chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had the Shingles vaccine and broke out/Suspected Vaccination failure; Broke out spots under arm turned dark; Very painful; Turned dark; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the Shingles vaccine and broke out/Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Broke out spots under arm turned dark), pain (Verbatim: Very painful) and skin discoloration (Verbatim: Turned dark). The outcome of the vaccination failure was unknown and the outcome of the shingles and skin discoloration were not recovered/not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and skin discoloration to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and skin discoloration to be related to Shingles vaccine.   Additional Information: GSK receipt date: 09-MAR-2023 The case  was received from the patient via interactive digital media. The patient reported that her husband and she, both had the Shingles vaccine. The patient broke out under my arm and then spots up and down in her right arm and it was very painful but not really itching as yet. The patient reported that it had turned dark now and physician had her on medication. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-JAN-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot# J005068, expire date 18-JAN-2015; dose and route unknown). The total cumulative excursion time was 92 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Vitamin D deficient" (unspecified if ongoing), notes: other medical history: Vitamin D deficient; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Amoxicillin, Penicillin, Ceclor, Cephalosporins; "known allergies: Cephalosporins" (unspecified if ongoing), notes: known allergies: Amoxicillin, Penicillin, Ceclor, Cephalosporins. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin, Penicillin, Ceclor, Cephalosporins; Ceclor, reaction(s): "known allergies: Ceclor", notes: known allergies: Amoxicillin, Penicillin, Ceclor, Cephalosporins. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of 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 drug ineffective, covid-19.  Clinical Course:Treatment, brand=Paxlovid,treatment start date was 03Feb2023, treatment stop date was 08Feb2023, indication=Treatment of COVID-19, Other medication details: other medication in 2weeks product was Flouxetine, other medication in 2weeks brand was Generic, Adverse event: Paxlovid Rebound  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
I'm not sure which kind of flu shot I got. I felt pain when the needle went in that was different from any other vaccine I've received - and it was higher on my arm than usual. I felt pain in that joint and had increasing lack of motion over the next six months.
Severe headache unable to go to work  for one day  Still not up to my normal abilities two weeks later.  More fatigue than usual.  Right and left leg pain and right arm pain.  Possible DVT but not tested  have had in the past so feels that way
This spontaneous report as received from a physicians assistant concerning a female patient of unknown age who on an unspecified date after one year of receiving the first dose of GARDASIL was vaccinated with dose 2 of 0.5 ml GARDASIL, IM, (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
8 x 8 centimeter local reaction to right arm. Mother took child to emergency room for redness and swelling of right arm.
Patient passed out about 10-15 minutes after receiving vaccine.  I was able to catch him before he completely fell to the ground.  EMTs were called and patient was fully conscious when they arrived.  They said they thought it was a vasovagal reaction and recommended he go to the hospital but patient decided against it and had a friend come pick him up from the pharmacy.
a pregnant patient was given adacel was mistakenly administered instead of fluzone,no AE.; a pregnant patient was given adacel was mistakenly administered instead of fluzone,no AE.; Initial information received on 03-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female pregnant patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] mistakenly instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number U6202BA, expiration 26 Feb 2021-reported for an unspecified vaccine) via unknown route of administration and unknown site on an unknown date of December 2019.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The actual date of delivery was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient's previous pregnancy details were not reported.   It was an actual medication error case due to wrong product administered and exposure during pregnancy.  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.
ANGINA DECUBITUS HYPOTENSION 10/5/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Injection site hot; Injection site itching; Tiredness; Injection site red; Muscle pain; legs started to hurt really bad; numb; could not really walk; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs started to hurt really bad), HYPOAESTHESIA (numb), GAIT INABILITY (could not really walk), VACCINATION SITE WARMTH (Injection site hot) and VACCINATION SITE PRURITUS (Injection site itching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (legs started to hurt really bad), HYPOAESTHESIA (numb) and GAIT INABILITY (could not really walk). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itching), FATIGUE (Tiredness), VACCINATION SITE ERYTHEMA (Injection site red) and MYALGIA (Muscle pain). At the time of the report, PAIN IN EXTREMITY (legs started to hurt really bad), HYPOAESTHESIA (numb), GAIT INABILITY (could not really walk), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itching), FATIGUE (Tiredness), VACCINATION SITE ERYTHEMA (Injection site red) and MYALGIA (Muscle pain) outcome was unknown.            Treatment information not provided. List of concomitant medication were not given.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional events Injection site redness, injection site itching, fatigue, injection site hot, muscle pain added.
I became pregnant in August. I started having some bleeding a few days before 10/25/2021. I went to get an ultrasound and they determined the pregnancy was not viable. They gave me Misoprostol on 10/26/2021 and I miscarried that day. I had blood work every 2 weeks since then to track the level of my pregnancy hormones. The pregnancy did not develop so there was not a fetus.
First odd thing was 8 hours post injection- allergic reaction with seemingly no provocation- sneezing, coughing, eyes watering- terrible tickle in my throat. took a Zyrtec and some vitamin C and it went away completely in 20 minutes. mild headache continued for a couple  days. Second reaction is a red mark- slightly warm at injection site- no fever or pain Called my MD and he recommended reporting here.
Pt reports having R upper eyelid swelling, itching, redness by that same eve after 2nd dose, and then had HA ride side from shoulder to around R ear, then nausea, felt clammy/hot, and by 4/13/21 dev'd R eyelid rash, drooping, and R upper lip drooping, worse as day progressed, cont'd HA pain and eye felt gritty.   Pt reports previous shingles to R thorax and severe chicken pox illness as child.
On 1/8/01, the physician received a phone call stating that the pt died on 1/6/01 in the A.M.
elevated temp 104, 105, drowsy sluggish, fussy uncontrollable crying 3 hrs;
I immediately had shortness of breath and my chest felt tight. It lasted a little while. That night I felt weak and tired. I went to bed and felt rapid heart rate/beats. I feel like I kept seeing things like hallucinations. I only hallucinate when the medication I take is too high.
Began breaking out in hives and running fever. Has to take prednisone and Benadryl.
First shot 12-22-20. Tested positive for Covid virus 1-4-21. Lost taste and smell. Headache. Second shot 1-22-21. I would get very tired and could concentrate at work for 4 months.
On 4/30/18 patient came to pick up other Rx and while here made us aware she experienced fever, chills, and fatigue for about 24 hrs after vaccine. She also complained of not being able to easily pick up an object with hand (rt hand) opposite of injection site arm (left arm). Pt states this also resolved w/in 24 hrs.
Initial information received on 02-Jan-2019 regarding an unsolicited valid serious case received from a nurse. This case is linked to case 2019SA005285 (same patient) This case involves a 59 years old female patient who experienced arthritis such as pain in her joints in her arms and hips (Rheumatoid Arthritis) and barely walk, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Tobacco user. It was unclear which Flu Shot she received last year. The patient complained of Left Shoulder pain and she stated it was placed in her bursa of her left arm last Flu Season. She did obtain an MRI. Her HCP stated that she is getting old and experiencing chronic changes. Her HCP stated it wasn't a side effect of the Flu shot. The patient's past medical treatment(s) and family history were not provided. On 18-Oct-2018, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6302AA, Expiration Date: 30-Jun-2019 via intramuscular route in the arm nos. On an unknown date, the patient developed a serious arthritis such as pain in her joints in her arms and hips (rheumatoid arthritis) 2 weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a serious arthritis such as pain in her joints in her arms and hips (arthralgia) 2 weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. The patient developed a serious barely walk (gait disturbance) 2 weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. (Other relevant tests included she had a Rhematoid Arthritis panel in the middle of Nov2018 and she definitely has Rheumatoid Arthritis.) Final diagnosis was barely walk and arthritis such as pain in her joints in her arms and hips. The patient is receiving Water Therapy to move better. The outcome of the event was reported as Unknown. Documents held by sender: none. Sender's Comments: This case concerns a 59 years old female patient who presented with Rheumatoid Arthritis such as pain in her joints in her arms and hips and gait disturbance 2 weeks after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible with the role of the vaccine. Patient's past medical history included Tobacco user, Musculoskeletal pain (Left Shoulder pain) and Bursa disorder with bursa of her left arm. She did obtain an MRI. Moreover, HCP stated that she is experiencing chronic changes due to old age and did not consider events as side effect of the Flu shot. Additional information regarding patient's condition at the time of vaccination, lab//radiological test excluding other degenerative factors are needed for complete assessment of the case. Based upon the reported information, no conclusion can be drawn regarding the role of the vaccination.
Patient was given vaccinated with Adacel. During the monitoring period, she informed that she was feeling week and felt that her blood sugar was going down. Her daughter who was assisting her was giving her candy as I was speaking to her. She noted once she was given the vaccine, she felt a rush in her head. Patient was given water and monitored longer prior to leaving pharmacy. There was no sign of rash or injection site reaction  she denied any trouble breathing or throat swelling.  After monitoring patient felt ok and stated she felt fine to go home.
Patient's arm started swelling red 30 minutes post vaccine. Pain, and swelling were increasing. Used ice and ADVIL (with food).
Patient developed palpitations and shortness of breath the day after receiving 1st dose of Moderna vaccine.  EKG and 48 hour holter monitor showing sinus tachycardia.  Kidney and liver function, electrolytes, TSH, Ddimer  and Troponin normal.  Intermittent tachycardia has continued since 8/28/21 with minimal exertion.  Referral to cardiology has been placed, Echocardiogram, chest xray, and Thyroid nuclear radiouptake scan ordered.
arm pain; headache; body ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included METOPROLOL, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and SIMVASTATIN (ZOCOR) for an unknown indication.    On 28-Jan-2021 at 12:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm pain), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea). At the time of the report, VACCINATION SITE PAIN (arm pain), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that headache was worst out of all symptoms. No treatment information was provided.
started to feel nauseous and hot.  he had a headache later and high blood pressure and heart rate
Patient reported and widespread rash. Patient came into the pharmacy and showed how the rash was spreading up her neck and down her back. This is not something that I had seen in any other reported dermatologic type reaction and was very atypical. Patient stated that it itched and that her skin was crawling.. Some areas presented some blistering on her back (reported by patient) and raised red areas around her whole body (except the top of her head and the bottom of her legs/feet).
Patient received her vaccinations on 28 April 2015. On 02 May 2015, the patient returned to the clinic with decreased ROM and increased pain to right upper arm. Right upper arm with edematous and sensitive to palpation.
arm hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced shingles in April 2021). Previously administered products included covid vaccinne with an associated reaction of pain in extremity (received COVID vaccine on an unknown date).   On 18th August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported.  The patient received shingles shot on Wednesday after having shingles back in April. The patient stated that the he/she would not going to threw that again, arm hurts worse than it did with covid vaccine.
Post-vaccination observation: immediately post-vaccination patient experienced vasovagal syncopal episode (10:42am) - patient placed in Trendelenberg position and provided ice packs. BP 88/52 HR 53 (10:45am). Instructed to wait additional 15 minutes for nursing observation - VS returned to normal BP: 101/68 HR 62 while sitting upright (11:02am). Provided patient water. After 30 min observation, patient stating he feels "good" and ok to leave the clinic. Patient left clinic in good health with his father accompanying him.
The day after the shot my arm was sore and hot to the touch. Following that I had generalized body aches and fairly severe joint pain in my shoulder, knees and kepis. I also had severe fatigue, lack of appetite, and diarrhea. On 5/2/2022 I noticed swelling underneath my armpit on my left arm and it was warm to the touch and the pain was mild to moderate. I took a Tylenol for that and slept okay that night. I looked for an urgent care the next day and finally found one two days later. The NP thought it was related to the vaccine and to keep an eye on it. She said if it got worse to come back or see my primary care doctor. I have just continued to take Tylenol for the pain.
patient received Tdap/ADACEL instead of the DTaP/DAPTACEL with no reported adverse event.; Adacel was mistakenly given to a 3-year old patient with no adverse event reported; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via Medical Information (MI) (Reference number- 00838697) and transmitted to Sanofi on 02-Nov-2021.  This case involves a three-year-old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of the DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered and product administered to patient of inappropriate age).  The patient's past vaccination(s) included DAPTACEL on 16-MAY-2018, on 16-JUL-2018 and on 17-SEP-2018.  The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided.  On 21-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection, lot U7184AA, expiry date unknown) via an unknown route in the left thigh for prophylactic vaccination.  It was an actual medication error due to wrong product administered and product administered to patient of inappropriate age. (latency: same day).  It was reported "Adacel was mistakenly given to a 3-year-old patient as the fourth dose in the diphtheria/tetanus/pertussis pediatric series. A patient received doses of Daptacel on 16May2018, 16Jul2018, and 17Sep2018. Then on 21Oct2021 for his fourth dose, Daptacel was intended, but instead Adacel was mistakenly administered in the left thigh."  At 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.
Vaccine series in Dec/Jan. LMP Feb 11. Breast lump noticed March 2. Positive pregnancy test March 14. Bleeding April 10, miscarriage April 14. D/C April 16
Redness, swelling and itchiness at site of injection -- reaction appeared a week after injection and lasted 7-10 days
tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-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 FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported by patient.   This case was linked to MOD-2021-310341 (Patient Link).
Child started having a rash on face spread to rest of body.  Varicella vaccine given the day before.  Rash blistered and scabbed over - some itching.  Had fever a couple days 0 up to 103.7 at one time.  Child saw Dr. 9-30-08 and was Dx with chicken pox.  Child goes to daycare but no other cases reported.