treatment information was provided.
This case was reported by a health professional and described the occurrence of an injection site reaction in a 30 year old female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. On 7/24/03, the pt received the second dose of Engerix B (5371A4). On 7/25/03, one day post-immunization, she developed an injection site welt that was raised, hot, tender and that itched. The pt was seen by the physician.
fever (low-grade), chills, body pain (myalgia), headache, weakness, nausea and retching which started ~ 12 hours after injection and lasted approximately 24 hours (ended 36 hrs from injection time); soreness at injection site ongoing as of 3/18/2021 but resolving
Soreness at the injection site/The symptom lasted for various weeks; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th March 2022, the patient received the 1st dose of Shingrix. On 7th March 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's comment:The same day after the Shingrix shot patient felt soreness at the injection site.  The symptom lasted for various weeks and eventually resolved.  The reporter did not consent to follow up. The reporter was provided information per package insert (PI) on adverse reactions and provided medical advise disclaimer.
Right hip pain with standing and walking, started 1 day after vaccine, got worse for 1 week, then got better
Pt received varicella vaccine on 10/4/16, red spots appeared on pt's face 5 days after vaccine administration, new lesions gradually over other parts of body, some with watery discharge. Presented in office on 10/21/16 with red bumps on legs, back and face. Mom used Aloe moisturizer, BENADRYL CREAM and CERAVE at home. No medication prescribed. Instructed to use calamine lotion for itchiness.
Patient describes strong headache on 01/29/21-01/30/2021 to right side of head, behind right eye and down into neck. Took some ibuprofen with some effect but not completely resolved.
A few days after first dose noticed ringing in both ears and didn?t really think it was related to vaccine. Condition worsened after second injection.
Possible overdose; This non-serious case was reported by a consumer and described the occurrence of overdose in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G9577) for prophylaxis.   Concurrent medical conditions included hypertension and blood cholesterol increased.   On 21-AUG-2023, the patient received Arexvy 1 ml. On 21-AUG-2023, an unknown time after receiving Arexvy, the patient experienced overdose (Verbatim: Possible overdose).  The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2023 The patient self-reported this case. The patient was receiving concomitant including Generic Ziac for hypertension and Generic Crestor for high cholesterol. The patient stated he received the vaccine at a local pharmacy. Their report indicates that he got a 1 ml dose, but GSK PI (package insert) shows that a standard dose was 0.5 ml. The patient asked if all this was correct, did he had something to worry about. The reporter gave permission to contact. The patient received vaccine dose more than recommended, which led to overdose.
had COVID twice/Caller also added: I've got my whole battery of COVID vaccinations with Pfizer.; had COVID twice/Caller also added: I've got my whole battery of COVID vaccinations with Pfizer.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team and product quality group. The reporter is the patient.  A 72-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "congenital absence of 100% IgA" (unspecified if ongoing); "IgG monoclonal gammopathy." (unspecified if ongoing); "Acute pulmonary infection" (unspecified if ongoing); "productive cough" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: had COVID twice. The patient's concomitant medications were not reported. Vaccination history included: Flu shot, for Influenza immunisation; Pneumonia vaccine, for Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "had COVID twice/Caller also added: I've got my whole battery of COVID vaccinations with Pfizer." Clinical course: Patient had a history of had trained as a Craniofacial Surgeon. Patient had a congenital absence of 100% IgA and also had an IgG monoclonal gammopathy. Patient came across about a concern how the mRNA COVID vaccine had been developed and the question arose is to whether or not the mRNA that is being used is actually a modified RNA and is specifically modified M6A site and if it's in fact a modified RNA does this pose any potential risk to the patient recipients to the stability of their DNA and does it pose risk a potential neurodegenerative process in particular. Because of immune history, patient got at least a half dozen times year an acute pulmonary infection, with a productive cough, often wind up with antibiotics, patient had COVID twice, the most recent episode in Aug2022 despite being fully vaccinated and being very cautious and masking constantly, had a very nasty episode of COVID with bloody cough, you know, hemoptysis, so got an annual flu shot, and got every 5 years the pneumonia vaccine, do intend to receive an RSV vaccine (ABRYSVO) in September. HCP asked if Abrysvo had any advantage to the Respiratory Syncytial Virus Vaccine  manufactured by (other company name). HCP asked if Abrysvo an mRNA vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300288361 same reporter/patent,different doses/AE;
Information has been received from a physician concerning a 9 year old female who 3 weeks ago, on approximately 10/28/03, was vaccinated with a dose of varicella virus vaccine live. The pt's mother called the physician's office on 11/17/03 and reported to the nurse that the child was "continuing to break out", but it was mild.  Unspecified medical attention was sought and a prescription drug was not required. A product quality complaint was not involved. The physician also reported breakthrough varicella in two other children after therapy with varicella virus vaccine live. The office nurse reported breakthrough varicella in her children after therapy with varicella virus vaccine live. Additional information has been requested.
Swollen right upper arm-tender to touch, area is 10 x 5 inch area-tenderness with arm motion radiating into neck.
patient called on 12/15/22 saying she developed a circular rash on the injection site 2 days after receiving flu shot (12/13/22). Advised her to take Benadryl and check with her doctor if its not resolved. Followed up with her on 12/18/22 and she said the rash has not gotten better since she took Benadryl for 3 days but there's no sign of progression. She said she will see her doctor.
1st day soreness. 3rd to 4th day got worse. Dr. on Friday. As of 9/25/16 patient reports limited mobility in her left arm and constant muscle soreness - taking ibuprofen.
Information has been received from a physician concerning a 7-day-old patient who on 16-JUL-2007 was vaccinated with the first dose of Rotateq. It was unknown if medical attention was sought. No adverse experience was reported. This is one of several reports from the same source. Additional information has been requested.
Vomiting, diarrhea-stool which is described as green, crying episodes where feet are brought up to the abdomen and is okay between these episodes, poor breast feeding, fever.  Onset of symptoms is reported as sudden, onset was yesterday, symptoms are improved.  Complaint is resolved.  9 week old male born 38 weeks C-section was in NICU s/p birth because of aspiration pneumonia/pulmonary hypertension presents to the ED today with diarrhea.  He has a history of GERD and is on Prevacid 15 mg BID.  Patient got Rotavirus vaccine and 2 month vaccinations on Wednesday.  Wednesday night into Thursday he had a slight fever to 100 which mom treated with Tylenol.  On Friday morning he started to have slimy green and foamy stools.  All last night mom says he cried and would rest for 10 mins and start crying again.  During these episodes he would scrunch his legs up to his chest.  He is breast feeding well, urinating well.  He has no runny nose, cough, vomiting.  Mom contacted PMD who referred her here to get evaluated.  Family is traveling to Europe on Monday and also daughter has a history of bowel obstruction after emphalocele repair.
Pt recvd 2 doses of Engerix-B; 2nd dose given 17JAN91 & 1 wk later pt devel generalized body rash; Reporter indicated that "rash will appear @ different times"; tx DPH;
weight loss; inability to eat becuase they have to go to the bathroom right after eating; inability to eat becuase they have to go to the bathroom right after eating; decreased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (weight loss), DECREASED APPETITE (inability to eat becuase they have to go to the bathroom right after eating), GASTROINTESTINAL HYPERMOTILITY (inability to eat becuase they have to go to the bathroom right after eating) and BLOOD PRESSURE DECREASED (decreased blood pressure) in an elderly female patient 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 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, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced WEIGHT DECREASED (weight loss), DECREASED APPETITE (inability to eat becuase they have to go to the bathroom right after eating), GASTROINTESTINAL HYPERMOTILITY (inability to eat becuase they have to go to the bathroom right after eating) and BLOOD PRESSURE DECREASED (decreased blood pressure). At the time of the report, WEIGHT DECREASED (weight loss), DECREASED APPETITE (inability to eat becuase they have to go to the bathroom right after eating), GASTROINTESTINAL HYPERMOTILITY (inability to eat becuase they have to go to the bathroom right after eating) and BLOOD PRESSURE DECREASED (decreased blood pressure) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route) and mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter states that patient has a friend who had the same side effects  after getting the Moderna Covid-19 vaccine inability to eat becuase they have to go to the bathroom right after eating, weight loss and decreased blood pressure. The friend has also been prescribed with Evushield to counter act the vaccine. Reporter does not have additional information about her friend's vaccination details. No treatment medications were reported.