chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11 year old patient who should have gotten Adacel so the patient was given the wrong injection which was not age appropriate/ no AE; 11 year old patient who should have gotten Adacel so the patient was given the wrong injection which was not age appropriate/ no AE; Initial information received on 08-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 11 years old patient (gender not reported) who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that 11 year old patient who should have gotten Adacel so the patient was given the wrong injection which was not age appropriate.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  No issues with the patient following vaccination.  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.  Information on the batch number was requested.  List of documents held by sender: none.
I flew out of town to see my new grandchild, I generally have a problem with the recirculated air on the plane. I chose not to wear a mask thinking I would be okay for the short flight. When I got home, I had a dry nonproductive cough. I did not go to the doctor as I know this is just what happens every time I am on a flight, it will go away with time.
Severe itching which started on 10/03/2000, approx. 20:00 and didn't stop until 10/05/2000. Painful at the vaccine area and stiffness in left shoulder.
June through July 2007: Symptom onset following receipt of anthrax vaccines which persisted for several weeks. Did not seek evaluation. Felt extremely tired, with bouts of generalized aching pain of muscles and joints, nausea and vomiting, fevers, felt hot alternating with chills, hair started falling out, and noted delayed healing time. After these episodes, noted increased frequency of infections and then noted onset of sores, including sores in her mouth. February 2008: Felt uncomfortable, with some joint and muscle pain, as well as noted fevers and malaise. June 2008: Acute onset episode preceded by feeling overheated alternating with chills and N/V/D, with severe chest pain and palpitations associated with loss of vision and reported heart rate in the 30s. Following episode SM complained of profound fatigue, joint and muscle pain, paresthesias, ongoing chest pain and dyspnea. headaches, problems concentrating, and irregular menstrual cycles. Symptoms improved slightly, but her health never returned to baseline. Between Sep 2008 and June 2009, SM "pushed through" her duties and did not seek medical evaluations. - June 2009: Acute episode of chest pain preceded by N/V and hot/cold intolerance and chills. Presented with intense but vague chest discomfort and shortness of breath with associated loss of vision. Admitted to rule out MI. Following discharge, SM experienced profound fatigue requiring 4 weeks of bedrest, sleeping 10-18 hours per day. She continued to experience multi-system symptom complex, with predominant symptom being fatigue. Not able to make it through an 8-hour day without napping, continues to require periods of bed rest and increased sleep, particularly after any physical activity. Began an extensive medical evaluation after admission in June.
Whole body itching and burning. Red rash to upper chest, R arm, abdomen. Small bumps on bilat arms, abdomen. Shaking (that could be due to anxiety). Pt was given Benadryl injection with improvement in itching and rash.
Received shot 12/4/2009.   Possibly had a small mild shingle rash on back a week or so later.  After that, started to have some intermittent discomfort along trigeminal nerve, the site of shingles in April.  Considered it post-herpetic pain. Eye started to feel quite irritated week of Dec 28.  Ophthalmologist indicated virus back in eye on Jan 4, 2010.    According to phone call to Merck prior to receiving vaccine no studies had been done specifically with people who have had shingles.  Timing of 'events' suggests, at least to me, a possible relationship to vaccine.  I believe some proactive work of followup (6 months to a year) should be done on this group of people.
Extreme fatigue, headache, joint aches, muscle aches, sweating, mild stomach pain.
Did not received 2nd dose; tinnitus in both ears but mostly in my right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus in both ears but mostly in my right ear) and PRODUCT DOSE OMISSION ISSUE (Did not received 2nd dose) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced TINNITUS (tinnitus in both ears but mostly in my right ear). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not received 2nd dose). At the time of the report, TINNITUS (tinnitus in both ears but mostly in my right ear) had not resolved and PRODUCT DOSE OMISSION ISSUE (Did not received 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient didn't receive second dose of vaccine, expressed concern that the second dose may make tinnitus worse.  Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Itching, rash, raspy voice, anaphylactic. Due to hx of numerous allergies (possibly eggs as well) was give FLUCELVAX and, had her wait in waiting room for 20 min. At about 15 min after vaccine given-started to develop s/s.
2 weeks after second dose of vaccine received I noticed my left eye lazy and loss of taste and feeling on left side of my tongue .  As the day progressed I noticed my left side of face felt different number , my mouth was not opening wide on left side .  I did a telemedicine call with a Dr that referee me to Er where I was diagnosed with Bell Palsy.
Information has been received from a physician concerning a female with latex allergy who was vaccinated with a dose of GARDASIL, IM, 0.5ml. Subsequently the patient experienced "some type of allergic reaction". Symptoms of reaction were unspecified by reporter. The patient sought medical attention, office visit. At time of the report the outcome of the patient was unknown. Additional information has been requested.
Headache for 6 days with high blood pressure of 239/139 Went to PCP he told me to go to ER. I was admitted for 2 days. I?m still at home with high blood pressure
Pt received 0.5 ml Flu vaccine and she should have received Fluzone.
While giving MMR vaccination I noticed three little bumps appear. I stopped pushing the serum into the arm and they mostly went away. I then proceeded to give the rest of the vaccine. While I was giving the rest the bumps reappeared. I notified the cg of what was going on. I marked where the bumps were and we watched it. It gradually started to get worse over one minute. I then administered 50mg of Benadryl, and called the EH Nurse. While talking to her would have been 5 minuets after the injection the hives expanded. She suggested taking her to the ER for observation. While we were walking over there her back became itchy. Stayed with her and filled out an injury report before leaving her in the ER.  Patient states she has had several MMR shots for school, and when she had babies. she was never immune to Rubella afterwards, there were not records in the state data base of any those.  She states it would have been shot 7.
After both of the Johnson & Johnson shots I got a UTI.  These have been my first and only UTI's.  My pee smelled, I was frequently urinating, never feeling like I got out all the pee, peeing when I didn't really need much to pee, extreme fatigue, foggy for weeks, depressed, and up throughout the night peeing.  I didn't understand what was happening the first time and it took me two months to see the doctor.  It had become so bad that I could feel it in my kidneys.  The second time I knew what was happening.  It took me two rounds of antibiotics to clear up the first one (possibly because I took so long to go to the doctor).  I just finished my 7-day supply of antibiotics and I'm almost recovered.  I'm hoping it doesn't come back like it did last time.  The tiredness, the depression, and the pee doesn't seem to be back to where it was.  I still smell a faint of the almost 'coconut like' smell that was there.
dizzy, nausea, tenderness in area of shot;no redness;no swelling;
This is a spontaneous report received from a contactable consumer or other non-HCP. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced alopecia (a patient who also experienced hair loss after being vaccinated), with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
no adverse effects; a patient was administered a improperly stored VARIVAX; This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 15-OCT-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX)injection, subcutaneously, lot number S015460 with expiration date on 20-MAY-2021 (dosage schedule, and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion of -11.5 degrees Celsius (C) for 76 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
left facial tingling, burning, throbbing, tugging feeling with itchy eye, pain in left ear and redness without blisters
No additional AE/PQC reported at time of call.; a dose of VAQTA with a labeled expiry of 1/16/2023 was administered to a patient on 1/17/2023.; This spontaneous report was received from a nurse manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W007382, expiration date: 16-JAN-2023, administered for prophylaxis (strength, dose and route of administration were not provided) (Expired product administered). No adverse event was reported.
pt recv vax 29SEP95 & 21OCT96 pt devel 10-15 lesions on trunk & 10-15 lesions on back;it was noted that pt had been exposed to 3 children w/chickenpox;
Redness, swelling, heat more than would typically be expected extending all the way to the elbow. Severe pain x 7 days.
eight hours after injection developed erythema and edema (5cm circular area) around injection site; also complained of headache for first 10 hours
pt recv vax & devel an inj site rxn p/vax;this is 1 of 4 pt from this facility to exp this rxn;
MULTIPLE HIVES ALL OVER BODY UP TO CURRENT TIME (3 WEEKS) PRESCRIBED TREATMENT - STEROIDS, ANTIHISTAMINES, PEPCID.
Case number PHEH2015US026904, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 57 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 06 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. No adverse reaction was experienced by the patient following the maladministration. Reporter stated she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day, and when she arrived the next day and the temperature was fine. It was a new refrigerator, and there have not been any problem since the temperature excursion. No further information provided. Follow up information was received from a nurse on 26 Jan 2016. Nurse comment added.
This spontaneous report was received from a nurse practitioner refers to a 44 years old patient who on 03-SEP-2012, was vaccinated subcutaneously with a dose of M-M-R II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Chills, followed by nausea, headache and repeated throwing up ~12 hours after vaccination.
Angioedema, PT reports history of recurrent angoedema approximately twice a week. She is being worked up. Pt came with Benadryl. Denied SOB, wheezing, hives, chest pain, n/v.
Patient is a nurse and was vaccinated with Pfizer vaccines on 12/13/2020 and 1/14/2021.  Symptoms mild nasal congestion and started 11/10/2021.  Tested PCR + for Covid on 11/10/2021.  Reported as breakthrough Covid illness.
Largely swollen and hardened bump surrounding injection site, 2? radius, total 4? diameter. Extremely sensitive to touch and movement. Swollen area is significantly hotter to the touch than the rest of the surrounding area. Swollen area also itching. Started probably while asleep, woke up the next morning (Wednesday 5/5 8am) with this issue, persisting into 2nd day 5/6, currently time 1pm.
When I received the vaccine I immediately felt a rushing feeling pass over my body. The headache kicked in a couple hours later. I took some Motrin. The headache never went away or subsided for a month. After 3 months of an ongoing headache I made an appointment with a doctor. I was having symptoms of heart burn after getting the vaccine. I was also having bad leg cramps at nights. The doctor told me to take some magnesium supplements. The leg cramps and headaches went on for a couple more months, but they eventually did go away. I declined getting the booster. On January 2, 2022 I went to the ER for abdominal pain and fever. The doctor told me that I have 3 different types of cancer. I have cholangiocarcinoma, liver cancer, and lung cancer. I was prescribed medications and pain killers, but I don't take them. I only took the nausea medication because I had extreme fatigue and nausea. I am also very tired all the time. I don't have the leg cramps or headache anymore, but I do still have the fatigue. I also caught Covid in March 2022. I had a high fever, and then I had chills while being outside in the sun. Then I started getting diarrhea and stomach cramping. I just felt weird. I thought I had an infection so I went to see a doctor, and they said I had Covid. The next day I got the Covid headache. I dint have a cough or anything. In April 2022 I caught Covid again with a fever and diarrhea, but I had a negative at home Covid test. I had milder symptoms. When I got a PCR Covid test did that one was positive.
3 days after vaccine with rash on arms, trunk, abdomen, groin.  Pruritis, eyes swelling.  Treated with Benadryl, Zantac.  8 days after vaccine continued rash and pruritis, maculo-papular rash.  Treated with Prednisone, Benadryl, Zantac.
Information has been received from a medical assistant concerning a 5 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #659533/1594U). Subsequently the patient developed an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This report is one of several from the same source. Follow up information has been received from a medical assistant concerning a 5 year old male patient with no pre-existing allergies, birth defects, or medical conditions, who on 21-JAN-2008, was vaccinated with a second dose of varicella vaccine live (Oka/Merck) (LOT #659533/1594U, dose not reported) subcutaneously in the left thigh. It was also reported that the patient had no illnesses at the time of vaccination. Other vaccination received on 21-JAN-2008 included hepatitis A virus vaccine inactivated (MSD) (lot number 654514/0304U) intramuscularly in right thigh. On 23-JAN-2008, the patient developed a red, hot swollen area at injection site on left thigh. On an unspecified date, the patient recovered. No further information is available.
W/in sev hours of above vaccines Dev swelling at site and hives on arm. Rash generalized to hives on trunk, ext. face rash at this time (10d later) is more dermatitis like with ID reaction - still getting new pruritic lesions S/P BENADRYL Now on prednisone and ZYRTEC.
This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a 33-year-old male patient who received BOOSTRIX (batch number X4J7D, expiry date 26th September 2017). On 7th September 2015, the patient received BOOSTRIX .5 ml. In September 2015, less than a week after receiving BOOSTRIX, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unchanged. It was unknown if the reporter considered the enlargement of lymph nodes to be related to BOOSTRIX. Additional details were received as follows: The patient experienced swollen lymph node near the collar bone, on the same side of the injection. The patient was asking if any data regarding this event was available. The batch number for BOOSTRIX was reported as X4J7B, which does not exist per sales data sheet and was updated to be X4J7D.
Uti infection; Limp with no strength/ patient couldn't stand; Liver enzymes were elevated; Fever; Extreme weakness; A spontaneous case was received from the consumer concerning female patient of unknown age who received Moderna's  COVID-19 vaccine and experienced UTI infection/urinary tract infection, extreme weakness/asthenia, limp with no strength/ patient couldn't stand/muscular weakness, fever/pyrexia, liver enzymes were elevated/hepatic enzyme increased.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Atorvastatin, Esomeprazole magnesium, Clavex, amlodipine, Cetirizine, Tramadol, Gabapentin.  On 28 Jan 2021 prior to the onset of the events, the patient received first of the two planned doses of mRNA-1273 (Lot Number: 038K20A) at unknown injection site for the prophylaxis of COVID-19 infection.  On 28 Jan 2021 the patient experienced extreme weakness. She experienced severe symptoms like she couldn't stand, limp with no strength, fever, UTI infection. Treatment of the event included antibiotics.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, UTI infection, extreme weakness, limp with no strength and patient couldn't stand, fever, liver enzymes were elevated was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
patient presented with welps on skin after Boostrix injection given approximately 3 hours later. patient went to emergency room and was given steroids and breathing treatments to resolve issue along with oral Benadryl
Progressive fatigue, numbness and sensation of heaviness in lower extremities and upper extremities, decreased exercise tolerance.
This spontaneous report was received from a pharmacist refers to a patient of unknown age or gender. The patient's concurrent conditions, medical history or allergy/drug reactions were not reported. On 16-FEB-2015, the patient was vaccinated with the first dose of GARDASIL (dose, route, anatomical location and lot # were unspecified). On 13-APR-2015, the patient was vaccinated with the second dose of GARDASIL (dose, route, anatomical location and lot # were unspecified). Then, the patient was vaccinated, on 13-MAR-2016, with the third dose of GARDASIL (dose, route and anatomical location were unspecified). (Lot # K023432, exp: 18-JUN-2016). No adverse effects were informed. No product quality issues was informed. Additional information has been requested.
Patient became limp, cyanotic, eyes rolled back in head, unresponsive x 60 seconds, color and eye mvmt and tone returned but pt with decreased responsiveness x 20 minutes, then felt to be hypotonic/hyporesponsive. Fully recovered.  5/19/2008 MR received for DOS 5/7-8/2008 with D/C DX: ALTE.  Pt presented to ER after an episode of perioral/facial cyanosis, unresponsiveness, eyes rolling back and limpness which occurred during a feeding. Lasted ~20". W/U was (-). No further episodes. Follow-up: This is follow up to prior communication. Initial VAERS report was filed 5/8/08. My interaction with patient was limited to in-house hospital care 5/7/08-5/8/08. I do not have access to the vaccine lot/manufacturers as the vaccines were administered 5/5/08. Please contact docs for vaccine information.
Noticed what I thought was a hemorrhoid developing approximately July 1, 2021.  Examined by doctor on July 14, 2021.  Doctor diagnosed hemorrhoid and prescribed Lidocaine HCL 2.8% -  Hydrocortisone Acetate 0.55% Gel with Aloe and use of Tucks pads.  Doctor was unable to determine cause of hemorrhoid outbreak.  Hemorrhoid symptoms disappeared after using  Gel and Tucks pads for approximately 5 weeks.  Symptoms have not reoccurred as of September 21, 2021
Initial report received from a health care professional on 09 Dec 2009: This patient, with an unknown medical history, was inadvertently administered FLUVIRIN 0.5 ml intramuscularly on 27 Nov 2009. The outcome of the event was not reported.
dizziness, palpitations, elevated blood pressure, nausea which alleviated after 35 minutes or so
Was given SANOFI PASTEUR'S TDAP product before patient was 11 years old.
Large red swelling at injection site which resolved 4 days post vaccine. Late on day 6 itching started. on Day 7 larger swelling started to spread which was 4-5 inches in diameter. Looked like histamine response, red, hot, and solidly hard. Started antibiotics as bacterial cellulitis could the cause of symptoms. Fatigue, headache, nausea, and brain fogginess have been part of the general reaction. No fever present at any time.
It was reported that a 2 month old male patient received a Tripedia, an ActHIB, an IPOL and a Hepatitis B vaccination on 4/11/00 at 12:00. Reportedly at 3:30PM that same day, the patient developed unconsolable screaming until 12:00AM. The patient would not eat until 4:00am on 4/12/00 and was very restless when he fell asleep that morning. As of 6:00PM on 4/12/00, the patient is improving. No additional information was provided from correspondence received at manufacturer on 5/2/00. Follow up #1 (7/3/02): during internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (added anorexia and nervousness).