chrisvoncsefalvay/vaers-outcomes huggingface dataset:
warmth( at the injection site); itching ( at the injection site); redness( at the injection site); soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmth( at the injection site)), MYALGIA (soreness), VACCINATION SITE PRURITUS (itching ( at the injection site)) and VACCINATION SITE ERYTHEMA (redness( at the injection site)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive tape allergy (Allergy to adhesive), Arthritis since 2017, Hypertension and Insomnia (Patient is taking Amitriptyline once daily for sleep). Concomitant products included TELMISARTAN for Blood pressure management, AMITRIPTYLINE for Sleepiness.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (soreness). On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warmth( at the injection site)). 09-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching ( at the injection site)) and VACCINATION SITE ERYTHEMA (redness( at the injection site)). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warmth( at the injection site)), MYALGIA (soreness), VACCINATION SITE PRURITUS (itching ( at the injection site)) and VACCINATION SITE ERYTHEMA (redness( at the injection site)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-034939, MOD-2021-034939 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received, added medical history, concomitant medications. Updated patient demographics and event outcome.
1/9/21 Approximately 2:00 AM I was woken with Chills/joint pain/Injection Site Pain/Nausea had dizziness and weakness 1/9/21 Approximately 4:00 AM had headache/difficulty breathing/fast heartbeat along with the above 1/9/21Approximately 6:00 AM had a fever along with the above but the difficulty breathing and fast heartbeat had passed The remaining of Saturday Am I slept off and on with a terrible headache/difficulty catching my breath at times and  taking IBP 2 times throughout the day/drinking plenty of fluids.
Caused severe numbness in 95% of my body, nerve pain, difficulty walking, loss of coordination??.symptoms of  and suspected diagnosis of CIDP- Chronic Inflammatory Demyelinating Polyneuropathy.
accidentally administered a partial dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 68-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4HY3A, expiry date 23-JAN-2025) for prophylaxis.   On 09-OCT-2023, the patient received Arexvy. On 09-OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: accidentally administered a partial dose of Arexvy).  The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 09-OCT-2023 The pharmacist stated that a pharmacy tech accidentally administered a partial dose of Arexvy to a female patient because the patient moved during injection and the needle came out before injection was complete which led to incomplete dose administered. There was still 0.2mL remaining in the syringe when the needle was removed during injection. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
CP, achy all over, sweating, SOB- dx of bilateral pulmonary embolus
Within 1 minute of receiving the vaccine, the patient lost consciousness & urinated herself. Within 1 minute she regained consciousness. Her vitals signs were normal after fainting & 30 min after vaccination.
Immediately post vax, the pt had a raised area with no redness. Observed pt for 15 minutes with no problems. Mother phoned that same afternoon reporting a fever. Dad had taken pt to physician who said fever may be reaction to vax. No one knows how high fever was.
Post immunization fever > 102 deg F and 3 times vomiting x 1 day
The next day fever, fatigue, and body ache lasted 1 day. A week after the shot, big red spot, hot and bright red and kept getting bigger and bigger and eventually wrapped around my arm 3-4 days. About 3-4 days (2 weeks later) rash started on top right and it moved to my left hand. My hand had little bumps and was patchy and it spread over the whole top of my hand. Saw the doctor 2.5 weeks after the shot, went to primary care. After a month, I went to dermatologist because the rash was getting worse. She thought it was psoriasis as the vaccine affects your immune system as I have a family history of psoriasis. Finally, betamethasone dipropionate ointment (augmented) meds worked. I used them 2 times a day and it worked quickly. It finally went away. With the 3rd booster, I didn't have the red spot but started having rashes and am taking the same meds for rashes.
EXTRACTION OF MODERNA VACCINE FROM THE VIAL WAS NOT CONSISTENT WITH A MODERNA TECHNIQUE I.E MORE THAN 20 DOSES WERE DRAWN FROM THE VIAL
Mild erythematous, papular itchy rash with somewhat swelling located to anterior aspect of left thigh. Rx BENADRYL PRN, topical Hydrocortisone. Allergist suggested different sites for IMs and wait 30 min after injections. Mom states this has happened since vaccinations at 2mos of age. Rash lasts 3-4 days and goes away.
Pt reported localized discomfort at the injection site and swollen gland in the left axilla.  Discomfort was eased with advil and discomfort and swelling gradually subsided.
Pt reports post vaccine fever, swelling (local), redness, induration to lat deltoid, tender nodes. Diagnosed with Serum Sickness Syndrome.
FELT LIKE SHE GOT RAN OVER BY A TRUCK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced felt like she got ran over by a truck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like she got ran over by a truck was not reported. This report was non-serious.
Information has been received from a physician concerning three patient who were vaccinated with GARDASIL and tested positive for a high risk strain of HPV. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. This is one of several reports from the same source. Additional information has been requested.
Pt recvd series of 3 hep B vax on 0-6 months schedule.Pt determined to be non-responder 15DEC90. Given booster dose & now has pos HBSAB;
I received this vaccine on October 12, the vaccine was given to me on my left hand. Since then I?ve been getting a numbing and tingling sensation from my shoulders to my fingers, the sensation is constant. It seems that this vaccine has somehow affected the nerves in my hand. I?m really regretting taking this vaccine now, I didn?t have any problems with my hand before and now I?m reading that this vaccine can cause nerve damage to some people. I wouldn?t be getting the second dosage.
No adverse event; The patient had an adverse event of greater than 36 days between primary series doses of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had an adverse event of greater than 36 days between primary series doses of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Sep-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had an adverse event of greater than 36 days between primary series doses of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had an adverse event of greater than 36 days between primary series doses of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had an adverse event of greater than 36 days between primary series doses of the Moderna Covid-19 vaccine).    Concomitant medication not reported. Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732792 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732792:Same patient
Feeling very worn out after second dose; Body aches after second dose; Received the second dose of  Moderna COVID-19 vaccine while pregnant; Sore arm after second dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling very worn out after second dose), VACCINATION SITE PAIN (Sore arm after second dose), MYALGIA (Body aches after second dose) and MATERNAL EXPOSURE DURING PREGNANCY (Received the second dose of  Moderna COVID-19 vaccine while pregnant) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 19-Dec-2020 and the estimated date of delivery was 05-Oct-2021. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm after second dose) and MATERNAL EXPOSURE DURING PREGNANCY (Received the second dose of  Moderna COVID-19 vaccine while pregnant). On 05-Apr-2021, the patient experienced VACCINATION COMPLICATION (Feeling very worn out after second dose) and MYALGIA (Body aches after second dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy. The delivery occurred  on 01-Oct-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Term Birth NOS. On 02-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received the second dose of  Moderna COVID-19 vaccine while pregnant) had resolved. At the time of the report, VACCINATION COMPLICATION (Feeling very worn out after second dose), VACCINATION SITE PAIN (Sore arm after second dose) and MYALGIA (Body aches after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2021-407358, MOD-2021-407515 (Patient Link).
The night of the day I got the flu shot I went to bed FREEZING cold, I was shaking I was so cold but i was sweating like a 300lb man on a 100 degree day in the sun. I work up in the middle of the night and had to lay down a towle to sleep on becsause my bed sheets and matress cover was soaking wet in my sweat. I was find by the next day.
This spontaneous report was received from a registered nurse and refers to a 12 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-JAN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 107 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Chills, Vomiting, fever, headache, joint pains, lethargic for 2 days after 1st vaccination
Headache  chills, body burning up, fatigue, sore left arm and  swelling. Narrative:
Fluzone HD was accidently given to 4 year old, with no ae; Fluzone HD was accidently given to 4 year old, with no ae; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a health-care professional (nurse) via phone.  This case is linked with 2019SA307286.   This case involves a 4-years male patient, who was vaccinated with a dose of INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE), (Batch number: UJ287AA and expiration date: 28-MAY-2020 at a dose of 0.5 ml via Intramuscular in Left Vastus Lateralis on 01-Nov-2019.  The patient medical history and concomitant medications were not reported.  It was the case of inappropriate age at vaccine administration and overdose.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Chills, joint pain (bilateral knees), fatigue, pain at injection site that radiated from deltoid to wrist
ADMINISTERED PAST THE CURRENT REFRIGERATION BEYOND THE USE DATE AS LISTED IN EUA
"COVID Arm" - slightly raised red rash with some swelling below injection site.  Some itchiness but not warm or tender to the touch.
RN drew up vaccines for twin siblings they were both to receive 15 mth shots so (4 each). I set up the vaccines in doubles and did not separate with each child thus when I didn't add diluent to hip I don't know which child received just the diluent.
pt recvd vax 25MAY95 & pt cried high pitched screaming for 1/2 hr during day immunized;no fever or local rxn reported; parent treated pt w/APAP
hives on face started about 10 to 15mins p/vax;large itchy-welts on face, arms, hands, legs & feet by the next morning;DPH prescribed; hives cont to reappear periodically;1DEC95 pt cont to have hives, fever of 104, cough, wheeze, dx virus
Redness and itching of both arms, (some on) chest, and a lot in groin area. Redness to all areas accompanied by hotness to the touch.
ROTATEQ (Merck) oral vaccine misadministered as 1st dose today, patient age 19 weeks. Recommended between 6 and 14 wks 6 days. Merck contacted and recommended to continue with ROTATEQ series. Follow up received 7/2010: Adverse event onset date 6/18/2010. No other adverse effects noted.
onset of tiredness and fatigue in March.Onset double vision September 2021 difficulty swallowing September 2021 presumed diagnosis of Myasthenia Gravis   test to be done blood work then visit to neurologist
Patient informed pharmacy this was his first covid vaccine.  After administration he then stated he had received the Jannsen months ago.
(L) arm. C/o arm "feels weird", hurts to move hand and arm. Equal grip & 1-2 sec cap refill bilat. TC to parent advising of situation-She stated child could go back to class. She would watch arm & contact PCP if sx cont.
This spontaneous case initially received on 18-Oct-2016, was reported by a non health professional and concerns a male patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On an unknown date, the patient received 'high dose' Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient experienced allergic reaction, lightheadedness and dizziness. Outcome for all events: Not reported.
Moderna COVID-19 Vaccine EUA   Near the arm I had vaccine, my arm has an area that is red, swelling and a bit itcy. Now the area is getting bigger after 2 weeks.
pt recv vax 24OCT96 & pt exp a migraine h/a & swelling around th eye rt on the noc of 24OCT96;pt recv shots in ER:d/c from ER w/steroids dose pack;
She had soreness; Redness; Swelling/large localized area in her arm which is now swollen; Itching; a delayed allergic reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (She had soreness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling/large localized area in her arm which is now swollen), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE REACTION (a delayed allergic reaction to the vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included CIMETIDINE, OMEPRAZOLE and LORATADINE for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (She had soreness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling/large localized area in her arm which is now swollen), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE REACTION (a delayed allergic reaction to the vaccine). At the time of the report, VACCINATION SITE PAIN (She had soreness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling/large localized area in her arm which is now swollen), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE REACTION (a delayed allergic reaction to the vaccine) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included antihistamines.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Significant follow up included reported AE duration and outcome, and second dose vaccine details.
first dose:2018, second not received yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th October 2018, (batch number 419A1AB, expiry date 16th March 2019)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
day of vaccine:  headache, low grade fever.  1st day after:  nausea, no appetite, low grade fever, start of body aches.  2nd day after:  low grade fever, nausea, no appetite, severe body aches
tired, I was nauseous and had a headache; tired, I was nauseous and had a headache; tired, I was nauseous and had a headache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on 22Jan2021 (age at the time 75-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in Jan2021, (about 12 hours after the shot), the patient experienced very very tired, nauseous and had a headache. This lasted about 7 days and even today. About 10 days later, she was still more tired than she normally was. She wanted to ask that, was it ok to get the vaccine in 2 different states. The outcome of events was unknown.   Information on lot and batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Tachycardic, hr 112; hives on both arms, chest, face.; Lips were tingly; This is a spontaneous report from a contactable other hcp. A 39-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 16:00 at single dose, right arm for covid-19 immunization. Medical history included Anti Myelin oligodendrocyte glycoprotein(MOG) disease. Known allergies included prednisone, methyl prednisolone. Concomitant medication included cyclobenzaprine, celecoxib and duloxetine hydrochloride (CYMBALTA). There were no other vaccine in four weeks. The patient previously received first dose of bnt162b2 for covid-19 immunization. The patient had hives on both arms, chest, face. Lips were tingly. Tachycardic, HR 112. The patient took 75 mg diphenhydramine hydrochloride(BENADRYL) and became slightly better. Adverse events start date was 25Feb2021 16:30. Events resulted in [Life threatening illness (immediate risk of death from the event)]. The outcome of the events were recovering. The patient had no COVID prior vaccination. There was no COVID tested post vaccination.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be  completely excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
The patient stated that her arm went numb and then she developed shooting pains down the limb.
myositis, arthritis in lt upper extremity where vax lasting >2 wks;
Heachache, whole body itching, "orange peel" looking rash. Resolved on it's own.
PATIENT STATES HER RIGHT ARM IS RED, SWOLLEN AND HOT. HAS GOTTEN PROGRESSIVELY WORSE. SHE IS CONCERNED THAT IT IS ABSCESSED. SHE HAS USED WARM COMPRESSES ON THE SITE.
Puking, headache, body ache, fever and cold chills, tightness in chest, fatigue,
At 0150 on 9/21/21 awaken feeling very nauseous and dizzy.  0730am dizziness and nausea became worse. Took BP 202/113 at 0830am on 9/21/21 with HR: 109;  subsequent BP reading on 9/21/21 were the following: BP 175/103 with HR: 94 at 0902am .  On 9/21/21 at 1020am 168/102 with HR: 81. On 9/22/1 at 0250am 183/111 and HR: 75.  On 9/23/21 BP: 171168/92 with HR: 64.  On 9/25/21 at 0232AM BP: 171/104 with HR: 64,