chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Certified Medical Assistant refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter refused additional contact.
Hib portion was reconstituted with normal saline and the DTap-IPV portion was not given/ no AE; Initial information was received on 28-Jul-2021 regarding an unsolicited valid non-serious case received from a Nurse via Agency (Reference number- 00701210) and transmitted to Sanofi on 28-Jul-2021.  This case involves a patient (unknown age and unknown gender) reported that while being treated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] Hib portion was reconstituted with normal saline and the DTap-IPV portion was not given with no adverse event (product preparation error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml (total) dose (once) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  It was reported that, "A Nurse reporting a medication error for Pentacel described as the Hib portion was reconstituted with normal saline and the DTap-IPV portion was not given. The caller reported that information is limited for this report do to not knowing all the facts; that she believes the Hib portion was given with normal saline; that the DTap-IPV portion was not given. PENTACEL blue top was given with just normal saline instead of green top. Is this dose suitable or does it need to be repeated? Product used: Used Still using product : No".  It was a case of actual medication error due to active ingredient not added to diluent (latency was on same day).  At the time of reporting, patient had no adverse event.  There will be no information available on batch number for this case.  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 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.
Mom, who is a pediatrician, notice hives on patient's legs the day after the vaccines were given. They appeared off and on over the next 4 days, mostly on her legs. No resp distress or facial swelling. Used Benadryl and she eventually did fine.
Can not calm down; Can not Lift the left Arm; Heart racing this morning but it is better now; Chills; Fever 100.0 F; Sore Left Arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Can not calm down), VACCINATION SITE MOVEMENT IMPAIRMENT (Can not Lift the left Arm), PAIN IN EXTREMITY (Sore Left Arm), PALPITATIONS (Heart racing this morning but it is better now) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm). On 19-Oct-2021, the patient experienced FEELING ABNORMAL (Can not calm down), VACCINATION SITE MOVEMENT IMPAIRMENT (Can not Lift the left Arm), PALPITATIONS (Heart racing this morning but it is better now), CHILLS (Chills) and PYREXIA (Fever 100.0 F). The patient was treated with IBUPROFEN on 19-Oct-2021 for Fever, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Can not calm down), VACCINATION SITE MOVEMENT IMPAIRMENT (Can not Lift the left Arm), PAIN IN EXTREMITY (Sore Left Arm), CHILLS (Chills) and PYREXIA (Fever 100.0 F) outcome was unknown and PALPITATIONS (Heart racing this morning but it is better now) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2021, Body temperature: 100 (High) Fever 100.0 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.
On 12/3/13 pt. developed rash; at night screaming x 4 hrs - evaluated in the ER on 12/4/13 at 1 am, diagnosed with AOM; azithromycin. On F/U in the office pt. had morbilliform exanthem on both extremities; only serum fluid on examination of middle ear (12/6/13).
Myalgia, Arthralgia, inj site soreness, chills, body aches, joint aches Narrative:
chills, hurting arm, lymph nodes under right arm swollen, weakness, body aches
bilateral hyperalgesia to the feet constant treated with gabapentin, toradol, PRN morphine, oxycodone, and tylenol
After the injection in the left arm it started feeling numb with a tingling sensation from upper arm down to the wrist, hand and fingers. The RN and MD had me stay almost and hour for observation but the feeling was still there. The night of 4/2/21 I had a fever of 99.4 at 11:30pm. As of today, I still have the numbness and tingling in the left arm that goes down to the wrist and hand but it is a little better. I feel pins and needles in fingers occasionally and my palm and hand feel extra warm.
Systemic: Exhaustion-Medium, Systemic: Fever-Mild, Systemic: Trembling all over from right side of arm to the legs.-Severe; symptoms lasted 1 day
He was complaining about fatigue shortly after his vaccine.  He hadn't eaten in several days and gets very angry when he is hungry.  We tried to feed him and he became irritable and violent.  The doctor's appointment was already scheduled for the following Monday.  Doctor suggested it might be from the vaccine.
Night of vaccination went from hot to cold and cold to hot feeling.  Couldn't sleep for that.  Next day felt achy, headache, and congested. Also felt sore throat on 2nd. day.  Took Ibuprofen and felt better.  On 2nd. day, felt better, but still a little congested and sore throat.
1639 - directly after receiving covid vaccine pt became dizzy unable to walk to observation area. pt carried by EOA and father to cot. Pt responding slow but appropriate no dyspnea noted.  EMS called. 1640 v/s  112/80, 99% o2 sat, 74 pulse,  16 respirations 1645  v/s  110/80, 80 pulse,  18 respirations, 99% 02 sat, dizziness getting better. EMS arrived pt stable refused to go to hospital.  1655 v/s 110/78, 78 pulse, 98% 02 sat, 18 respirations, asking for water sat up denies dizziness drank small amount of water.  Denies  dizziness.  1700  Pt walked to chair sat down no dizziness or c/o. 1715  Pt v/s 114/80, pulse 84, resp  16, 02 sat 98%,  Pt discharged to home via PV with father. Instructed father good idea to follow up with PMD.
p/vax pt exp breakthrough varicella;pt mom noted approx 50 lesions, itching & a low grade temp;tx w/APAP & DPH;
?COVID Arm?: Itching at vaccination site followed by red rash. Symptoms began on evening of the 9th day following first dose of Pfizer vaccine. This report is being submitted on the 10th day following vaccine as symptoms have continued.
pt recv vax 21MAR96 & 22MAR96 pt devel a rash & a low grade fever of 100 which subsequently inc to 103;the rash was described as small bumps on the child's neck & cheeks-looked like very small pimples;MD felt rash not r/t vax;
10-15 second episode - unresponsiveness to verbal stimuli, flexion of torso and all extremities with turning of upper extremities medially. Pt claims previous similar episodes had work-up at facility. Referred to ER.
Swelling, rash and discomfort of arm. This was reported by the patient to the clinic's customer service line. She did not come to the clinic for an exam. On further follow-up she states that she is doing better but not completely resolved.
headache; body aches - could barely walk; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (body aches - could barely walk) and VACCINATION SITE PAIN (injection site pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced HEADACHE (headache), MYALGIA (body aches - could barely walk) and VACCINATION SITE PAIN (injection site pain). On 23-May-2021, HEADACHE (headache), MYALGIA (body aches - could barely walk) and VACCINATION SITE PAIN (injection site pain) had resolved.            No treatment informations were reported.   This case was linked to MOD-2021-325332 (Patient Link).
glossopharyngeal neuralgia; pain/ the pain is similar to shingles; This case was reported by a consumer via call center representative and described the occurrence of glossopharyngeal neuralgia in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 31st July 2019, 2 days after receiving Shingrix, the patient experienced glossopharyngeal neuralgia and pain. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the glossopharyngeal neuralgia was not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the glossopharyngeal neuralgia and pain to be related to Shingrix.  Additional details were provided as follows: A couple days later the patient started experiencing glossopharyngeal neuralgia. The patient stated the pain was similar to that from shingles. She was prescribed pain pills and steroids and she was doing better. The reporter did not consent to follow up Emergency room visit required.
Coughing, fatigue, shortness of breath, dizzy, sore arm, next day had no taste, fever, chills, hot flashes, blurry vision
Client had emesis x2 and multiple episodes of diarrhea. Client seen in ER and received bag of Nacl and ABX d/t ER staff finding a UTI while client was in the ER.
Fever; Fatigue; Headache; Fatigue; Discomfort in the arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), the first episode of FATIGUE (Fatigue), LIMB DISCOMFORT (Discomfort in the arm), PYREXIA (Fever) and the second episode of FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and UKNOWN) for COVID-19 vaccination.     No medical history reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (Headache), the first episode of FATIGUE (Fatigue) and LIMB DISCOMFORT (Discomfort in the arm). On 22-Feb-2021, the patient experienced PYREXIA (Fever) and the second episode of FATIGUE (Fatigue). On 22-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, HEADACHE (Headache), LIMB DISCOMFORT (Discomfort in the arm) and the last episode of FATIGUE (Fatigue) outcome was unknown.      No relevant concomitant medications were reported.  Treatment details not included.   This case was linked to MOD-2021-023100 (Patient Link).
By 9:15 pm I developed a splitting headache, I could not look at any light. I tried wearing sunglasses but that didn't help. I was dizzy. I had taken Advil at 8:30 and my temperature was still 100.5. (I kept taking Advil and my temp remained at 100.5.) The pain in my head was the worst I had ever felt and was intense and stabbing .I had waves of  nausea, and had extreme chills. I had severe hot and cold flashes. I also had a stomach ache.  I tried to watch TV but it was too painful. I was really scared and I did not think the night would end.
Experienced moderate debilitating flu symptoms day after vaccination and recovered the following day.  Over one week later (3/25) developed skin sensitivity on the neck which later spread to back, torso, and legs.  Skin sensitivity persists still one week after onset, is a severe chafing feeling when skin comes into contact with clothing.  No rash or any visual signs.  Along with the skin sensitivity, mild to moderate chills from day to day as well as muscle fatigue and upper/lower back pain.  Symptoms varied in severity day to day; used ibuprofen and it seemed to offer limited, temporary relief.  Concurrent with second onset of symptoms, noticed gradual abdominal inflammation and developed sensation similar to UTI but urine dip and lab test results were all normal.  Doctor concluded immune reaction to vaccine as no other allergies or changes in routine as well as no prior medical history of any of these symptoms. Prescribed daily prednisone for three days to calm immune response; after one day symptoms were greatly improved.  Abdominal inflammation has improved and UTI sensation improved.  Still experiencing slight chills and skin sensitivity unchanged.
vaccine was administered on 9/29/23 and on 10/3/23 approximately about 11 pm I was awaken with pain in my left eye that felt like something was in it, and did continue to get worth I kept looking into and saw nothing and by Friday it felt I had a gash on my eye, the last time I felt that was when I had the COVID vaccine. That is when I knew it was the vaccine I had, I did have some hives which I treated with a corticoid steroid cream I tried to call my doctor on Friday but haven't been able to read him yet. My vision is extremely blurry and my eyes are swollen and now the other eye feels the same. I am treating it with erythromycin ointment  I had from so many eye infections I kept getting from the COVID vaccine. I went on 9/28/23 and just got a clean bill of health  with the ophthalmologist.
had two of the shots and got it/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had two of the shots and got it/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that he/she received two doses of Shingles vaccine and still experienced shingles. The patient stated that you can not really count on these vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Patient had already received one dose of Moderna COVID19 vaccine. Patient came in expecting a second dose of Moderna COVID19 vaccine.  No adverse reaction occured.
Patient presented to the ED and was subsequently hospitalized for alcohol-induced acute pancreatitis within 6 weeks of receiving COVID vaccination.
Redness and swelling to injection site. Still has swelling to injeciton site x1month later with welt.
Fluzone given on 11/03/2003.  On 11/05/2003 developed. Tired, pain at joints, runny nose, mild fever.
Very large, painful cold sores on lip.  Used Abreva.  Did not help.
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004183, MCM-004184, MCM-004185, MCM-004186, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Immediately following shingles vaccination I experienced itching, pain and swelling at injection site by early evening I had a severe headache and dizziness. I felt hot and cold and flu like for several days and had diarrhea for several days. Pain and swelling at injection site continued to increase over the first week. The area grew in size and was hot to touch and hard. Over several weeks a  Severe rash appeared and itching and sharp pricking pain increased. Spread all over arm. The redness, swelling and rash Rash was present for one month with sharp shooting zinging pain and itching. I also developed Severe sharp intermittent nerve pain in my breast at week 3 and this weird shock like pain is still present 2 months post injection. I would never never recommend this vaccine to anybody and angry it was recommended to me!!!!!!
Within 5-10 minutes following vaccination, the right side of my throat began to feel tight.  I didn't experience shortness of breath or trouble breathing so I didn't inform anyone of the tightness there.  2-3 hours after vaccine, I started to notice some improvement in tightness but it didn't go away completely.  I also had a stomach ache after returning home and throughout the evening experienced burping/belching, acid reflux type symptoms.  About an hour or two after returning home, I had a very short time, maybe 5 minutes or so in which palm of right hand felt itchy and then it went away.    Tightness was better on Sunday, not present most of the day on Monday, but later in the day on Monday and today, the right side of my neck feels slightly tight and different from the left side.
Left shoulder pain immediate, severe.  Decreased after 2 days but persists >3 months later.  Decreased ROM of left shoulder.  No prior injury/trauma.
About 5-6 hours after receiving the booster, I felt an increase in the symptoms/sensations associated with trigeminal neuralgia (increased facial pain, sensitivity to touch and wind). These symptoms/sensations have been well-controlled for several months.
Pain in arm pit on injection side; racing heart rate at random intervals; headache; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 11:30 (at the age of 48-years) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included hypertension, high cholesterol, Generalized anxiety disorder (GAD) from an unknown date. The patient had no allergies. Concomitant medication(s) included lisinopril; atenolol and citalopram all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced pain in arm pit on injection side, racing heart rate at random intervals, headache on 10Feb2021 18:30. The patient did not receive any treatment for the events. The outcome for all events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 5JUL95 on AM of 12JUL95 pt was awaken w/red hot whelps on lt arm in deltoid area, tender to touch; on 8JUL or 9 noted discomfort in lymphadeno entire arm; hx of extreme fatigue;
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536: US-009507513-2005USA003382: