chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Appears c/o clammy ,light HA, syncope & hypotension VS: B/p 98/61,HR 72,RR 22 O2 100% of sat, appears anxious lying on the floor which improved w//in few seconds. repeat VS: @1243: B/P 113/73 HR: 83; RR 20 W100% on RA ; @1250: B/P 120-115/69-74; HR 78; RR 20. stable.
chills; fever; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority Support. A contactable consumer (patient) reported that a male patient of unspecified age received second dose of BNT162B2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 20Mar2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient got the second dose of the Covid 19 vaccine yesterday (20Mar2021) and he was reporting adverse events like chills and fever he experienced today (21Mar2021). He asked what medication that he can take. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
VACCINE WAS IN THE FREEZER PAST THE DATE IT WAS TO BE MOVED TO THE THE FRIDGE,  AFTER CONSULTING WITH THE PFIZER AND CDC THEIR RESPONSE WAS TO RECOMMEND THE PATIENT TO BE REVACCINATED IN THE OPPOSITE ARM. PATIENT STATES NO ADVERSE REACTIONS AT THIS TIME
C/O feeling lightheaded and upset stomach follow vaccine.  Client voice that she had eaten breakfast but had not taken BP meds.  Client seen and assessed by EMT and v/s are:  b/p 160/72, HR 84, O2 97.  Client voiced that she had same reaction with 1st dose and she felt better on third day.  Client advised to seek medical attention if worsen.  Cleared by EMT.
Woke up with headache, took migraine medication. Progressed to body aches, fatigue, body tingling.  5/19/10 noticed reddened area at injection site and golf ball sized reddened area below injection site.  Warm to touch.
Outcome was chills, headache, fatigue, and a fever through out the entire night and into the morning following the shot.
Side effects; This spontaneous case was reported by a consumer 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) (batch no. Not Provided) 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.       Concomitant medications was not provided by the reporter Treatment information was not provided
red itchy eyes; Feeling hot; red,itchy rash in both armpits, mid abdomen, both outer thighs; itchy rash in both armpits, mid abdomen, both outer thighs; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red,itchy rash in both armpits, mid abdomen, both outer thighs), RASH PRURITIC (itchy rash in both armpits, mid abdomen, both outer thighs), EYE PRURITUS (red itchy eyes) and FEELING HOT (Feeling hot) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN for High cholesterol, MULTIVITAMIN [VITAMINS NOS] for Nutritional supplement, ACETYLSALICYLIC ACID (ASPIRIN 81), ACETYLSALICYLIC ACID (BABY ASPIRIN) and MINERALS NOS, VITAMINS NOS (CENTRUM JR [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH ERYTHEMATOUS (red,itchy rash in both armpits, mid abdomen, both outer thighs) and RASH PRURITIC (itchy rash in both armpits, mid abdomen, both outer thighs). On an unknown date, the patient experienced EYE PRURITUS (red itchy eyes) and FEELING HOT (Feeling hot). At the time of the report, RASH ERYTHEMATOUS (red,itchy rash in both armpits, mid abdomen, both outer thighs), RASH PRURITIC (itchy rash in both armpits, mid abdomen, both outer thighs), EYE PRURITUS (red itchy eyes) and FEELING HOT (Feeling hot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Biopsy: normal (normal) fungus or dermatitis negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-200973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Updated with patient demographic information and newevent as feeling hot, itchy eyes. concomitant drug information added.
Clinical mild Varicella (onset 6/5/07) also exposure to Varicella pain to vaccination.
See first dose box symptoms. Repeated symptoms within three week of covid vaccination. Dr requested Health dept report this occurrence.  Symptoms of macula going into erythema and intense urticaria. Rash occurs throughout body into scalp, not profuse, very irritating with itch. Used gold Bond with Lidocaine to offer relief.  Dr wrote prescription for steroids. z-pack will pick up today .
Initial unsolicited report received from a consumer on 05 November 2016. This case involves 74-year-old female patient, who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose series and site of administration were not reported) via intramuscular route on 01 November 2016. The patient's illness at time of vaccination: denies and pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided (no known allergies). Concomitant medication reported as none. On 01 November 2016, straight away following vaccination, patient had runny nose. On 04 November 2016, in the morning three days following vaccination, patient's arm really hurt at the injection site, she had a low grade fever, with sweats intermittently and felt really bad. On an unspecified date following vaccination patient experienced some issues with her bowels. Laboratory data and corrective treatment were reported as none. Outcome of the events was reported as unknown. List of documents held by sender: none.
The symptoms started with mild runny nose, cough, fatigue and headache. I did not see a doctor I was at home and took a COVID-19 test that was positive and I have medical training, so I treated myself at home.
pain under arm; It is also painful; large area of swelling that is a large lump or mass the size of a golf ball under his arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EW0170), via an unspecified route of administration, administered in Arm Left on 27Apr2021 10:00 (at the age of: 56-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was reported as none. Concomitant medications were not reported. The patient previously received first dose of of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in Arm Left on 06Apr2021 (at the age of: 56-years-old) as dose 1, single for covid-19 immunisation. It was reported that Patient received the second dose of the Covid-19 vaccine on Tuesday 27Apr2021. On Wednesday 28Apr2021 he had a really large area of swelling under his arm that had gotten worse. It was also painful. The swelling was a large lump or mass the size of a golf ball. On 29Apr2021 he also had pain under arm. He was thinking of going to the urgent care. Outcome of large area of swelling that is a large lump or mass the size of a golf ball under his arm and pain under arm was not recovered and outcome of pain was unknown.  No follow-up attempts are needed. No further information is expected.
After about 12 hours of receiving shot, had bad shakes that lasted about 3 days.
Received vaccine in left arm at 2:30pm. 6:30pm left arm muscle soreness noted.  Difficulty sleeping due to left arm pain.   Next day, 4:30am left arm muscle soreness at injection site, chills, fatigue, body ache, headache.   6:30pm headache and fatigue continue, left arm muscle soreness at injection site..
Three days after vaccine, woke up with the left eyelid swollen, itchy and a dark reddish brown in color. Per eye doctor, apply cold compress and before bedtime use OCuSoft Lid Scrub wipes and applied 1%Hydrocortisone Cream for 14 days. No change. Per dermatologist starting 6 days of prednisone. Dermatologist also noted discoloration (reddish brown) on the inside of the right eyelid.
On 01/17/2001, in the evening, the patient developed a very mild rash, maybe 8 lesions, that appeared to be chickenpox. The patient sought medical attention. Additional information has been requested.
This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: controlled high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced 12 hours after injection felt nauseous like flu coming on but more intense, quite intense. On 08-MAR-2021, the patient experienced basically wiped out. Laboratory data included: Body temperature (NR: not provided) Not over 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 12 hours after injection felt nauseous like flu coming on but more intense, quite intense, and basically wiped out on 09-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20211031835.
itchy at the injection site; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 Vaccination.     Concurrent medical conditions included Hypertension, Cholesterol, Diabetes and Breast cancer. Concomitant products included NICOTINAMIDE (VITAMIN B COMPLEX [NICOTINAMIDE]) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). On 25-Feb-2021, VACCINATION SITE PRURITUS (itchy at the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications included unspecified blood pressure medication, cholesterol medication, diabetes medication and unspecified medication for breast cancer. No treatment information was provided.
Headache, Myalgia, Arthralgia & Fever Narrative:  dose 1-day 1-2 sorearm; pain/ swelling dose 2- day 1 pain inj site; day 1 - 5 chills; fever; jointpain; muscle ache; fatigue
Patient experienced headache night of. Patient started experiencing extreme muscle pain in 24 hours as well as chills and fatigue.
nurse administered an expired menactra to a patient with no reported adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 22 years old male patient who was administered an expired menactra  with no reported adverse event , after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE ( lot U6952AA and expiarion date: 09-Jun-2022) at a dose 0f 0.25ml via intramuscular route in the left deltoid for immnuization.  On an unknown date , the patient administered an expired menactra with no reported adverse event (expired product administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  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 guidelines. 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.
limp x2 days. 2 puncture wounds left thigh. Area of hardened induration- from top of knee to groin 20cm lens. 8cm x wide no erythema, moving leg normally
Dose administered after 30-day Use By Date/03Sep2021 4 doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/03Sep2021 4 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/03Sep2021 4 doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/03Sep2021 4 doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided  Treatment medications were not provided  Reported that 68 doses of the Moderna Covid-19 Vaccine (all from lot 939902) used after the vials were stored in the refrigerator for 30 days.Dose administered after 30-day Use By Date.  Date the vial was initially stored in the refrigerator: 02-Aug-2021.  Date of vaccine administration was reported as 03 Sep  2021- 4 doses, 20 Sep 2021 -4 doses, 01 Oct 2021- 7 doses,18 Oct 2021 -4 doses , 25 Oct 2021 -19 booster doses, 26 Oct 2021- 14 booster doses, 27 Oct 2021 -19 booster doses.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received on 28-Oct-2021 contains: Date(s) of administration of vaccine added and updated in I narrative.
81yr old male who presents to ED via private car with complaints of weakness.  Patient states he was seen in the clinic today and received a call this evening that he was covid positive and to return to ED due to kidney function.  Patient states he was vaccinated for covid in March.  Patient states he received the flu shot 1 week ago and has been getting worse since that time.  Patient denies pain. pneumonia, weakness, dehydration, elevated AST, elevated CRP, COVID virus detected.
high temperature; chills; fever; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient experienced high temperature, chills and fever on an unspecified date. The patient underwent lab tests and procedures which included body temperature: high on an unspecified date. The outcome of the events was reported as unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
One week after the injection, the injection site became swollen, red, hot to the touch and itchy.  The spot was 4 inches in diameter.  After two days it has improved, but still red, a touch swollen, warm to the touch, and itchy.  I took advil and Benedril and put hydocortisone cream on it and an ice pack.  I also took prilosec to help with the itching.
Information has been received from a physician concerning his wife with no known allergies or pertinent medical history, who in November 2006, was vaccinated SC with a 0.5 ml dose of Zostavax. Concomitant therapy included levothyroxine Na (SYNTHROID) and Atenolol. On approximately 12-FEB-2007 the patient developed a very mild case of chickenpox on her torso and extremities. Unspecified medical attention was sought, there were no labs tests performed. On an unspecified date the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Flu-like syndrome.  Myalgia, pyrexia, arthralgia, intermittent, some dysphagia, some scattered dysesthesias
Swelling, redness and itchy welt at the injection site. First presented 8 days after injection and persisted for 3 days.
Monday 4/5/21 about 8am I woke up eyes Buffy Didn?t think anything of it As the week progressed I noticed my face itching and little fine rash starting. Still  not thinking about the shot at that time By Tuesday and Wednesday I had to take Benadryl  Because the rash was itching and beginning to spread and  I startled sneezing and feeling like I was having Allergies from being outside  Like high pollen count or something. I really noticed the rash spreading in my face  Around the eyes and everything prominently by Thursday. I itch a little bit under my breast and chest but no rash  It really feels like allergies which I?m used to except the rash I only get this creepy itchy rash when I have eaten something I?m allergic to like anything citrus. I am taking Benadryl and if it persist over the weekend. I?ll make an appointment to see my doctor on Monday  4/12/21
pounding headache, fevers, chills, night sweats, fatigue, myalgia, arthralgia, anorexia
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 57 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 to 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Hospital Course: Came in for (+) COVID-19 and hypoxia. Started on dexamethasone. Remdesivir was held due to AKI on CKD. Home O2 was passed on 12/21 but needed to watch patient overnight to ensure adequate renal function and urine output. Metabolic panel this morning was significantly improved. Will RX Robitussin PRN to assist with secretions/cough. Of note, patient had a (+) DVT in Right upper extremity. Will continue same Therapeutic Lovenox dose (80 mg BID) and repeat US in 1 week. She does have a follow up appt with Dr. in the local clinic on January 4, 2022. Will discharge with 2 additional days of dexamethasone and follow up with PCP in 1 week. Patient has home O2 and a spO2. She will continue to monitor her O2 status and was instructed to call her PCP or UH for an additional 5 days of dexamethasone (10 days total) if her spO2 is <90%.
chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VOMITING (vomiting) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and VOMITING (vomiting). At the time of the report, CHILLS (chills) and VOMITING (vomiting) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were reported.  No treatment medications were reported.
Initial unsolicited case received from a consumer on 16 Oct 2017. This case involves 67-year-old female patient who was vaccinated with 0.5 ml one dose of FLUZONE QUADRIVALENT (Batch number, expiry date were unknown) intramuscularly in right deltoid on 06 Sep 2017. Patient medical history was not reported. Concomitant medications were not reported (it was also reported that patient had not received any other vaccines). On 06 Sep 2017, within three hours after the vaccination, patient developed difficulty in breathing with eyes were swollen and puff. The patient went to ER and had unspecified steroids which helped. Relevant lab tests and other corrective treatment were not reported. On an unknown date, patient recovered from both the events. Upon internal review the company decided to consider the case as serious due to important medical events difficulty breathing and eyes were swollen and puff. List of documents held by sender: none.; Sender's Comments: The patient experienced difficulty breathing, eyes were swolledn and puff post vaccination with FLUZONE QUADRIVALENT. Time to onset was compatible and was indicative of an anaphylactic response. Patients medical histroy should be requested along with any allergic testing reports from past. Information regarding patients previous vaccinations and their tolerance should also be requested. ABsed upon reported information it looks like an allergic response but alternate etiologies should also be investigated. No conclusive inference could be drawn untill additional information is received.
Localized acute left axillary lymphadenopathy. Also expiratory wheeze, intermittent non-productive cough.
7 days after second dose, I was found with a rash on the upper half of my body (chest, back, arms, underarms). Doctor diagnosed me with Pityriasis Rosea