chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On arrival to facility I   pre medicated with 1000mg tylenol and 10 mg allegra. I was given the Pfizer-BioNTech covid 19 Vaccine EUA in my left arm.   Within about 5 minutes of injection I noticed bilateral arm redness an itching.  The PA observed.  I then proceeded to note numbness and tingling to inside of mouth, lips and tongue.  The staff nurse came in to assess me, epi at bedside ready.  I then started to develop  a area of swelling across the bottom of my lower lip and note thickness sensation to tongue and uvula. RN notified the on staff physician who came in and assessed me.  The redness on arms was improving but other symptoms remained unchanged.  On staff doctor recommended that I go be assessed in ER.  I called for a ride to ER and was brought in to department and given 60 mg steroid orally.  My initial VS were abnormally high 170/109 bp.  I was then observed until improved symptoms.  Upon leaving ER I had mild generalized itching, small swelling to lower lip and small amount of tingling to tongue and lip.  I was instructed to take Benadryl 50 MG once home and pick up prescription for additional steroids and epi pen.  I have continued to use the steroids as instructed.  I notice that the numbness to tip of tongue and is still there prior to scheduled dose of steroids.  I have not had to use the epi pen
"flu like symtoms"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS ("flu like symtoms") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS ("flu like symtoms"). At the time of the report, INFLUENZA LIKE ILLNESS ("flu like symtoms") outcome was unknown.          AE: "got my second shot and now have flu like symptoms. Can my wife catch these symptoms from if she hasn't had her shots
POST VACCIANTION, PT. REPORTS RINING IN BIALTERAL EARS, TRANSFERRED TO MED OBS VIA WHEELCHAIR ACCOMPANIED, UPON ASSESSMENT IN MED OBS, PT. REPORTS RINGING IN EARS SUBSIDED, CONTINUES TOREPORT MILD HEADACHE, VS OBTAINED. OFFERED LITE SNACK AND WATER. REPORTS SYMPTOMS SUBSIDED. PT. ESCORTED TO EXIT WITH STAFF AND FAMILY MEMEBR VIA WC AT 1429. VS AS FOLLOWS 1412 BP SITTING 144/61 HR 68 RESP 17, O2 SATS 94% 1417 BP SITTING 134/62 HR 68 RESP 17 O2 SATS 98% 1421 BP STANDING 135/72, HR 69, RESP 17, O2 SATS 98%
2 weeks post vaccination developed dysphonia, globs, LPR, vocal cord paresis, cough
2/9, 1900:  fatigue, slight dizziness; 2/9, 2000: full body aches, sensitive skin, joints, light headache; 2130: chills, moderate, no fever; 2230: chills, severe, no fever; 2330: insomnia, possibly due to chills; 2/10, 0130: insomnia moderate; 0930: spiked fever 102.0  (took acetaminophen 500 mg); 1000: fever dissipated; 1030: moderate fatigue, slept all day; 1630: fever reappeared 101.5 (took acetaminophen 500 mg again); 1730: fatigue continue, slept 2/11, 0600: woke without symptoms.
stretching movements in car seat en route home from MD office 35-40min p/inj;pt now sleeping & mom says not easily awakened;23JUN95 f/u baby taken to ER seen in ER was fine;poss sz;
Red, swollen area 2x3" wide on left arm. Advil and Benadryl and warm compresses.
stroke; blood clot; feeling bad; headache all night; nausea; vomiting; feeling icky; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 29Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received the 1st dose of BNT162B2 on an unknown date for Covid-19 immunisation and no events were reported. On 02Sep2021, the patient started feeling bad, had headache all night, experienced nausea and vomiting, and was feeling icky. She said had headache, nausea, and vomiting again last night. She said it has already been 5 days. With that, consumer wants to know how long the side effects last, if she needs to go to a hospital or if the side effects are signs of stroke or blood clot. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
PMHx to include RA, history of + PPD treated with 6 mos INH therapy in remote past, COPD with questionable ILD and OSA.  Hospitalized  from 6/6/21 - 6/10/21 for worsening shortness of breath. Found to have hypoxemic respiratory failure. Question if this was progressive ILD related to his RA versus methotrexate ALI as his dose had recently been increased. He was treated with corticosteroids and discharged home with 02. On 6/30/21 he notes improvement in his dyspnea but remains winded with minimal exertion. HR goes up with activity as well. His methotrexate was discontinued. He was placed on Humira as per his rheumatologist.
pt recvd vax & devel headache; also Lt arm & shoulder started to hurt 30 min after inject; felt like pulled muscle in arm & shoulder;
Hearth irregular palpitations ,lose feeling to left arm ,head ache body pain dizziness still have
Narrative: After receiving dose #2 of the COVID-19 vaccination, veteran developed shortness of breath on exertion and had a few blood clots in suprapubic catheter. He was already on apixaban and family declined additional workup for PE. Of note, patient had a previous COVID-19 infection that was asymptomatic,  but date is unknown to the writer as it is not documented in chart.
Information has been received from a mother her 2 year old son who at the age of 3 months had all kinds of problems and was hospitalized for a respiratory infection, RSV, pneumonia and developed asthma which was treated with inhaled steroids. At 9 months of age, the patient experienced 8 seizures in 15 hours and was hospitalized. Treatment at that time included Phenobarbital for 7 months. Subsequently the patient was placed on divalproex sodium. The patient received a dose of MMR (dosage and date not specified). In approximately October 2000, the patient was diagnosed with autism. The mother reported that she does not think that MMR was related to her son's autism. It was reported that the patient had not been on any seizure medication in the last 6 months (since approximately March 2004) and the patient had not experienced any seizures. In follow up information it was reported that the patient had received a dose of the mumps virus vaccine live (unspecified) on 9/7/04 and was doing fine. No further information was provided. Upon internal review autism was considered to be an other important medical event (OMIC). Additional information has been requested. Follow up 03/03/05: Patient has not recovered from the adverse events.
Severe brain fog; difficulty concentrating, slow reaction speeds, struggling with articulation/ word-finding, memory issues, general confusion and struggling to take in information. Inability to sleep despite fatigue. It feels like my IQ dropped 10-15 points.
Patient was administered the ASO1B diluent without reconstitution; Patient was administered the ASO1B diluent without reconstitution; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comments: The nurse reported that a patient received ASO1B diluent without reconstitution with the powder antigen component of Shingrix vaccine. The reporter did not consent to follow up. Additional Supportive Information: The patient received diluent without reconstitution with the powder antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Left leg injection site red, swollen, and hot to touch.  Advised to use Advil for discomfort and swelling and use cool compress.
This spontaneous report was received from a licensed nurse referring to a 12 year old female patient. The patient had no pertinent medical history. Concomitant medication was not reported. On 12-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M004116, expiration date 12-OCT-2017); dose, route and anatomical location were not reported, and a dose of VAQTA (dose, route, dose number, lot# and expiration date were not reported). Approximately in August 2016 (reported as following administration), the patient experienced rash in her upper extremities, arms, face and chest, which was not raised but was itchy, spotty. No treatment was provided to the patient after this reaction. The patient fully recovered on an unspecified date in 2016. On 14-OCT-2016, the patient was administered the second dose of GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018); dose, route and anatomical location were not reported) and developed a worse rash. The rash was raised, appeared on the upper extremities and face, and was more pronounced than the first time. The reporter stated that no other vaccine was administered on that date. The patient was given a couple of doses of BENADRYL 50mg for treatment which did not provide much relief. The nurse reported that the patient completely recovered from the second reaction after a few days. The patient sought medical attention and called to physicians office. No laboratory test were performed. The reporter did not assessed the relatedness between the suspect therapies and the events. Additional information has been requested.
In March of 2022, my son began complaining of a sharp pain in his chest on the left side, it was bothersome enough that he cried and it hurt when he was resting and hurt outside, too. His pediatrician said it sounded like precordial catch syndrome. She said she could do an EKG to ease my mind but it was likely just going to happen until he was grown. I had them do the EKG, which showed an incomplete right bundle branch block. She sent a referral to the pediatric cardiologist.  My son was not able to take his Ventolin medication after that due to the meds increasing heartrate, it was recommended we not get him any further vaccinations until we saw the cardiologist, and he was told to take it easy at home.
Patient felt diaphoretic, nauseous and dizzy. States that felt side effects right after side effects. Vital signs taken and observed, vital signs stable throughout, placed supine, given juice. Patient left clinic after 30 minutes, no concerns.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves an eight-year-old patient who was vaccinated with FLUBLOK QIV (batch number, expiration date, dose, route and site of administration was not reported) on an 20-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. (it was reported that vaccine was for 18 years of age and older patients and that was given to an 8 year old patient). It was unknown whether the patient had any 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 Directive and Module VI of the 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. List of documents held by sender: none.
This spontaneous report was received from a pharmacist refers to a 67 year old male patient. There was no information regarding patient's pertinent medical history, drug reactions and allergies. On 01-NOV-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M004318, expiry; 12-OCT-2017) intramuscular. The patient was using VIAGRA and other multiple unspecified medications concomitantly. The pharmacist reported that, on 02-NOV-2016 the patient was seen at an unspecified walk in clinic (demographics unspecified) because there was a hard nodule at the injection site, the arm was red to elbow and the patient had fever. The patient was diagnosed with cellulitis and treated with cephalexin on an unknown date in November 2016. The pharmacist also reported that patient was admitted to an unspecified hospital (demographics unspecified) on 04-NOV-2016, because the entire arm was red and the fever persisted. On an unknown date in November 2016, the patient's wife called the pharmacy and informed that, the patient's White Blood Cells (WBC) count was 18,000 (units unspecified; from an unspecified lab test). It was reported the patient was not recovered from the event cellulitis at the time of this report. There was no product quality complaint (PQC) involved. Upon internal review the event Cellulitis was considered to be serious due to hospitalization and being medically significant. Additional information has been expected.
No adverse effects reported; Patient received improperly stored PROQUAD; This spontaneous report was received from registered nurse and refers to an approximately 4-year-old patient (reported as most likely around 4 years) of unknown gender. The patient's concurrent condition and medical history were not reported. On 28-MAY-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) from lot # R026351 with expiry date 15-MAR-2020 for prophylaxis (dose, route, and anatomical location were not reported) (product storage error). Concomitant therapy included properly stored sterile diluent (lot # S000130, expiry date: 23-AUG-2021). The vaccine was exposed to a temperature excursion of 6 degree Fahrenheit (F) to 14 F (6.4 F) for 1 hour and 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality compliant (PQC) was reported.  This is one of the three reports received from the same reporter.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 05-OCT-2015, the patient was vaccinated with expired dose of ZOSTAVAX (lot# K009198, expiration date 05-SEP-2015, dose, route of administration and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
I had the shot and I got the shingles 2 times/suspected vaccination failure; shingles 2 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said well, she/he had the Shingles shot and got the Shingles 2 times in a year. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:35, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M011665) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505:
Vaccine was picked up on 12/07/2021 to be stored in fridge and used by 01/07/2022. Patient received this dose three days past the vaccine usage date. Patient reported no known symptoms.
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves four-months old patient who was vaccinated PENTACEL and HIB (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was actual medication error due extra dose administered. It was unknown whether the patient had any 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 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. List of documents held by sender: none.
The symptoms began on 1/16/22 at 5:40am, I woke up with chest pain that was unremitting. I took 2 Advil and the pain went away.  At 4pm the same day the chest pain started again the pain was in the center of my chest and radiated out to both my left and right arms and up my neck.  I then began to feel nauseous and hot but had no temperature.  I took 2 Advil and (4 )81mg aspirin. The pain did not stop so I called my parents to take me to hospital this was at 7pm.  I went to the hospital and was brought back immediately and then admitted after several tests. I was treated with Nitroglycerin and Heparin.
received only the adjuvant (diluent) portion; received only the adjuvant (diluent) portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the adjuvant (diluent) portion of the Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Healthcare professional did not have details about the patient or event at the time of the reporting. The reporter consented to follow up. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192922:same reporter US-GLAXOSMITHKLINE-US2021192920:same reporter
shingles; Information was received from a lawyer regarding a case in litigation referring to a 71 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 24-SEP-2015, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis. As a result of receipt of zoster vaccine live(ZOSTAVAX), on 09-OCT-2015, patient was caused to suffer shingles, including any and all of its sequelae. As a result of receipt of zoster vaccine live(ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.
After 48 hours of injection, right arm was extremely red, spreading from shoulder to elbow, and wrapped all of the way around arm.  Area was red, hot to the touch, and very itchy.  When area was scratched, it stung.  Fever and diarria accompanied symptoms for appoximately 96 hours.  Within 5 days of injection, redness was reduced, however, patient experienced extreme pain in ALL joints, to where patient could not get out of bed, walk, or barely move.
Child had DTap, PREVNAR-13, HIB vaccines on 08/08/2011. The next day within 8 hours woke up with severe rash all over body, maculo papular urticarial large blotches all over the body, no wheezing, but bruise, red, cellulitis on both thighs, on exam after 4 days, resolving rash, blue discoloration of the groin bilaterally, tenderness at site of administration. MOTRIN given, advised to apply ice. Referred to Allergy Specialist.
Tinnitus - persistent (main reason I am filing this report). Swollen and painful lymph nodes under my left armpit.
Previously had neurological issue which causes patient to lose control of muscle , he seems to have relapsed. Unsure as a result of vaccine or just timing
burning, neuropathic pain at right at T1 dermatome, lasted 3 weeks then blister and scab formed, painful