chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEVERE ACHING (ACROSS SHOULDER, BACK AND BOTH ARMS); FELT COTTON-MOUTH WHERE MOUTH WAS VERY DRY; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 74 year old female with unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol consumption (once a month), non smoker. The patient had no known drug allergies, no drug abuse or illicit drug usage. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry was not reported), 1 in total, dose was not reported (dose number series 1) on 07-Apr-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s.(dose number series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 20-MAR-2022) 1 in total, dose was not reported (dose number  series was 2) on 27-OCT-2021 at 10:45 vaccinated on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-OCT-2021 at 20:30, following vaccination with booster dose of covid-19 vaccine ad26.cov2.s (dose number series 2), the patient started experiencing severe aching (across shoulder, back and both arms), felt cotton-mouth where mouth was very dry, chills and fatigue. On unspecified date in OCT-2021, laboratory data included: Body temperature (NR: not provided) Normal. Treatment medications (on unspecified date in OCT-2021) included: Three Ibuprofen tablets. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe aching (across shoulder, back and both arms), felt cotton-mouth where mouth was very dry, and chills on 28-OCT-2021, and was recovering from fatigue. This report was non-serious.
This spontaneous report was received from a registered nurse referring to a 14 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
pt recv vax 22OCT98 & around 2PM cranky, unable to sleep;5OCT edematous, flushed w/a rash both lower legs;redness has decreased;
Did not receive second dose; A spontaneous report was received from an 85 year-old female patient who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and did not receive the second dose/missed dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   At the time of report, the patient had not received the second dose.   Action taken with mRNA-1273 in response to the event was not applicable; Reporter's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot# (unknown), with no associated adverse events.
Fever 106.7 degrees F starting one day after Tdap & PNEUMOVAX. Abdominal discomfort, body aches, joint pain.
Fever, chills, full body pain, swollen lymph nodes in my armpit, lethargy for about 2 to 3 weeks.
Pt given Pneumovax & Influenza vaccine in left deltoid IM 1 inch apart. Pt to ER on 3-11-07. Treated with Rocephin 1 gm IM and Toradol 60mg IM. Pt seen again on 3-12-07 in clinic - treated with Augmentin 875 mg PO Q 12 hrs x 10 days. Pt has not been seen in clinic since this visit.
This spontaneous report as received from a registered nurse via field representative refers to a 12 year old patient. On 02-APR-2018 or 03-APR-2018, the patient was vaccinated with GARDASIL 9 from lot N021732 expiry date 01-FEB-2018 dose 1 by intramuscular route for prophylaxis. Nurse reported that while administering GARDASIL 9, the dose appeared to leak out of the syringe. No adverse effect reported. Product quality complaint (Product quality issue) has been filed. The outcome of Product quality issue was unknown. Causality assessment was not provided.
Patient received the bivalent booster on 09/12/2022, but heard through a television advertisement that he needed a second bivalent booster and was confused.  The second bivalent booster dose was administered before the error was discovered.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 21-JUN-2017 the patient was vaccinated with VAQTA lot # N005274 for prophylaxis. Concomitant therapies included PREVNAR 13. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for epistaxis. Vaccination took place on 02/27/09. According to physician the relationship is 'None'.
This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Nov2021 at 15:45 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Mar2021 (at the age of 29-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 (at the age of 29-year-old); both as single dose for COVID-19 immunisation. On 17Nov2021 at 09:00, the patient experienced fatigue, slight aches and pains and lower back pain. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue, slight aches and pains and lower back pain was resolved on an unknown date in Nov2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I counselled the patient prior to giving him the Pfizer Covid19 vaccine.  He received the vaccine at 10:10am.  During the 15 minute observation period, one of my technicians was standing next to him talking to another patient.  She saw some papers slip out of patient's hand and noticed he was unresponsive when she tried to talk to him.  She yelled out for help and I ran out and saw his head rolled back, eyes open, and he sounded like he was snoring.  He never left the chair--just his head rolled back.  We tried to rouse him awake and I had my other technician call 911.  I also called for a store manager.  The patient came to about 15-30 seconds later.  I asked him his name, what day it was, and if he knew where he was.   He answered all questions correctly.  He told me that he's fainted before after vaccines, however he never disclosed this to me prior to the vaccine and had answered "no" under the question if you've ever had a serious reaction to the vaccine.  We gave him some water and a cold paper towel.  The paramedics came and evaluated him.  He declined to go to the hospital and his wife came and picked him up.
Patient was administered an undiluted dose of the COVID 5-11 Pfizer vaccine.
Movement disorder- discoordination of movement. Unknown date of onset. Not noted at 2 mo. exam. Began prior to 4 mo. exam.
When getting pneumonia shot her arm was red; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (trade name unspecified, manufacturer: Pfizer, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date not reported) as unknown, single for immunization. Medical history and concomitant medications were not reported. The patient experienced that when getting pneumonia shot her arm was red on an unspecified date. Clinical outcome of the event was unknown.   No follow up attempts are needed. No further information is expected. Information about lot/batch number has been requested.
eye pain; Dizzy; Headache; Fever; Start date (note dates for any subsequent dosing): 21Dec2020 and 07Jan2021; chills; body aches; dry mouth; This is a spontaneous report from a contactable Other HCP (Nurse). This Nurse reported on behalf of a physician for a female patient. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 2 via an intramuscular route of administration on 07Jan2021 at 13:00 (at the age of 30-year-old), as DOSE 2, SINGLE 0.3 ML for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient Medical History (including any illness at the time of vaccination) was none. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an intramuscular route of administration on 21Dec2020 (at the age of 30-year-old), single 0.3 ML for covid-19 immunisation and experienced Temp 102 within 24hrs, Chills, dizzy, body aches, headache and dry mouth. On 07Jan2021, the patient experienced chills, body aches, dry mouth, eye pain, dizzy, headache and fever. The clinical details of the events as follows: Upon receiving second dose, the patient had same side effects with additional eye pain started following day and lasted from 5am-01:30pm. The patient was not admitted to hospital due to the events. The AEs did not require a visit to Emergency Room and Physician Office. No treatment was required to treat the events. The patient was not patient deceased. Relevant tests were none. The primary infection site was Unknown. No culture was performed. There were no predisposing factors reported. The patient outcome of the events was Resolved on an unspecified date in 2021. Causal Relationship: it was reported that there was a reasonable possibility that the event was related to suspect product/s.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Pharmacist states that Adacel expired on 04Apr2022 it was accidentally given to a patient with no reported Adverse Event.; Initial information received on 31-May-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 53 years old male patient it was reported by pharmacist states that diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] expired on 04apr2022 it was accidentally given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunisation.  On 31-May-2022, the patient received a  dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (lot U6628AA: expiry date 04-Apr-2022) via intramuscular route in the left deltoid for Immunization it was reported by pharmacist adacel expired on 04apr2022 it was accidentally given to a patient with no reported adverse event. (expired product administered). It was asked by reporter that "if the patient needs to be revaccinated and if so, when"  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event pharmacist states that adacel expired on 04apr2022 it was accidentally given to a patient with no reported adverse event.   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 guidelines. 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.
complained of lightheadedness, dizzy, flushed, taken to medical observation. BP 132/73 HR 100 R 20 Pulse ox 100 BP 135/101 HR 88  BP 121/82 HR 92 Pulse OX 99 Discharged from medical observation via wheelchair in stable condition to facility exit
First chills/shaking, then fever that lasted about 14 hours and peaked at 103 degrees.
Patient got 1st shot on 4/1/2021.  Patient was feeling sick and abdominal pain on 4/3/2021.  She went to the ER and was admitted for 5 days.  She was diagnosed with colitis with no problems prior to the vaccine.  Patient was anemic with a hemoglobin of 8.
he doesn't have any energy, he is real low on energy; real sick; tired; freezing to death; Chills; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Jan2021at single dose for COVID-19 immunization. Medical history includes hearing aids user from unknown date. There were no concomitant medications. On 17Jan2021 Sunday, the patient was freezing to death, had chills and diarrhea and still has them right now. The patient was fully aware that second dose is on 04Feb2021, and wants to know more information, is this going to continue, etc. The patient stated he was real sick, but while being sick, he read the papers, and it actually told him, this was supposed to happen. He was supposed to have chills and fever and all that, and by golly his body has done a good job of that. The real thing is, he is fine with taking it again, but after such a reaction, he wants to know if it is safe to take it again. The patient stated he lost one of his hearing aids, he needs to have another one sent, he had a terrible day yesterday. His symptoms came on in the middle of night, got in clothes stayed in bed. He has no primary care doctor, he has one here but doesn't know if he wants to mess with him. For events freezing to death and chills outcome was the he feels good, he was not chilling or doing anything anymore, but one thing that is bothering him, he doesn't have any energy, he was real low on energy. The freezing to death and chills started leaving yesterday morning, and went away over the day, he is just kind of down with it, just tired. He doesn't know why. The diarrhea didn't hang around a long time. The outcome of the events freezing to death, chills and diarrhea was recovered on unspecified date. The outcome of the remaining events was unknown.  Information on the Lot/Batch number has been requested.
Dizziness and shortness of breath. Unable to catch breath easily. Went to  the first Saturday after my Vaccine shot. occasion I was treated for labyrnthitis at visit on 4/17/2021  which attributed to the dizziness. Dizziness lasted 3 weeks but increasingly got better over time. I still felt a tightening in my chest after this visit and breathing felt a bit labored. It felt better when standing upright but was difficult laying down especially on my sides. I went back to on 4/20/2021 for a follow up. Lungs looked clear from X-Rays. Was treated for Asthma like symptoms but have never been treated for Asthma previously. Symptoms have improved. I am able to sleep on my side now but will still have times where I can't seem to breathe evenly when I lay down.
Vaccine Administered on 02Feb06 with a cough an congestion started on day 6 (mild). Day 8- Fever in the evening 102 by thermometer. Motrin given.  Day 9- Smallpox reaction (8cm) with 14 cm lymphangitis and + axillary lymph nodes no fever Lungs Clear. Day 10- no fever lungs clear rash noted to chest, back, and arms bilat approximate 30 lesions total. Left deltoid immunization site decreased in size by approximate 3 sm no lymphangitis. Cough and congestion improving. Differential Diagnosis- Generalized vaccina vs non-specific rash.
70-year-old patient who received MENACTRA, with no adverse event; Initial information received on 10-Dec-2021 regarding an unsolicited valid non-serious case from an other health professional via Information (under the reference 00893595).  This case involves a 70 years old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Product use issue).  The patient's medical history included Asplenia.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines.   In 2018, the patient received a dose of suspect MENACTRA (Oral solution, total, once, lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to drug use in unapproved age group (same day latency).  It was reported "Medical assistant states they have a 70-year old patient with asplenia who received MENACTRA in 2018; states he is supposed to get a booster 5 years later. Medical assistant asks if his booster should be 1 dose or 2 doses?"  No adverse event reported.   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.  There would be no information on the batch number for this case.
Rt. Deltoid swollen from shoulder to elbow, Mother called in to report. Rn recommended to apply ice and call family MD.
Patient was brought to office on 10/11/2017 with abdominal pain, fever, diarrhea, and vomiting. Was diagnosed with a left ear infection and started on 10/11/17. Patients mother called office to be seen  again on 10/12/17 and we had her go to lab to get a stool culture and then to come to the office.  Patient was brought in with complaint from mother that infant still is not feeling better. Patient did have an ear infection, but when leaving the office patient changed diaper and it appeared to have blood in diaper. Patient was sent to Medical Center to be evaluated and treated.
In late April I began having spells of numbness of the right side of my face and tongue. They would come and go. I'd have slight slumping of the right side when Id raise my eyebrow or smile, but they would resolve themselves. This kept happening through May, June, and July then on July 18th my whole right side went numb, my arm, my leg, my face, and my tongue. I was told to go to the hospital where they ran tests and ruled out a brain bleed or blood clot (stroke). Those were ruled out. The numbness went away, but the full right sided numbness has come back a few more times in the last week.
Pressure Headache that lasted 12 days, right facial tingling  around day 5, visual disturbances on day 2, foggy thinking 10-12 days, fever 100.6 after 30 hours, body aches  lasted 48+ hours, irritability for 7+days, neck pain lasting 7-10 days with thoracic pain lasting 12-14 days, left arm soreness lasted 4-5 days, loss of appetite lasted 2 days
Developed urticarial lesion on upper lip immediately after IPV, HEPA. No resp. or airway symptoms.
Received flu shot on 10/5/2017 and had an allergic reaction 10/5/2017 with signs of swelling on the right face and breathing problem. Staff was  given SOLU-MEDROL, BENADRYL, PEPCID and DUONEB.
1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster; 1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster) and EXPIRED PRODUCT ADMINISTERED (1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 PRODUCT STORAGE ERROR (1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster) and EXPIRED PRODUCT ADMINISTERED (1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster). At the time of the report, PRODUCT STORAGE ERROR (1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster) and EXPIRED PRODUCT ADMINISTERED (1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. 1 vial of Moderna vaccine was opened on Friday and placed in the vaccine refrigerator (temperature between 37-43 F). The vial was used on Monday for a COVID booster after remaining in the vaccine refrigerator over the weekend.  No treatment medications were reported.
3 month old exam. Brought in for first vaccination and congestion. Foster mother had no with immunization records. IIS was checked no records found ordered the following combination vaccines. PENTACEL, KINRIX and Hib computer did not display any warning. Immunization given. Informed doctor with her mother.