chrisvoncsefalvay/vaers-outcomes huggingface dataset:
may have kidney stone; dramatically increase in the white blood count, "its off the chart".; dramatically increase in the white blood count, "its off the chart".; he gets manic; confused; cant sleep; This is a spontaneous report from a contactable consumer, the patient. A 43 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 via an unspecified route of administration on 29Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 on an unknown date. The patient's concomitant medications were not reported. The patient had blood labs done that showed a dramatic increase in the white blood count, "its off the chart," he gets manic, confused, can't sleep and may have kidney stone on an unspecified date . The patient underwent lab tests and procedures which included blood count: increase in white blood cells. The outcome of increase in the white blood count "its off the chart," manic, confused, can't sleep and may have kidney stone was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained
I took my 2nd Covid dose in April 2021 and then a series of 2 shingles vaccines, the 2nd one being in October of 2021. 3 days after my shingles vaccine I started having a lot of heart palpitations and chest pains, which eventually right around Halloween it turned into a heart attack. I did an Angiogram and they didn't find any blockages but the Doctor found microvascular spasms and they don't know why I rapidly had an onset of that. I started having a lot of heart palpitations too, and they put me on 6 or 7 different medications. I am going to see a specialist tomorrow (04/06/22) for the palpitations, but the symptoms are ongoing and I have to take nitroglycerin everyday, and it's been a wild ride. I was hospitalized for a couple of days because of it and it's just ongoing issues. It's my belief that it's a combination of the Covid vaccine and Shingrix vaccines that it may have had an interaction with each other (Covid booster was in December). I was hospitalized for a couple of days because of it and it's just ongoing issues. I've had brain fog as well. There were no blockages and I was completely wide open and Doctor's can't understand why I had a heart attack. (Shingrix Vaccines: 1st Dose 08/13/2021 Shingrix Zoster Lot #9727R; 2nd Dose Shingrix Zoster 10/08/2021 Lot #7CX2C.
Ear Infections every 4-6 weeks and diarrhea every 6 weeks.
Fever of 102, severe joint aches, headache, fatigue that lasted 24 hours.  Rash around injection site and down to elbow, very warm to touch.  All sx's (with the exception of arm pain/swelling) resolved after 40 hours
still laying in bed - lethargic; This is a spontaneous report from a non-contactable consumer. A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 (at the age of 71-years-old) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19 was unknown. On 09Feb2021, the patient was still laying in bed - lethargic. The patient had not received treatment for the adverse event. Batch/lot was unknown as it was not available or not provided to reporter at the time of report completion. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt devel rash which looked like measels; eyes sensitive to light & tender; eyes red & glassy; achy especially hand & wrists; fingers painful & swollen, disfigured purple looking; no strength in hands or wrists; pain, itchy, dry scaly skin;
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 030B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 3:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 3:22 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Oct-2021 at 9:44 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    No treatment medication was provided.
6/02/2021: 2 hives on my right eyelid. Took benadryl 25 mg  upon arriving home at 17:00 and 1000mg extra strength tylenol. Used warm compress. Took another benadryl 25 mg at 23:30. At that time itching was almost gone and 1 hive was gone the other was smaller. 6/03/2021: No benadryl taken. Warm compress applied twice during day.  6/04/2021: Remaining bleb still there but very small and just slightly itchy. No benadryl taken.
We vaccinated with PFIZER COVID BIVALENT and were not aware that it was no longer authorized for use.
The child developed hives initially on the back of her ankles by 10:00 AM.  Was given anti itch medication at that time. The hives subsequently spread to cover most of her body by evening.  No respiratory distress.  Mother called ED at hospital and gave liquid Benadryl at bedtime.
Patient vaccinated in left arm on 12/31/20 on 1/8/21 noted spot of redness, swelling and pain.  Not sure if this is a cellultis
Pt had covid vaccine #2 at approx 9 am.  Within 10 min had roof of mouth swelling and skin crawling, ear itching.    No airway compromise.    Declined epi pen administration     Benadryl given at 932 Sx began resolving within 10 min.   OBJECTIVE: Alert nad 125/82 95% 16 pulse 94 Initially sl flushed no hives.  Op clear Voice indicated soft tissue swelling No respiratory distress.   CV:  Regular rate and rhythm, no murmurs.  Pulm:  Bilaterally CTA no wheezing.   repeat vitals at 950  119/71/88/98%   By 10:20 sx improving 119/71/, 88, sat 98%   By 1030 near complete resolution of symptoms, throat swelling improved, minimal itching.  Repeat prior to discharge at  101/66 80, 98% 1045 pm   Epi pen ordered for emergency use,  Husband picking up at clinic.
Left arm soreness.; Chills and shivering on the night of the vaccine; Severe body aches and back pains; Severe body aches and back pains; Severe headaches; This is a spontaneous report from a contactable physician (patient). A 31-year-old male patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EK923) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 08:00 for COVID-19 immunization. Medical history included test positive for COVID/ diagnosed with COVID-19 from Apr2020. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not have COVID prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. And the patient did not take any other medications within 2 weeks of vaccination. The patient had COVID test post vaccination in Dec2020(also reported that the patient had not been tested for COVID-19 since the vaccination). The patient had left arm soreness; chills and shivering on the night of the vaccine; severe body aches and back pains; severe headaches; event onset date reported as 30Dec2020 02:00. The patient was tested positive for COVID in Apr2020 and symptoms felt exactly the same. All the events were reported as non-serious. No treatment was received for the events. The outcome of the events was not recovered.
Patient has not received any doses of primary series previously. Patient received bivalent booster as 1st dose today (should have been monovalent). Per CDC guidance on clinical considerations site, will continue with schedule of dose 2 (monovalent) in 3 weeks, dose 3 (monovalent) 4 weeks after dose 2, and 4th dose (bivalent) 2 months after dose 3.
Her allergy reaction was wide rash on her body with the itchiness but no swelling or breathing problem.
No additional AE reported; Medical assistant called for evaluation of VARIVAX that was mistakenly stored in the refrigerator on 30Mar2023.  On the following day 31Mar2023, the product was administered to a patient.  Medical assistant requested AE Follow Up letter be addressed; This spontaneous report has been received from a medical assistant, regarding a 12-months-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 30-mar-2023, a vial of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection was mistakenly stored on a refrigerator.  Then on 31-MAR-2023, the patient was vaccinated with a dose of this varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters (ml) as prophylaxis (lot number: W006413,which was determined to be valid, with an expiration date on 23-FEB-2024) (strength, route and anatomical location of administration were not reported) The administered dose underwent a temperature excursion of 4 degrees Celsius (C) for 24 hours. There was not any previous temperature excursion reported.   No additional adverse event was reported, and no further information provided.
Received the Moderna vaccines who tested positive for covid; Got sick; 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 COVID-19 (Received the Moderna vaccines who tested positive for covid) and ILLNESS (Got sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  In December 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Received the Moderna vaccines who tested positive for covid) and ILLNESS (Got sick). At the time of the report, COVID-19 (Received the Moderna vaccines who tested positive for covid) and ILLNESS (Got sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.
Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked to case 2018SA196049. This case involves an individual, who experienced an accident,  while he/she received vaccine ADACEL, when the flange broke and it cut the medical office assistant's finger (administering the vaccine to the patient). On 06-Jul-2018, the patient  received a partial dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5875AA via skin contact. On 06-Jul-2018, the patient had a non-serious event of possible underdose. It was also a case of syringe issue (product use issue). 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  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. List of documents held by sender: none.
Moderna COVID- 19 Vaccine EUA: patient reports to emergency department five days after vaccination with left arm from shoulder to mid-hand diffusely tender, swollen, and erythematous with lymphadenopathy.  Vital signs within normal ranges except for blood pressure 163/100.  Patient given intravenous fluids, steroids, antimicrobials, analgesics, antihistamines, and treatment for abnormal electrolytes and discharged to home with follow-up in place.
30 minutes after vaccine - had a sudden wave of feeling like my tongue and face became warm, felt swollen, tachycardia chest tight - lasted about 1 minute.
pt recv vax 14OCT96 & 23OCT96 pt exp a fever & red ears;no further details were provided;
Mom noticed that L arm (DTaP) was extremely red and swollen 11/29/01 night. She states arm (deltoid area) on up into shoulder was red, swollen and hot. She took child to the ER. Dr gave her benadryl & motrin. Arm noted w/redness & swelling about 50 cent piece size.
Cts grandmother/mother noticed "dime" size red area on 8/13/2002. 8/15/2002 mid deltoid right arm is warm and hard with erythema.
Bleeding and heavier flow until now, I am completely frightened and scared about it, because I just want to have my normal life again. Having symptoms I never had, longer than ever flow and super heavier. Leg pain and tiredness
This spontaneous case reported by a consumer, describes the occurrence of pruritus (itching on arm of injection), feeling hot (rash is warm to the touch on arm of injection) and rash on arm of injection in a 63-year-old female patient who received mRNA-1273 (batch# 025A21A) for COVID-19 immunization. No medical history reported. On Apr 17, 2021, patient received the first dose of mRNA-1273 intramuscular; 1 dosage form. On Apr 30, 2021, patient experienced pruritus (itching on arm of injection). On May 2, 2021, patient experienced feeling hot (rash is warm to the touch on arm of injection) and rash on arm of injection. At the time of the report, pruritus (itching on arm of injection), feeling hot (rash is warm to the touch on arm of injection) and rash on arm of injection outcome: unknown. The action taken with mRNA-1273 intramuscular: unknown. No treatment-related information reported.
11 days after receiving the Moderna COVID vaccine booster, I developed intense dermatographia. I sought medical treatment when I was unable to suppress the symptoms with Benadryl and was advised to switch to Zyrtec. So far, the symptoms are mostly managed through 10-20 mg of Zyrtec per day and by avoiding eggs in my diet. I am still experiencing symptoms and am trying a gluten-free diet as an effort to reduce inflammation. To date I've had symptoms for 23 days. Symptoms have abated somewhat since the first onset, but I have not yet been able to wean off oral antihistamines.
Mom and daughter back today. Patient (R) arm red, swollen, hot, hard to touch. Mother states patient has allergies to NEOSPORIN down latex? 100m x 120m - reaction site Started 8/4/09 around 1000 mm mother gave TYLENOL 500 mg this AM referred to PCP or ER for follow - up.
Pt complained that after he got a both shots he got home and the same evening started feeling really bad: fever, body ache, chills.. ect. He had symptoms for the next 3 days. He had never went to see a doctor.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated intramuscular with 0.5 ml PNEUMOVAX23 lot # H014653, expiration date: 19-APR-2014. The anatomical location was not reported. On an unknown date the patient experienced fever. The outcome of fever was reported as recovered/resolved. This case was linked to cases 1303USA005018, 1304USA002367 and 1304USA002385 based on the same reporter. Additional information is not expected.
Left upper arm cellulitis, treated with Keflex 500mg bid x 7days.
lump on her neck; lymph nodes on her neck that are still swollen; tired; mild headache; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 06Aug2021 (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. Medical history included she had COVID-19 at the beginning of March. The patient concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced lymph nodes on her neck that are still swollen, tired, mild headache and lump on her neck on 09Aug2021. It was reported that patient was due to receive her second dose of Pfizer Covid-19 Vaccine on an unspecified date (Friday). She still had lymph nodes on her neck that are still swollen. She received her first dose on Friday, 06Aug2021. That Saturday she felt ok. She was tired a little and had a mild headache. On Monday, she experienced a lump on her neck, and she went to emergency room, and it was actually going down now. The patient was asking what she experienced normal and should she get her second dose of the Pfizer Covid-19 Vaccine on Friday or not. Received call from consumer regarding the Pfizer COVID vaccine. She took the first dose and goes back this Friday to take second dose. After the first dose, she had lymph nodes on her neck swollen. It has not gone down and needs to go down some more. She wants to know if it will be ok to get second dose with this still swollen. She stated that she has friends that were fully vaccinated in mid-March and February and today, they have caught COVID-19. They experienced no symptoms, and they were all fine. Investigation Assessment was not provided. The case was reported as non-serious. She did not wish to complete report and did not wish to provide a date of birth or address. No further details provided. The patient outcome of the events was Unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
TIREDNESS, MUSCLE PAIN, CHILLS, SWEATS, JOINT PAIN,  FAST HEARTBEAT, DIFFICULTY BREATHING, WEAKNESS AND DIZZINESS
Arm pain, redness, swelling. Went to ED, had cellulitis arm unknown, tried to call patient to verify.
Painful and enlarged left axillary lymphadenopathy; Painful and enlarged left axillary lymphadenopathy; This is a spontaneous report from a contactable physician. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on 21Dec2020 08:15 at a [SINCLE DOSE] and (lot number EK9231),via an unspecified route of administration on 08Jan2021 10:30 at a [SINCLE DOSE] for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took aspirin (e.c.) and experienced drug hypersensitivity. On 09Jan2021, the patient experienced painful and enlarged left axillary lymphadenopathy. The outcome of the event was not recovered.
tiredness; headache; chills; Achy; threw up; nausea; This is a spontaneous report from a contactable consumer (patient wife) reported for her husband (patient). This is the report 2 of 2. A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm right on 05May2021 at 15:45(at the age of 61-years-old) as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history included high cholesterol, ongoing from an unspecified date, high blood pressure, ongoing from an unspecified date and acid reflux, ongoing from an unspecified date. It was reported that, the patient takes medications for these, but the reporter does not feel these medications are relevant. The patient's concomitant medications were not reported. Patient took Covid-19 vaccine to prevent Covid-19 virus. No other vaccinations within four weeks prior to the vaccination. The history of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Adverse events following prior vaccinations were reported as none. The caller stated that, 14 days after receiving the first Covid-19 vaccine, the patient experienced tiredness, chills, headache, achy, nausea and he threw up when he got to work on 19May2021. Stated that, she does not have her husband's Covid-19 vaccine record card with her at the time of the call. It was reported that, no adverse events required a visit to emergency room or physician office. The relevant lab tests and procedures included were none and no investigation assessment was reported. The outcome of the events was recovering.   Follow up (25May2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer(patient wife) reported for her husband (patient) included RMH, Patient details, outcome details, suspect product details, event details.  Information about batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021599251 same report/drug/AE, different patient
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-JUN-2016, the patient was vaccinated with a first dose (Oka/Merck) VARIVAX immunization series (lot# L043624 with expiry date on 03-NOV-2017 or lot# L040419 with expiry date on 14-OCT-2017 or lot# reported as M000156 with expiry date on 06-JAN-2018 (it was not specified which lot# was used); exact dose and route of administration were not reported), that were improperly stored. The vaccine was exposed to a temperature of -10.1 Celsius degrees for 90 minutes. Data logger was used. No adverse effects were reported. No product quality complaint was involved. Lot number M000156 is an invalid lot number for VARIVAX (Oka/Merck). This is one of two reports received from the same reporter. Additional information has been requested.
She has a little patch of eczema on her and under her mouth. I treated it for a couple of weeks with 1% hydrocortisone over the counter. She was itching and irritated so I sent her doctor and the doctor called back and said she was going to call in desonide .05% cream to treat the symptoms on September 02. It did seem to help. We are still using it twice a day. The Eczema is a chronic condition but generally it's not as bad to the extent it is bleeding. I do believe she has made a complete recovery from this flare.
Hardness, swelling, redness, and severe itch 8 days after vaccination.
I had lymph node swelling, high fever, chills, nausea, shortness of breath, body swelling, and all my lab work is off. My endocrine organs have been off in my labs, I'm having re-tested in a couple weeks.