chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This infant had a fever of 105 four hours after his shot. A fever of 103 lasted 2 1/2 days, which was managed w/ children's Advil. Then a low grade fever for two days; 2nd low grade day, roseola developed.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE ERYTHEMA (Big Red Mark (injection Site)) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE ERYTHEMA (Big Red Mark (injection Site)). At the time of the report, VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE ERYTHEMA (Big Red Mark (injection Site)) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided.  Treatment information was not provided.
Pt was given 3rd dose of COVID-19 (Moderna).  Pt scheduled an appt. for the vaccine.  Pt did not inform us that he had the series of vaccine.
This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 69-year-old male patient who received SHINGRIX. The patient's past medical history included shingles and ophthalmic herpes zoster (it reoccurred again in 15th June 2017). Concurrent medical conditions included lymphoplasmacytic type lymphoma (Kiel classification) (In partial remission since Dec 2014). On 21st December 2017 16:52, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th January 2018, 29 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the ophthalmic herpes zoster was not recovered/not resolved and the outcome of the injection site pain was unknown. The reporter considered the ophthalmic herpes zoster to be unrelated to SHINGRIX. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: In March of 2017, the patient was first diagnosed with shingles on his forehead. With medication, it resolved but on 7th April 2017 it returned and was in patient left eye. The patient took medication and it resolved, so was titrated off the medication. Then on 15th June 2017, shingles came back in his left eye and was again treated. On 13th November 2017, the patient doctor said he was clear of shingles. After receiving vaccines, on 19th January 2018, after receiving vaccination, the patient broke out again with shingles in his left eye. Less than a year after receiving vaccination, the patient experienced sore arm. No information was gathered for the sore arm other than they assumed the shot was given intramuscularly as both he and his wife had sore arms. This case was linked to the case US2018032694 (case reported for patient's wife).
At 12:30PM, I started getting a migraine, nauseated, and fatigued.  By 1:15PM, I was having a  hypertensive crisis.  I went to my doctor's office with a  blood pressure of 191/109.  I was administered an EKG, which came out abnormal.  I was prescribed new blood pressure medication and sent home.  My blood pressure continued to spike out of control, and I had chest pains, shortness of breath and nausea.  I went back to my doctor on the 15th and had another abnormal EKG.  She sent referred me to a cardiologist, who I saw on the 16th.  She prescribed new blood pressure medication.  I made an appointment for additional testing, but ended up hospitalized on the 23rd when my symptoms worsened.
CoughWheeze Patient stated throat was itchy, advised to transport employee to ER, employee refused Narrative:  Vital signs were taken Blood pressure 208/135, Pulse 100, O2 Saturation Room Air 98%. Patient states that blood pressure is around 200/100 and his provider is aware.
Patient should have received pfize bivalent for >12 y.o has given pfizer bivalent 5-11, no adverse reaction
Red, hot spot on arm-feverish-headache-extremely tired- a bit nauseated.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: pt developed itch and rash around neck 10-15 min after shot. Hasnt had flu shot in 20 years, 50mg benadryl given, Emergency called. Pt had no other symptoms. vitals were checked by emt, and pt was advised to go to urgent care if needed. oxygen saturation 98%. pt went home with family.
Vaccine continuously stored in stable freezer environment, only stored in fridge on date of administration for thaw period; Patient received expired dose of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine continuously stored in stable freezer environment, only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine continuously stored in stable freezer environment, only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine continuously stored in stable freezer environment, only stored in fridge on date of administration for thaw period) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Swelling at injection site; Severe pain shooting through arm to armpit and allthe way to middle of chest.; Shortness of breath; Severe pain shooting through arm to armpit and allthe way to middle of chest.; Severe pain shooting through arm to armpit and allthe way to middle of chest.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 12Apr2021 at 09:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included chiari and high blood pressure. Concomitant medications included morphine hydrochloride (MORPHINE), hydrocodone bitartrate (HYDROCODONE), tizanidine (MANUFACTURER UNKNOWN) and amlodipine besilate (AMLODIPINE) started on an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 20:00, the patient experienced swelling at injection site, severe pain shooting through arm to armpit and all the way to middle of chest and shortness of breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling at injection site, severe pain shooting through arm to armpit and all the way to middle of chest and shortness of breath were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Swelling, redness and itching noted to left ears. 10:40 Benadryl 5mg given IM.
The vials were frozen and underwent 4 temperature excursions total; 7 doses given from 5 vials were eventually punctured and used after the 2nd excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The vials were frozen and underwent 4 temperature excursions total) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials were eventually punctured and used after the 2nd excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vials were frozen and underwent 4 temperature excursions total). an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials were eventually punctured and used after the 2nd excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The vials were frozen and underwent 4 temperature excursions total) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials were eventually punctured and used after the 2nd excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  On 13-Jan-2022 the freezer got to 5.4F for 15 minutes, then returned to the appropriate temperature range. On 20-Jan-2022 the freezer got to 6.1F for 15 minutes, then returned to the appropriate temperature range. On 11-Feb-2022 the freezer got to 10.8F for 10 hours and 15 minutes overnight into 12-Feb-2022, then returned to the appropriate temperature range. On 25-Feb-2022 the freezer got to 22.6F and was out of range for 20 hours total into 26-Feb-2022 then returned to the appropriate temperature range. The storage condition at the time of the excursion was frozen.  The vials were moved from freezer to refrigerator on 1 dose/vial on 20-Jan-2022. No visual inspection was done, noting any vaccine state change. No treatment medication reported.
Pt came back @ 11:40 am after flu vaccination with c/o "lightheadedness and sick to stomach". After 35 minutes pt had red, splotchy spots on chest and red ears. No itching, no wheezes, at 1:01 pm, pt c/o difficulty taking deep breath. O2 24 min per NC applied. Pt sent to ER via EMS with mom accompanying her. 12/15/09: 5:05 pm spoke to family member stated pt doing better and is on her way home from ER.
pt recvd vax 945AM & had t101, localized redness to arm & chills; pt recvd APAP for pain;
Patient called 36 hours after she received ZOSTAVAX injection to state that she had a raised, painful injection site reaction and a visual, non-erythematous total body rash, plus a 101 degree F fever. She used APAP to reduce fever and reported no further sx the following day. She did not seek medical treatment.
Developed red area  with in duration and pain to touch initially a single lesion on right forearm on  1/5/21. Initially lesion got larger over first 12 hours. It then became itchy on 1/6/21 in the morning with a second smaller lesion just proximal to the first one. Thought it was hives. On evening of 1/6/21 developed similar lesions on left knee and posterior left ankle. Took Allegra and Zyrtec that evening. Lesions on right forearm looked like bruises on 1/7/21 with resolution of lesion on left knee. Lesion on left ankle has stayed red, swollen, itchy, and painful. Did not respond to Allegra, Zyrtec, or benadryl.  I went to primary care provider on 1/8/21 at 2:45 PM. I had labs drawn and received prescription for steroids.
Fever, chills, fatigue, no appetite, fainting and seizure. From early next morning for 72 hours total
Urinary tract infection; Spontaneous report received on 13DEC2019.  A pharmacist reported that a female consumer developed urinary tract infection (UTI) (PT: Urinary tract infection), following immunization with Vivotif. On an unknown date, the consumer started taking Vivotif. It was reported that she developed UTI while she was taking Vivotif. The consumer completed Vivotif four day before reporting and was prescribed with Macrobid (nitrofurantoin; 100 mg; 1 capsule twice daily for 5 days) for UTI which has not been started yet. Action taken with Vivotif with respect to reported event was dosage maintained. At the time of report, she was not recovered from the event.   Reporter considered the event urinary tract infection not related to Vivotif.  Company Comment: A consumer developed urinary tract infection while being on Vivotif. She was prescribed with nitrofurantoin for treating the event. A follow-up query was requested to know after how many days of completing Vivotif course she has started nitrofurantoin. The causality of the event is assessed as not related to Vivotif due to the infectious pathogenesis of the event, urinary tract infection.; Sender's Comments: A consumer developed urinary tract infection while being on Vivotif. She was prescribed with nitrofurantoin for treating the event. A follow-up query was requested to know after how many days of completing Vivotif course she has started nitrofurantoin. The causality of the event is assessed as not related to Vivotif due to the infectious pathogenesis of the event, urinary tract infection.
Client presented for covid vaccine with a history of anaphylaxis to antibiotics. Nurse had client agree to staying for observation for 30 minutes due to history and client agreed. Client reported her throat "felt funny" roughly 15 mins post vaccination. Nurse monitored client and asked her to report any new or worsening symptoms.  BP 120/60; P 68 Resp 22. Client asked for help at 1:45 with worsening symptoms, about 25 minutes after vaccination. Vitals taken and were the same as earlier. Client  took home albuterol at 1:51 pm and 1:54 pm without any change in swelling or throat sensation. EMS called. EPI given. Symptoms did not improve with EPI and client was transported by 2:20 pm.
A few weeks after my first vaccine shot I noticed ringing in my ears (tinnitus). It is consistent throughout the day and has not gone away.
I was walking the dog around noon and the dog yanked on the leash and I about passed out I had aches and pains all over my body with a bit of a headache and real watery diarrhea.
Case number PHEH2012US014989 is an initial spontaneous report received from a nurse on 27 Jul 2012: This report refers to an 11-year-old female patient. She was given only the CYW-135 liquid component of MENVEO vaccine (batch number: X11046) intramuscularly on 27 Jul 2012. No other adverse reaction was reported following this administration error.
Pt fainted in observation room approximately 5 minutes after vaccination in left arm. Pt lost consciousness for approximately 30 seconds. Pt able to converse with medical personnel after that time, able to sit up approximately 10 minutes after episode and able to  walk to his vehicle approximately 25 minutes  after episode. Pt driven home by spouse.
Missed dose/ Missed a dose of medication; Leg cramps and aches; Leg cramps and aches; This is a spontaneous report from a contactable consumer based on the information by Pfizer (Mrf. Con-trol Number: 2021IN000980). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported) via an unknown route of administration on 03Feb2020 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation and taking ruxolitinib phosphate (JAKAFI, tablet, Lot Number: 9959035) via orally from 19Feb2015 to an unknown date, at 10 mg, daily for an unknown indication. The patient medical history was not reported. Concomitant medications included calcium, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and multivitamin taken for an unspecified indication, start and stop dates were not reported. The patient experienced missed dose/ missed a dose of medication, leg cramps and aches on an unspecified date. At the time of the report, action taken on JAKAFI was unknown. The outcome was unknown for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever greater than 100.0 Body aches Joint pain Shortness of breath  Tenderness/soreness at injection site
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer (History of prostate cancer (10 years ago).). Previously administered products included for an unreported indication: AMLODIPINE, LATANOPROST, MULTIVITAMIN & MINERAL, TAMSULOSIN and SERTRALINE. Concurrent medical conditions included Prediabetes, Hypertension, Benign prostatic hyperplasia, Hernia (Left in wall hernia) and Depression.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  The patient received their first dose of the vaccine on 24-Jan-2021 and experienced a sore arm.   This case was linked to MOD-2021-319746.
Case number PHEH2011US01888 is an initial spontaneous report received from a health care professional (medical assistant) on 17 Aug 2011. This report refers to a 12 year old female patient. She was vaccinated with MENVEO (batch number: A10062/X10062) 0.5 ml, intramuscularly on 17 Aug 2011, which was stored out of range temperature during shipment on 17 Aug 2011. No adverse event was reported following the vaccination.
A 52 year old female received an intramuscular injection of MassBiologics Td (Lot #A096B) in the left deltoid on June 19, 2017 for wound prophylaxis after cutting her index finger while cooking. On June 22, 2017, the patient experienced warmth at the site of injection and pain in her left arm. The patient reported to her provider that she had experienced symptoms for about 2 weeks before recovery. The only treatment the patient received was an ice pack applied to her left arm. No follow-up was required as the patient had fully recovered by the time of the report.; Sender's Comments: Both adverse events reported in this case were assessed as non-serious and labeled. The patient reported receiving an injection of Td (manufacturer unknown, Lot #U4669AA) in January 2016. Please note that reports 'US-MassBiologics-AE1703' and 'US-MassBiologics-AE1705' have been linked to this report. These three adverse events were reported to MassBiologics at the same time by the same primary source reporter.
Parents described redness left thigh 1 day after vaccines infant had fever 103 degrees F. Parents concerned for lump left thigh at vaccine site (2.5 cm x 1.5 cm measured) on 5/18/16 at office for re-check.
Patient awoke screaming/crying, eyes tightly closed with brief jerking of upper arms, then flailing of arms and hitting parents. Seen in our ER where above description noted with eyes squeezed shut and crying and hitting parents. Vitals stable, afebrile. Crying lasted 4 hours. Recovery complete.
Right shoulder aching the first two days, fairly extreme stomach pain still felt on day 3, fatigue thru day 2 and a little into day 3, minor headache
On June 9, 2021 I developed paralysis on the entire right side of my face.  I could not raise my eyebrow, close my eye, nor would the right side of my mouth move when I tried to smile.  I was taken by car to Urgent Care, and from there to Hospital by ambulance.  There I was placed under Stroke Protocol where multiple tests were conducted to rule out the possibility of a stroke.  After the testing was completed, I was admitted to the hospital for the night for observation and was seen by several different doctors.  I was eventually diagnosed as probably having Bell's Palsy and was put on a regime of prednisone and antiviral medication for 10 days following my release.  The symptoms worsened for about 48 hours before stabilizing.  To date, the paralysis has not lessened.
Moderna COVID-19 Vaccine EUA Initial response injection site symptoms (redness,  warmth, itching, swelling, pain) were slowly dissipating.  Approaching 1 wk after vaccination, however, itching increased, followed by a marked erythemal response that continues to advance, along w/return of warmth.
Very painful administration. Arm pain, now lasting over 4 weeks. Limited use of arm. Pain primarily in upper right arm. Visited doctor. On NASID for 2 weeks - no relief. Pain on movement - primarily in horizontal motion.
MILD SWELLING AND REDNESS AT SITE APPROX 5 CM DIA.STATES VERY LITTLE DISCOMFORT.  TOLD MOTHER TO GIVE TYLENOL AS NEEDED AND USE WARM COMPRESS.
Patient developed fever, body aches, SOB, loss of taste/smell 8 months and tested positive after being fully vaccinated for COVID.
Started with a mild upset stomach, then nausea, then vomiting, followed by severe diarrhea.  The vomiting & diarrhea continued throughout late evening.  Severe chills after going to bed.  Very weak by next morning but the illness had passed.  Ate only soup the next two days and suffered weakness.  By 1/11/2011 the illness had ceased.
On 3/5 Body aches and stiffness started that lasted about two days. No treatment and it went away by itself.
UPPER LEFT ARM CHANGED COLOR TO RED. IT STARTED IN THE EVENING ON 09/27/18, PATIENT CAME TO BACK TO THE PHARMACY ON 9/29/19 TO SHOW ME HIS ARM. HE DID NOT APPLY OR TAKE ANY MEDICATION TO CONTROL IT.
Body aches; Vertigo; Pain in joints; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 13:15 as dose 4 (booster), single (Lot number: GL0446) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; TRAZODONE. Vaccination history included: Covid-19 vaccine (DOSE: 01, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 02, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 03, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 12Nov2022 at 06:00, outcome "recovered", described as "Body aches"; ARTHRALGIA (non-serious) with onset 12Nov2022 at 06:00, outcome "recovered", described as "Pain in joints"; VERTIGO (non-serious) with onset 12Nov2022 at 06:00, outcome "recovered". Therapeutic measures were not taken as a result of arthralgia, pain, vertigo.  Additional information: No other vaccine was in four weeks. Other vaccine in two weeks were Crestor, Trazodone, multi vitamin.  No follow-up attempts are possible. No further information is expected.