chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 66-year-old male patient who received TWINRIX (batch number B9H95, expiry date 29th November 2017). On an unknown date, the patient received the 3rd dose of TWINRIX. On an unknown date, unknown after receiving TWINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follow: On an unknown date, the patient was inadvertently administered a dose of TWINRIX, which was already expired on 29th November 2017. Follow up information was received from a pharmacist on 8th May 2018: The patient's demographic details were updated. On 4th April 2018, the patient received the 3rd dose of TWINRIX vaccine (1.0 ml) intramuscularly. After vaccination, the nurse realized that the vaccine was expired and the patient was contacted immediately, who stated no adverse event. The patient was followed up on 4th day, at the time he stated had fatigue and general malaise, for 3 days following vaccination. Latency for fatigue and general malaise was less than a week. The patient was advised to return for vaccination but he refused. No additional adverse effects were reported. It was unknown if the reporter considered the fatigue and general malaise to be related to TWINRIX. The VAERS details were added. This case was associated with a medication error with an adverse event.
pt recv vax 1MAY96 & approx 1mo p/vax pt devel swollen, puffy, erythematous, itching eyelids which subsequently flaked;pt thought @ the time may have been a contact dermatitis;
Swelling and tingling of tongue, rash at vaccination site, hives on chest and neck. Given a steroid and Benadryl in emergency department.  Was real eases with a prescription for steroids and direction to continue taking Benadryl.
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unspecified age. On an unknown dates in 2014 (exact date unspecified) the patients were vaccinated with ROTATEQ (therapy route defaulted to oral, dose, lot number was not reported), which was improperly stored since 28-OCT-2014. No adverse effects were reported. Follow-up information has been received from the Licensed Practical Nurse. In 2014 (exact date unspecified), unspecified number of patients were vaccinated with an improperly stored since 28-OCT-2014 ROTATEQ (therapy route defaulted to oral, lot# K007243, expiry date: 13-DEC-2015). No adverse effects were reported. The reporter also stated that she did not have the information available at that time but she might fax the information at a later time. The reporter stated, that the refrigerator's main thermometer was broken and the backup thermometer did not show any temperature excursions. This is one of several reports from the same reporter. Additional information has been requested.
No other vaccines on this date. Pt has a 5x5 red, warm (not raised) arm in the deltoid area. She noticed this after she got home from work on 2/9/18.
fever, chills, injection site pain, arm stiffness, cough, vomiting, diarrhea
Vaccinia vaccination 2/13/03, 2 days of feverish feeling and chills, erythema, induration, lymphangitis, lymphadenopathy likely vaccinia cellulitis.
Hypothermia, lethargy, unresponsive, change in skin color, sleep apnea. 1 week NICU stay, antibiotics, NG tube, oxygen.
Narrative:  this is a 62 years old male who was received as a transfer from another Hospital emergency room. Patient presented to OSH for generalized aches, shortness of breath and productive cough associated with intermittent fever and chills. As per patient he was here last Tuesday for his podiatry appointment and was asymptomatic. Patient started feeling sick yesterday. He has had 2 Covid vaccines and denies any known sick contacts. Smokes 1 pack/day. On arrival to first hospital patient was noted with SPO2 levels below 90 and he was requiring 3 L to keep SPO2 above 92%. He does not wear oxygen at home. Chest x-ray showed no evidence of pneumonia and remains without any elevation of inflammatory markers. Additionally patient has history of coronary artery disease, with significant lesions noted in the right coronary artery on angiography performed in 2002. The patient did undergo percutaneous intervention of both the proximal and the distal bifurcational stenoses. ASSESSMENT & PLAN ************* 1) COVID illness with acute hypoxic respiratory failure requiring supplemental oxygen 3 L by nasal cannula
Pediatric Engerix b administered to adult; Pediatric Engerix b instead adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's comment: Pharmacist reported that the patient was administrated with the pediatric dose of Engerix B instead of the adult dose. No adverse event was reported. No patient's identifiers, lot number and expiration date were provided. The reporter consented to follow-up. Additional Supportive Information: The adult patient received pediatric dose of Engerix B, which led to underdose and adult use of child product. This case had been linked with case US2022132051, reported by the same reporter.; Sender's Comments:  US-GSK-US2022132051:Same reporter
PATIENT RETURNED TO CLINIC 4:04 PM. PATIENT COMPLAINED OF METALLIC TASTE AND ZERO NUMBNESS.
This spontaneous report was received from a physician via company representative regarding a male patient of unknown age with no pertinent medical history reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (dose, route and anatomical location not reported). No other suspect therapies were reported. Concomitant medications included fish oil (dosage and manufacturer unspecified). On an unknown date the patient developed an hematoma on the spleen, high fever and vomiting after receiving the GARDASIL shot. The patient was hospitalized and the hospital was monitoring the patient but no treatment was being given (length of stay unspecified). The outcome for hematoma on the spleen, high fever and vomiting was unknown at the time of the report. The reporter did not assess the causality between hematoma on the spleen, high fever and vomiting and GARDASIL. Additional information has been requested.
Patient came to the pharmacy on 05/31 (26 days after getting immunized), that he has left shoulder joint pain and it is swollen. He spoke to the RPh on duty, that his left shoulder top started hurting a couple of days/ within a week of getting the shot. RPh told him if it was painful & swollen, he can take Ibuprofen, Advil, or Tylenol and put some ice on the swollen shoulder. Per Rph pt refused to take those meds he recommended to alleviate pain but instead told him he had went to dr to have an xray & gave the RPh the rejection from insurance that they won't pay for the vaccine that was given to him on 05/05/18.
Patient was given the varicella vaccine and contracted chicken pox. Pt presented with fever and blister like rash when we checked on patient on 9-5-13 patient was recovering well.
Adverse Events: Fever, Extreme Body Aches, Headache, Extreme Nausea/Vomiting, Fatigue, Sore Arm. Treatment: Zofran, Phenergan, Rest at Home, Ibuprofen
1 week after vaccines, patient presented to office with infantile spasms. In ER and admission, Infantile spasms were confirmed on EEG and MRI demonstrated thalamic stroke
Since vaccination the patient has had a severe headache (unlike her typical episodic migraine), and then developed left hemibody anesthesia, LUE drift. CTA demonstrated Right ICA dissection (of unknown duration) with string sign, acute right MCA artery to artery sub-occlusive embolus, MRI shows right MCA ischemic infarct.
Pt, reported to me on am of 1/19/2017 that experienced pain at inj. site then swelling began in evening and continued through next day. Reported pain gone now and swelling not getting worse.
26th 0130-can't move, all joints bones-Can't get out of bed. No eating.  Poor voiced quality.  She's been vomiting.   When I asked her the Lot# and manufacturer-she said-stop yelling- don't get frustrated-began to cry-I softy asked the question again Lot# and Manufacturer. Told to go see her PCM.
Angioedema; psychosis; Body aches; Fever; This case was reported by a nurse via sales rep and described the occurrence of angioedema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), psychosis, pain and fever. The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the angioedema, psychosis, pain and fever were unknown.   It was unknown if the reporter considered the angioedema, psychosis, pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The doctor advised the patient who was undergoing chemotherapy to receive Shingrix with the approval of her oncologist. It was reported that, within several hours 1 to 2 hours, after receiving Shingrix, the patient experienced body aches and fever. The patient also experienced angioedema and psychosis for a period.
10APR95 very angry @ being vax flushed, hot;vax given 10AM mom states pt was very irritable w/1 hr crying spells x 3, all over body aches;2PM APAP given;9PM mom consulted w/PMD & cont APAP & began DPH per MD;inj site red & swollen & hot
Pt received vaccine at 11:39 am in RUA.  After sitting in observation for about 10 minutes, pt c/o feeling dizzy and lightheaded.  Pt put in w/c and taken to privacy area and placed in reclining chair.   Skin cool and hand clammy.  No pallor to skin.   VS: B/P 130/88, P-96, R-18, T-36 C, O2 sat 99%.  Pt also c/o a "fluttering" in the chest underneath the sternum area but denied having chest pain.  Pt stated she also has had a fast heart rate and "palpitations" recently that has been waking her up at night.  She saw a cardiologist yesterday for this issue and will be getting a monitor to wear for two weeks.  Pt states the fluttering seems to come and go and has not had any of it before today.  She also says she was a little worried about getting the vaccine.  EMS was called at 1220 pm and arrived at 1227 pm.   EMS personnel assessed pt and recommended her to go to ER.  Pt complied and was taken by EMT's to hospital.
Moderna COVID19 Vaccine vial was taken out of the fridge and left at room temperature; Administered dose past the 12-hour mark; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Moderna COVID19 Vaccine vial was taken out of the fridge and left at room temperature) and EXPIRED PRODUCT ADMINISTERED (Administered dose past the 12-hour mark) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID19 Vaccine vial was taken out of the fridge and left at room temperature) and EXPIRED PRODUCT ADMINISTERED (Administered dose past the 12-hour mark). On 22-Oct-2021, PRODUCT STORAGE ERROR (Moderna COVID19 Vaccine vial was taken out of the fridge and left at room temperature) and EXPIRED PRODUCT ADMINISTERED (Administered dose past the 12-hour mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided. This is first patient. Lot number(s): 037F21A Number of doses/vials: one vial, 4 doses administered. Date(s) and time(S) vial was first punctured: 21Oct2021 at 9:15 AM. How was the vial stored post puncture? room temperature Did the vial undergo any temperature excursions? No Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 27.5 hours.   This case was linked to MOD-2021-363303, MOD-2021-365032, MOD-2021-364190 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Non-significant follow up Appended - reporter details and narrative updated.
Similar to first dose.  Severe flu like symptoms.  Head ache almost immediately, significant muscle ache within a couple of hours, chills and severe shaking.  Acetaminophen and iburprofen reduced symptoms.  Not reported although present after first vaccination:  insominia.  Frankly, I could not imagine the impact of similar side effects on my 86 year old mother.
pt recvd vax & exp nausea, stiff neck, sore throat & lt arm pain; pt was unable to work on 4AUG93 (2 days p/vax);
Redness to Rt deltoid area on 1/25/10 at 5 P.M. and rash < itch to both lower legs above ankles. Vesicle like lesions-was seen here 1/26/10 at 9:30, was given BENADRYL OTC and MEDROL dose pack. 7 days after H1N1 given.
Patient  (9 years old) was mistakenly given adult Pfizer covid vaccine instead of pediatric covid vaccine.  The mother was notified immediately upon discovery. At this time, the patient's mom had consulted the pediatrician and no adverse events had been reported.
29JUN98 PM ran fever 104-no other sx;30JUN98-2JUL98 fever gone p/antipyretics-started 102 ranging 101-102;no other sx;4JUL98 rash on neck, then chest, back, then to groin 6JUL98-now better on 7JUL98;
pt states she allergic reaction to the covid vaccine when she received the first dose; This is a spontaneous report from a contactable nurse. A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as single dose for COVID-19 Immunisation. The patient's medical history and concomitant medications were not reported. Past medication history included tofacitinib citrate (XELJANZ XR, 11 mg, Tablet (30'S), Lot number: Unknown, Expiration date: 28Feb2023) orally, daily in the spring season 2019. The patient stated, she had allergic reaction to the Covid vaccine when she received the first dose. Outcome of the event was unknown. No additional information provided.  No follow-up attempts possible. No further information expected.
A report was received from a healthcare professional on 10/29/2002, concerning a 70 year old male vaccinee who received last years batch of Fluvirin intramuscularly on 10/23/2002. ON 10/23/2002, the vaccinee was inadvertently administered last years batch of Fluvirin (dated 30 June 2002) intramuscularly.  It was reported that the vaccinee did not experience any adverse event in relation to the incident. The reporter has assessed the relationship of the vaccine to the event as related.
20 y/o male with no past medical history that presents with diaphoresis and paleness post vaccination administration. Patient states that this is his 1st dose in the two-dose series. Patient denies headache, sore throat, difficulty breathing, shortness of breath, rash or itch. NP and Paramedics at patient side. Patient was taken to the partitioned area and placed in Trendelenburg. Patient was provided a protein bar and a bottle of water. Patient initially hypotensive (prior to Trendelenburg) but all other vitals normal (73/44 BP, 99% RA, 84 Pulse, 14 Resp). Glucose was attempted but monitor not working. Patient observed closely by the NP and the Paramedic. Patient was no longer diaphoretic or pale, patient stated that he was feeling better after resting and eating. Patient vitals normal prior to being discharged home (124/81 BP, 99% RA, 85 HR and Resp 12). Patient was able to ambulate without difficulty and no longer symptomatic.
Moderna COVID-19 Vaccine EUA about ten minutes after IM injection patient started complaining of troubling swallowing and coughing violently. Vitals were checked: O2-100%, P-110-120 regular, BP-142/90.  25mg of benadryl was administered IM in the right deltoid. Shortly after that pt. stated it was getting easier to swallow. EMSA was contacted to respond for transport. Pt was monitored on site until transported to local hospital for further evaluation.
Has to schedule her root canal appointment/but has to also take antibiotics; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (Has to schedule her root canal appointment/but has to also take antibiotics) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTH DISORDER (Has to schedule her root canal appointment/but has to also take antibiotics). At the time of the report, TOOTH DISORDER (Has to schedule her root canal appointment/but has to also take antibiotics) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported. Patient has stated that she scheduled to get her second dose of the Moderna vaccine on Friday 26Feb2021 and has to schedule her root canal appointment but has to also take antibiotics.
pt has anxiety and fear of needles  after vaccine felt flushed and given water while sitting in chair, pt then felt hearing fade and ringing in ears  placed in wheelchair and brought back to OBS for evaluation,  pt stood and transferred to stretcher laying down   feeling better when laying in bed.   vs as noted   dr at bedside reviewed vs and assesssed patient.  pt sat up  to dangle to standing without complaints of symtpoms feeling better.  ambulated to exit at 1415 without diffiuclty vs 1400 bp 144/79 hr 71 rr 20 o2 97  1405 bp 148/95 hr 85 rr 18 o2 99  1410 bp 143/89 hr 77 rr 18  o2 99
Feeling kind of rundown; lymph node in my neck have been swollen; Feeling not well; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a sponsored program (004756). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DEPRESSED MOOD (non-serious), outcome "unknown", described as "Feeling kind of rundown"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "lymph node in my neck have been swollen"; MALAISE (non-serious), outcome "not recovered", described as "Feeling not well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
my breast is really swollen and very very tender to touch, I just got scared; my breast is really swollen and very very tender to touch; underneath her arm and to her breast was swollen, and describes it as tender, sore, and painful; Lymph node gotten inflamed; underneath her arm and to her breast was swollen, and describes it as tender, sore, and painful; underneath her arm and to her breast was swollen, and describes it as tender, sore, and painful; underneath her arm and to her breast was swollen, and describes it as tender, sore, and painful; This is a spontaneous report from a contactable nurse (patient) via Medical Information team. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EP6955) dose 2 via an unspecified route of administration in left arm on 26Mar2021 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Medical history was not provided. Concomitant medications included vitamins unspecified. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On 27Mar2021, last evening after midnight she noticed that underneath her arm and to her breast was swollen, and describes it as tender, sore, and painful. She saw her physician regarding this side effect. She got the injection under the armpit and connected onto her breast was really swollen and very very tender to touch, she just got scared. A lymph node gotten inflamed on 27Mar2021 because vaccine was administered on that side but it was very very tender and sore to touch and very swollen. She just took Tylenol this morning. The patient underwent lab tests which included Metabolic Panel, CBC/complete blood count all the things normal on an unspecified date. The outcome of events was not recovered.  Relatedness of drug to reaction(s)/event(s): events Lymph node gotten inflamed, breast is really swollen and very very tender to touch assessed as Related. Source of assessment: Primary Source Reporter. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
After getting both the tdap and not sure which one and the flu vaccine I began to have extreme entire leg swelling daily.