chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients skin the medication ran out onto the patients' arm, with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA430802(CLUSTER).  This case involves a 22 years old female patient to whom skin the medication ran out onto the patients' arm, with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On 12-Oct-2022, the patient received a 0.5ml 1X(once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength: unknown, lot UT7716JA and expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for Immunization.  On 12-Oct-2022 the patient developed a non-serious event of patients skin the medication ran out onto the patients' arm, with no reported adverse event (accidental exposure to product) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The reporter stated that when she placed the needle on the end of the syringe, she heard a click sound prior to administration.  Action taken : not applicable.  Outcome: Unknown  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.
A day after covid vacine shot  7:00 am 4/9/21 ,I developed shortness of breath and fatigue. Then I developed a fever of 99.1 at 3:00pm that afternoon and O2 saturation was at 92 percent on 4/9/21.  Saturday evening at 5:30pm I developed a fever of 99.4 and sereve fatigue and 89 O2 saturation level.  Later that night at 9:00 pm on 4/9/21 my fever rose to 100.7 and O2 dropped to 85 when I tried to fall asleep. I took two puffs of an inhaler, two extra strength Tylenol and one Allegra D 12 hour tablet at 10pm. My fever broke at 1am on 4/10/21 and at 2am 4/10/21 my O2 stabilized at 92 percent saturation.
This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 20-year-old female patient of an unspecified ethnicity received her first dose of TRUMENBA, via an unspecified route of administration on an unspecified date in Jun2016 at single dose. Medical history and concomitant medications were not reported. The patient experienced dizziness, fainting, chills, and had to sit down on an unspecified date in Jun2016. No treatment was required and no visit to emergency room needed. The outcome of the events was resolved.
COVID-19; COVID-19; Urinary tract infection; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4257593-0.  A 25 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Aug2021 (Batch/Lot number: unknown) at the age of 25 years as dose 2, single and intramuscular, administration date 19Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown), second regimen subcutaneous from 2021 (Batch/Lot number: unknown) to Nov2021 and third regimen subcutaneous since 22Jan2022 (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "COVID-19"; URINARY TRACT INFECTION (non-serious) with onset 2021, outcome "unknown", described as "Urinary tract infection". The reporter's assessment of the causal relationship of the event with the suspect product was possible at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events Drug ineffective , covid 19 , Urinary tract infection and the suspect drug BNT162B2 cannot be excluded
Patient received his vaccine at 1600 and began feeling lightheaded with transient palpitations @ 1615, B/P 154/103 HR 64. 1630 still with lightheadedness B/P 162/106 HR 87 rapid response called.  1700 still lightheaded 175/113 HR 73 O2 99%. Pt. said he still felt dizzy but just wanted to sit for a while longer and did not want to go to ED at that time. 1705 Pt. did end up electing to go to ED because he said he wasn't comfortable going home. Pt. escorted via wheelchair to ED- no further signs of lightheadedness.
pt recvd vax;began v;also had muscle aches; small reddened area was present at inject site;no d;
Information has been received from a literature article concerning a 12 year old female patient developed uveitis, following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17. The median time from vaccination to onset of ADRs was 30 days; time to onset was unknown in 1 case; the time to onset in this case was of 50 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports form the same literature source. Additional information has been requested.
07feb90 pt vax hepta B.  same evening pt devel. nausea, achiness, and flushing. pt noticed sore throat and chest pain on the 3rd day followed by repeated flushing on 4th day. 5th day pt devel. rash that became worse the 6th day.  See worm..
kicked my butt for 48 hrs; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (RECOMBINANT NON-LIVE).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient reported that this vaccine was no joke either.  The patient reported that 1st dose was ok. The 2nd dose kicked his/her butt for 48 hours. The follow-up could not be possible as no contact details were available.
8/25/11 vaccination given 4:30 PM. Adverse event occurred 8/25/11 4:40 PM after immunization. The patient (an employee) was asked to rest for 20 minutes in the managers office at which time she suffered a seizure.
Myalgia, Arthralgia, CoughWeeze, Chills/ Fatigue Narrative:
First dose was Johnson and Johnson. About 2 weeks after vaccine, my lips started swelling. I took Benadryl and it went away. Then, 3 weeks 12/06/2021 later I lost my voice for 3 hours which was my larynx. And on 12/08/2021, my larynx was swollen and lost my voice again. I went to my doctor and they did not see anything wrong. She thought it could be my asthma and prescribed me an EpiPen. On 12/15/2022 I has a mild case of lip swelling. On 1/7/2022, I woke up and my lip and eyelid was swollen. I called my doctor and the next day and my larynx, lip, and eye was swollen. I was referred to an allergist. My tongue had swollen and I could not talk. I was put on Zyrtec twice a day and Prednisone. I was diagnosed with Angiopathic Angioedema by my allergist. Since taking the Zyrtec, I have not had this episode to happen again.
Received the vaccine and tested positive for Covid today; Received the vaccine and tested positive for Covid today; This is a spontaneous report from a contactable nurse. This Nurse reported similar events for two different patients. This is second of two reports.  A female patient of an unspecified age received bnt162b2, via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine and tested positive for covid today (24Dec2020).It was further reported that the patient showed up positive today (24Dec2020) and her symptoms have been on and off, she just got her vaccine 21Dec2020. The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Preventive effect of BNT162b2 is documented after 7 days from the second dosing. This case does not match this requirement.,Linked Report(s) : US-PFIZER INC-2020513367 same reporter/drug. different patient and event.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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: (24May2022) Negative, notes: tested negatively on home tests; (04Jun2022) Positive, notes: Today I tested positive again on two different tests; (04Jun2022) Positive, notes: Today I tested positive again on two different tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment for covid-19 from 17May2022 to 22May2022 and in 2 weeks patient took other medications such as Adderall, Trazodone, Clonazepam and Fluoxetine. It was reported that congestion, sore throat, laryngitis. Patient tested negatively on home tests, numerous brands, starting on 24May2022. Today (04Jun2022), patient tested positive again on two different tests and have complete laryngitis, which was a new symptom.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Felt very ill - shivering a lot and could not eat or even want to talk felt so bilious!!!!!
01/26/22 presents to ED for "intentional ingestion". "No pertinent past medical history"
Friday  Forehead / front of the headHeadache Friday    remady :ibuprofen  Blood sugar dropped  eat chees and honey and food  Forehead / front of the head   Headache :Forehead / front of the head  Saturday 3 pm Activity : tennis 2 hours  11 pm  Headache :Forehead / front of the head  Sunday  6 Am  Activity :work out 2 hours   11 AM  Sunday  Headache :Forehead / front of the head   6 Am  3 pm 11:45 pm Monday  6 Am  11 AM  Sunday  Activity :work out 2 hours   6 Am  3 pm 11:45 pm Tuesday  Headache :Forehead / front of the head  6 Am  1  pM  remady :ibuprofen then its gone
tingling on the left side of his face and left fingers/numbness and tingling on the left side of my face; numbness and tingling on the left side of my face; nerve issue in my face / my nerve were damaged from a previous cavernoma bleed; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date, NDC, UPC number: Unknown), via an unspecified route of administration on 25Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cavernoma from an unknown date and unknown if ongoing, and reported as, I have a Cavernoma in my brain. I am getting the vaccine and let the vaccine that just causing some sort of nerve issue in my face where my nerve were damaged from a previous cavernoma bleed. No concomitant medications were reported. The patient reports he received the first dose of Pfizer covid vaccine 25Jul2021 and immediately started experiencing tingling on the left side of his face and left fingers. Caller reports he has a condition Cavernoma. The patient further stated as, "So, I got the Pfizer BioNTech (captured as COVID 19 Vaccine) on Sunday and on an unspecified date in Jul2021, the patient had some numbness and tingling on the left side of face. I have a Cavernoma in my brain, so it seems like these two might be related because it would be very hard for me to have a bleed from my cavernoma at the same time I am getting the vaccine and on an unknown date, let the vaccine 'that's' just causing some sort of nerve issue in my face where my nerve were damaged from a previous cavernoma bleed. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
He had hardly any side effects for the 1st 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 003A21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses). At the time of the report, IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
This spontaneous report was received from a physician via company representative concerning a male patient of unknown age. The patient's medical history included unspecified lung issues in the past. It was unknown by the reporter if the patient had any drug reaction/allergy. The patient received the first dose of PNEUMOVAX23 on an unspecified date in approximately 1999. On an unspecified date in 2016, the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported), however, he was supposed to receive a dose of PREVNAR 13. On an unspecified date in approximately 2016 (reported as following the administration of the vaccine) the patient experienced  an injection site reaction described as painful, swollen and red (Injection site pain, injection site erythema and injection site swelling). The physician reported that the injection site reaction did resolve on an unspecified date but then the patient got sick (Malaise), he also reported that he recovered from the "sickness" on an unspecified date. It was unknown if treatment was given to the patient or if lab diagnostics studies were performed. The patient did seek medical attention for the events. The outcome of injection site pain, malaise, injection site erythema and injection site swelling was reported as recovered. The reporter did not provide the causality between the events and PNEUMOVAX23. Additional information is not expected as there was no consent to contact the reporter.
Approximately 3 days after my 2nd COVID-19 shot on my right hand, my  pinky, ring, and middle finger become numb and forearm become very weak, and has gotten worse since them.
Admistered error- patient was suppose to be given the first dose of Moderna monovalent but instead patient was administered Moderna Bivalent. Patient tolerated well and had no adverse reaction or symptoms.
On April 24, 2021, a vein in my arm swole up like a blood clot, the a cephalic vein. I started experiencing nerve burning and tingling in hands, arms and shoulders. The blood clot was in an area that I had damaged years ago and is now clogged. Today is 4/27/2021 and I still have the blood clot and tingling, sometimes in my face also, burning in the shoulder blades, very similar to symptoms of brachial neuritis. I am scheduled for my second shot on 5/4/2021, but thinking I may not get the shot since I am having so much trouble. I have an appointment schedule with a vascular doctor to have an arterial dopler on 5/6/2021, and have the vascular doctor advise.
EXACTLY, 12 HOURS AFTER STARTED WITH BODY ACHES; TEETH EVEN HURT; HEAD ACHE THAT WAS SO BAD COULD NOT TAKE HEAD OFF THE PILLOW; HAD INTERMITTENT FEVERS FOR ABOUT A WEEK; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown drug abuse or illicit drug usage. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced exactly, 12 hours after started with body aches, teeth even hurt, head ache that was so bad could not take head off the pillow, and had intermittent fevers for about a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from exactly, 12 hours after started with body aches, teeth even hurt, head ache that was so bad could not take head off the pillow, and had intermittent fevers for about a week. This report was non-serious.
Diagnosed with COVID after receiving the vaccination.  Symptoms started on 9/29/2021 with a headache, cough, shortness of breath and stomach upset.
Patient is having joint pain since receiving both Moderna vaccines. Patient saw his provider and further lab work has been ordered. 1st dose 02/12/21 & 2nd dose 03/19/21
sever pain on left arm, numbness on fingers, sharp pain to chest. Cannot sleet at night. Using pain medications,/
Shaking, profusly sweating, visual disturbance (patient states everything went black) and very nauseated.
hives & SOB began approx 24hr p/shot;(Fatigue began 4hr p/shot)seen by MD 30MAR99 & treated w/DPH;still has  eczematous rashes but no hives;
Dizzy; thin and weak; thin and weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; WEIGHT DECREASED (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "thin and weak".  Additional Information: The reporter (patient's brother) mentioned that the patient laid down because he went riding on a scooter and thought that it was what made the patient dizzy. The reporter further asked if it was common for the patient to feel dizzy and weak.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from nurse refers to a 2 month old female patient. On 09-DEC-2013, the patient was vaccinated with ROTATEQ, 2 ml, oral. No concomitant medication reported. It was reported that the patient has no medical history and allergies. It was reported that mother of child was at the health department yesterday feed the child her formula, and then ROTATEQ was administered. The mother of child called the doctors office and stated on 09-DEC-2013 (yesterday), the child vomited after a dose of ROTATEQ and spit up everything including the formula and ROTATEQ. The patient sought medical attention (called doctors office). The outcome of child spit up everything and vomited after a dose of ROTATEQ was unknown. Additional information has been requested.
Initiail report received on 30 Nov 2005 from a patient in USA. A female patient with no reported age and medical history had a minute puncture at the tip of the right index finger when rim of the back of the plunger crashed and broke off after pushing to give typhoid vaccine (Typhim VI), lot no: X0300-2 on 30 NOve 2005. It was reported that, applied pressure and no medical treatment required. The patient recovered at the time of the report.
dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "many allergies" (unspecified if ongoing); "allergy to sulfur" (unspecified if ongoing); "allergy to gatorade" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; NEXIUM [ESOMEPRAZOLE SODIUM]; MONTELUKAST; PRAVASTATIN; VALTREX. Vaccination history included: Bnt162b2 (Lot number: EN6200 in left arm at 16:00 as dose 1, single), administration date: 26Feb2021, when the patient was 71 years old, for COVID-19 immunisation, reaction(s): "Hives", "Swollen lymph nodes in neck", "Rash on legs". The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness". Therapeutic measures were not taken as a result of dizziness.  Additional information: Patient's medical history included "fibro" (as reported). The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe body aches, chills, tiredness, decreased appetite. Fever 99.9 F. Alternated with Tylenol and ibuprofen to help with body aches. Started feeling bad at 6pm the night of the vaccine and felt bad for 2 days after injection. Felt bad enough I missed work for 2 days.