chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received the 1st dose of Shingrix over a year ago/ did not receive 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 08-JUN-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: patient received the 1st dose of Shingrix over a year ago/ did not receive 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-OCT-2023 The pharmacist stated that, a patient received the 1st dose of Shingrix over a year ago and wanted to know, did the patient need to start the series over. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
15 MIN AFTER INJECTION ITCHING OF RIGHT HAND , 30 MIN LATER ITCHING OF FULL RIGHT ARM, 1 HOUR AFTER INJECTION HAD MILD ASTHMA ATTACK AND ANGIOEDEMA OF ANTERIOR CHEST. EPI, BENADRYL AND PEPCID ADMINISTERED AND RESPONDED WELL. SENT TO ER.
APPROXIMATELY 2 MINUTES AFTER GIVING THE INJECTION, A QUARTER SIZED LUMP APPEARED AT THE INJECTION SITE. AFTER 1 HOUR, THE LUMP HAD DISSIPATED.
A week before I had trouble breathing at night, contacted doctor was prescribed cortisone and AUGMENTIN.
discomfort; little swollen arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (discomfort) and VACCINATION SITE SWELLING (little swollen arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DISCOMFORT (discomfort) and VACCINATION SITE SWELLING (little swollen arm). At the time of the report, DISCOMFORT (discomfort) and VACCINATION SITE SWELLING (little swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment history was not provided  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial report received from a patient/consumer via healthcare professional on 07 May 2012. 12-0273. A 66-year-old female patient, whose medical history included thyroid, osteoporosis, HBP (high blood pressure), GERD, Arthritis and Pinched nerve and concomitant medications were not reported, had received a intramuscular dose of ADACEL vaccine in right deltoid (lot number U4046AA) on 26 March 2012. On 26 March 2012, the patient developed left arm was tender right after the injection. Bruising occurred and lasted 1 to 1.5 weeks. Lumps developed on the left side of her head. The patient had ear and throat pain. The visited to the physician and physician examined the patient and made diagnosis of clusters of lymph nodes on the left side. The patient also had complaint of headaches, a throbbing pain, which occur only left side of head. Patient also felt tired much of the time. The patient laboratory data included: none. The outcome of the events was reported as not recovered. Documents held by sender: none.
At 10 minutes post-vaccine, tingling in fingers/hands.  At 12 minutes, intense dizziness, difficult speaking clearly, racing heart and light-headedness.  About 30 minutes post-vaccines some mild facial hives, itchy nose and stuffy nose.
Evening of immunization, pt had a fever and was limping.  5 days later, developed red spot on thigh at injection site.  Seen here and at hospital ER over weekend.  Had surgery on ankle for infection.  No culture available. Final dx from discharge summary: septic ankle, left. Tx was arthrotomy with irrigation and debridement 2/13/00.
Pt got 3 dose of Pfizer at 1436 and experienced headache and bilateral hand tingling at 1446. Patient was observed for water and vital signs were taken. S/S resolved and vss. Patient left home after 1 hour
Subsequent to vax (received 1989), this pt experienced an anaphylactic reaction reaction. Upon medical review the pt's experience was determined to be an important medical event. No further information is available.
Patient went to get her annual mandatory Flu Shot. She states that the RN giving her the Flu shot gave it high on the right shoulder area. The RN stated at the time to patient that she had difficulty injection the immunization from the pre-filled syringe. Patient has had pain and   loss of FROM with the right shoulder since receiving the Flu Shot. She has taken Tylenol and OTC NSAIDS with no relief. she has had pain at night waking her from sleep.
nausea started at 1pm day of vaccine and lasted  72 hours,   DIARRHEA (severe) started at 2pm  day of vaccine and lasted  48 hours, VOMITING  (severe) started at 4pm day of vaccine and lasted 13 hours,   The following symptoms started at 3pm day of vaccine and continued for 72 hours aches and pain entire body,  muscle and joint pain, chills, dizziness, weakness, headache, pain at injection site.
He presented with worsening redness and swelling to his left eyelids.  States he received second dose of his COVID vaccine on 4/6 and a rash developed on 4/9, then worsening redness and swelling to the area after taking  amoxicillin which was prescribed by an urgent care provider. Therefore, he was advised to come to the ER for further evaluation.  He denies any fever or chills.  Denies any visual disturbances.  He is afebrile.  White count is 4000, hemoglobin 13, hematocrit 41.  He has been started on intravenous antibiotics, Rocephin and vancomycin.  He had a CT of his facial bones, which confirmed left preseptal cellulitis without fluid collection or abscess.  Blood cultures are currently pending.  Preseptal cellulitis of the left eye.  No abscess noted on CT.  He received COVID-19 vaccine 4/6. He noticed a rash to his left eye on 4/9, then developed redness and swelling. Denies trauma or insect bites. Questionable if this is related as possible delayed reaction to his vaccine.  Brand of Covid-19 vaccine is UNKNOWN.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL1283), in right arm, on 04Feb2021 as dose 2, single (Lot number: EL9264), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 60 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Initial bowel syndrom" (unspecified if ongoing), notes: other medical history: Initial bowel syndrom. Patient had no known allergies. There were no concomitant medications, reported as the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid. Clinical course was reported as, on 16May2022, a few days after completing a course of Paxlovid, various Covid symptoms returned; runny nose, scratchy throat, intense fatigue and they continue as of today, 18May2022.     .; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
first dose of Shingrix on 1/9/2020 / never received the second dose due to COVID-19 / / receiving first does / on 1/9/2020  and / second dose on 12/4/2020; pain and soreness at the site of injection; series of bumps along the spine  / under the skin / above the skin / base of the neck / continue down below the bra strap; bumps have a pink-ish hue that varies from day to day; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The patient never received the second dose due to COVID-19.  The reporter consented to follow up.   Follow up information was received from consumer on 5th January 2021: The patient received 2nd dose of Shingrix on 4th December 2020 and less than 2 months, the patient had pain and soreness at the site of injection. The reporter reported developing a series of bumps along the spine a day and a half after receiving 2nd dose of Shingrix. The patient stated that the bumps began under the skin and were currently above the skin. The bumps begin at the base of the neck and continue down below the bra strap and were in a straight line. The bumps were of the same or very similar size. The bumps had a pinkish hue that varies from day to day. The patient reported no pain associated with these bumps. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021001360:same patient, 1st dose
Pt got shots and left, about 10 min. later Dad came running back in with child saying the pt is itching a lot. Upon assessing pt - she was scratching around her neck and face area, back and stomach area. SHE had a red area that encircled her lips and went along her jawbone up to her ears and around her neck. She never had any trouble breathing. Referred to local ER. Also saw a colostomy at that time when pt was moving her arms around scratching (which Dad never mentioned). On 9/20 Mom stated pt doing well, rash and itching was gone.
Patient started having pain at the injection site later that night. Stated the next morning the site of injection was hard as a rock. The site was sore to touch and warm to touch. She stated she was unable to move and function Monday.
GS CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (GS CHILLS) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (GS CHILLS). At the time of the report, CHILLS (GS CHILLS) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
On 3/20/01 at 11:00 am the child received vaccines. At home at 5:00PM the pt had a febrile convulsion, with a temp of 102.1. Treated with Tylenol without improvement and then on 3/24/01 was diagnosed with RSV with treatment of antibiotic steroid and albuterol with a recovery in 7 days.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 06-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not specified). On an unknown date, the patient was treated by an unspecified provider for the following injury resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster. He claimed damages as result of injury to himself, loss of consortium, loss of services and economic losses. The outcome of herpes zoster was not reported.
Patient is a 4 year old that received a 5-11 year Covid Vaccine incorrectly.
Patient returned to pharmacy with more serious local injection site reaction, needing medical attention/antibiotics. I referred to PCP.
Pt recvd vax & exp generalized itching immed afterwards which was treated w/DPH; itching has lasted for months; refused 3rd dose;
HPV vaccine give with expired date Lot 00114 Exp 21 Mar 09 - Saw date as 21 May 09.
C/O body aches, low grade fever, lack of appetite, and diarrhea--developed wheezy cough 8/19/10-used albuterol inhaler x1 with relief 8/20/10 feels much better-eating again.
Red rash right arm on 11/13 then spread to trunk and back 11/14 pt already on daily Claritin. Mom adding Benadryl prn.
pt recv vax 1105AM pt found on floor;c/o h/a & feeling funny taken to clinic for eval;
Aching; Headache; there's no fever only chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching), HEADACHE (Headache) and CHILLS (there's no fever only chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE (HYDROXYCHLOROQUIN), AZATHIOPRINE and VITAMIN D NOS for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN (Aching), HEADACHE (Headache) and CHILLS (there's no fever only chills). At the time of the report, PAIN (Aching), HEADACHE (Headache) and CHILLS (there's no fever only chills) outcome was unknown. Unknown      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.   Concomitant medication AZOR to treat blood pressure was reported. Treatment medication is not reported.   This case was linked to MOD-2021-116402 (Patient Link).
Vaccine adm. approximately 11:25 AM. Watch in rx no symptom. 2:30 -2:45 difficulty swallowing, SOB, eyes swollen excreting water, refused EPI-PEN & to call 911. Reported to pharmacy / gave BENADRYL 25mg capsules. Treated at hospital for allergic reaction - 2 hours put on Diphenhydramine.
Patient reported that her arm was tingly and had numbness about 15 minutes after receiving the vaccine. Monitored patient for an additional 5 minutes and symptoms were not getting better.  Patient was able to breathe and walk without any issues. Advised that patient seek additional medical attention at near emergency room. Walked patient to her car and her husband drove her to the emergency room. Patient reported back that symptoms lasted about 2 hours and she was diagnosed with a delayed hypersensitivity to the vaccine.
On 22OCT pt devel a fever, cough & congestion was seen by MD who dx OM; later that day pt had sz & was taken to ER w/fever of 104.5 oral; No other sz occurred;
01/25/22 presents to ED for "vomiting" "High Blood Sugar". PMHx of "T1DM"
diarrhea; shortness of breath; feeling very tired; dehydrated; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea), DEHYDRATION (dehydrated), DYSPNOEA (shortness of breath) and FATIGUE (feeling very tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065f21a, 021b21a and 027b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced DEHYDRATION (dehydrated). On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (diarrhea), DYSPNOEA (shortness of breath) and FATIGUE (feeling very tired). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), DEHYDRATION (dehydrated), DYSPNOEA (shortness of breath) and FATIGUE (feeling very tired) had resolved.            Patient reported that she takes medications for her thyroid. Patient took water as treatment for dehydration.   This case was linked to MOD-2021-390844 (Patient Link).
Cellulitis at the injection site developed 12 hours after vaccine (Dtap) received.
Initial unsolicited report received from non-health care professional (Medical assistant) on 10-Aug-2016. This case involves a 16-year-old female patient who was vaccinated with a dose of MENACTRA (batch number: U5259AA, expiry date: 13-May-2017, dose was not reported) intramuscularly in the left deltoid on 03-Aug-2016. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies to Ceftin. Patient had no other vaccinations within 4 weeks of vaccinations. On 03-Aug-2016, same day "ever since received vaccination" following vaccination, the patient experienced numbness in different parts of her body. On an unspecified date, following vaccination patient also has started having twitching. Lab test and corrective treatment were not reported. The outcome of the events was unknown. List of documents held by the sender: None.
Within a few minutes after vaccine, I fainted and fell out of my chair onto my head. That night, I had headache, nausea, chills and pain at the vaccine site.
Employee received FLUVIRIN on 10-2-09 apx. 11:00. After lunch rt. eye lost partial vision and rt. ear ringing. B/P increased-base usually 140/80 ranged 150-160/90. Sight returned, 3 day still had rt. ear ringing and B/P increased apx 10 diastolic and systolic.
gave Adacel to an elderly patient with no reported adverse event; Initial information received on 28-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 74 years old male patient (59 kg) and it was reported Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] was given to an elderly patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Apr-2023, the patient received 0.5 ml of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: U7648AA, Expiry date: 15-Feb-2025) (Frequency-once; Strength: Standard) via intramuscular route in the right deltoid for immunization.  On 28-Apr-2023, it was reported Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] was given to an elderly patient with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  It was reported, Caller, a pharmacist intern, stated he has a clinical question about Adacel. Caller stated they gave Adacel to an adult more than 130 pounds with a 5/8th inch needle. Caller asked if the vaccine would be effective for tetanus and diptheria or would the patient need revaccination. Caller states that ADACEL was administered to a patient intramuscular in the right deltoid but was administered with a 5/8th inch needle. They are inquiring if this dose be counted as valid.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt recvd vax in 1988 & 1989 w/no adverse exp & was given booster dose 6JUL92 & 3 1/2 hrs following vax devel severe h/a, chills, diarrhea, nasuea, vomiting; pt recovered by following morning; 6JUL92 UA revealed traces of hemolyzed blood;
complained of nausea and salivating.  BP 153/103.  Rested for 30 min.  BP came down to 147/99 at 1600.  Agreed to follow up with primary MD.
On 12/26 had a flash of nausea. On 12/27 and 12/28 had no appetite at all and went into the urgent care clinic. The urgent care clinic performed a rapid test and it was positive. Had no real symptoms except loss of appetite and nausea. Went on 12/28 to pharmacy for another test and it was positive as well. Symptoms resolved on their own after a few days. Still have slight appetite change.
Red raised areas on chest, back, arms, t100.3 was seen in ER 21JUL91 time 15:45;
Information has been received from a nurse referring to multiple unspecified patients of unknown ages and gender. On unknown dates the patients were vaccinated with doses of improperly stored hepatitis b vaccine (recombinant) (manufacturer unknown) (lot#, strength, dosage, frequency and route unspecified). The vaccines were exposed to -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Hib and IPV were administered 2 weeks after 1st dose due to documentation error on immunization card from NICU.