chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; HCP calling to report a child inadvertently received RECOMBIVAX HB and PEDIARIX.; This spontaneous report was received from a medical assistant and refers to a 6-month-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-OCT-2023, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter, lot #W002938, expiration date: 18-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided); and  diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX), administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).  On 23-OCT-2023, the patient experienced HCP calling to report a child inadvertently received RECOMBIVAX HB and PEDIARIX (Accidental overdose). No site effects were reported. No additional adverse event was reported.
They gave patient 4 shots supposeably thought the gave her only 3 the shot they gave her twice of the same thing HTapd and HIB  when when should have gotten DTaP, PREVNAR, Hib and H1N1.
Patient presented to the ED and was subsequently hospitalized for  Possible ischemic colitis status post sigmoidectomy within 6 weeks of receiving COVID vaccination.
came in for a typhoid fever vaccine but was given YF-VAX with no reported adverse event; given YF-VAX intramuscularly instead of subcutaneously with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid  non-serious case received via Nurse.  This case is linked to cases 2023SA326768(CLUSTER) and 2023SA326868(CLUSTER).  This case involves a 12-year-old male patient and reporter reported came in for a typhoid fever vaccine but was given yellow fever vaccine - [YF-VAX] with no reported adverse event and given yf-vax intramuscularly instead of subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 20-Oct-2023, the patient received 0.5 ml total dose of suspect yellow fever vaccine, Solution for injection (lot: UJ819AA, expiry date: 18-Apr-2024) (strength: unknown) via intramuscular route in the arm nos for immunization and came in for a typhoid fever vaccine but was given yf-vax with no reported adverse event (wrong product administered) and yf-vax intramuscularly instead of subcutaneously with no reported adverse event (incorrect route of product administration) (latency: same day).  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.
Severe itching on legs only 2 hours after immunization. No rash. Shot given in left deltoid.
"pt recv vax 8JUL95 & 17NOV96 pt exp rash w/a few lesions;the reporter indicated two other children, WAES 97010425 & WAES97010426;"
Blood pressure was way down; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a  Years-old male/female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event list his BP was 119/87, 116/79 - below normal reading.  The patient's medical history was not provided. relevant concomitant vitamin C 100mg multivitamin for eyes plavix 75mg Voltaren gel 1% Toprol xl 50mg twice daily doxycycline 100mg Vit D 2 once a week acetaminophen 500mg prn 2-3 in a day imipramine 50mg   On Date or unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031M20A )   Laboratory details  was not  provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 14-feb-2021, The outcome of event is recovered and resolved.  The reporter assessed the event BP was 119/87, 116/79 - below normal readings related to study drug.
lateralized pain on one side of his body, particularly his leg; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (lateralized pain on one side of his body, particularly his leg) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (lateralized pain on one side of his body, particularly his leg). At the time of the report, PAIN IN EXTREMITY (lateralized pain on one side of his body, particularly his leg) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.   This case was linked to MOD-2022-526524 (Patient Link).
Rash began on face 17SEP spreading to back, arms & legs; no cough, runny nose; no known exposure x/to 1 child w/ ? rash 3 days ago; IgM titer 18SEP; given DPH for itching;
high fever of 102 degrees  vomiting for 8 hours severe musculoskeletal pain
Itchiness everywhere; feeling weak 2 hours post vaccine; redness (size of baseball) around injection area.
3rd dose administered by accident; This non-serious case was reported by a physician via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-OCT-2023, the patient received the 3rd dose of Shingrix. On 27-OCT-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered by accident). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 27-OCT-2023 It was reported that 3rd dose of Shingrix was administered by accident which led to extra dose administered. No events reported yet.
Lymph node swollen the size of a golf ball; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swollen the size of a golf ball) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included AMITRIPTYLINE and PROPRANOLOL for Migraine, FLUOXETINE HYDROCHLORIDE (PROZAC) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph node swollen the size of a golf ball). At the time of the report, LYMPHADENOPATHY (Lymph node swollen the size of a golf ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication use was reported.   This case was linked to MOD-2021-313320 (Patient Link).
every bone in my both hurt so bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bone pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   On 16-SEP-2023, the patient received RSV vaccine. On an unknown date, the patient received FLU VACCINE (NAME UNKNOWN). In SEP-2023, less than a day after receiving RSV vaccine and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), the patient experienced bone pain (Verbatim: every bone in my both hurt so bad). The outcome of the bone pain was not reported.   It was unknown if the reporter considered the bone pain to be related to RSV vaccine.   It was unknown if the company considered the bone pain to be related to RSV vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 and 18-SEP-2023 The case was received from the patient interactive digital media. The patient went to Sunday (from the day of reporting) and got his/her flu shot and RSV shot and when he/she woke up 3 hours later every bone in his/her both hurt so bad but Medicaid did paid for it. The follow-up could not be possible as no contact details were available.
Vaccine administered 8 days passed expiration date. Expiration date 8/9/2022, administered 8/17/2022.
post vaccine pt reported funny taste in mouth and began to panic. Pt evaluated in tent and recovered.
Monday I received my Pfizer vaccine. Next day Tuesday morning 4/13/21 woke up to Muffled clogged ears, vertigo, brain fog , confused , feeling intoxicated, loosing balance , tinnitus . So far I have been presenting these signs  all week . Went to see a Provider on Friday was told it could be an adverse reaction to the vaccine
Bruising and minor swelling. Bruising down entire upper arm. 2nd shot given on 1-26-2021 and bruising did not appear until 1-31-2021
Pt has rash and irritation on sites where live vaccines were administered. Pt states that sites were warm, hard and painful.
A bit sore; I have Pleurisy, pain in my right lung when I move.; A spontaneous report was received from a healthcare professional concerning a 64-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events i have pleurisy, pain in my right lung when i move, a bit sore.  The patient's medical history was not provided. Concomitant medications reported were Medication for asthma, Medication for high blood pressure for drug use for unknown indication.  On 12 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection. On 8 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 132L2OA) via unknown route for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) i have pleurisy, pain in my right lung when i move. On an unknown date, the patient experienced the event(s) A bit sore.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), i have pleurisy, pain in my right lung when i move, , a bit sore was unknown.
Migraine; Nausea; Backache; Cough; Kanker sores in mouth; Fever; Chills; Full body skin rash; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 20Sep2021 at 17:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 20Sep2021 at 18:15, the patient experienced migraine, nausea, backache, cough, kankersores in mouth, fever, chills and full body skin rash. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of rash which included treatment with unspecified cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, nausea, backache, cough, kankersores in mouth, fever, chills and full body skin rash was resolving at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I noticed a skin rash and it got worse and it spread all over my body and then it went away. I was told by the doctor to stand in the sun and it helped to clear it up.
Pt states he was vaccinated with J&J at 1500 yesterday. Pt c/o difficulty breathing, ha, body aches, and n/v. Pt went to  sick call which referred him to ED.Pt is able to drink water w/o issue.
Patient's extremities are red and splotchy.  Patient has swelling under right eye that is sore to touch. Patient reported no issues with vision but has slight blur of vision at times that goes away when blinking. She is taking Benadryl to help with swelling and will follow up with physician if symptoms do not improve.
Patient was erroneously given Pfizer instead of Moderna for dose 2. Patient was contacted to notify patient of error and to follow-up with patient if they had any side effects on 3/5/21. No side effects noted by patient during call.
Patient received second dose of Pfizer Covid-19 vaccine on 10/4/21.  On 10/5/21 Patient called to report that she had chest pain that is "worse than any chest pain she has ever had".  Patient reports that she has had chest pain in the past unrelated to vaccination and that she experienced chest pain with her first vaccination, but considered the levels tolerable.  With her second dose of Pfizer Covid-19 vaccination, while she realizes that it is common to experience worse side effects than the first dose, she considers the level of discomfort with this dose intolerable.  She originally contacted her PCP by phone, but she reports that they told her to ask the pharmacy about her side effects(our facility).  I recommended that she see her physician, and that chest pain was great enough a concern to seek treatment.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot# 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 04-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
on and off pain in my right upper back same side of my vaccine; 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 BACK PAIN (on and off pain in my right upper back same side of my vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (on and off pain in my right upper back same side of my vaccine). At the time of the report, BACK PAIN (on and off pain in my right upper back same side of my vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
Case number PHEH2013US018018, is an initial spontaneous report received from a pharmacist on 22 Aug 2013. This report refers to a 24 years old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X12009), intramuscularly without being reconstituted with Men A lyophilized conjugated vaccine component on 14 Aug 2013. No adverse event was reported following this administration error.
Spots in eye diagnosed as Shingles / Mild shingles on face after 1st shot; Mild shingles on face after 1st shot; Spots in ear diagnosed as Shingles; Redness, red spots on face, eye, ear, hairline; Hard spots; Arm was sore; Hard red spot in her eye; Sore in the corner of mouth; This case was reported by a nurse and described the occurrence of ophthalmic herpes zoster in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included disability. Additional patient notes included patient never had shingles outbreak before.   On 17th January 2023, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced soreness corner mouth, injection site pain and eye red. On 19th January 2023, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, herpes zoster otitis externa (serious criteria GSK medically significant), localized erythema and induration. On an unknown date, the outcome of the ophthalmic herpes zoster, shingles, herpes zoster otitis externa, soreness corner mouth, localized erythema, induration and eye red were unknown and the outcome of the injection site pain was recovered/resolved.   The reporter considered the ophthalmic herpes zoster, shingles and herpes zoster otitis externa to be possibly related to Shingrix. It was unknown if the reporter considered the soreness corner mouth, localized erythema, induration, injection site pain and eye red to be related to Shingrix.     Additional Information: GSK receipt date: 25 Jan 2023 and 26 Jan 2023 Reporters comment: The case was reported by the nurse for herself. The nurse reported that the she developed mild case of shingles in left side of face after taking her Shingrix shot she took last Tuesday from reporting day which had been verified by her doctor. On 19th January 2023 Thursday the shingles outbreak started. It started as a sore in corner of mouth. By Thursday evening there was redness. By the weekend there were red spots on her face and upside of face and in eye and ears along hairline. The patient went to the physician and was diagnosed with shingles. Patient also reported that arm was sore (arm pain in injected arm). The patient though that Shingrix caused the shingles outbreak and stated it caused her to had shingles. The patient was plan on taking the second shot as she hopes it would keep her from hopefully every having full blown shingles. She had questions about when she takes it again what she might expect if it could even be worse, what had been other people experience. She had waited for years to take this but could never afford it now could take it free she jumped at the chance to take it and having been in the nursing field she know how bad shingles could get. She did not want a full-blown case. The reporter did not have the lot number of Shingrix shot which she was given but that information should be on record at pharmacy. The reporter consented to follow up.
12/07/2021  The patient presents with COVID-19 infection. Pt states has experienced worsening cough, nausea, vomiting, headaches and myalgias since 12/1. Has had some shortness of breath while coughing. Tested positive for COVID-19 x3 days ago. Pt has low grade fever in ED. Denies loss of taste/smell, dysuria, hematuria. Pt was on amoxicillin at home and took Robitussin with some relief. Pt vaccinated for COVID-19 in March, 2021 with Pfizer.  The onset was 12/1/21.  The course/duration of symptoms is worsening.  The character of symptoms is COVID symptoms.  Risk factors consist of COVID infection.  Therapy today: over the counter medications including Robitussin and prescription medications including amoxicillin.
Initial unsolicited case received from a consumer (patient herself) on 19 Sep 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS VACCINE) (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date years ago. The patient medical history and concomitant medications were not reported. On an unknown date, after receiving unknown tetanus vaccine in the past, the patient developed high fever. Lab tests and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
This report was received from Pfizer concerning adult patients on haemodialysis who on unspecified dates were vaccinated with a dose of PNEUMOVAX 23 (lot#s not reported). It was reported that the patients had been low responders to PNEUMOVAX 23. This was originally reported by a health care professional in a pharmacy intern. Additional information has been requested.
experiencing numbness of the arm which travels up the neck; experiencing numbness of the arm which travels up the neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (experiencing numbness of the arm which travels up the neck) and HYPOAESTHESIA (experiencing numbness of the arm which travels up the neck) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE ANAESTHESIA (experiencing numbness of the arm which travels up the neck) and HYPOAESTHESIA (experiencing numbness of the arm which travels up the neck). At the time of the report, VACCINATION SITE ANAESTHESIA (experiencing numbness of the arm which travels up the neck) and HYPOAESTHESIA (experiencing numbness of the arm which travels up the neck) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-094799 (Patient Link).