chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Daptacel given, No AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a one years old male patient who vaccinated with 0.5 ml expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5367AA and expiry date: 30-Jan-2020) via intramuscular route in the right vastus lateralis on 03-Feb-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fatigue, dizziness onset within several hours of shot.  Redness and itchiness at injection site. After approximately 28 hours= Significant pain in lymph nodes in armpit and breast area on same side as shot that lasted several days, diminishing over time.
Pt. noted to have - dark erythema and hives around area of MMR inject. approx 5 min after administration of vaccine. Cold pack applied & given 5 cc diphenhydramine. The swelling & redness subsided after 15 min.
Diarrhea. Patient stated he had stomach issues/diarrhea since 1st dose. Cancelled 2nd dose.
Patient describes gradual onset of bilat LE weakness and "sore muscle pain" that progressed into bilat UE. These symptoms started axially and progressed into the feet and then hands. He also developed frontal HAs. He denies that there was any difficulty with breathing or swallowing. There also was no proceeding symptoms C/W viral or bacterial infection. He went to the ER for care and had a full W/U to include multiple spinal taps, blood work, and CT - all of which were non-diagnostic. He was sent home with medication for symptomatic relief. The symptoms slowly resolved over the course of two weeks. He now denies any residual symptoms and has a normal physical examination.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age who was an employee of the pharmacy. The patient was vaccinated with ZOSTAVAX (lot number, route and dose not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient developed a rash after the administration of ZOSTAVAX. The patient subsequently developed scattered pink, raised lesions on his left arm and on his face. The lesions were not painful or itchy. The patient was evaluated by his unspecified physician and was prescribed an unspecified topical ointment for treatment. The patient fully recovered from the events (date unspecified). This is one of reports from the same source. Additional information has been requested.
I was in so much pain - that was back that it started with. I went to Urgent Care and she sent me to Hospital for Cat Scan and Ultrasound and my insurance didn't cover them. And so I went into ER and they did a CAT Scan and they thought the kidney stone had passed because they didn't see it. They tested my stomach and started talking about my liver. Dr said he was pretty sure it was a kidney stone and it had passed already. It was a strong dose of medication and maybe it was small doses of Fentanyl at first and then maybe one big dose of Fentanyl lastly - and then they sent me home  but I kept throwing up  when I got home and I had to go back to ER. At the ER - they hydrated me and they gave me something to stop throwing up. On the safe side, they encouraged me to get Gall bladder checked- said I needed to get an ultrasound. I had that and they said my gall bladder was fine. But that first doctor was pretty sure that I had had  a kidney stone - and that it had passed. I do still have some back pain here and there but I am trying to be careful with what I am eating. I am trying to make sure I don't eat what causes kidney stones.   Immediate after the 2nd vaccine : 10:00PM of night chills and was freezing one night and that's just not me - I normally am hot.  That might have just been an overnight thing.
Flushing, numbness left hand and fingers, quivering and burning in chest, numbness and tingling of lips with metallic taste. Blood pressure 160/100, Heart rate 125-130. O2 saturation on room air 96-98%. Patient transported to Emergency Room via private vehicle. Patient declined ambulance transport.
The Pfizer monovalent was administered to this patient instead of the Pfizer bivalent booster. Wrong vaccine administered.
Post menopausal bleeding started 6/21 and lasted for 24 days straight.  Menopause occurred in 2013.
No problems from any of the 4 covid vaccines.   Developed Covid 10 weeks after dose #4 of covid vaccine.
Initially a few hours after the 1st dose of the vaccine I got a bad headache, body aches, and extremely tired. As well as my arm being sore and painful. After a couple days, I felt better. Then, on 04/24/2021 around 6pm, I noticed my arm was hurting again, I looked and noticed that there is a red splotch where I received the vaccine that is warm to the touch and sore. It is about 2.5" wide and 1.5" high (I measured with a measuring tape)  I used my contactless thermometer to see the temp difference. the 'normal' part of my arm was between 97 to 97.3 F. The splotch was between 99 and 99.3 F. I have also been experiencing nausea and diarrhea today 4/25/2021 as well.
RECEIVED JOHNSON JOHNSON VACCINE ON 8/29/2021. FOLLOW UP WITH BOOSTER MODERNA AS RECOMMENDED BY PHARMACIST ON 1/5/22. HANDWRITTEN  LOT NUMBER IS NOT CLEAR ON MY CARD. I TOOK A RAT HOME TEST THE DAY BEFORE MY BOOSTER TO CONFIRM I WAS NEGATIVE. GOT BOOSTER ON 1/5/22 AND WAS SICKLY AND POSITIVE THE NEXT DAY.
rash on the arm on the entry point; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "rash on the arm on the entry point".  Additional information: Medical Information: NO medical questions addressed by this program forwarded/referred to Medical Information No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bilateral numbness, tingling and pain to arms that started the same day he received his 2nd dose. Patient did not have information on 2nd dose of vaccine he received, however states that it was the 2nd dose . Dose was given on 7/8/2021. on left deltoid. He also kept stating it was Moderna?  He did not have proof of 2nd dose, only card showing first dose. This report and information on vaccine dose was made with the only information he had at this time.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Apr2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 65 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: sulfa antibiotics" (unspecified if ongoing), notes: known allergies: sulfa antibiotics. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin; Keflex, reaction(s): "known allergies: keflex", notes: known allergies: keflex. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: positive test 5 days after turning negative; Positive, notes: positive test 5 days after turning negative. Therapeutic measures with Paxlovid from 22Jul2023 to 26Jul2023 were taken as a result of drug ineffective, covid-19.  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.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event (DRUG INEFFECTIVE, COVID-19) and BNT162B2.
This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (therapy type: Digital data logger; lot # L031196, expiry date: 05-FEB-2017; lot # L017757, expiry date: 08-APR-2018). Healthcare worker stated that the vaccine underwent a temperature excursion at 49.5 degree Fahrenheit for 186 hours. There were no previous temperature excursions. Healthcare worker confirmed that the vaccine was administered on unspecified dates before their expiration date. No adverse effects were reported. This is one of the six reports received from the same reporter. Additional information has been requested.
Mother called the store and talked with floating pharmacist on duty who administered the vaccine. The pt had itchy, red, blotchy bumps on her forearm on the same side as the vaccine was given. The pharmacist told the mother to give Benadaryl to  her to help with the reaction. When I called pts mother the next morning she said the symptoms had resolved with the Benadryl.
Dry mouth, chills, swollen Lft. axilla, sore arm, myalgias, nausea, pain in breasts (fatty tissue) and pecs, pain in jaw bone bilaterally, pain in back, spine, gluts (muscles and fat), 101 F temps, weakened mobility and discomfort.
Narrative:  Patient is a 69-year old male patient Covid vaccinated (Moderna x2 02/2021) with PMH of chronic multiple sclerosis with secondary neurogenic bladder/bowel on indwelling Foley cath/wheelchair-bound On Ocrevus infusions q 6 months, chronic debility/FTT Group Home Resident, type 2 diabetes mellitus non-insulin-requiring , vitamin D deficiency admitted after transferred from group home to ED on 10/08 for change in behavior, diminished energy and poor appetite. At the ED COVID-19 (10/08/2021) detected with hypoxia requiring 6 L O2 and chest x-ray with Covid pneumonia and possible superimposed RLL secondary pneumonia or possible aspiration. #1. Acute toxic metabolic encephalopathy 2/2 multiple etiologies: Covid Pneumonia with Hypoxemia/bacteremia: resolved ,patient is back to baseline mentation - Head CT scan : Unremarkable -s/p Lumbar puncture (10/08) at ED -CSF : culture and WBC/G/S :neg #2. Acute hypoxic respiratory failure secondary to COVID Pneumonia and superimposed RLL Pneumonia possible aspiration: resolved #3.Acute COVID Pneumonia : Covid vaccinated with Moderna(02/2021) with superimposed secondary Pneumonia (RLL) possible Aspiration: resolved - on IV Remdesivir 10/08 - 10/12,IV Decadron 6 mg 10/08 - 10/18 - completed Ceftriaxone 2 gms daily 10/12 IV Zosyn 10/09 - 10/12 s/p Vancomycin x1 dose (10/08) #4. Positive blood cultures: 1 of2 positive Klebsiella pneumoniae and staph epidermidis,source unkown ?pneumonia: resolved #5. Acute kidney injury likely prerenal secondary to dehydration 2/2 poor oral intake: resolved #6. Acute electrolyte disorder: Acute hypernatremia likely secondary to dehydration: resolved #7. Type 2 diabetes mellitus non-insulin requiring: Hemoglobin A1c 9.4% (08/03/2021). -Outpatient regimen: Metformin 500mg daily -Started patient on basal and bolus insulin #8. Chronic multiple sclerosis with secondary neurogenic bladder/bowel on indwelling Foley cath s/p removal 10/30 now Condom cath -On Ocrevus/ocrelizumab infusions q 6 months #10. Chronic vitamin D and B12 deficiency -Continue cholecalciferol and cyanocobalamin #11. Buttock and sacrum decubitus wounds ,Unstageable(POA): resolved #12: Urine Cx + Klebsiella (11/06): resolved
pt recvd vax & saw a scotomatous area in lt visual field,went to ER;dx viral induced papillitis;
pt recv vax 9MAY97 & 18MAY pt devel chickenpox w/approx10-15 lesions & a fever;pt recovered from exp;
Prolonged hypotension post vaccine lasting several months now. Blood pressure is now 90/42 to 92/47 and symptomatic. Regular blood pressure pre vaccine was 120/80. For months my heart felt like it was racing all the time and like I was going to faint but my HR was actually in the low 50?s to 60?s. I?ve been an athlete my whole life and am struggling now with simple workouts where my HR can hit 210. Drs said no booster until I can get tested for an allergy to components of the vaccine. Allergist says they have no way to test.
Information has been received from a physician concerning an 83 year old female patient with osteoarthritis, elevated cholesterol, degenerative joint disease, hypertension, and no allergies who on 22-APR-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # not reported), 0.65 ml subcutaneous. The physician reported that on 14-FEB-2009 the patient developed shingles. The patient was seen in the physician's office again on 23-FEB-2009 because she still had the shingles and was experiencing pain. The shingles were located under right breast radiating under arm to her back. the physician interested in PCR analysis. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information has been received from the physician concerning the female patient with hypertension, osteoporosis, degenerative joint disease, generalised anxiety disorder, osteoarthritis, elevated cholesterol, and no known drug allergies and a status post pulmonary embolism (x2) who on 22-APR-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported), 0.65 mL subcutaneous.  Concomitant therapy included lovastatin (manufacturer unknown), TOPROL, warfarin, BONIVA, citalopram and levothyroxine sodium.  Rash did not occur at the site of injection or elsewhere within 42 days of the vaccination.  Shingles developed on 14-FEB-2009 in the right T5 dermatome.  Pain described as 6-7.  The patient has a history of chickenpox in her childhood.  There was a recent exposure to shingles, not to chickenpox.  A sample of the lesion was collected on 25-FEB-2009.  The sample was taken from a vesicular lesion and a scab on the chest under her right breast (results not reported).  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The sample of the lesion was collected on 25-FEB-2009.  The PCR results from a vesicular lesion and a scab on the chest under her right breast identified the presence of WT VZV.  Follow up information from her physician revealed that the white female patient (weight: 184 pounds, height: 64 inches) who on 22-APR-2008 was vaccinated with a dose of ZOSTAVAX (lot # not reported), 0.65 mL subcutaneous.  On 10-FEB-2009 developed zoster.  The physician stated that there was no adverse events, but it was considered a vaccine failure.  The patient recovered on an unspecified date.  Additional information is not expected.
itchy; redness; swelling; The reaction is localized just in the injection site; lump in the injection site; chills; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchy), ERYTHEMA (redness), SWELLING (swelling), INJECTION SITE REACTION (The reaction is localized just in the injection site) and INJECTION SITE MASS (lump in the injection site) in an 85-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 370268) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna (batch no-011A21A  and 1st dose) on 02-Mar-2021; for Product used for unknown indication: COVID-19 VACCINE on 28-Oct-2022, RSV vaccines - 2 weeks before in October 2023 and Flu vaccines - 2 weeks before in October 2023. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, Flu vaccines - 2 weeks before, Moderna and RSV vaccines - 2 weeks before. Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulfa drugs).    On 10-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy), ERYTHEMA (redness), SWELLING (swelling), INJECTION SITE REACTION (The reaction is localized just in the injection site), INJECTION SITE MASS (lump in the injection site) and CHILLS (chills). At the time of the report, PRURITUS (itchy) had not resolved, ERYTHEMA (redness) and INJECTION SITE MASS (lump in the injection site) was resolving and SWELLING (swelling), INJECTION SITE REACTION (The reaction is localized just in the injection site) and CHILLS (chills) had resolved.            No concomitant medication was reported. The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient started the call by saying that the patient was feeling much better. The patient received Spikevax and experienced a reaction. The patient had a lump in the injection site. It was quite uncomfortable. It was the first day that the arm was not swollen and red. It was still mildy red and awfully itchy. The itch started about half way from receiving the vaccine until now. The reaction was localized just in the injection site. The patient also had chills for one day. The patient thought that the patient was never getting warm again. The patient stayed in bed for 2-3 days. This was the first time the patient had any reaction.  No treatment medication was reported.
p/vax pt collapsed in chair; light-headed; eyes upward; looking toward ceiling; pale color; P80; BP 110/76, R16
pt recvd vax; 8dec94 swollen glands parotid; MD thinks it was an allergic rxn;
After child received vaccine child was sitting in chair in shot room. Patient leaned over and when I asked if she was ok, the father stated that the child gets dramatic sometimes. After some encouragement by the father, the child walked to get a drink of water while the father collected the shot record. Upon leaving doorway, child leaned to side of wall and fell to ground. Patient was taken to waiting area with father with vital signs monitored. At 1615 child was up in chair with ice pack to neck and glucose tube in hand. At 1615 B/P 102/67, HR 69, O2% 98. At 1635 child still up in chair taking sips of glucose with ice packs on head. No lump upon palpation of the head - only a red area that has the ice pack on it. Patient is alert and oriented x3. 1650: B/P 102/67, HR 69, O2% 97. Upon walking around lobby patient states her head hurts. Patient left with father at approx. 1715. Explained to father to take child to ER immediately if child has any neuro. issues including dizziness, fainting, seizures, or high fevers that don't go away with medication. If father takes child to doctor, I explained to him that the facility should be notified the child received a vaccine today and that they need to complete a VAERS report. Advised father to watch child next time when she receives her vaccine, even if she seems ok.
expired vaccine given. patient reports no adverse effects. patient states he was already re-vaccinated for flu elsewhere on 1/18/22 because he did not remember that he had gotten vaccinated 12/17/22.
I had small red bumps on my abdomen below the breast line that went around to underneath my arm in like an equator line and on my back. There was no pus or nothing coming out but it was itchy. I applied remedy for itching as needed and it went away.
Fever; Headache; Chills; This is a spontaneous report from a contactable nurse. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm right on 08Apr2021 at 14:45 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertrophic cardiomyopathy, acute heart failure and allergy to avocado. The patient did not receive any other medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm right on 18Mar2021 at 14:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation and Wellbutrin on unknown date for unspecified indication and experienced drug allergy. 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 vaccination. On 09Apr2021 at 07:00, 16 hours post 2 dose of vaccination, the patient experienced fever, headache and chills. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care visit. Therapeutic measures were taken as a result of events and included treatment with Tylenol. The clinical outcome of the events experienced fever, headache and chills was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse practitioner via a company representative and refers to a 72- or 73-year-old female patient. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23, 0.5 ml (route of administration, lot# and expiration date were not reported). On an unknown date in June 2017 (reported as "within the last day or two"), the patient developed an injection site reaction and cellulitis after receiving the vaccine. The patient sought medical attention by visiting the nurse practitioner. An unspecified treatment was given to the patient for the events, on an unknown date. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was no reported. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.