chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 101.2 F, fatigue What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these):  *** I reviewed Q400, 401 and 408. I adv can try some APAP as desired if this is something that can safely be taken without issues, stay hydrated, and if fever >102.5 F with APAP use consider evaluation and please call back if any worsening/persisting issues. Provided phone number and PCC/Covid line will check back on them on Sunday
Rash started on my right side and then my left side.  It continues to spread to my stomach and was on a majority of my trunk and continuing to spread which is why I went to Urgent Care
Within an hour - shortness of breath, wheezing, throat closing up/tight/itching Itchy rash on neck within an hour Received IM steroid, benadryl Tingling /shooting pain feet within 2 hours tingling/shooting pain of hands within 6 hours Muscle aches/ fatigue
A report has been received from a pharmacist concerning a patient of unknown gender. No medical history, concomitant diseases and concomitant medications were reported for consumer. The patient received FLUMIST QUADRIVALENT (intranasal) on unknown date. It was reported that when administering FLUMIST QUADRIVALENT (intranasal) the patient flinched and only one nostril received, also the dose went into the patient's eye. Did not have information on patient or lot number at time of call. Action taken for FLUMIST was not applicable. Outcome of both events were unknown. The report was considered to be non-serious by reporter.
pt recv vax 17APR96 & 22APR96 devel t104 to ER dx OM;med given;29APR96 rash onset to ER 30APR96 rash gen;blood drawn for IGm to TDH;cough, coryza, conjunctivitis, lymphadenopathy, koplik spot per MD;dx thrush
Case number PHEH2013US025573 is an initial spontaneous report received from a physician on 09 Dec 2013. This report refers to a 04-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 07 Dec 2013. The FLUVIRIN PFS and unopened MDVs reached 10 C from 05 Dec 2013 through 07 Dec 2013, reached 9.7 C on 08 Dec 2013 and reached 11.7 C on 09 Dec 2013. No adverse event was reported following this administration error.
Tetanus shot was done Friday it only looked like a size of a dime and now it has grown bigger and hot to touch and painful and swollen.
Patient was administered the second dose of her Moderna Covid Vaccination only 8 days after her first dose. She had a fever and aches and pains starting 24 hours later, and then felt fine by the 2nd day post vaccine.
Pt recv vax on 9/10/98; 10 mins later pt exp anaphylactic reaction w/ urticaria, sore throat, difficulty breathing, and puritis.
9/14 - called complained bump in area and a little sore. 9/16 - called her in am. Bump went down but bruising shoulder to elbow on 9-15 when she woke up. 9-16 - called her 1 pm and said she was fine but bruised.
Patient received the J&J COVID vaccine around 10:00 a.m.  In the evening began experiencing subjective fevers, chills, nausea, headache.  He took ibuprofen around 4:45 a.m. in the morning and went to work.  Symptoms do not improve and patient presented to ED for evaluation.  Patient denies chest pain, shortness of breath, vomiting, diarrhea, dysuria.  No Hx anaphylaxis.  Denies sensation of upper airway stridor or other respiratory symptoms.  Past medical history is unremarkable.  He is not on home medications.  Denies smoking or illicit drug use.   Patient was given 1 gm Tylenol, 10 mg metoclopramide, and 1 L NS.  Patient improved, and was discharged
She did receive her first shot i will do an AE on her because of the pregnancy; The patient received first dose of bivalent vaccine; No Adverse Event; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (She did receive her first shot i will do an AE on her because of the pregnancy), WRONG PRODUCT ADMINISTERED (The patient received first dose of bivalent vaccine) and NO ADVERSE EVENT (No Adverse Event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (She did receive her first shot i will do an AE on her because of the pregnancy), WRONG PRODUCT ADMINISTERED (The patient received first dose of bivalent vaccine) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (She did receive her first shot i will do an AE on her because of the pregnancy) had resolved and WRONG PRODUCT ADMINISTERED (The patient received first dose of bivalent vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for MATERNAL EXPOSURE DURING PREGNANCY (She did receive her first shot i will do an AE on her because of the pregnancy) and WRONG PRODUCT ADMINISTERED (The patient received first dose of bivalent vaccine).    Concomitant medications and treatment medications were not reported.  Company comment. This non  serious spontaneous case concerns an adult female patient, with no medical history reported, with maternal exposure during pregnancy and no adverse event reported. It was stated that the patient received a first dose with mRNA  1273.222 (Original/Omicron BA.4/5) vaccine. Additionally, wrong product administered was noted. Gestational period was not disclosed. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Reporter did not allow further contact
numb lips; numb fingers; bad headache; nausea; This is a spontaneous report from a contactable consumer or other non hcp. An unknown pregnant female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified) dose 1, via an unspecified route of administration on 17Feb2021 as single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if known allergies occurred. It was unknown if covid prior vaccination or if tested post vaccination. On 18Feb2021, the patient started developing numb lips and fingers, bad headache, and nausea. It was unknown if treatment was taken for adverse events. The outcome of the events was reported as unknown.  Information about lot/Batch number has been requested  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Given COVID Vaccine on 08/13/21, on 08/14/21 started having a hard time breathing, and a elevated heart rate, was taken to hospital on 08/14/21, pt recently moved to rehabilitation facility for continued care on 09/29/21
This case was reported by a physician via sales rep and described the occurrence of lethargy in a 16-year-old male patient who received BEXSERO for prophylaxis. On 21st August 2018, the patient received the 1st dose of BEXSERO. In August 2018, less than a week after receiving BEXSERO, the patient experienced lethargy, headache, fatigue and fever. On an unknown date, the outcome of the lethargy, headache, fatigue and fever were unknown. It was unknown if the reporter considered the lethargy, headache, fatigue and fever to be related to BEXSERO. Additional information was reported as follows: The patient was around 16.5 years old and complained of headache, fatigue or lethargy and fever. On 22nd August 2018, the following day after vaccination, the patient was brought to the emergency department for evaluation. The patient was monitored and released. The physician given permission to contact him, preferably by phone.
a small brain bleed, possible stroke, and is being evaluated for multiple sclerosis.; possible stroke; multiple sclerosis; vasculitis; This is a spontaneous report from a contactable other healthcare professional (Nurse). A 55 year old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262, expiration date unknown), dose 1 intramuscular, administered in Arm Right on 22Jan2021 13:45 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included COVID-19 on 29Oct2020 (She stated that some of her symptoms started in November when she returned to work). The patient concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and it was unknown that the patient received other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. On 22Jan2021, the patient experienced vasculitis, small brain bleed, possible stroke, and is being evaluated for multiple sclerosis. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 29Oct2020. The patient visited doctor or other healthcare professional office/clinic. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cerebral haemorrhage, cerebrovascular accident and multiple sclerosis cannot be completely excluded based on information provided. The case will be reassessed if more information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
No Adverse event; patients received the vaccines after the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date).    No concomitant medications were reported.  It was reported that, the patient received a bivalent Moderna COVID-19 vaccine after the 30-day beyond use by date of 12-Dec-2022 from 13-Dec-2022 to 17-Dec-2022.  No treatment medications were reported.  This case contains information for the 5th of 10 patients described by the reporter.
Injection sites visible both upper biceps with surrounding erythema and swelling without induration. Recommend icing both upper arms every few hours, NSAIDS or tylenol prn, monitor temp follow up for  fever or change is status for recheck. Left upper biceps - site of vaccine administration noted with surrounding erythema, heat covering medial to lateral & 6-7cm wide area. ** right upper arm vacine administration site noted with 6cm well demarcated area of erythema, swelling and heat.  All area have demarcated borders and no exudate or crusting. No open lesions. Remainder of body is free of lesions or rash.
PATIENT RETURNED TO THE PHARMACY 5 DAYS AFTER RECEIVING THE FLU IMMUNIZATION PRESENTING WITH A LARGE MODERATELY BLUE/YELLOW BRUISED AREA WHICH WAS APPROXIMATELY 3-4 INCHES BELOW THE SITE OF INJECTION AND TO THE LEFT OF THE INJECTION SITE. THE BRUISED AREA WAS NEVER PAINFUL TO THE PATIENT.
that evening experienced on her face especially her ears the next day the itching increased but facial edema started appearing along  with drainage from her ears on Saturday Jan 9th, eyelids edematous plus increased facial edema and increased ear drainage seen in the clinic on Saturday Jan 9th and was prescribed medications
Skipped 2 days between the first and second dose; Spontaneous report received on 16DEC2019.  A male consumer reported that he "skipped 2 days between the first and second dose" (PT: Inappropriate schedule of product administration) while being on oral Vivotif for typhoid fever prophylaxis. On 12DEC2019, the consumer took the first dose of Vivotif and took the second dose of Vivotif after two days on 15DEC2019. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer skipped 2 days between the first and second dose of Vivotif (Inappropriate schedule of vaccine administration). Considering the nature of the event, the causality of the event is assessed as not related.; Sender's Comments: A consumer skipped 2 days between the first and second dose of Vivotif (Inappropriate schedule of vaccine administration). Considering the nature of the event, the causality of the event is assessed as not related.
developed sx including runny nose, sore throat, cough, shortness of breath- tested positive for covid on abbott id now molecular test 10/7/2022  up to date w/ covid vax- not due for bivalent booster till 10/9/2022, primary series and 2 boosters all Moderna
Redness at site that is approx 2 inch long.  No pain.  Some itching.
Arm was extremely sore after the second vaccination I noticed that it was hot and red and on day four after the vaccination was given it started to itch I understand this is something called Covid arm I put Benadryl cream on it very disturbing
After injection, within 1 hour, started having left arm muscle tightening, up to left shoulder.   Following morning: facial numbnes/decreased sensation; mild facial droop.  Onset 9am on 12/28/2020.  Went to ED for evaluation.   Sensation started to resolve, continues to be slightly diminished on left side of face. Droop has since resolved.
fever & vomiting beginning approx 2hrs p/vax;fever & vomiting lasted into the evening about 8-12hrs;felt better next morning 17NOV95;arm sore @ inj site 18NOV95
4:55 p: Decreased O2 saturation, 70's. Copious frothy trach secres, oral secres. Rx - suction, increased FiO2 (4:55 - 6:20 pm - back to room air). No wheeze. 5:15pm: Flushed - total body; c/o itch. Gave GT Diphenhydramine 5:30. About 5:50 pm: HR still high greater than or equal to 160 pm, L.O.C. altered - ?seizure (has sz d/o). 5:55 pm: 5 mg DIASTAT and extra dose TEGRETOL 150mg GT. 6:15p: Asleep, Hr 140-150, in room air, asleep.   8/31/09 PCP medical records 7/2/07 to 8/27/09. Assessment: Seizure. Decreased O2 saturation, altered level of consciousness, increased heart rate.
Information has been received from a health professional concerning a 21 year old female with no known allergies who on 26-DEC-2006 was vaccinated with first dose of GARDASIL (therapy route not provided, lot # 654389/0961F). On 01-MAR-2007 and 20-AUG-2007 the patient was vaccinated with the second and third dose of GARDASIL (therapy route and lot # not provided) respectively. On 22-FEB-2011 the patient had a pap smear performed that resulted positive for human papilloma virus (HPV). A copolscopy exam was scheduled. Patient sought unspecified medical attention. At the time of reporting, the patient's status was not provided. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient, The patient's medical history included unspecified cardiac history, back pain and itchy skin. On 25-NOV-2014 the patient was vaccinated with ZOSTAVAX lot# K012924, expiration 29-NOV-2015, 0.65ml subcutaneous. Concomitant therapies included ATARAX. It was reported that the patient developed "red bumps along her spine that itched a week after she received ZOSTAVAX, and the red bumps lasted about a week and then went away." The pharmacist did not observe "bumps" and does not know it the patient developed a rash. It was unknown of the patient informed her physician or sought medical attention. No additional information reported. Follow up information was received from the pharmacist on 17-DEC-2014. The pharmacist reported that the patient sought medical attention from her pain physician. It was reported that the pain physician could see spots that he thought could be shingles. No further information. Additional information has been requested.
3 cm by 2 cm area of erythema/induration on right thigh at site of injection. Fussy, no fever.
Immediately after giving the immunization, Prevnar, the area surrounding the injection was red. The area of redness was still present 10-15 minutes post vaccine.  No redness was noted in her right deltoid where the Hepatitis A was given. Mom contacted PHN on 3/6/01. She reported her left deltoid area was red and puffy over the weekend. She reports the redness to be approximately 2" in diameter & a bubble at the injection site. Mom denied her having a fever, body aches. Mom reports the swelling and redness to be going away.
Pt vaccinated DTP/OPV experienced very atypical, high pitched scream for 1.5 hrs the evening of administration. Resolving without treatment.
Our facility only has the capability to store COVID19 vaccines in the refrigerator. Patient was given a vaccine that was outside of the 10 week expiration window. The 10 week expiration date was 6/10/22, patient was given the vaccine on 6/17/22. Patient has not reported any adverse events or symptoms to our facility.
Patient stated on 10/21/05 @ 1400 that he had "some type of reaction" from the flu shot given on 10/19/05.  Pt stated that his chest broke out into "hives" and his arm is red. the nurse obseved the following, after the sleeve of the (L) arm was pulled up it was (bright), hard and warm to the touch.  the chest area from the bottom of the neck was very red similar to a person blushing or being flushed on a hot day.  From the top of the collar bone the area was concentrated red then began to get less and less red as it descended to the nipple area of the chest.
Swelling on right side of face, puffy itchy eye, nasal discharge right side of nose 2 hours after injection, swelling and rash moved from left tip of ear to ear lope and rash on cheeks. Dizzy first 24 hours, headache 48 hours.
(L) deltoid erythematous area approximately 4cm x 3cm with pain. No other s/sx. Outlined area return if worse or not improving. Erythema and pain tx with ibuprofen and cool compress.
leg cramping/severe leg cramps/pain; leg cramping/severe leg cramps/pain; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9264), intramuscular, administered in Arm Left on 09Feb2021 12:15 as single dose for covid-19 immunisation. Medical history included blood cholesterol increased, anxiety, thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included Rosuvastatin (Tablet), orally ongoing at 20 mg once daily taken for blood cholesterol increased, Levothyroxine (Tablet), orally ongoing at 50 ug once daily taken for thyroid disorder and Sertraline (Tablet) orally ongoing at 50 mg once daily taken for anxiety. On 10Feb2021 09:00, the patient experienced leg cramping/severe leg cramps/pain. The action taken in response to the events for BNT162B2 was not applicable. The outcome of event was not recovered.
Patient presented 7/2 with SOB, fever, muscle aches, generalized weakness, and dry cough.  Diagnosed with COVID-19.  Reportedly started on ivermectin, dexamethasone, azithromycin, and an inhaled steroid by PCP with initial improvement, and then significant worsening warranting admission.  Was admitted to ICU, and emergently intubated on 7/2.  As of 7/6, patient remains intubated on mechanical ventilation in the ICU.
This spontaneous report has been received from a registered nurse, referring to an unspecified number of unspecified patients whose age and gender was unknown. Information about the patients' pertinent medical history, previous drug reactions and allergies was not provided. The nurse reported that, from 28-MAR-2018 until 28-SEP-2018, the patients were vaccinated with an unspecified number of improperly stored VARIVAX injection, for prophylaxis (doses number, frequency, route and anatomical location of vaccination were not provided; lot number N023956, expiration date 01-SEP-2019). The Merck sterile diluent (lot numbers R005481 [expiration date 30-NOV-2020], N029876 [expiration date 16-MAY-2018] and N030845 [expiration date 12-JUN-2020]) used concomitantly to reconstitute vaccines was properly stored according to reporter. The VARIVAX injections involved, were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (8.4F) for a time frame of 25 minutes, as was recorded by the Digital Data Logger. Previous temperature excursion was not reported.
pt stated that she had chills the night after rcvg vax.  The second night pt states she had an irregular heart beat.   Heart was beating about 30 beats faster than  usual at about 80-90 beats per minute.  Pt states when she woke up the next day she was back to normal so she has not contacted her PCP at this time.
Morbilliform rash surrounding injection site 7d post injection. Itchy & warm to the touch, lifted sleeve to see was also erythematous. No swelling noticed. No new tenderness (tenderness x2d followed administration date but did not return). Resolved within 48hrs. Felt fatigued during this same time period (but just because I?m a vet tech and, as I imagine applies with any human nurse, any given day I could have had a long exhausting day. So the fatigue may just have been that!
This spontaneous report was received from a back office lead and refers to a 56-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 02-FEB-2016, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (deltoid, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Arthralgia, chills, bodyaches Narrative:  Employee reporting chills, body and joint pain, fatigue, h/a after receiving 2nd vaccine on 1/8/21. unable to work on monday and tuesday, feeling better.