chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ordered Boostrix (Tdap), but instead Adacel (Tdap) was inadvertently administered to the patient with no reported adverse event; Initial information was received on 17-Sep-2021 regarding an unsolicited valid non-serious case received from a nurse via physician via phone  This case involves a 11-years old female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) (wrong product administered).  The patient's past vaccination included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTaP).  The patient's medical history, past medical treatments and family history were not provided.   On 13-Sep-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number: C5667AA and expiry date: 26-Sep-2021 via intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error due to Wrong vaccine administered (same day latency).  It was reported "Nurse calling to see what they need to watch for after a patient was given the ADACEL vaccination instead of the Boostrix. Nurse stated that the physician had ordered Boostrix (Tdap), but instead Adacel (Tdap) was inadvertently administered to the patient. No concomitant vaccines were given. Patient had received DTaP in the past, but this was the patient's first Tdap dose."  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
fever; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and DIARRHOEA (diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PYREXIA (fever) and DIARRHOEA (diarrhea). At the time of the report, PYREXIA (fever) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment RX not given Drinking Pedialyte.
Patient received infant Moderna dose (6 month to 5 years). He was 5 years + 10 days. No adverse reaction happened.
The pain in my ears has not come back. On 7/5/2022 my fever spiked to 102.00. I had a telehealth appt. My Dr. ordered blood work, urine testing and a CT. The results were negative for any kind of bacteria, then I was given instructions to treat my fever by alternating between TYLENOL and ADVIL and to check back in if needed. My symptoms weren't getting better and since it was a weekend I went to urgent care. They did some specialized blood cultures and tested for pneumonia, they all came back negative for Pneumonia. I had a telehealth appt with my dr. the following Monday. They haven't been able to confirm a diagnosis except it seems like it's all stemmed for the first booster.
Patient called and said she had a rash on her stomach. She talked with her doctor who was very upset she got the vaccine. He is treating her with antibiotics and plans to admit her to the hospital for observation and to give her Varizig.
Approximately 8:10AM reaction; red, warm/hot to touch, itching.  Given Ibuprofen, can use Benadryl cream or Hydrocortisone.
Dec 15 I presents congestion when I went to the doctor, and I was offered codeine, but I asked for Dextromethorphan. Then she was done it didn't help I coughed all night. The morning of the 18th I went to the hospital, and I was diagnosed with acute bronchitis, and I was then given Dexamethasone, Ventolin Inhaler, Zyrtec-D and a oral steroid. I really didn't get much relief until I my increased my Zyrtec-D by 100% with the Zyrtec During this time I tested for COVID-19 and I was negative both times.    Coming up on Christmas I called the doctor back because I still wasn't feeling well so I asked for an antibiotic. I was given a Z-pack which was very helpful, and I believe I needed it because the office was going to be closed for the holidays.    I am very grateful for all the things the government has done to protect us.
Two weeks after my head started feeling funny, slight headache. Then my head started feeling weird then a week later or two during that time my ears started ringing. They have not stopped ringing. Doctor gave antibiotics and weeks later still has ringing. Went back and was referred to ENT and the ENT stated he didn't see any issue but had heard that ringing was a common adverse effect.
Hip and knee excruciating pain in Right leg...went to hospital for blood work the next morning...eventually determined after many specialists  that I had an attack of arthritis, hip bursitis, knee arthritis, psoriatic arthritis.
Over the last three months: Dizziness, heart palpitations, chest pain, faint feeling, at times shortness of breath, headaches, blurred vision, tingling sensation in arms and legs, random burning feeling, off-balance  The only issue that has been consistent is the dizziness and vision issues.
Moderna COVID-19 Vaccine EUA Immediate side effects were left hand numbness for about few minutes, Nausea, then throughout the day I had headache, weakness/fatigue, severe joint/muscle aches. today on 8/24/21 I woke up with left arm swelling and pain
extreme fatigue since April 21; chemical type burn appeared at injection site on April 23; May 2 had sudden drastic drop in blood pressure (symptoms were nausea, extreme hot flash with profuse sweating; lightheadedness to the point I thought I would pass out, dizziness); May 15 both arms broke out into a rash
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of abdominal discomfort (experienced fever, chills, malaise and fatigue after 1st dose received on 7th May 2018, refer case US2018GSK181075). On 6th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue, chills, malaise, fever and upset stomach. In August 2018, the patient experienced injection site warmth, injection site erythema and injection site swelling. Rechallenge with SHINGRIX was positive. In August 2018, the outcome of the injection site warmth, injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the fatigue, chills, malaise, fever and upset stomach were recovered/resolved. It was unknown if the reporter considered the fatigue, chills, injection site warmth, malaise, injection site erythema, injection site swelling, fever and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The next day after receiving SHINGRIX, the experienced upset stomach, fever, chills, malaise and fatigue. The patient stated that these symptoms started to resolve after a few days and then got worse a few days later. The patient stated that on the 5th or 6th day following the 2nd dose of SHINGRIX, she noticed a pronounced red circle that was larger than a half dollar on her left arm that was puffy and warm to the touch. The patient stated that the puffiness and warm to touch only lasted for 1 hour, however, the red circle lasted for a few days. On 13th August 2018, one week later the patient went to see the doctor for the symptoms that occurred after the 2nd dose.
Patient did not recall receipt of a Pfizer COVID-19 bivalent dose on 9/17/2022 at an out-of-town pharmacy.  Confirmed with pharmacy that patient did receive the Pfizer vaccine dose lot #GH9702 in the right deltoid.  Patient denies any side effects/adverse events following receipt of Moderna COVID-19 bivalent dose on 12/12/22, extra dose.
Unauthorized age group; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group) had resolved.        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.
Persistent shortness of breath with exertion, requiring prescription of the Albuterol inhaler.  Conservative outpatient treatment adequate for this case.
tachycardia, HR up to 130s 1 hour after vaccination. Tachycardia while sitting down. Lightheadedness. Tachycardia improved but still100-118 while at rest for hours
None, no adverse event.  10yo given DTaP instead of Td.  Out of range for DTaP.
Initial case was received on 05 November 2010 from a healthcare professional. A 57 year old female patient received on 11 July 2010, the second of a series of injections of IMOVAX with lot number D0869-1, for "possible rabies exposure." The first in the series of injections of IMOVAX with lot number D0792, had previously been given on 08 July 2010. One week after the IMOVAX vaccination received on 11 July 2010, the patient experienced numbness and tingling of left side of face, body tingling and as of this report experienced numbness and tingling of both arms. She was being treated by a healthcare professional and a neurologist. The patient had "several" prior IMOVAX vaccinations for past history of "possible rabies exposures" (no dates provided). No pre-existing medical conditions, allergies or concomitant medications were reported. The outcome was not recovered. List of documents held by sender: None.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
muscle soreness, joint soreness, difficulty swallowing which resulted in one vomit session, wrist weakness
This 35-year-old states her last menstrual period (LMP) was @ 24 April 2004 with two negative home urine pregnancy test in May/June.  She presented for her first anthrax immunization on 21 June 2004 voicing concerns over a possible pregnancy. By dates from her last menstrual cycle, this would have estimated the pregnancy at 8 week 2/7 day.  A repeat urine pregnancy test on 21 June 2004 was performed with showing a negative result, thus she received her first anthrax vaccination.  One week later, still concerned about a possible pregnancy she repeated the urine pregnancy test and now showed a positive result.  The medical staff was advised and she was transferred.  She presented to clinic with questions on anthrax vaccination with pregnancy and was referred to the Vaccine Healthcare Clinic. She was seen during the month of July 2004, where repetitive serum blood quantitative HCG were noted to drop. She reports an ultrasound being done showing a 6-7 week pregnancy when her dates stated she should be 13 weeks. On 2 August 2004 her pregnancy was medically terminated for failure to grow.  She reports no complications associated with her anthrax vaccination site or her recent surgery.
-Monday, Oct 24 ? Started feeling tightness in my mid-back. This is not usual for me. This started after my workout. -Tuesday, Oct 25 ? Back was tight and enough I didn?t want to work out with it, so did not work out in the morning. Went to Chiropractor, he tried to adjust, but was unable to. He says come back tomorrow. -Wednesday, Oct 26 ? Chiropractor unable to adjust my mid-back again, suggested I go to Emergency and get stronger muscle relaxants. If better by Friday, go back to visit him then. Prescriptions: 1. orphenadrine 100 mg 12 hr tablet - Take 100 mg by mouth every night. 2. naproxen 500 mg tablet - Take 500 mg by mouth 2 (two) times per day with meals. 3. diclofenac sodium 1 % gel - Apply 4 g topically 2 (two) times per day. Apply to knee, ankle, and foot as directed. -Thursday, Oct 27 ? Back is getting better and looser. -Friday, Oct 28 in the AM ? Visited Chiropractor, he was able to adjust as he need it to. -Friday evening, Oct 28 ? Started to feel a little off on the left leg. Didn?t think much of it, thought maybe it was as a result of his adjustment and will go away. -Saturday, Oct 29 at 2:30AM ? Didn?t sleep well, thought something does not feel right. Got up out of bed and almost fell over. Had to do 3 point contact all the way to the bathroom. Sat down and tried to release, but would not respond. Maybe I didn?t have to go, but when I got up, then felt the urge, so tried again. Still could not go. At this point, I woke my wife and told her we need to go to the Emergency Room. Got to Emergency, they did a CAT scan, seemed to take forever to get the third-party to read it, but decision was to fly me using Med Air to hospital.  -Saturday, Oct 29 at roughly 10:00AM, about the same time they put me on the plane, that is when I lost all feeling and control of my lower limbs. -Got to Hospital, they did an MRI, discovered they want me to go to surgery ASAP. Was in Surgery roughly after 6:00PM. They did a Laminectomy from T6 ? T9. Found Abscess inside the spinal column at T7 pressing against the spinal cord. Cleaned out, antibiotic powder, sealed up. They did medical cultures on it and think it?s non-resistant MRSA Staph (not sure about the technical name). They?ve been pumping me full of antibiotics and steroids for inflammatory control. -At present, I am not on any heart monitor, or any other restrictions other than mobility. I can feel vague sensations (temperature) on my right leg, the left leg has portions where I can feel more perceptive feelings but also other areas that are just vague temperature changes. I can move my left big toe and my left quad muscles on demand, but I can?t feel them activating. -A representative from Hospital Rehab Center specialized for Spinal Cord Injuries visited yesterday and is hoping to get me to alternate facility tomorrow, depending on insurance and med flights.
Patient stated arm of injection site was itchy later that day and late that evening/early the next morning her arm became swollen radiating from injection site.
experience high blood pressure/her brother also experienced the same scenario following his 2nd dose of the vaccine; fluctuations in her blood pressure/her brother also experienced the same scenario following his 2nd dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "experience high blood pressure/her brother also experienced the same scenario following his 2nd dose of the vaccine"; BLOOD PRESSURE FLUCTUATION (non-serious), outcome "unknown", described as "fluctuations in her blood pressure/her brother also experienced the same scenario following his 2nd dose of the vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated there were no family history of high blood pressure. After receiving 2nd dose, reporter's mother began to experience high blood pressure and since being placed on the 2nd medication, the mother experienced fluctuations in her blood pressure, with it first increasing substantially before dropping 20-30 points. Reporter then stated that her brother also experienced the same scenario following his 2nd dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331362 Same reporter, suspect drug and events; different patient.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little arm pain) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (a little arm pain). At the time of the report, PAIN IN EXTREMITY (a little arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were blood pressure and cholesterol. No treatment medications were reported.
Large swollen lymph node in armpit of shot; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 15Jan2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, hypothyroidism and depression. The patient had history of allergy to several antibiotics (unspecified). The patient received other prescribed medications (unspecified) within 2 weeks of vaccination for an unknown indication and from an unknown date. 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 COVID vaccine. On 18Jan2021, the patient experienced large swollen lymph node in armpit of shot. The patient reported that the swollen lymph node went away after 2 weeks. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 05Feb2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient reported that 2 months later after the second dose of vaccination, he experienced swollen, red lymph node in the same armpit and reported it to be inflamed one week to date. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported event. The clinical outcome of the event large swollen lymph node in armpit was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
12:39 pm- 0.5 cc Fluvarin seasonal vaccine injected IM into left deltoid. 12:40pm- Patient became very flushed, eyes watering, c/o "do not feel well", headache. 12:41pm- Patient got weak and headache worsening, slowly laid down to floor. Administered 0.3 cc Epinephrine sub-q  deltoid. BP 120/80  pulse 100. 12:48 pm-  Patient c/o "heavy chest", lungs clear, called 911 and requested ambulance. Pulse 92. 12:50pm-    Pink face (redness lessening), chest heaviness relieved. Pulse 89  SPO2 98%. 12:56 Ambulance/EMS arrived, SPO2 92%
Extreme muscular pain, muscle weakness, fever, swelling of entire upper arm, nausea, chills, sweating , insomnia
Initial report received on 02 September 2009 from a nurse. The nurse had received the information from a friend of the patient. A 44 year old male patient, with no known medical history, received YF-VAX (lot number C3337AA) on 21 August 2009. On 31 August 2009, the patient was admitted to a hospital, with an all over body rash, bruising, and platelet count of "1000". Apparently, the physician advised the patient that he believed that the reaction was vaccine related. According to the patient's friend, the physician was afraid that the patient "may bleed out". At the time of the report, the patient had not recovered. The reporting nurse was planning to get further information. 10/13/09 Vaccination records received. bhp 10/13/09 Received MR from Hematologist. DX: Immune thrombocytopenia after receiving vaccinations for Hepatitis B, YF, meningococcal. Steroid induced diabetes. Initial symptoms: Pt received vaccinations to Hep B, YF, Meningococcal, and Dukoral on 8/21/09 denied any illness at time of vaccines. Was seen by ER on 8/31/09 for c/o petechial rash and his platelets were 1. Given oral tx with no response. IVIG was given. Platelet then 49. Presenting symptoms at time of consult: denies any rash or decrease in energy. (+) occasional drenching sweats, decrease in weight. Recent dx with sinus infection. Pt following a naturopathic therapy. Impression: Most likely immune thrombocytopenia which has not shown response with steroid therapy. Would like to do bone marrow biopsy and suggest a splenectomy and f/u.   12/17/09 and 12/23/09 DC summary received for DOS 08/31/09-09/05/09. DX: thrombocytopenic purpura, rash, constipation, hyperglycemia.  Pt with rash that improved. Tx: prednisone, Solu-Medrol, CPAP,
Pt called to report that approximately one week after second dose of Moderna, he developed a rash on his abdomen, that progressed to his arms and legs. Described rash as red, raised and sandpaper texture.  Has not improved.  Severe itching associated with rash.  Has also experienced low grade temps (100.1) and headaches on and off since that time.  Has been seen by PCP who has administered 2 injections of steroids and steroid dose pack.  Did not experience any issues immediately following the administration of either dose or any problems after first dose of vaccine.
PATIENT WAS HERE TO RECEIVE 4 VACCINES. SHE RECEIVED BOOSTRIX FIRST, THEN TYPHOID. SHE STATED SHE WAS FEELING LIGHTHEADED, SO WE TOOK A BREAK, AND MOMENTS LATER SHE FAINTED. I CAUGHT HER, AND SHE WAS AWAKE MOMENTS LATER.
I have had both Moderna shots now.  The 2nd shot was a week ago.  Beginning with the 1st shot, I get a stomach ache after eating a meal.  Seemed to get better after 1st shot, it is back with 2nd shot.  At times keeps me from falling asleep at bedtime after evening meal.