chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inadvertently given Adacel instead of Daptacel; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old patient who experienced inadvertently given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   On 12-Jul-2019, the patient received a 0.5 ml  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  it was case of actual medication error due to wrong vaccine administered  It was not reported if the patient experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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  List of documents held by sender: none.
Initial report was received from a non health care professional on 02 April 2014. This case is one of a cluster of two identified patients who experienced similar adverse events following administration of ADACEL. The events for the other patient were captured in case 2014SA042580. A 15 year-old male patient with a history of asthma had received on 08 June 2009 an intramuscular first dose of ADACEL, lot number C3057AA and approximately 57 months later developed wheezing, coughing, SOB (shortness of breath), vomiting and fever of 104. The patient's Mother thought it was an asthma attack. The patient was evaluated by a physician on 12 March 2014 and was treated with Azithromycin pack times two. On 26 March 2014 (also reported as 27 March 2014), the patient was evaluated by a pulmonologist and was diagnosed with pertussis. Laboratory data included an IgG and IgM (results were not reported). No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Gave patient adult Hep A instead of pediatric Hep A dose. Patient was 17 & 11 months of age.
I developed upper chest tightness and heart pounding the next day  that lasted a few hours. On day 2 post vaccine, around noon, I again developed chest tightness and extreme heart pounding. It was also an effort to take a deep breath. I sat in an area at work where I could take my mask off and soon felt like I was going to pass out. These symptoms continued the rest of the day and I fell asleep with them. Since then I have and shorter periods on and off of chest tightness, heart pounding, and it has been an effort to take a deep breath during that time. My heart rate is always around 60 during these time even though my heart feels like it?s pounding.
Moderna COVID-19 Vaccine  Large area of redness at the injection site. Area is raised from the skin and warm to the touch (looks like a large hive). Noticed itching of the skin earlier in the day, prior to discovery of the red area.
CHEST PAIN, SOB. GIVEN: Quetiapine 25 mg, atorvastatin 80 mg, clopidogrel 75 mg tab, ticagrelor 90 mg, metoprolol 25 mg, ibuprofen 600 mg
Body aches, chills headaches, nausea , diarrhea, fatigue    fever of 102-103 degrees F. From 12-20 hours after vaccination to current (2 days)
Asthma exacerbation treated with prednisone and (2) DUONEB with improvement in the ED.  Discharged home with (5) day course of prednisone.
A week later I developed Bronchitis. Then, I started having nose bleeds and I had blood in my urine. I was prescribed an antibiotic, cefdinir. I am still dealing with this at this time. It has gotten so bad. I started having trouble breathing now. It is like my throat is swelling up. I have a lot of congestion in my chest too. They put me on prednisone because I can't seem to get rid of this.
Soreness for 2 hours after shot (2:45 pm-4:45 on). No other symptoms until 9:50 pm. Severe joint inflammation and all over bodily inflammation. Chills and fevers throughout the night. Chills and fever subsided at 7:23 am. Joint inflammation still mild as of 12:20 pm the next day.
Enlarged lymph gland on right side of neck; swelling and pain under chin; mandible to right ear; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: BV02123480) via an unspecified route of administration in the left arm on 25Mar2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, parathyroid disorder, sarcoidosis and gout. The patient had no known allergies to food, medications or other products. Concomitant medications included levothyroxine sodium (SYNTHROID, 125 unspecified units) azilsartan medoxomil, chlortalidone (EDARBYCLOR, 40 unspecified units) for unknown indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 08:00, third day after the vaccination in the left arm, the patient experienced enlarged lymph gland on right side of neck, swelling and pain under chin and mandible to right ear. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of AEs and included treatment with CT scan with contrast and Clindamycin. On 29Mar2021, the patient underwent CT scan with contrast and the result was Level 2 lymph node near tail of right parotid 12 x21mm x 19mm per CT of soft tissue neck with contrast. The clinical outcome of the event enlarged lymph gland on right side of neck, swelling and pain under chin and mandible to right ear was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient developed bilateral ankle joint swelling which progressed to ohter jointsand was diagnosed ultimately with RA, questioned whether the vaccine was related. I told her I would report her onset of this disease.
Fever, headache for more than a month.  I lost 35-40 lbs, but regained it up to 178 lbs.  A bump grew on my left groin followed by reddish/purple dots down my thigh to the back of my thigh.  I noticed the back of my thigh when my blood vessel started aching.  The Spike Protein is a Slow, silent killer.
Dose administered after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The vial was initially stored in the refrigerator on 16-SEP-2021.  On 18-OCT-2021 and 21-OCT-2021 two vaccines were administered.  On 19-OCT-2021 and 22-OCT-2021 one vaccine was administered.  On 20-OCT-2021 and 26-OCT-2021 three vaccines were administered.  On 27-OCT-2021 eleven vaccines were administered.  On 28-OCT-2021 twenty-nine vaccines were administered.  On 29-OCT-2021 fourteen vaccines were administered.  On 01-NOV-2021 and 02-NOV-2021 twenty-one vaccines were administered.
Information has been received from a health professional concerning a female patient 60 to 70 years of age with an allergy to codeine and prednisone who on 01/13/2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 647660/0945N).  There was no concomitant medication.  Subsequently, about 10 to 12 hours after the injection the patient experienced redness and swelling at injection site and whole upper arm.  The patient also experienced fever and chills.  Unspecified medical attention was sought.  There were no relevant diagnostic laboratory tests performed.  No product quality complaint involved.  The patient was reported to be recovering.  It was also reported that other patients had a similar reaction.  Additional information has been requested.
Patient brought to the ED via EMS on 10/22 for hypoglycemia. On EMS arrival, O2 sats were in the low 80's room air and he had a low sinus rhythm in the 40's. While in the ED, he had a COVID PCR test done which was positive. Patient was admitted to the hospital on 10/22 for hypoglycemia, sepsis, and acute hypoxic respiratory failure possibly secondary to COVID. Patient was placed on supplemental oxygen and intermittently required supplemental oxygen. Patient has received COVID vaccine and boosters. During his hospitalization, he was diagnosed with pneumonia, COVID vs aspiration pneumonitis/pneumonia.
Pneumonia vaccine.  24 hours after injection, flu like joint/muscle pain, sensitive skin, chills during evening (8-10 PM).  4 inch x 3 inch oval redness as site of pneumonia vaccine injection, which lasted 4 days.  Flu symptoms lasted approximately 36 hours.  Took aspirin to start and then Benadryl.  Applied Benadryl cream to arm/site of injection.
ICU nurse appointed to me form 1 hour  due to adverse reaction on 1st dose. 15 minutes post injection, she noticed my voice changing, asked to take drink some water. Unable to completely swallow without choking. All within the next 30 minutes, diaphoretic, unable to clearly compose thoughts, somewhat lethargic, itching and linear hives on arms .Slight increased pulse normal respirations. Within 2 hours of shot, headache and fever. followed by exhaustion, extreme vertigo with unsteady gait,  severe chills and fever reached 101. that lasted close to 12 hours.
8 year old had FLUZONE on left deltoid yesterday at 3:30 pm. The area around the site of injection became red yesterday night. Mom drew a line around the redness. It measured 8 x 6 cm. After hockey his arm was hurting more. He complained of pain at bed time but pain did not wake him up from sleep. Today the area of redness has increased passed the line. He is complaining of itching and arm pain. Mom was called to the school today due to symptoms. Patient denies any cough, shortness of breath, vomiting or diarrhea. No fever.
- Tinnitus since the injection - vertigo starting 03/29/21 with 6-7 incidences so far. Three episodes were severe enough to impact ability to work or function for several hours. Others were more mild and could be managed with anti-nausea meds.  - I did seek treatment for the most severe episode from my physician
Patient admitted for vertebral osteomyelitis and discitis, being treated with antibiotics. Patient remains in hospital
Immediately post vaccination at 1753, pt appeared slightly less responsive than normal. Legs elevated, ice packs applied to nape of neck. Water provided to the pt. The pt lost consciousness for approximately 10 seconds. VS initiated, WNL. Pt denied hx of vasovagal. VS taken q4. At 1808, pt verbalized that he was feeling better. Pt was escorted over to observation for an additional 15 minutes.  Pt left observation at 1824, ambulatory with a steady gait. Pt left alone in an uber with all symptoms resolved. Education provided to pt regarding when to seek medical attention.
About 5 min after vaccination, the patient was leaning back in his chair with his eyes closed while in the waiting room after his vaccination. I approached him and asked if he was alright and gently tapped his shoulder. He did not respond. I spoke louder, he did not respond. I shook his shoulder and spoke very loudly, he opened his eyes and rolled his head around and told me that he felt really dizzy. His skin was warm and he was sweating. He reported that he was breathing fine, that he just felt dizzy and hot. Over the next 5 minutes his dizziness decreased. He reported that the site of vaccination felt numb. Vaccination site did not show any redness or signs of local reaction. He reported that he was still breathing fine. His dizziness continued to decrease, and 25 minutes after the vaccine he reported that he did not feel dizzy anymore.  He asked for some water, which I gave him. He stayed sitting in the chair until an hour after the vaccine. He got up and walked around and reported feeling no more dizziness and that he felt fine driving home.
On the first day i felt my nerves shoot up into my neck. Got stiff neck and back 3 days after the vaccine. The stiffness turned into nerve problems and I felt hot and tingly on my neck, back and head for several days. 8 days later from the vaccination day i got a huge rash on my left arm. On top of that my armpit area was severely sore . Soreness and pain from the arm continued 2 weeks later.
Tdap inadvertently given to client instead of Td.  Pt seen in clinic with flu-like symptoms resolving 2 days later - probably not related to vaccines.
Pt vaccinated with Influenza Trivalent A&B at 11:00AM on 9OCT90 fever noted at 8:00AM 11OCT90 Pt died 2:30AM 12OCT90.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-OCT-2015, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-DEC-2015, the patient was treated at Medical group for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 17-JUL- 2016, the patient required subsequent treatment for continued and worsening symptoms of shingles pain, at which time he was diagnosed as post-herpetic neuralgia, a condition of chronic pain and nerve damage secondary to shingles infections. On or about  18-OCT-2016, the patient sought additional treatment  for continued symptoms and post-herpetic neuralgia. The patient was prescribed topical ointment for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
KIDNEY PAIN; LOWER BACK PAIN; PAIN IN LEFT SIDE; DIZZY; VOMITING BILE; NAUSEA; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included gallbladder removed, and concurrent conditions included anxiety, and post-traumatic stress disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced dizzy. On 22-MAR-2021, the subject experienced vomiting bile. On 22-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced kidney pain. On 26-MAR-2021, the subject experienced lower back pain. On 26-MAR-2021, the subject experienced pain in left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting bile, had not recovered from nausea, kidney pain, lower back pain, and pain in left side, and the outcome of dizzy was not reported. This report was non-serious.
I experienced side effects from the vaccine and my symptoms were itching, redness, and also expanded down my arm and was burning.
Client contacted Dr.'s office on 10/27/09 approximately equal to 0900 c/o feeling lightheaded and was not sure whether it was due to low BP or having received an H1N1 injection the day prior (10/26/09). Position: ESE Paraprofessional (worked with special needs children). An autopsy will be performed.  10/29/09 PCP medical records received service dates 10/26/09 to 10/28/09 includes vaccine records. Assessment: URI, low blood pressure, fatigue.  On 10/27/09 Patient presents with low blood pressure and fatigue. Slight sore throat and post nasal drainage. Weak, 'woozy'. Weight loss of 38 lbs since 2/08. On 10/28/09 notified that patient had expired.  12/28/09 Note from Medical Examiner. DOD 10/28/09. Patient found unresponsive in bed at home. History of recurring deep vein thrombosis. Autopsy results show saddle embolus resulting in death. Local Health Department requested this office's assistance in regards to possible infection with H1N1.   1/5/09 Autopsy Report received. DOD 10/28/09. Final Cause of Death: Pulmonary Thromboembolism Due To Recurrent Lower Extremity Deep Vein Thrombosis. Additional Information Abstracted: Contributing - Morbid Obesity, Uterine Leiomyomata.
Pain/Reddness and Swelling at injection site, Body pains, weakness, Chills, Loss of voice, seeing doctor 4/9/21
disabling myalgia for two weeks, resonved with high doses of prednisone, fully resolved after 4 weeks
Redness, induration, pain, itching, warmth, 14cm x 11.5 cm area surrounding injection site. Local cellulitis.
Received both vaccines on the same arm, next morning I noticed significant swelling on my child's vaccined upper arm and extended to elbow. Then later if that day, noticed low grade fever 99.9 . Gave him children's Tylenol. Fever went away. The following morning, I noticed even worse swelling on the same arm, swelling and redness spread to lower arm/forearm. That entire arm is hot to touch, my child saying the arm itchies.
Patient experienced seizure like activity. EMS was on site to evaluate patient and transported him to emergency room. Spouse reports frequent seizure activity.
Fever and vomiting lasting 12 hours. Low grade fever continued with onset of headaches, sinus pain, and yellow discharge. Symptoms lasted four days before migrating into upper respiratory track. Constant cough, fatigue, and thick green and brown phlegm persisted three weeks. A cycle of symptoms reoccurred with sinus infection four days and respiratory infection three weeks. Chronic fatigue lasted three months following remission of symptoms. No physician prescribed treatment.
eruption of red, swollen itchy spots; eruption of red, swollen itchy spots; eruption of red, swollen itchy spots; Nerve pain in right arm; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes viral infection nos. Previously administered products included Shingles vaccine (Received years ago, went about 5 years of no recurrence or outbreak) and Shingrix (1st dose received in September 2021).   In February 2022, the patient received the 2nd dose of Shingrix. In March 2022, 1 month after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the patient experienced red spotty rash, itchy and swelling. On an unknown date, the outcome of the nerve pain, red spotty rash, itchy and swelling were unknown.   It was unknown if the reporter considered the nerve pain, red spotty rash, itchy and swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-Aug-2022 Reporter's comment: One month later after receiving Shingrix, the patient experienced nerve pain in right arm, 2 months later eruption of red, swollen itchy spots. The patient was referred to healthcare professional. The consent to follow up was given.
Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient did take other medications in two weeks. Patient took Paxlovid, starting on 22Jul2022 and (lot G06416) for treatment of COVID-19. other medication in 2 weeks product include NyQuil, Aspirin, Ibuprofen, multivitamin. Reported Event included Bitter taste in mouth, similar to grapefruit started on 22Jul2022, outcome was not recovered without treatment and device date was 23Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.