chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 3 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 30-NOV-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168:Original Case : 1701USA004150 US-009507513-1701USA007912: Original Case : 1701USA007906 US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Lymph nodes swollen; Booster shot in her shoulder/HCP sanitized with alcohol her side bicep and applied the vaccine/HCP is not manipulation the vaccine correctly/carried the vaccine in pocket; Receiving her Booster shot in her shoulder and never receiving a vaccine so high; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes swollen), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Booster shot in her shoulder/HCP sanitized with alcohol her side bicep and applied the vaccine/HCP is not manipulation the vaccine correctly/carried the vaccine in pocket) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Receiving her Booster shot in her shoulder and never receiving a vaccine so high) in a 52-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph nodes swollen), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Booster shot in her shoulder/HCP sanitized with alcohol her side bicep and applied the vaccine/HCP is not manipulation the vaccine correctly/carried the vaccine in pocket) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Receiving her Booster shot in her shoulder and never receiving a vaccine so high). At the time of the report, LYMPHADENOPATHY (Lymph nodes swollen), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Booster shot in her shoulder/HCP sanitized with alcohol her side bicep and applied the vaccine/HCP is not manipulation the vaccine correctly/carried the vaccine in pocket) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Receiving her Booster shot in her shoulder and never receiving a vaccine so high) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient received Booster shot. Patient  has no allergies. Treatment information was not provided.   This case was linked to MOD-2022-511971 (Patient Link).
3-4 minutes after immunization.  Tingling arms, back and lightheadedness so patient was reclined.  Then complained of worsening arm, neck, back and chest pain.  Continued to worsen over 5 minute period.  Ambulance called.  Crew reported hypertensive both laying down and sitting and high blood glucose.  Patient transported by family to ER for follow up.
At night had chills and headache. Chills resolved after 6hrs but headache continued Arm is sore
Lump in her throat; This spontaneous case  was received on 13-Jan-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-00155) and concerned a 46-year-old, female patient.  The patient's concurrent conditions included anxiety disorder. The patient's concomitant medications were not reported. The patient stated she had influenza vaccines before and never had an issue.  On 03-Jan-2013, the patient was vaccinated with Afluria (TIV) (influenza vaccine; route of administration, anatomical location, dose: not reported) as prevention of seasonal influenza. The batch number was not reported.  On the same day, after receiving Afluria (TIV), the patient experienced a lump in her throat. The patient stated she had no swelling in her throat and was able to breath. Moreover, the patient stated she did not experience any anaphylactic shock and had no other complications.  On an unspecified date, three and a half months after receiving Afluria (TIV), the patient was still experienced "a lump in her throat".  On an unspecified date, the patient visited emergency room (ER), and had blood oxygen level and blood pressure measured, and results were all good. The patient also stated she is going to consult with an allergist and requested to be provided the ingredients of the Afluria (TIV) vaccine.  At the time of initial reporting, the patient had not recovered from the event.   The reporter did not provide a causality assessment, but the patient stated she was not sure if the above experienced adverse event is related to her anxiety disorder or not.  The case was assessed as non-serious.  Company Comment: A 46-year-old, female patient developed a pharyngeal mass on the same day after vaccination with the suspect product Afluria (TIV). More information regarding the related diagnostic findings is needed. Due to plausible time relationship, causality of the suspect product cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).; Sender's Comments: A 46-year-old, female patient developed a pharyngeal mass on the same day after vaccination with the suspect product Afluria (TIV). More information regarding the related diagnostic findings is needed. Due to plausible time relationship, causality of the suspect product cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).
medical assistant accidentally gave a Adacel vaccine to a 6 month old instead of a flu vaccine, no AE; medical assistant accidentally gave a Adacel vaccine to a 6 month old, no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from non-healthcare professional.  This case is linked to cases 2019SA273055 and 2019SA273064 (same reporter).  This case involves a six months old patient who accidentally received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported via unknown route in unknown administration site instead of INFLUENZA VACCINE (lot number not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  At the time of report no adverse event was 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 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.  Information on the batch number was requested.  Documents held by sender: none.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 1 day after receiving SHINGRIX, the patient experienced fatigue and pain in arm. In May 2018, the outcome of the fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the fatigue and pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The pharmacist reported the case for himself. The patient experienced delayed arm pain. The patient mentioned to the field representative that it hurt a lot. The patient had denied permission to contact his physician, and him for further information.
patient who is age 36 with NO immunocompromise who received one dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 36-year-old male patient who received Herpes zoster (Shingrix) (batch number ZS3D7) for prophylaxis.   Additional patient notes included Not immunocompromised..   On 13-SEP-2023, the patient received the 1st dose of Shingrix. On 13-SEP-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient who is age 36 with NO immunocompromise who received one dose of Shingrix).  The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt date: 22-SEP-2023 A pharmacist reported that a patient who was age 36 with no immunocompromised who received one dose of Shingrix.  The reporter stated that he/she are trying to determine the next steps, and whether or not the patient should receive dose 2 on the typical 2-6m schedule, or if it should be deferred. The 36 years old patient received Shingrix which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Erythema, warmth and itching began yesterday. Patient marked site with a pen. He reported that today the erythema had progressed. He had erythema, edema, and warmth from site of vaccination to his elbow.
Immediately upon receiving injection, my left arm began to tingle down to my fingertips.  This lasted about 48 hours with intermittent tingling and numbness.  About a week after the injection, both of my arms began experiencing intermittent numbness, tingling, and pain.  This then spread to my left leg also.  It has now been four weeks since vaccination, and I still experience this.  The symptoms are worst in my left arm.
The next morning following the vax, the pt complained of a sore throat, coughing, had phlegm, had to blow nose. The pt called the triage nurse. The pt was told to treat the symptoms as a cold. Treated with Codeine Cough at night and OTC during the day.
Received vaccine 10/31/02. Wakened with nausea/vomiting 4AM 11/01/02; gone by 8AM 11/01/02. Chills, headache, upper body aches remainder of 11/01/02. Woke on 11/2/02 completely recovered.
First dose vaccine administered third trimester pregnancy. Local soreness evening after vaccine that worsened the next day but asymptomatic by 2 days post-vaccine. 7-8 days later, experienced itching and wheal/redness at injection site. Mild itchiness only persists 2 days later.
On August 5th AM Pt. admitted for focal seizure. Intubated transferred to Childrens. Extubated diagnosed with enteroviral meningitis. Pt. placed on Phenobarb sent home 8-8-11.
Information has been received from a physician concerning a 24 years old female patient with unspecified kidney issue, who on 05-SEP-2012 was vaccinated with the first dose of GARDASIL 0.5 ml (route and lot # not reported). No other co-suspects were reported. Concomitant medications included: MIRENA. The physician informed that on 19-SEP-2012, while on GARDASIL, the patient experienced joint pain in her chest, arms, legs and back. On an unknown date the patient recovered from the events. No treatment was given for the events (also reported that AE improve on therapy). The patient did not seek medical attention. The relatedness for the events was unknown for GARDASIL. Additional information has been requested.
LPN rpt pt recv 1dose of varivax in 8/95 & 5/98 devel chickenpox w/5-6 lesions.
FEVER; TIRESOME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (unspecified manufacturer). (Dose number in series 1)  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 23-OCT-2021 for prophylactic vaccination. The batch number was not reported.(Dose number in series 2) The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 24-OCT-2021, the patient experienced fever that had  lasted for 3 days, its tolerable just tiresome.(Dose number in series 2)   The patient had no side effects from the first covid-19 vaccine. (Dose number in series 1)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the fever and tiresome was not reported.  This report was non-serious
The patient is a little less than four months from her 3rd shot, or 1st booster. She was vaccinated the 3rd time on 1/14/2022 and I mistakenly gave her another dose today, 05/02/2022. I did not look up her information until after I had vaccinated her.
1.  Within 30 minutes of shot, I developed a pre-migraine aura around my vision.  The aura disappeared in 15 minutes and no migraine HA occurred.  I got auras before migraines years ago but they are rare now.  2.  Three hrs after the shot, I suddenly developed severe imbalance/dizziness which made me nauseous and I broke out in a cold sweat but no fever occurred.  I laid down to relieve the nausea and keep from falling.  In approx an hour, I was back to normal.  This has happened twice previously approximately 2 years ago (cause unknown) so I am not sure this event was due to the shot.  I did not seek medical attention and nothing has occurred since then.
pt inadvertently recv HIBTITER & ACTHIB on 3/3/98;f/u 8/24/98 it was reported that pt recovered from this exp;
Arm soreness at injection site, warm to touch for 4 days after injection. Chills and 98.8 light fever (I usually run at 97.6) 24 hrs after injection. Fatigue for a total of 3 days. Treated symptoms with drinking more water, taking temperature, taking 1000 mg of Tylenol twice a day, on 3/25 and 3/26. Cold washcloth to injection site for relief.
ADMISSION DATE:                    11/20/2021 DISCHARGE DATE:                   11/25/2021   SERVICE:                                   Internal Medicine ATTENDING PHYSICIAN:             PRINCIPAL ADMISSION DIAGNOSIS:   AHRF due to COVID-19 infection   DISCHARGE DIAGNOSES: Active Hospital Problems   Diagnosis   ? (Principal) ACUTE HYPOXEMIC RESPIRATORY FAILURE   ? DM 2   ? CORONAVIRUS COVID-19 DISEASE   ? CAD, PRESENCE OF STENT     Resolved Hospital Problems No resolved problems to display.     ISSUES TO BE ADDRESSED AT FOLLOW UP: 1) COVID infection - 50 y/o M patient was admitted pn 11/20/21 due to COVID infection causing AHRF, and required 3 days on HFNC supplemental oxygen support. On HD4 patient was weaned off HFNC and did well on RA, with oxygen saturation 95-97% on day of discharge. Patient did not develop a cough or other bothersome symptoms. Please ensure complete resolution of symptoms and any follow up support patient requires.   Per current CDC guidelines, patient should self-isolate for a total of 20 days from the last time was febrile, which was on admission to the hospital on 11/20/21.  Thus, patient should self-isolate through 12/12/21. Patient instructed to wear a mask when outside of house and keep 6 feet of distance between himself and other individuals. A work note was provided stating patient should remain off work through 12/13/21. If patient is still not feeling fully recovered as that date approaches they are encouraged to contact their PCP for an extension of the time off from work.   2) Insulin dependent diabetes management - patient presented with blood glucose in the 300-400 range. Last A1C 11.8%, up from 6.0 in 2018. Patient's insulin regimen was adjusted for improved glycemic control. By discharge blood glucose levels were in the 100-200 range. Please follow up on new diabetes regimen and titrate medications as needed. Referral to Diabetes Care Manager placed.
Within 12 hours I became to have severe muscle aches and joint aches. All my joint felt hot, it was bad enough I wasn't able to sleep. I took Ibuprofen   to help sleep.  I slept most of Friday I has extreme fatigue. On Saturday I has muscle weakness and tingly in my hands, the muscle aches have gone away. I couldn't knit ot fine motor skills, It bothered me. I woke up on Sunday where I had extremes muscle weakness in both my legs. I called my PCP, they were surprised by how the reaction was delayed.  They wanted me to get a test for the strength in my legs and sent me to the ER. I wen to the Er they tested for stroke, blood work, scans, they were worried about Guillain Barre Syndrome.  I stayed there about 5 hours. Yesterday afternoon the tingly went away from my hands but my legs are still kinda goofy. The muscle in my forearm  and thigh feel like my muscle are really sore, like they have been tense
itching; develop a strong skin rash just after my first shot in January last year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 (Lot number: EW0172) at the age of 73 years as dose 3 (booster), single, administered in arm left, administration date 02Feb2021 (Lot number: FIV5318) as dose 2, single and administered in arm left, administration date 11Jan2021 (Lot number: EL3249) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bladder cancer" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL (ongoing); AMLODIPINE (ongoing); LISINOPRIL (ongoing); PROZAC (ongoing); SYNTHROID taken for thyroid disorder (ongoing). The following information was reported: RASH (non-serious) with onset Jan2021, outcome "not recovered", described as "develop a strong skin rash just after my first shot in January last year"; PRURITUS (non-serious), outcome "unknown", described as "itching". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pruritus. Additional information: Patient have received three Pfizer COVID19 vaccine shots. He was about to get number four, but realized that he began to develop a strong skin rash just after first shot in January last year. The rash persists today and has been unresponsive to various treatments by dermatologists. He was about to get a fourth shot because he is immunocompromised and when he was reading the description, disclaimer for the vaccine they asked him if he had any allergic reactions and he have got allergy. He have got a rash all over body that develops after he had the first shot. Now, he have been working with dermatologist to try to figure out what's caused this allergy and have done all sort of things and nothing else makes any sense and this well other then the fact that this is a severe rash caused from the interaction with the vaccine. He is very appreciative that we have this vaccine but its a fact he believe that it is affecting his body. So, he decided not to get the fourth shot and then he asked people whether he could switch to Moderna and since it's a mRNA type vaccine they said no, don't do that. He have taken many gels. He is using many ointment and gels. He is taking a number of ointments to try to alleviate the itching but don't have the names of them here. He have bladder cancer but it's under control right now. So, that's why he is immunocompromised. In his treatment he get an immunotherapy and right now everything is under control.  No follow-up attempts possible. No further information expected.
# Malaise # Muscle pain # Chills # Nausea # Fatigue
Rash to right arm - silvene cream placed to wound site, Tylenol 460mg given and Keflex 250mg PO given under orders from Dr.
Shoulder Pain; Headache; This case was reported by a physician via call center representative and described the occurrence of shoulder pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2019, the patient received the 2nd dose of Shingrix. On 24th May 2019, less than a day after receiving Shingrix, the patient experienced shoulder pain and headache. On 25th May 2019, the outcome of the shoulder pain and headache were recovered/resolved.   It was unknown if the reporter considered the shoulder pain and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband and did not was to provide her details. The age at vaccination was not provided. The patient got Shingrix on Friday and from the date of reporting had shoulder pain and headache for 24 hours. No vaccine information was provided. The reporter consented to follow-up. This case was linked to case US2019096151 through same reporter. There is a discrepancy between the outcome reported in the structured field (resolved/resolved) and the outcome reported in the source document (resolved with sequelae). The outcome of these events retains as per the structural field.
On 9/15, mother called to report rash on abdomen-tiny blanching red papules with no other symptoms.
This spontaneous report was received from a medical assistant referring to a patient of unspecified gender and age. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 21-SEP-2017, an improperly stored dose of VAQTA 2 ml, once, lot#N017094, expiration date 31-AUG-2018 (route of administration and anatomical location were not reported) was administered to the patient. The dose was stored in temperature 33.8 degrees Fahrenheit for 20 minutes and in temperature 35.8 degrees Fahrenheit for 2 minutes. No previous temperature excursions were reported. No adverse effects have been reported. Data logger was involved. Product quality complaint was not involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA012899: US-009507513-1709USA011805: US-009507513-1709USA011805: US-009507513-1709USA012897.