chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: Fj6369) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Sep2022 at 12:30 as dose 5 (booster), single (Lot number: As7143c), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Apr2020; ATORVASTATIN, start date: 01Jun2019. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Sep2022 at 12:30, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: and after several days of no symptoms and negative antigen tests; Positive, notes: Strong rebound symptoms (sinus congestion, headache, fever) for 5+ days. Strong positive antigen test results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201336672 same patient; different product and event;
3 wks after injection, eczema erupted and kept spreading 4 weeks after I had normal lupus blood work and platelet count was 5,000. Was admitted into hospital for 4 days and was given 40 mg dexamethasone for 4 days and  2 sessions of IVIg.   PLatelets started to come back slowly. after 4 weeks back to normal count 198,000
The pt is a 19 yo previously healthy male who developed GBS as a new accession with symptom onset in week 1 BCT. His immunization record states he received 7 vaccines on 15 OCT, 2018 including adenovirus, MMR, varicella, TWINRIX, IPV, Meningococcal & Tdap. However, the nursing documentation states he also received FLUCELVAX but not IPV & meningococcal in the same note.  Causality assessment is been requested for determination of potential for vaccine relationship.
Patient received DTaP and began to vomit 30 minutes later. Patient Rx ZOFRAN and checked vitals before sending home. Followed up with patient.
I had a fever, body aches and chills for about three days. In 11/2022, I started having dizziness and lightheaded at random times. In 02/2023, I also started having double vision. I have noticed it happens when I look at something in the distance. I have seen my ophthalmologist who to my primary care physician. Next doctor to see is a neurologist. On days that the symptoms start I stay home and just try to adjust. I previously tested positive for COVID-19 on 07/28/2022. I contacted a provider and got a prescription for Paxlovid. I tolerated the medication without any complications.
25Mar91 pt vax;  26MAr91 devel large local reaction w/ redness & swelling; also crying & irritable & did not sleep well for 3 nights.
my arm sure is sore; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer (patient) reported that a patient of unknown age and gender received pneumococcal 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) (PREVNAR 13) on 04Sep2020 at single dose via unknown route of administration for pneumonia shot. Medical history and concomitant medications were not reported. Patient stated his/her arm sure was sore. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected. Information about lot number/ batch number could not be obtained.
After a week the arm is still tender with a red mark at the injection site that is itchy, red and hurts to the touch.
This spontaneous report was received from a nurse referring to 1 or 2 patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered improperly stored doses of GARDASIL 9 (Lot # L007560; expiration date: 15-JUN-2017) (dose and route not provided). Concomitant therapies were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 10 degrees C for 552 hours (23 days). No previous temperature excursion was reported. Additional information has been requested.
Headache, chills, muscle aches and Swollen lymph nodes on the side where the shot was administered. Went to clinic on 10/31/22 and was diagnosed with strep throat.
Information has been received from a healthcare student referring to a unspecified patient of unknown age and gender. On 18-MAY-2015 the patient was inadvertently administered an expired dose of ZOSTAVAX (lot # J014809, expiration date: 20-FEB-2015, route and dose were unknown) (expired vaccine used). No adverse effect was reported. Additional information has been requested.
One week post vaccine administration a large, red, itchy, painful rash appeared on Left arm in location of injection. Rash became worse over the following days and has remained for four days now.  The area is raised and inflamed and still itches and hurts.
Onset asthma symptoms without usual stimuli-(dust/cats). Persistent x 4 days at time of report. Not controlled with prn inhaler. Using nebulizer with some relief. Still symptomatic. Sx persisted through 1/1/03.
Felt a little dragged out; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number : 1), for Covid-19 immunization. The following information was reported: SEDATION (non-serious), outcome "recovered", described as "Felt a little dragged out".  Additional Information: It was reported that the second one when the patient went for that shot, he said he felt a little dragged out, laid down for a while, was fine, and went to work. It did not effect him even though he had COVID, but he had a mild case of COVID in November. It was very mild because he got positive test of COVID, but was at work the following day. He needed to go for testing due to work.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning unspecified number of patients of unknown age and gender. The reporter stated that doses of VARIVAX (dose, frequency and route were unknown, lot# K021933, expiration date 11-OCT-2015) which had been exposed to temperatures outside of the recommended range, had been administered to unspecified patients on unspecified dates since 22-APR-2015. No adverse effect had been reported. Additional information has been requested.
My daughter cried and twitched for a month straight. She was inconsolable and agitated. I could not get her to sleep normally after that doctor visit.
This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L032760, expiry date 24-FEB-2017, L008355, 11-SEP-2016 expiry date, L031601 expiry date 18-FEB-2017. No adverse effects reported. Temperature of -12 degree Centigrade, time frame of 94 hours and 50 minutes. This is one of the two reports received from the same reporter. Additional information has been requested.
Side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effects) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. No Medical History information was reported.
Arm was so sore; Flu like symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm was so sore) and influenza-like symptoms (Verbatim: Flu like symptoms). The outcome of the pain in arm and influenza-like symptoms were not reported.   It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received second dose of Shingles vaccine and experienced his or her arm was so sore and it gave him or her flu like symptoms. The patient stated that it was nothing compared to the virus. Follow-up would not possible as no contact details were available.
Left upper thigh red, swollen, warm & tender to touch. Area measures 11 1/2 cm x 10 1/2 cm. Rx for KEFLEX 250/5 ml 3 tsp BID x 7 d & BENADRYL.
Tongue thrush - severe- now treating with oral suspension meds - now experiencing numbness in hands.  I had sudden onset of a massive amount of tongue thrush. I have been a dental office manager for over 20 years and I don?t think I have personally seen a case as severe as mine. My throat hurt also so the Doc has me swallowing the medication rather than simply swishing and spitting.  I really hope this numbness in my hands  resolves itself. It is hindering my ability to write.  I took my first dose of Pfizer.
Staff members leg and foot gave out. She went to the ER.  She had incontinence. Numbness in right leg.
7/31--presently admitted 57y.o. female known to me as an outpatient who has been struggling ever since her husband and her dog died recently.  Patient became very agitated and manic.  Was potential danger to herself and was admitted on a locked inpatient psychiatric unit for protection of self. 8/1 Tested positive for COVID on 7/31/2022. Previously tested positive for COVID 2-3 weeks ago on a home test. Currently asymptomatic. It has been more than 10 days since the initial positive. COVID isolation precautions have been discontinued.
Fluad given to patient who was 64 years old, not yet 65 years.
Fatigue and arm pain the day of, tapering off in the days following (arm pain was bad enough that arm could barely be lifted without pain). Shortness of breath and chest tightness after about three days following vaccine.
14 year old female was given Tenivac instead of Boostrix, with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00814581).  This case involves a 14-years-old female patient who was by mistake given dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [BOOSTRIX].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   Concomitant medications included HPV VACCINE (HPV VACCINE) for and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO) for prophylactic vaccination.  On 12-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6922AA and expiry date:22-Jan-2023) (Frequency: once) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (latency on same day).  It was reported caller would like to know how long to wait before administering the proper vaccine for patient's age range. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test--0.5ml.  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 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.
Arm was swollen; Arm can't move; This is a spontaneous report from a contactable consumer or other non health care professional (patient).  A 58-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in Arm Right on 19May2021 (age at vaccination: 58-years-old) as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. The patient got the vaccine on Wednesday, 19May2021, then after she got that shot she came home, her arm was swollen she could go to work since Wednesday and Thursday her arm could not move, so she called off at work. Patient did not receive any treatment for the events. The outcome for the events was unknown.   Follow-up attempts are needed. Further information is expected.
He got both doses of the vaccine already. He mentioned that he had a stroke; The initial case was missing the following minimum criteria: no adverse event or at-risk situation. Upon receipt of follow-up information on (01Sep2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer  from a Pfizer-sponsored program.     A 86-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. The patient medical history was not reported.     There were no concomitant medications.  On  08Jan2021 the patient received the first dose of BNT162B2 vaccine (Batch/Lot Number: EL3246; Expiration Date: Apr2021).  The patient got both doses of the vaccine already. he mentioned that he had a stroke  (medically significant) on an unspecified date with outcome of unknown.
Vertigo from 1:00 AM to 6:00 PM Extreme fatigue - slept roughly 20/24 hours from 1:00 AM on
Covid Positive, COVID Pneumonia, Acute respiratory failure with hypoxia requiring high flow oxygen and encephalopathy with history of COVID Vaccine  on March 8th 2021 requiring hospital admission to ICU on March 28 2021
Coughing; Very Sick; Very Bad Body Aches; Fever of 103.6F; Severe Chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), ILLNESS (Very Sick), PAIN (Very Bad Body Aches), CHILLS (Severe Chills) and PYREXIA (Fever of 103.6F) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 03-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 CHILLS (Severe Chills). On 05-Feb-2021, the patient experienced COUGH (Coughing), ILLNESS (Very Sick), PAIN (Very Bad Body Aches) and PYREXIA (Fever of 103.6F). At the time of the report, COUGH (Coughing), ILLNESS (Very Sick), PAIN (Very Bad Body Aches), CHILLS (Severe Chills) and PYREXIA (Fever of 103.6F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever of 101, vomiting, muscle aches, stomach cramps, diarrhea.  Administered infant acetaminophen to break fever and relieve muscle aches, fever broke around 11 am, vomiting stopped about 2 am, baby feeling better but not completely back to normal at about 1pm on 10/16.
Very red, painful sore throat, headache, sneezing, malaise, myalgia, coughing, profuse perspiration, blowing large amount of mucus from nose, temperature between 99.4 and 100.4. Moderate soreness and itching at injection site.
Information was received on 27-OCT-2016 from a pharmacy intern. It was reported that on 26-OCT-2016 a male patient (age unknown) was vaccinated with a dose of PNEUMOVAX 23 (lot #L003188, exp. 06-JUL-2016) that was expired. No adverse event was reported. Vaccine was properly stored prior to administration. No other information was provided. No further information to report. Additional information has been requested.
This spontaneous report was received from a physician refers to a 21 years old female patient. On 08-JUL-2014 the patient was vaccinated with GARDASIL dose 2, 0.5ml, intramuscular in the patient's left deltoid (lot# was not reported). It was reported that the patient got her first dose of GARDASIL in August 2012. Third dose had not been administered at the time of this report. No adverse effects were reported. Additional information has been requested.
Started the day after  with a fever of 100.8 and a small red, itchy, hot circle around the injection site. Fever only last one day but  Within 2 days the circle doubled.
This case was reported by a physician via call center representative and described the occurrence of myalgia in a 81-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hypothyroidism (complex history), Factor XI deficiency, vasculitis (uncharacterized), herpes zoster ophthalmic and drug allergy. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia, malaise and lightheadedness. On an unknown date, the outcome of the myalgia, malaise and lightheadedness were unknown. It was unknown if the reporter considered the myalgia, malaise and lightheadedness to be related to SHINGRIX. Additional details were provided as follows: This case was received via webform email. The age at vaccination was not reported. The patient had a truly miserable 5 days of systemic symptoms after her initial dose. She wanted to proceed with the booster, but was leery of repeating the suffering.
This spontaneous report was received from a registered nurse concerning a 13 year old female patient. Weight of the patient was reported as 104 (units unspecified). As reported as 64 inches. On 29-OCT-2012, at 14:57:25, the patient was vaccinated with dose 2 of improperly stored (that was exposed to 31 Fahrenheit for up to 68 hours) GARDASIL (lot number and expiry date reported as 672721/0101AE and 10-OCT-2014 respectively), intramuscularly in the left arm at a private doctor office or hospital with the private funds. No concomitant medications were reported. No adverse effects were reported. A signed informed consent form was obtained in which the parent of the patient had signed. This is one of two reports from the same source. Additional information is not expected.
Patient c/o headache.  She was an older women in a wheel chair and the temperature in the stadium was extremely cold and most of the people were shivering even if they had no other problems. The patient  complained of headache after 12-15 minutes. She was alert and oriented X3 in NAD. Vital signs: BP-118/82 HR-86 O2 Sat-98%. She did not have any visual problems, nausea, vomiting ,chest pain ,stridor,  SOB , or rash. I listened to her with the stethoscope.  Her lungs were clear . No rales or wheezing and heart rate was normal.  She was watched for almost 40-45 minutes .She had headache but it improved somewhat. I informed her to drink enough fluids, take pain killer either Tylenol or Advil whatever her MD recommends- to take when she has pain. I also informed her daughter to keep a close watch on her for 2 days  and if any problems call her MD and  take her to ER. I watched her very closely in the post vaccination area before she left.
Itchy redness spread to her abdomen; Itchiness; swelling on the injection site; Area around the injection site became intensely red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Itchy redness spread to her abdomen), PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Area around the injection site became intensely red) and VACCINATION SITE SWELLING (swelling on the injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Area around the injection site became intensely red). On 16-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling on the injection site). On 17-Apr-2021, the patient experienced PRURITUS (Itchiness). On 18-Apr-2021, the patient experienced ERYTHEMA (Itchy redness spread to her abdomen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Itchy redness spread to her abdomen), PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Area around the injection site became intensely red) and VACCINATION SITE SWELLING (swelling on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. Treatment information included- Benadryl capsules did not helped.
I ended up with a bumpy rash that felt and looked exactly like eczema.  Lasted about a week.
Suffered the following side effects starting at 2am on Sunday and ending around midnight on Sunday. Fever Sweating Tingling tongue Sore body to the touch - Almost like the nerve ending in my skin were hypersensitive Headache Swollen shoulder Diarrhea
lot expired 10/13, vaccine given on 10/8. moderna investigation confirmed the lot should give full coverage. no adverse event reported
Palpitations, presyncope, tachycardia, elevated blood pressure, sweating, chest pain