chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: ER8729), in left arm, on 23Apr2021 as dose 2, single (Lot number: ER8736), in left arm and on 27Feb2022 as dose 3 (booster), single (Lot number: FG3527) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Grave's disease" (unspecified if ongoing); "Over weight" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Azuma, reaction(s): "Known allergies", notes: Known allergies: Yes. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19; received Paxlovid from 19Jun2022 to 23Jun2022 as treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
01/15/04: Complained to parent of itchiness and rash development all over body.  Low grade temperature 100.1.  Seen in ER 01/15/04, given Benadryl, Cortisone injections.  To start taking Benadryl and Mediol as prescribed by ER MD.
Nasal Swab; PCR: Positive; Nasal Swab; PCR: Positive; Throat irritation; Nose stuffiness; Nose irritation; Feels more like sinuses/upper respiratory irritation; Coughing; Reduced appetite; Have a strange rash pop up on my right arm; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 32-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset 10Apr2022, outcome "unknown", described as "Coughing"; RESPIRATORY TRACT IRRITATION (non-serious) with onset 10Apr2022, outcome "unknown", described as "Feels more like sinuses/upper respiratory irritation"; RASH (non-serious) with onset 10Apr2022, outcome "unknown", described as "Have a strange rash pop up on my right arm"; NASAL DISCOMFORT (non-serious) with onset 10Apr2022, outcome "unknown", described as "Nose irritation"; NASAL CONGESTION (non-serious) with onset 10Apr2022, outcome "unknown", described as "Nose stuffiness"; APPETITE DISORDER (non-serious) with onset 10Apr2022, outcome "unknown", described as "Reduced appetite"; THROAT IRRITATION (non-serious) with onset 10Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Apr2022, outcome "unknown" and all described as "Nasal Swab; PCR: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Apr2022) Positive, notes: Covid test type post vaccination=Nasal swab Covid test name post vaccination=PCR; (unspecified date) Negative. It was unknown if therapeutic measures were taken as a result of throat irritation, nasal congestion, nasal discomfort, respiratory tract irritation, cough, appetite disorder, rash.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to an 18-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 18-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity: ; manufacturerstate: ; manufacturercountry:  devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Student received Tdap immunization on 8/14/13.  On 8/19/13 injection site became warm to touch, red and developed small bumps under arm.  No associated fever.  No visible abmornality at injection site, no tenderness. Small raised bumps on rim of axilla.
Pt developed several chicken pox that lasted less than 10 days. She had less than 25 pox. Paternal grandfather had shingles, and pt was exposed during incubation.
I had a severe headache - couldn't get up without being nauseous. That lasted about 24 hours. At 6 PM on the 19th, I finally took Excedrin PM for the pain. I had fatigue. Fatigue was also about 24 hours.
blood clot in left leg/by the size of the clot it had probably been building for a while; Swelling; Severe Pain; second dose given >35 days from first dose; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (blood clot in left leg/by the size of the clot it had probably been building for a while) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient experienced THROMBOSIS (blood clot in left leg/by the size of the clot it had probably been building for a while) (seriousness criterion medically significant), SWELLING (Swelling), PAIN (Severe Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given >35 days from first dose). The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. In September 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given >35 days from first dose) had resolved. At the time of the report, THROMBOSIS (blood clot in left leg/by the size of the clot it had probably been building for a while), SWELLING (Swelling) and PAIN (Severe Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: diagnosed blood clot (abnormal) diagnosed blood clot via an ultrasound of left leg.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: This is a case of Inappropriate schedule of product administration in a 75-year-old male patient with no relevant medical history, who experienced the unexpected event Thrombosis. The event occurred approximately 6 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This is a case of Inappropriate schedule of product administration in a 75-year-old male patient with no relevant medical history, who experienced the unexpected event Thrombosis. The event occurred approximately 6 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
The day after receiving the second Pfizer vaccine dose, I had a 99.5 degree fever, severe muscle aches, weakness, increased appetite, irritability, and overall just felt horrible. These symptoms lasted 48 hours. On the third day after receiving the vaccine, I had a moderate headache that lasted 24 hours.
A mother reported that her daughter received her 1st dose of DTP vaccine. Seven days, post vax, the child developed hives. No further information was available at the date of this report. This report of a non-serious, labeled event is being forwarded in a 15-day time frame as requested by the FDA.
Case number PHHY2011US29432, is an initial spontaneous report from a health care professional received on 04 Apr 2011: This patient was vaccinated with MENVEO (batch number M10028) on an unspecified date. The nurse administered diluent only, without reconstitution. No other information reported.
This is a spontaneous report from a non-contactable consumer who reported for her mother. A 96-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The reporter mentioned that on an unknown date the patient "was much dying of the shot over a while, she ended up sleeping for about a week, she was very very tired for a couple of weeks, her arms got sore for almost 3 weeks (she has never recovered from it) and she had bad breathing, poor oxygen and she got worse". Patient not recovered from "arms got sore" and "bad breathing"; the final outcome of the other events was unknown. No follow up attempts possible. No further information expected.
Hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 16:30 (Lot number: ER8732) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: URTICARIA (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "Hives".  Additional information: Medical history was not reported. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, the next day of vaccination the patient woke up with hives and it lasted a day or so.   Follow-up attempts are completed. No further information is expected.
Information has been received from a pharmacist concerning a 62-year-old female who in September 2006, was vaccinated with 0.65 milliliters of Zostavax. Subsequently, the patient experienced a swollen arm, sore underarm and her right arm was itchy. Unspecified medical attention was sought. No laboratory/diagnostic tests were performed. It was reported that the patient recovered. No product quality complaint was involved. Additional information is not expected.
Fever started at 2:00AM on 12/19. I took a COVID19 at home rapid test at that time, that was positive. Went to take a PCR test at urgent care the next morning where I work, it was also positive. I called my PCP and he prescribed PAXLOVID. I started with severe cough, fever, just really didn't feel well, and was hurting everywhere. The second day I felt a little bit better, I think the PAXLOVID was working. The wheezing started on day 3 and I called my medical advocate and she put me on steroids and an antibiotic because I have a history of Pneumonia so we were concerned about that. She also put me on a long acting broncho-dilator and told me to take that twice a day every 12 hours, which helped me sleep better because I wasn't up all night coughing. I was also told to take MUCINEX DM. My symptoms didn't really start getting better until day 10. They extended the steroid and antibiotic as well as the broncho-dilator to make sure I didn't get raspy while talking. It was about 6 weeks before I could stop taking that every 12 hours. I finally tested negative on day 11. I did develop an abscess over a tooth with a crown on it, which my medical advocate said she has seen before. I did have to have emergency oral surgery for my tooth on February 5th. I know I got COVID19 from my husband who went to an out of town work meeting, but he didn't have any of the symptoms I had. I'm just not getting back to walking outside, I'm not as fast as I was but I'm starting to get back into my normal routine. Sleep was definitely a problem for a long time and I am just now getting back to my normal sleep. This was my only Pfizer vaccination, all of my other ones have been Moderna, and I plan on going back to Moderna.
I woke  early Saturday morning  (after Fri eve shot) with shivering, joint pain, headache fever (103) and exhaustion.  Broke out in cold sores on lips. Slept all day Saturday, Sunday temp dropped to 101,aching body/joint pain, headache and exhaustion continue through Monday. My normal body temp is 97.6. The mild  poison ivy I had spread like crazy with my temp. Temp drops to 99 for Tues & Wed and body aches and tiredness continue. I stay out of work M-Wed. Thursday and Friday no temp but still tired and cold sores stubbornly don't respond to Abreve (they usually do.)
covid infection; covid infection; This is a spontaneous report from a contactable consumer reporting for herself  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection),dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported.The patient's concomitant medications were not reported. The patient experienced covid infection (drug ineffective) on an unspecified date with outcome of unknown ,covid infection (sars-cov-2 test positive) on an unspecified date with outcome of unknown.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Caller is looking for guidance on administering the covid vaccine in a patient with a history of covid infection between both doses. DSU: E-transmitting AE noted after call. A patient confirmed covid positive post 1st dose of the covid vaccine  The events were considered as non-serious by the other healthcare professional.The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Initial information received on 26-Sep-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves a patient (age and gender not reported) who experienced allergic reaction/ anaphylactic, while he/she received vaccine FLUZONE QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious allergic reaction/ anaphylactic (anaphylactic reaction), following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Relevant tests were not reported. Final diagnosis was allergic reaction/ anaphylactic. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Documents held by the sender: none.; Sender's Comments: Patient developed anaphylaxis after vaccination. Exact time to onset is unknown. Anaphylaxis is listed with the vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 14-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml in the right upper arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
Rec'd MMR vaccine 1/30/13. Hours later had headache, fever & decrease appetite. Took ADVIL that moment. Had to be in bed all next day & then began feeling better. A week later had stiff neck headache. 2/12/2013 noticed enlarged lymph nodes to neck & behind (R) ear.
2"x1" red raised area. Pt. was given BENADRYL & MOTRIN.
(L) arm - pain when stretching or moving sideways, small knot when touched/rubbed. Sore at injection site. Injection date 9/30/2016. Patient called to report this 11/20/2016. He has not seen his PCP yet.
about 24 hours after vaccination pt reported itching, redness and inflammation at site, reported headache and fatigue. 3 days after feels much better injection site is sore if pressed. only treatment Benadryl and rest
No longer able to work; Difficulty sleeping; High Colesterol; Vitamin D Deficiency; Fever Blisters; Indigestion; Low Energy; Low vitamin D3; Fatigue; Migraine; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 (at the age of 62-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included destroyed gall bladder hence gall bladder removed, attention deficit hyperactivity disorder, Acid reflux (esophageal), hemorrhoids, menopause, UTIs, yeast infections and abnormal mole. Concomitant medications included ocrelizumab (OCREVUS), diphenhydramine hydrochloride (BENADRYL) and melatonin. On an unspecified date in 2021 the patient experienced no longer able to work, migraine, difficulty sleeping, high cholesterol, vitamin D deficiency, fever blisters, indigestion, low Energy, low vitamin D3 and fatigue. On unknown date patient started therapy with Pfizer COVID-19 vaccine for unknown indication. The patient underwent lab tests and procedures which included antibody test: COVID-19 antibodies not detected in blood on 2021. The outcome of the events was unknown. No further information was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client called today to report Infectious Disease doctor did MRI with contrast 1/16/08 and was diag. with encephalitis secondary to PEP series. Doctor and client will submit VAERS report. Per client report symptoms include low gr. fever, anxiety attacks, breathing diff., mood swings
dizziness; This case was reported by a nurse via call center representative and described the occurrence of dizziness in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2021, the patient received the 1st dose of Shingrix. On 1st February 2021, less than a day after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but it could be 68 to 69 year. The patient received Shingrix and experienced dizziness. The reporter consented to follow up.
Pt took 1st dose VIVOTIF 7 AM on 11/6. About 5 pm 11/6 developed stomach ache. Vomiting x 2 at 1-2 AM on 11/7 with stomach pain, muscle aches, HA and nausea. Able to resume eating by 11/7 pm sx all resolved by 11/8 pm. Only trt was ADVIL for HA 11/7 pm with improvement. Currently feels well, normal as before.
ITCHINESS OVER THE ENTIRE BODY; CHEST PAIN FELT LIKE PINS AND NEEDLES; PINS AND NEEDLES FEELING OVER THE LEFT SIDE OF THE BODY; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no change in lifestyle. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 08-SEP-2021 08:50 for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced itchiness over the entire body. On 08-SEP-2021, the patient experienced chest pain felt like pins and needles. On 08-SEP-2021, the patient experienced pins and needles feeling over the left side of the body. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itchiness over the entire body, pins and needles feeling over the left side of the body, and chest pain felt like pins and needles. This report was non-serious.