chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm pain at the injection site; fever (100 degrees F) later that night lasting into the next day; This is a spontaneous report from a non-contactable consumer. A 26-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EK9231) intramuscularly on 20Jan2021 (at the age of 26-years-old) at 0.3 mL as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received dose 1 of BNT162B2 intramuscularly on 30Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 21Jan2021 at 00:00, the patient experienced arm pain at the injection site and fever (100 degrees Fahrenheit (F)) later that night lasting into the next day. The patient did not receive any treatment for the events. There was no hospitalization for the events and the reporter assessed the events as non-serious. The clinical outcomes of arm pain at the injection site and fever (100 degrees F) were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 11-FEB-2011, 01-JUL-2011 and 05-AUG-2011, the patient was vaccinated with three doses of RECOMBIVAX HB respectively (dose, route, application site and lot# not reported). On 07-JAN-2015, the patient received an expired fourth dose of RECOMBIVAX HB, lot # H018689, expiry date: 07-NOV-2014, (dose, route, application site and lot# not reported). The fourth dose of RECOMBIVAX HB did not have any previous temperature excursions and was supported with post-expiry data. No adverse symptoms reported. Additional information has been requested.
Severe Premenstrual like symptoms. Severe mood swings, cramps, body aches, migraines and bloating. Menstruation does not occur until 16 of the month. PMS starts several days before.
Started to get small rashes and bumps on several parts of my body on Saturday 4/10. After 24 hours the rashes became smaller bruises
One year 4 month old who received DTaP, Hib, Hep B and Prevnar immunizations at about 1600 on 7/14/03. Exam at time was normal. At about 1830 she developed acute edema and tearing of her eye-unilateral. Enough swelling to prompt ER visit. No respiratory symptoms. Rx with Benadryl. No further sequellae. Uncertain whether immunizations contributed to reaction.
This spontaneous report was received from a Licensed Practical Nurse and refers to a 67-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (dose and route of administration were not reported) lot # N010106 with expiration date 15-NOV-2018. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001308.
This patient had a local reaction, 4 x 4 erythema scratch in the center.
Symptoms began 1 day ago, are reported to be severe. Location is right upper arm. Aggravating factors include MMR/ Varicella vaccine.  Associated symptoms include itching, burning, redness and swelling in the injection site.
Now she has permanent vocal cord hoarseness; she has this weird stiffness in her neck; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support via a contactable consumer (patient herself). An 8-decade female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date it was reported as now she has permanent vocal cord hoarseness. She got vaccinated, with Pfizer, and now she has this weird stiffness in her neck and is having to go to the chiropractor. Outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Severe redness, inflammation, and swelling from the upper left arm (injection site) going down to my elbow. I was diagnosed with cellulitis. After 24 hours of antibiotics I am doing much better.
Muscle ache/soreness at site, red "welts" by bedtime 10/6/14 all welts gone no further symptoms.
ELEVATED TEMP OF 101, CHILLS ACHES, HEADACHE, WEAKNESS
This spontaneous report has been received from a pharmacist referring to multiple unspecified patients. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, these unspecified patients vaccinated with ZOSTAVAX (dose, route, lot# and expiration date not reported) for prophylaxis. On unknown dates, the patient developed injection site reactions (no further clarifying information was provided). The outcome of the injection site reactions was unknown. The causality between ZOSTAVAX and injection site reactions was not reported. The pharmacist accepted the offer to receive the varicella zoster virus identification program (VZVIP) packet. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA007593:
edema & erythema @ inj site;next day 3/4" in diameter;c/o muscle soreness & soreness & inj site to rt elbow until 3MAR96;site seen 7<AR06 w/scab formation & c/o mild itching;
Welts noted on both legs & stomach AM after DTP received. Welts lasted 35-45mins. No other s/s, no treatment.
Pain and blisters all up and down my left arm, the arm that received the vaccine. Painful nerve burning feeling all up and down my left arm. Surges of pain all up and down my left arm.
Date and time adverse event started: Approx. 2-3 days from date 2nd dose rcvd (3/29/2021) approx. time unknown.  Patient reported that with the first dose he had a mild headache which went away. Reported that from the second dose rcvd (3/29/2021), same day had left shoulder soreness and stiffness which went away two days later without any treatment. Reported that the headache felt worse from rcvding the 2nd dose, which occurred 2-3 days later. Pt is still experiencing the headache which has not gotten better, there's pain and stiffness in the back of his neck and skill area (lots of discomfort in the neck and skull area from trying to rotate his head). Also reported that he can't sleep, and the chills are still coming off and on (chills also started approx. 3 days from 2nd dose rcvd). Patient reported since his headache started 2-3 days from rcvding 2nd dose, he has been taking Tylenol 650mg tablet (dosing approx. 2-3x per since headache started) which helps alleviate the headache for approx. 30-45 minutes and then the headache would return. He had tried to reach out to his PCP but his PCP has moved. Patient advised will go to urgent care today to get check out.  ***NOTE***  Counseled patient to stay hydrated (recommend water or fluid with electrolytes, and avoid caffeine to prevent dehydration) and can continue to take Tylenol as needed just a long as he does not exceed 4,000mg per day. Counseled patient to avoid consuming alcohol while taking alcohol to prevent drug interaction with Tylenol. Recommend patient to seek medical care since his headache his not gotten better and he has been taking Tylenol for almost a week now. Patient called back 4/6/2021 at 9:09am: Patient reported that he felt much better today headache, pain or stiffness in the back of his neck or skull areas, and slept fine last night. Patient stated he did not get a chance to go to urgent care. He stated he took Tylenol last night. Recommend patient to continue to stay hydrated, and if his headache comes back to contact his PCP for further follow up.
Bitter taste in mouth immediately following vaccination.; Food/Drink does not taste as it normally does; Severe body aches; chills; fever; high heart rate; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old, non- pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 26Mar2021, at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included neuromyelitis Optica, postural orthostatic tachycardia syndrome (POTS), narcolepsy and adult onset stills disease. The patient had a history of allergy to bananas and tree nuts and amoxicillin. Concomitant medications included eculizumab (SOLIRIS), mycophenolate mofetil (CELLCEPT), prednisone (MANUFRACTURER UNKNOWN), and carbamazepine (MANUFRACTURER UNKNOWN) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 04Mar2021 at 16:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 21:00, after 5 hours of vaccination, the patient had experienced bitter taste, chills, fever, taste abnormal, high heart rate and severe body aches. it was reported as patient had bitter taste in mouth immediately following vaccination, food/drink did not taste as it normally, severe body aches, chills, fever and high heart rate. The patient did not receive any treatment for the reported events. Adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of bitter taste, chills, fever, taste abnormal, high heart rate and severe body aches was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Insomnia, change in sleep pattern used to go to sleep around 1am, waking  up around 7am, now can't go to sleep until 5am, waking up around 10am.
Cough, mild fever, rash (30+ on 10/10), severe body ache on 10/09 night.
Initial shot a couple of years ago / due to various things including the pandemic / unable to get the second shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st shot two years ago, from the day of reporting).   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 for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patients had the initial shot a couple of years ago but, due to various things including the pandemic, they were unable to get the second shot.  The reporter was asking if they should start over and get two shots or just get the second shot. The case is linked with the case- US2021AMR145748, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR145748:Same reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: ER8732), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8732), in left arm and on 19Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hx Hbp" (unspecified if ongoing); "bariatric Gatric RNY recently" (unspecified if ongoing); "asthma" (unspecified if ongoing); "chronic intestinal issues" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOL [PANTOPRAZOLE], start date: 29Jul2021, stop date: 12Sep2022; ADDERALL, start date: 11Nov2020; VITAMIN A [RETINOL], start date: 30Jul2022, stop date: 15Sep2022; CALCIUM, start date: 31Jul2021; VITAMIN B12 [CYANOCOBALAMIN], start date: 30Jul2022. Past drug history included: Tegretol, reaction(s): "Known allergies: Tegretol", notes: Known allergies: Tegretol. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details: Patient revived Covid-19 treatment with Paxlovid  from 13Sep2022, to 18Sep2022.
The patient is an immunocompromised host with multiple comorbidities, being admitted with COVID infection.  He has mild hypoxia and a portable chest x-ray consistent with pneumonitis superimposed on scarring.  Right middle lobe collapse could not be excluded, so will obtain a PA lateral and start remdesivir with dexamethasone and consult Transplant Infectious Disease for further recommendations
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced shingles, some time after vaccination with the first dose of SHINGRIX. The healthcare professional did not had any additional information and stated that the manager would had to call back for the further information.
Patient displayed bruise and swelling at injection site immediately after shot. Patient became limp and eyes rolled back and he collapsed to the floor.  Epi pen admitted at that time. Patient immediately regained consciousness and said he felt ok. He was sweating heavily. Paramedics arrived and took him to hospital after taking vital signs and interviewing him.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 6 weeks old patient of unknown gender. On 16-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX, (strength, route, anatomical location, dose, frequency, dose number, lot number and expiration date were not reported), for the permanent prevention and protection against shingles and zoster-related conditions/injuries (prophylaxis). No other suspect or concomitant therapies were reported.  On an unknown date, the patient was diagnosed with shingles (herpes zoster) and/or other zoster-related injuries after and despite being inoculated with the zoster vaccine live(ZOSTAVAX) (vaccination failure), and suffered serious physical, emotional, and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life (Quality of life decreased); increased risk of premature death, aggravation of pre-existing conditions and activations of laten conditions (condition aggravated), lost wages, loss of earning capacity and other losses and damages.  On or about 30-NOV-2016, the patient was treated for shingles. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to Zoster Vaccine Live(ZOSTAVAX).  The reporter determined adverse events as medically significant, disabling and life-threatening events.
This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 79-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3246), on 05Feb2021 as dose 2, single (Lot number: EN9581), on 26Sep2021 as dose 3 (booster), single (Lot number: FC3124) and on 04Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 79 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Stable  CAD" (unspecified if ongoing). Concomitant medication(s) included: ASA, start date: 01Jan2020; AMLODIPINE, start date: 01Jan2020; TOPROL XL, start date: 01Jan2021; PANTOPRAZOLE, start date: 01Jan2020; HTZ, start date: 01Jan2020; HYTRIN, start date: 01Jan2020; PRAVASTATIN, start date: 01Jan2021, stop date: 24Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Negative, notes: Neg antigen; (10Jul2022) Negative; (11Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Covid rebound. Neg antigen 03Jul2022, negative 10Jul2022, positive 11Jul2022. Symptomatic 09Jul2022 minimally. Anti-Viral details: Product covid-19 Treatment Brand: Paxlovid Treatment start date: 24Jun022 Treatment Stop date: 28Jun2022 Indication: Treatment Covid-19  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Around 9:00 that night, I had body aches and tossing and turning then with sleep because of body aches. Next day I was in bed all day the next day because of the severe body aches. Cough got worse for the next few days or so after that.  I had some shortness of breath because of the coughing. Migraines started - strong headaches. The first one was the morning after the vaccine. During the next day (third day after vaccine) I had another migraine.  Symptoms were acute for three days.
Redness and swelling at injection site 9 AM 5/10/14. Dizziness, headache, fever 5 PM 5/10/14 until 6 PM on 5/11/14. Redness and swelling on upper arm still evident 5/13/14 some itching. Swelling area was approx 2 x 5 inches.
Initial report received from the infant's father (who is a physician) on 02 Dec 2009. This 20 month old infant was administered 0.25 ml dose of FLUVIRIN intramuscular on 01 Nov 2009 by the reporter. No adverse event was reported.
Pt vaccinated with DTP then death occurred 3/90. Cause of death listed as reaction to DTP vaccination.
Tight chest, numb lips, cotton mouth...  Benadryl and steroids given through IV.
Pt reported hives and throat tightness within 1 hour of receiving Yellow Fever vaccine.
after vax approx 7p  exp r parotid gland, swollen & tender, difficulty swallowing.
Pt. reported throat tightening and lip tingling. No lip/tongue swelling/dysphonia/wheezing or vital sign instability, including stable oxygen saturation measured.
26OCT96 started w/cold sx;27OCT96 felt worse, fever, cough;25OCT96 went to own MD started on amoxicillin;almost had pneumonia;1NOV95 r/c wife states pt much better; improved 29OCT96;
This health care worker who received the vaccine was happy to get a headache like she normally does with other vaccines; This is a spontaneous report from a non-contactable consumer.  A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache; it was specified that this health care worker who received the vaccine was happy to get a headache like she normally does with other vaccines. The patient recovered from the event on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache, Myalgia, Fever, NauseaVomiting, Localized pain; fatigue, chills, Narrative:  Other Relevant History:
Patient developed a sterile abscess on right thigh (DTaP injection site). Incision 2 drainage done at Hospital.
Client did not disclose that they had already recieved a dose of Janssen vaccine on 3.12.21 Lot # 1805018 from another provider. Requested  a dose of Moderna vaccine as her first dose, and it was administered as requested.