chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a 26 year old female was administered Daptacel by mistake instead of Adacel, no AE.; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 26 years old female patient who was administered with a dose 0.5 ml of vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel] (lot number C5621AA  and expiration date 23-may-2021) by mistake instead of diphtheria-2/tetanus/5 ac pertussis vaccine [adacel] via intramuscular route in the left deltoid on 31-Dec-2019.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); VARICELLA ZOSTER VACCINE (VARICELLA ZOSTER VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN).  It was an actual medication error case due to wrong product administered.  No adverse event reported at the time of reporting.  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.
59 year old patient inadvertently administered high dose quadrivalent influenza vaccine, intended for patients 65 years and older, instead of adult quadrivalent influenza vaccine.  Pt was informed and was instructed to contact clinic RN if any adverse effects.
I received the first of the two Shingrix shots on June 12, 2019. On June 15 I was beset by pain on my right flank, from mid back to navel. I went to my physician on June 20 as the pain had worsened. She found four shingles blisters and diagnosed the cause of the pain as shingles. She placed me on the anti viral med for a week and confirmed the diagnosis with lab results the next day. No more blisters appeared but the pain persisted for about 6 weeks.
No additional AEs reported; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report has been received from an other health professional concerning a 11-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 24-AUG-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # w003118 and lot # w015191, has been verified to be a valid lot numbers for hepatitis a vaccine, inactivated [VAQTA], expiration dates reported and upon internal validation established as 13-JUL-2023 and 27-OCT-2023 respectively) (dose, anatomical location, and route of administration were not reported) for prophylaxis. The vaccine was improperly stored at a temperature of 11.3 Celsius (C) during 34 minutes (Product storage error). The vaccine did not have previous temperature excursions.  No adverse events were reported.
Patient received a flu shot around 3:40pm & 15 minutes later she felt dizzy & fell on her way out. Called 911 & patient was checked out & she was fine Patient's mom was contacted by the administering pharmacist and was told that patient is doing fine and taking a nap at that time (5:30pm). Vaccine Adverse Event was entered in patients profile. Pharmacist will contact the patients primary care to inform them of the adverse event.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown ages and genders. On an unknown dates the patients were vaccinated with VARIVAX (Merck) (route, dosage, dose number and lot number unknown). The healthcare worker reported that since unknown date improperly stored doses of VARIVAX (Merck) were given to unspecified patients. No adverse effects were noted. Additional information is not expected because there is no permission to contact physician.
Late afternoon after receiving FLUZONE in my left arm on 10/22/2008, my upper arm started to ache and get stiff but I had no bruising or tenderness in the actual shot area. By that evening, I could not raise my elbow away from my body w/o pain shooting into my biceps, nor could I lift anything up with my left hand- it hurt my arm. It was tough to get dressed, shower and pick up things or carry my children who are 1 & 3 yrs old. I took Tylenol a couple times over the next 3 or 4 days & it eventually went away. On early Sunday morning on 11/01/08, I woke up from a movement that hurt my left arm & took me by surprise. Now my arm hurts all over again two weeks later. It was the same pain & stiffness & I cannot lift my arm outward from my body w/o the shooting pain. I have not seen my family doctor as yet and as of 11/05/05, I am still having the same problem with my arm
has not yet received their second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (received first dose of Shingrix in October 2021).  On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received their second dose). The outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 03-MAY-2023 Pharmacy technician reported that, the patient received first dose of Shingrix in October 2021 and had not yet received their second dose. No additional adverse event (AE) details available at this time per Healthcare Professional (HCP). The vaccine administration facility was the same as primary reporter. VAERS details provided for 1st dose. The reporter had consented to follow-up. Until the time of reporting, the patient did not receive the second dose of vaccine, which had led to incomplete course of vaccination.
Pt recvd Hep B vax & devel elevated GGT level; pt had no other sx & there was a question of a poss lab error;
Patient had dizziness. High BP 181/95 -- > 180/98, advised to follow up with PCP. Given water. FYI had rash after first dose.
Complaint of shortness of breath/difficulty breathing, cough, chills, elevated temperature, sore/scratchy throat, headache, runny nose/congestion, myalgia, malaise and diarrhea.
Pt. received H1N1 vaccination during a school based clinic- Pt. is a school staff member. Reports nausea began about 1 and 1/2hrs vaccination illness required pt. to leave work early. Once home- pt. slept for several hrs. and woke with c/o knot behind knee which limited ambulation. I encouraged pt. to f/u with MD- as of 1/25 pat had not seen MD.
Three days after the patient received vaccine she started with extreme fatigue, fever, pain in joints, fibromyalgia, shortness of breath. The patient became bedridden for 2 weeks, she visited the ER with severe pain through out her body.
Patient reported on 11/18/2019 after he was released from nursing facility that he had an adverse reaction to the flu vaccine administered on 9/24/2019. The symptoms started approximately 5 hours after the vaccine was given. They included nausea, vomiting, loss of strength, and difficult breathing. Patient went to the hospital and was admitted on 9/26/2019 and stayed until 10/28/2019 when he was transferred to a nursing facility. He was released from nursing facility on 11/18/19 when he reported the adverse event to me. Patient could not tell me exactly the diagnosis or reason why he was in the hospital. He mentioned "chest tubes", "stents in esophagus?", "g-tube", "sepsis?",and "almost died".
Explosive diarrhea with cramping for 12-14 days following 2 mos immunizations.
I woke up around 1:30 in the morning I had fever and chills (100.3 temperature), and shaking. When I checked my temperature at 7:30 AM and it was 100.7. I have a slight headache and injection site pain.
Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # L023387, expiration date 22-JUN-2017) (dose, frequency and route not provided). No adverse effect was reported. The minimum of temperature was 0.8 degree C and the time frame was unspecified. There was no previous temperature excursion. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Patient reported  on 11/13  the area around the injection site was red and itchy since 11/11 when she got the vaccine and that the redness continued to get larger and the itchiness persisted.  She visited her doctor on 11/13 and received a cortisone shot and was instructed to take Benadryl.
Arthralgia, NauseaVomiting, Left arm pain.swollen, stomach pain, face swelling Narrative:  Other Relevant History:
warm, red, hard, painful 6 cm lump (L) deltoid joint pain, lethargy
Pt recvd 2nd dose of Hep b vax on 16DEC90 & devel generalized arthralgia including swelling of the ankles; pt seen by MD 24JAN92; PE revealed tenderness of the hands, wrists, mid-feet, metatarsophalangeal;
Patient was given KINRIX before the age of 4. Patient did not have any adverse event.
Site: Pain at Injection Site-Medium, Systemic: Fever-Severe, Systemic: blistering in corners of mouth and inside mouth-Medium
C/o swollen lip (upper) and cheeks, developed after he went to sleep, woke up with tingling in lip and face. Started MEDROL po, BENADRYL po --> ER SALU-MEDROL. No allergies, has flu vaccine yearly, never any reaction.
I developed fibromyalgia. There is no history of fibromyalgia in my family.
Subsequent to receiving first and second doses of varicella virus vaccine live on 12/11/98 and 1/20/99, the pt experienced redness and soreness at the injection site 24-48 hours post vax. The pt learned she was pregnant after the second dose. During the pts pregnancy the pt developed asthmatic bronchitis and was treated with Proventil, Flovent and Biaxin. The pt gave birth to a normal healthy girl.
severe vomiting; Weakness in legs; Weakness; Headache; Muscle pain; Joint pain; nausea; feeling unwell; fast heart beat; Injection site pain; felt like a large marble under the skin that was red and real hard; redness at injection site; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (Batch/Lot Number: EN6202),  via an unspecified route of administration, administered in Left arm on 01Mar2021 12:00 (at the age of 72 year old) as dose 2, single for COVID-19 immunisation.  Medical history included, she was paralyzed and had to learn to walk again, where she has been having ongoing physical therapy for a year and a half and had weakness all the time, pain, Indigestion, Constipation, Cholesterol, Depression, Blood pressure high, Asthma, Neuropathy from the waist down from a spinal cord injury, blood thinning, mild signs of osteoporosis, bladder control, shrinking and Joint pain all from an unknown date. Concomitant medications included aspirin [acetylsalicylic acid] for blood thinning from 2016; calcium carbonate for mild signs of osteoporosis from 2016; hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) for Blood pressure high; magnesium citrate for constipation from 2017 ; naproxen for pain; omeprazole for Indigestion; fish oil for cholesterol; paracetamol (TYLENOL) for pain from 2020; codeine phosphate, paracetamol (TYLENOL W/CODEINE NO. 3) for pain from 2020, probiotics for constipation; sertraline for depression from 1996; metformin for diabetes mellitus from 2013; tolterodine for bladder control from 2013; verapamil for blood pressure from 2013; salbutamol sulfate (VENTOLIN HFA) for asthma from 2011; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) for neuropathy from 2020, unspecified multivitamins, and unspecified supplements. No history of previous immunisation and patient did not receive any other vaccines within 4 weeks prior vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN5318, via an unspecified route of administration in left arm, on 29Jan2021 (at the age of 72 year old), as single dose for COVID-19 immunization and the patient experienced no side effects. On 02Mar2021, after the vaccination, she had pain at the injection site and she felt like as she had a large marble under the skin, that was red and real hard. It was smoothing out. She reported as she was fine on that day. On 03Mar2021, at 5:00 am, she woke up with severe vomiting, and also she had weakness in her legs, headaches, muscle pain, joint pain and nausea and was feeling unwell. It was reported that, she had weakness all the time but it was really bad after the shot. On the same day, 03Mar2021, she experienced fast heart beat. It was up to 94 then 91. At the time of report, her heart beat is 89. She did not have chills, fever or swollen lymph nodes. The outcome of the events severe vomiting was recovered on 03Mar2021, and headache, joint pain, nausea was recovered on 04Mar2021 and of other events was recovering.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a unspecified patients (reported as clients) of unknown age. The unspecified patients medical history was not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored PROQUAD (Merck) (dose, frequency, route and lot # were not reported). No adverse effects were reported. No product complaint was reported for PROQUAD (Merck). Additional information is not expected as the reporter did not wish to contact.
pt recv vax 6AUG97 & exp inj site rxn ( 3 1/2-4inches) described as being red, swollen, & hard;rxn lasted approx 2 to 3 days & then resolved;
Rapid heart rate onset approximately 3:00 AM on 5/2/2003.  To ER via pvt. car/ambulatory.  Treated-symptoms subsided at approximately 6:00 AM.  In ER- received Cardizem, Rythmol.  DX=new onset A-fib, rate controlled.
Pt was given incorrect dosing: 0.9 ml instead of 0.5ml by medical assistant. Pt was notified of event. After 15 minutes of event, Pt denied lightheadedness or dizziness or any signs of anaphylactic reaction. Pt alert and oriented. Pt was monitored by medical staff for over 30minutes, no acute changes in status.   BP 109/74 HR 72 SPO2 95%
Initial report received from a healthcare professional on 11 July 2013. A 24-year-old female patient, whose medical history, risk factors, health during pregnancy and concomitant medications were not reported, had received an intramuscular dose of ADACEL vaccine, batch number: U4617AA in left deltoid on 11 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was not reproted and the estimated date of delivery was 18 August 2013. Laboratory investigations were not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: none.
10 days post vaccine patient was diagnosed with Bells Palsy at the local ER.  No hospitalization required.
Narrative:  Patient with breakthrough covid infection.  Tested positive for covid 9/2/21. J&J covid vaccine 4/9/21.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 12 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Sep2021 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single and intramuscular, administration date 14Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "recovering", DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown" and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of COVID-19 and Drug ineffective with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN) was Possible. The reporter's causality for the event(s) of COVID-19 and Drug ineffective with HUMIRA (ADALIMUMAB) was no reasonable possibility.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a causal  relationship between reported events drug ineffective, suspected Covid-19 and suspect BNt162B2 cannot be excluded.
vaccine came out the side of the syringe pt did not get dose. Pt had to have a second injection
Intermittent arm pain, inability to lift or use arm, sleep disruption continues to the present day. Doctors have recommended stretching and icing, which has been ineffective.
on and off  headaches,sometimes severe. itching to palms on and off experienced too.
swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node). At the time of the report, LYMPHADENOPATHY (swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Shortly after vaccination I broke out  with severs case of shingles.  After the initial out break of shingles the visible symptoms cleared  I developed a severe case of Post Herpetic Neuralgia.
Patient has worsened rising of uric acid in blood; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BLOOD URIC ACID INCREASED (Patient has worsened rising of uric acid in blood) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006B21A) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukemia.    The patient's past medical history included Splenomegaly in 2015, Kidney failure from 2016 to 2017, Palpitation, Dehydration and Splenectomy in 2015. Concurrent medical conditions included Penicillin allergy (Penicillin allergy manifested by rash), Mitral valve prolapse, Chronic lymphocytic leukemia and Alcoholic (Four glasses of wine a week, regularly, started 1968) since 1968. Concomitant products included ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) for Chemotherapy, METOPROLOL for Palpitation, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for an unknown indication.   On 12-May-2020, the patient started VENETOCLAX (VENCLEXTA) (Oral) 20 milligram. On 12-May-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 10 milligram once a day. On 19-May-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 50 milligram once a day. On 26-May-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 100 milligram once a day. On 02-Jun-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 200 milligram once a day. On 09-Jun-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 400 milligram once a day. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD URIC ACID INCREASED (Patient has worsened rising of uric acid in blood). At the time of the report, BLOOD URIC ACID INCREASED (Patient has worsened rising of uric acid in blood) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood uric acid: (High) Comprehensive metabolic panel- Uric acid is trending up. On 17-Mar-2021, Blood uric acid: Comprehensive metabolic panel- Uric acid is trending up. On an unknown date, Blood uric acid: (High) Unknown date, uric acid rising up.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered BLOOD URIC ACID INCREASED (Patient has worsened rising of uric acid in blood) to be not related.    Concomitant medications included drug for prevention of pneumonia. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: No new information.
On 10/16/17 Complaint of a/an area of redness on skin. The area of redness is located L upper arm, deltoid region. The redness was noticed 5 days ago after receiving the Tdap vaccination. Patient reports she noticed a red lump which increased in size over 5 days. Site is tender and warm. The patient has tried home or prescribed treatment(s): OTC hydrocortisone and cool compress. This is the patient's initial encounter. Associated symptoms includes, chills which started today. On 10/23/17 L arm localized allergic reaction/treatment for cellulitis - patient was seen in clinic last week and diagnosed with cellulitis of L deltoid for which taking antibiotics as prescribed. Patient returned to clinic 5 days after receiving Tdap booster in L deltoid with C/O worsening warmth, edema, redness and tenderness at injection site. Patient diagnosed with cellulitis and prescribed doxycycline x 10 days. Patient states itchiness, stinging and pain much improved. Site is healing however skin is darkened. Patient admits to Hx darkening of skin with healing. No further burning and rare itchiness. And on 10/27/17 The lesion has improved - she does still have intermittent itching and intermittent episodes of aching pain and pressure - much improved then they were initially but still present. There is a "knot" below the skin which she noticed after the vaccine that has decreased in size significantly. No redness, drainage, no fevers, no chills, nausea, vomiting, or diarrhea.
muscle spasms for 12 hours starting 8 hours after the vacine, low grade fever , headachy, weak and tired for 4 days.
High fever 103.6F; Pain on injection site.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever 103.6F) and VACCINATION SITE PAIN (Pain on injection site.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 044B21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced PYREXIA (High fever 103.6F) and VACCINATION SITE PAIN (Pain on injection site.). At the time of the report, PYREXIA (High fever 103.6F) and VACCINATION SITE PAIN (Pain on injection site.) outcome was unknown.            No concomitant medications were mentioned. No treatment drugs were reported.
Rash noted in AM with few previous night, tired not self, no other symptoms. Macules, papules, vesicular/pustular lesions lower abdomen to pelvic area, few on back > 30 lesions.