chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "known allergies : Sulfa" (unspecified if ongoing), notes: known allergies : Sulfa. Concomitant medication(s) included: LISINOPRIL; SERTRALINE received in two weeks. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies : Morphine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with anti viral medication, Paxlovid. Treatment start date was 27Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 71 years old male patient who received vaccines INFLUENZA VACCINE (FLU SHOT) and FLUZONE HIGH DOSE. The patient's past medical history, concomitant medication and family history were not provided. On 07-Nov-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ044AB, expiry date 04-Jun-2019 via unknown route in the left arm. On 07-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA VACCINE (FLU SHOT) produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. It was an actual medication error due to extra dose administered. It was reported that Patient received flu shot on 07-Sep-2018 and received FLUZONE HD on 07-Nov-2018. The pharmacist states that may be the patient has dementia. He states that he would verify it with the doctor but he has no idea who the doctor is. It was unknown whether patient experienced 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. List of documents held by sender- none.
Hospitalization: 1/24/2023 - 1/25/2023 (29 hours) Presentation to the ED: worsening symptoms: cough, sore throat, fever.   COVID + date: 1/24/2023 Treatment: none. patient was stable on room air.  Discharge to: home.  031L20A 2/4/2021 027A21A 3/8/2021
No adverse event occurred. This is the reporting of an administration error. A syringe with a retractable needle was utilized. The vaccine was drawn up properly according to protocol in a 1 mL retractable needle syringe. During vaccination the vaccine was injected with the plunger fully depressed however did not "click" and therefore the needle did not retract into the hub. Therefore there is concern over the full dose not being given because there is a minute amount of vaccine still within the needle itself when un-retracted.   The patient was informed of what happened and he was thankful that he was informed and stated he was not concerned about it. He did not ask any further questions and stated no further needs at the time.
Received a spontaneous report on 12JAN2017, 13JAN2017 and 18JAN2017 from personnel. The physician reported that on 09JAN2017, a patient who was traveling soon, was administered a dose of BIOTHRAX which had expired on 07JAN2017. The subject did not experience any adverse events. Further information was not available.
Patient began to experience symptoms consistent with an upper respiratory infection one day after getting 1st dose of COVID-19 vaccine. By day four, she developed an ear infection and began antibiotics. It is now exactly one week after the shot and 3 days after starting antibiotics and she still feels miserable. She?s losing her voice, throat is sore, and both ears feel infected.
Fainted after 2nd dose; there was a delay (late) in her receiving her 2nd dose due to a hailstorm; there was a delay (late) in her receiving her 2nd dose due to a hailstorm; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted after 2nd dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (there was a delay (late) in her receiving her 2nd dose due to a hailstorm) and PRODUCT AVAILABILITY ISSUE (there was a delay (late) in her receiving her 2nd dose due to a hailstorm). On 20-Apr-2021, the patient experienced SYNCOPE (Fainted after 2nd dose) (seriousness criterion medically significant). On 19-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (there was a delay (late) in her receiving her 2nd dose due to a hailstorm) and PRODUCT AVAILABILITY ISSUE (there was a delay (late) in her receiving her 2nd dose due to a hailstorm) had resolved. On 20-Apr-2021, SYNCOPE (Fainted after 2nd dose) had resolved.            No treatment information for the event was reported.  Company comment:This case of 31- year-old female patient who experienced unexpected event of syncope and there was a delay in her receiving her 2nd dose due to a hailstorm (product availability issue, inappropriate schedule of vaccine administered). There were no reported AEs associated with the events of product availability issue/inappropriate schedule of vaccine administered.  Based on temporal association with the use of mRNA-1273 vaccine and onset of syncope, a causal relationship cannot be excluded.; Sender's Comments: This case of 31- year-old female patient who experienced unexpected event of syncope and there was a delay in her receiving her 2nd dose due to a hailstorm (product availability issue, inappropriate schedule of vaccine administered). There were no reported AEs associated with the events of product availability issue/inappropriate schedule of vaccine administered.  Based on temporal association with the use of mRNA-1273 vaccine and onset of syncope, a causal relationship cannot be excluded.
Mother  stated the Right bottom thigh  were  the  mmr immunization  was  given,  developed a red  hard  nodule the  size of a  half dollar.  Then  on 10/22/2006 broke  out   in  hives under her arms  and  over  the rest  of her  body.  The  areas  that  were  scratched  did scabe  over.  No complaints  of a fever or  lethargy. 24  hours  after  the development of  hives  the  intensity has deminished.
Information has been received from a nurse practitioner concerning a 62 year old female with morphine allergy and medical history of breast cancer who on 26-MAR-2009 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). There was no concomitant medication. On 27-MAR-2009 the patient experienced warmth, redness, and itching at site of injection after administration of ZOSTAVAX (Merck). The patient's skin felt lumpy but did not have any blisters or hives presented. The patient was treated with BENADRYL and VALTREX. At the time of reporting, the patient did not recover. The patient had an office visit for medical attention. Follow up information was received from the nurse practitioner who reported the retired female patient was subcutaneously vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 663894/0129Y) into the right deltoid on 26-MAR2009. There was no illness at time of vaccination. In the afternoon on 26-MAR-2009, the patient developed localized rash, red, raised, and itching about 3 cm in diameter. On 02-APR-2009, the patient recovered from the above events. Addition information is not expected.
Shot given 8/6/08. Parent called triage nurse at 8:30 pm same night with concern about his arm.  They were directed to go to the ED.  Seen for large blister on arm.  Blister was lanced and cultured in Ed.  Patient was given script for Bactrim in the ED.  Seen for follow-up in doctor's office on 8/8/08.  Redness and warm area was larger in office than it had been in the ED(having been marked on his arm by ED staff).  Patient stated the area was itchy but not painful.  Dr. placed him on prednisone and benadryl.  Unable to contact mom today for further follow-up.
The next day I woke up with low fever and aches headache, which all got worse throughout the day into chills fever of 101.4 and weakness. The second day I have a low fever and ache all over. Slight headache, Soreness in glands and weakness.
severe headache, chills for about 6 hours; flushed cheeks; body aches
reconstituted with sterile water; reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 3BD9E, expiry date 6th April 2023) for prophylaxis.   On 11th November 2021, the patient received Shingrix. On 11th November 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The Shingrix was reconstituted with sterile water prior to administration to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Pt gave multiple names. When legal name confirmed, records showed pt had received a single dose Johnson and Johnson COVID vaccination. Pt received first dose of Pfizer prior to information being confirmed. Pt left with no adverse symptoms noted.
Patient reported fatigue, headache, and achiness the day after receiving her SHINGRIX and FLUZONE HD shots. After following up w/her, she states she was sick for a few days. I recommended TYLENOL, hydration, and rest and asked her to report any other unusual Sx and to let us know if she ended up needing to go the Dr. She did not report doing so.
Rash, fatigue, lethargy,  decreased appetite,  decreased thirst,  Aortic dissection,  autoimmune system compromise,  Stroke,  blood disorder.
Pt presented to the hospital with progressive weakness and the inability to walk. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistant with Guillain-Barre Syndrome and was treated with IVIG.
He had first dose of Mederna COVID vaccine and then 2 days later developed sob and LE pain/swelling. Now dx with extensive femoral vein to pop DVT to calf and bilateral PE with right heart strain
On and off ear pain for a couple of months. I went to the mountains and went white water rafting in 60 degrees rainy weather, after coming home, that night I had terrible ear and jaw pain that would not go away (10/06). I went to the doctor the next day where I was diagnosed with a double ear infection and was prescribed Augmentin 875-125mg tablets PO q12 for 10 days. I have finished the antibiotics and have been doing well, but a couple of days ago I had a moment of random ear pain again. I may be going back to the doctor soon to make sure the infection is gone.
This spontaneous report was received from a registered nurse and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 12-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L019999, expiration date 02-JUN-2017 (dose and route of administration were not reported). Concomitant therapy was not reported. The administered dose of vaccine was exposed to a temperature of 15.4 Fahrenheit degrees, for 13 hours 30 minutes. There were no previous temperature excursions. Temperature was back in range. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Approximately two weeks after administration of the above vaccine, I was notified by the patient (who was also a co-worker at the time) that she was struggling with numbness and tingling in her feet, legs, hands and face. That feeling continued to worsen, I encouraged her to go to the local hospital ER for a neurological evaluation for Guillian Barre. She was seen at the ER, discussed with that staff that she had previously had a vaccine, she was sent away with medication for panic/anxiety. After being seeing at the ER several times for worsening symptoms, she was seen by Dr. who diagnosed her with Guillian Barre Syndrome from previous influenza vaccine.
Aching and all that so, For couple of days to first two vaccine; 1st dose: 09March2021; second dose: 24March2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Lot number: ER8734) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic type-I" (unspecified if ongoing); "Coronary artery disease" (unspecified if ongoing); "Imuno-deficiency syndrome" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Lot:EN6204), administration date: 09Mar2021, when the patient was 44 years old, for COVID-19 Immunization, reaction(s): "Aching and all that so, For couple of days to first two vaccine". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Aching and all that so, For couple of days to first two vaccine"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "1st dose: 09March2021; second dose: 24March2021". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: an immune deficiency (history) and I have had some of the side effects with the last two shot cause she had just achy and stuff for couple of days, but this one was two weeks out and she was still feeling that way, she don't know but she should still be feeling the effects this far out."  Follow-up attempts are completed. No further information is expected.
Patient received dose 2 moderna vaccine at 1600. At 1610, she reported a mildly "scratchy" throat to the observation nurse. She was given 25 mg of Benadryl by mouth with water. She had no issue with swallowing. Patient was observed until 1710 at which time her mother picked her up and took her home. Vital signs at 1620: HR 86, RR 18, temp 98.1, lung sounds clear to auscultation, no stridor. Vital signs at 1624: HR 88, RR 18, O2 saturation 99%, lung sounds clear to auscultation, no stridor. Vital signs at 1629: BP 110/74, HR 86, RR 18, O2 saturation 98%, lung sounds clear to auscultation, no stridor.
After the vaccine, I felt like I was feeling the effects of COVID-19. I got a sore throat, headache, no tastes, and congestion. I was bedridden for 8 days. I took a COVID-19 test and it came back negative. I slowly started to get better, but I still didn't feel like I was at 100%. Three months later on 1/2/2022, I got a strong pain in my side, by the next day it had worsened so I went to the ER and was admitted. They ran tests and found a Pulmonary Embolism in my left lung. I stayed in the hospital for 3 ½ days then put on a blood thinner and told to use an Berodual Inhaler. As of 5/4/2022 I feel about 95% better.
POST 10 MINUTES OF RECIEVING VACCINES,PATIENT PRESENTED WITH SWOLLEN EYES AND REDNESS AND COUGHING  SCRATCHING HER EYES WITH DIFFICULTY BREATHING MD ADMINISTERED EPINEPHRINE 1;1000 0.2MG  SQ,ORAPRED 30 MGPO,AND BENADRYL 12.5MG PO
Case number PHEH2015US018520 is an initial spontaneous report received from a health care professional on 17 Sep 2015. This case refers to a 63 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN, (batch number: 1514501) at a dose of 0.5 ml intramuscular on 14 Sep 2015, which was left out of refrigerator from Friday night until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out of the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72 hours and the excursion did not exceed this time frame. No adverse reaction was experienced by the patient following this medication error (incorrect storage of drug). The reporter declined further follow up contact. Follow up information received from the health care professional on 27 Oct 2015: Clinical notes updated.
Laryngitis or Hoarse voice set in 27 hours following booster along with congestion.; Laryngitis or Hoarse voice set in 27 hours following booster along with congestion.; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 17:45 (Lot number: FD0809) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 05Nov2021 (Batch/Lot number: unknown). The patient had no relevant medical history. Concomitant medication(s) included: NYQUIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 03:30 PM), administration date: 02Apr2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 10Mar2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: LARYNGITIS (non-serious), DYSPHONIA (non-serious) all with onset 06Nov2021 20:00, outcome "not recovered" and all described as "Laryngitis or Hoarse voice set in 27 hours following booster along with congestion."; PAIN IN EXTREMITY (non-serious) with onset 06Nov2021 20:00, outcome "not recovered", described as "sore arm". Therapeutic measures were not taken as a result of laryngitis, dysphonia, pain in extremity.  Additional information: The patient had no known allergies. The patient had no covid prior vaccination and not tested for covid post vaccination. No other vaccines within 4 weeks of vaccination.   Follow-up attempts are completed. No further information is expected.
I was vomiting with diarrhea and a temperature or fever of 103 degrees, my heart rate has been running @ 119BPM and occasionally has spiked to 132BPM.
Patient was notified of the error the next day.  Patient did not have an allergic reaction.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: pt was advised to wait 15 minutes after the vaccine but was in ahurry. He fainted in the front of the sore @115pm. vitals signs were taken and everything was okay. we also called 911 and he was transported to the hospital with mional injuries. Deviation of his nose and nose bleeding were the prmary effecs.
T 103 and redness and swelling at DTaP injection site 12 hrs after injection swelling/ redness 13 x 7cm.
Patient started developing rash on 11/3/15 at night. Patient now has erythematous rash around injection site. Reaction is delayed 1 week after vaccine administration. Steroid ointment given.
more stiffness at the vaccination site; tiredness/fatigue; slight bleeding after the injection; when lifting my left arm/It felt heavier; pain at the time of syringe injection; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 06Jan2021 13:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Dec2020 for COVID-19 immunization and experienced vaccination site pain, vaccination site stiffness and  vaccination site movement impairment. The patient completed the second administration and had finalized his vaccination process. At first vaccine administration the patient mentioned it was no different from regular influenza vaccine. There was no special side effect. The patient woke up in the morning and there was pain at the time of syringe injection the same as 1st administration but there wasn't much feeling of the syringe being injected. After the administration, the patient was watched for around 30 minutes, but had no specific allergic reaction, just like the 1st administration. When he woke up this morning, and also in the evening of the vaccination day, although it is not sure if it is due to the vaccine, the patient had tiredness. His wife and child checked body temperature and pulse every 30 minutes. At the time of report, the patient woke up slightly early, but anyhow the difference was feeling of tiredness. Also there was more stiffness at the vaccination site that was felt more strongly than at 1st vaccination, especially when lifting left arm compared to the first vaccination. It felt heavier and sorer. The patient is feeling better and without any pain now. When talked about the second vaccination that he received, the patient look as though he was in pain when receiving it and reporter replied yes, slightly. At 1st administration there was no bleeding after the injection. But at 2nd administration there was slight bleeding after the injection so the patient was surprised. In summary, the patient had pain at injection with the syringe at 2nd administration,when the syringe was injected and also had pain a little after the injection, other than that, he had no special side effect. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10-1-15 present. Severe shoulder pain. Swelling, cellulitis. Very limited range of motion. MD visits and antibiotics, steroids, X-ray, anti-inflammatory. Steroid injection, MRI, physical therapy.
Narrative: Timing ERROR only, 2nd dose given 46 days after 1st