chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Chills; Body aches; Headache; Joint pain; Tired; Decreased appetite; A red injection site; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th October 2019, 1 days after receiving Shingrix, the patient experienced diarrhea, chills, general body pain, headache, joint pain, tiredness, appetite lost and injection site erythema. On 29th October 2019, the outcome of the diarrhea, chills, general body pain, headache, joint pain, tiredness, appetite lost and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the diarrhea, chills, general body pain, headache, joint pain, tiredness, appetite lost and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient woke up with chills, body aches, headache, joint pain, tired, decreased appetite, and a red injection site. On 28th October 2019, the symptoms improved and by 29th October 2019 they were all resolved. The reporter consented to follow up.
no additional AE's reported/no symptoms were reported; Proquad administered since the excursion occured on 22-JUL-2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # T037955, expiration date 09-MAY-2022, dose 1 (unit not provided) (injection site and route of administration were not provided) for prophylaxis.   On 22-JUL-2021, the administered dose experienced a temperature excursion of 13.02 degrees Fahrenheit for 1 hour and 30 minutes The digital data logger was involved in recording the temperature excursion details. Previously the dose experienced a temperature excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (14 degrees Fahrenheit) for 6 hours, 14 degrees Fahrenheit to 46 degrees Fahrenheit (46 degrees Fahrenheit) for 14 hours and 47 degrees Fahrenheit to 77 degrees Fahrenheit (48.9 degrees Fahrenheit) for 30 minutes. The vaccine was given a new expiry date of unknown date in September 2021. No additional adverse events were reported.   This is one of 5 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA004806: US-009507513-2108USA004804: US-009507513-2108USA004805: US-009507513-2108USA000973:
Pt given shot 6JUN91 approx 930AM; On 7JUN91 mom phoned MD stating pt screaming, fever 104R, twitching of limbs; Advised to give APAP stat, sponge bath & to call MD if temp didn't lower; W/in 45min pt seen by MD in ER-t103R in ER;
Patient received KINRIX outside of recommended age range. No S/S of adverse event. Pt did not have to obtain any treatment due to administration error.
My symptoms started around 10pm on April 24th and begin with minor chest pain and sore ribs.  After going to sleep I awoke in bed around 2am.  My symptoms were unable to take full breaths without extreme chest pain.  I was unable to lay on my stomach or side.  I could only lay on my back while taking very shallow breaths.  I ended up in the ER in the morning and given tests for my heart and lungs.  It was unclear what had caused this but the doctor provided a diagnosis of Pleurisy.
On night on vaccination (01/22/2021), experienced headache, fever, chills, nausea, and vomiting. On 01/23/2021, experienced same symptoms plus dizziness and muscle aches. Vomiting subsided on 01/24/2021 at 3:00pm. Muscle aches subsided on 01/25/2021 at 10:00am. Other symptoms persist. Nausea, fatigue, and dizziness are severe.
Pain on my armpit and my armpit is swollen; Pain on my armpit and my armpit is swollen; Headache; Chills; This is a spontaneous report from contactable consumer (patient). A 49-years-old female patient received second dose, via an unspecified route of administration (Batch/Lot number was not reported) on 25Apr2021 as Single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine included patients received first dose, via an unspecified route of administration (Batch/Lot number was not reported) on 03Apr2021 for covid-19 immunisation. The patient experienced chills and a little bit of a headache and started having pain on her armpit and her armpit was swollen in 2021. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Redness at injection site, no pain, last for 1 week. No treatment necessary.
OK to get another Shangrix, even if we got it 6 years ago; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix 6 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: OK to get another Shangrix, even if we got it 6 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-APR-2023 The case was reported by patient's wife. The reporter stated that six years ago patient had a shingles vaccination but we did not remember which one or where we got the shingles vaccination.  The reporter stated that it was okay to get another Shingrix, even if it was Shangrix that he received six years ago. The reporter also asked how many years after having Shingrix and the booster he need to get the series again or it would give permanent immunity to shingles. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2023AMR058045, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR058045:Same reporter.
dizzy/dizziness; hot flashes; This is spontaneous report from a contactable other healthcare professional (the patient). An 83-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 22Mar2021 (Lot Number: ER6955), dose 2 on 14Apr2021 (Lot Number: ER8735) (Time the Vaccination Was Given as "1000", it did not specify if it refers to the first/second dose), both via an unspecified route of administration in the right upper arm at age of 83-year-old at single dose for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Medical history included vertigo that happened 6-7 years ago and she was hospitalized for this. No family medical history relevant to AE. The patient's concomitant medications were not reported. The patient experienced the dizziness and hot flashes after the first dose of the vaccine (2021), the caller did not know dates of the dizziness and hot flashes she experienced after the first dose of the vaccine. The symptoms then weren't as bad as the ones she was having currently after the second dose of the vaccine. The caller stated that she had been dizzy, it was almost like vertigo that she had once before, she had been dizzy since Friday 16Apr2021 and was very dizzy on Saturday 17Apr2021 (after the second dose). She had also been having hot flashes. She has Meclizine and had taken those a couple of times. The patient had the same symptoms after the first dose of her vaccine but they were not as severe. Caller stated she did not know if her symptoms were caused by the vaccine. She thought they might be since they started after the vaccine but is not certain. No Emergency Room or Physician Office visit. The outcome of the events was recovering. The events were not serious.  No follow-up attempts are needed. No further information is expected.
Pt was given a Peds Hep B instead of an adult dose.  The patient did not have any adverse reaction to the medication.  No allergies listed for this medication.  MA accidently took the medication from the wrong stock.
Day 1 - soreness in neck and shoulders that became worse as the evening progressed. Day 2 - soreness especially in neck and shoulder areas, but ached all over my body. Day 3 - Soreness greatly lessened, but tightness is chest began. Days 4 and 5 - tightness in chest and frequent coughing Treatment - Tylenol every 4 hours; rest; stayed home from work two days.
Headache for 6 weeks, didn't respond to ibuprofen, Tylenol, Excedrin, or Tylenol migrane. Missed 3 months of my period, followed by 4 back-to-back periods with only 10 days in between (and the associated fatigue and discomfort that comes with this type of period cycle).
approx 5min p/vax pt c/o tingling to front 1/2 of tongue;approx 20min p/vax c/o throat feeling thick;pt refused treatment;gradual resolve of sx over 35min;
Mild chest pressure and shortness of breath.  Followed with itching of ears, neck, fingertips, scalp and flushing of face and chest.  Medicated with Benadryl 50 mg at 2:30 PM.  Continued itchiness and flushing.  Medicated with Ranitidine 50 mg IV at 3:30 PM.  Medicated with Dexamethasone 4 mg IV at 4:30 PM.  Continued Dexamethasone 4 mg PO BID X 2 days and Ranitidine 50 mg PO BID X 2 days and Benadryl 25 mg PO Q 8 hours X 2 days.
This spontaneous report was received from a Licensed Practical Nurse on 13-DEC-2016, concerning a 4 years old patient of unknown gender. On 14-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD for prophylaxis (lot number L050907) (dose number, frequency, route of administration and anatomical location were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756: US-009507513-1610USA013820: US-009507513-1610USA013819: US-009507513-1610USA010040: US-009507513-1612USA008582: US-009507513-1612USA008583: US-009507513-1612USA008584: US-009507513-1612USA008585: US-009507513-1610USA010040.
On the afternoon of December 31st a rash broke out on my forehead.  When I woke up on January 1st it had started changing to blisters and the whole right side of my face hurt and started swelling.  I thought it was just a contact dermatitis.  Woke up the next day and it had gotten worse.  Finally, on the morning of the 3rd I realized it was something else and went to the urgent care.  I was immediately diagnosed with Shingles and was prescribed and anti-viral medication.  Because of the location I immediately had to go to the Opthamologist to make sure it was not in my eye.  At this point it is not in my eye but I have to go back to the Doctor again on Monday the 10th for another staining.  It has continued to worsen over the last 2 days.
EMS CALLED TO NH FOR SYNCOPAL EPISODE ON 7/7/2021. PT IS DNR. ON ARRIVAL TO ER, NO CHEST WALL MOVEMENT NOTED NOR BREATH SOUNDS HEARD. WEAK CAROTOID PULSE; BP UNABLE TO BE DETECTD. PT PRONOUNCED AT 8:00:00 EXPIRED.
I had vaccination on 10/25/2022. On 01/07/2023 I started to experience fatigue, cough, body aches, scratchy throat and diarrhea. I tested COVID-19 positive on 01/08/2023. My doctor prescribed PAXLOVID. I am feeling presently fine on 01/25/2023.
Pt seen two days after administration of vaccine with complaint of left deltoid soreness with slight erythema and lymphadenopathy-1.5cm lymph node left neck above claricle and anterior to sternocleitomostoid.
severe abdominal distress-including nausea, vomiting, diarrhea, and abdominal (stomach) cramping
pt had a positive COVID test on 8/11/21 from a local Medical Center; pt died at home ; natural death; causes of death:  Acute CVA, coagulopathy with thromobocytopenia, COVID 19
pain, numbness and tingling to L thumb and index finger radiates upward to arm  and L side of face ( lips and cheek) x 4 months. Reports symptoms began 1 day after Flu vaccine adminstration.
PATIENT RECEIVED PFIZER VACCINE AT 11:45 A.M.   AT 12:30 P.M.   PATIENT EXPRESSES NAUSEA, DIZZINESS AND WEAKNESS.    EMT PROFESSIONAL TAKE VITAL SIGNS AND HER BLOOD PRESSURE WAS 190/70 RIGHT ARM,  240/70 LEFT ARM,  PULSE: 59 BPM, 02: 98%, BLOOD GLUCOSE 127 MG/DL.    SITE CONSULTING DOCTOR EXPRESSED TO TRANSFER PATIENT TO THE EMERGENCY ROOM.   PATIENT EXPRESSES SHE RECEIVED 14 DAYS BEFORE A HEART STENT BY INGUINAL CARDIAC CATHETERIZATION.
p/vax pt exp a cellulitis type rxn w/an inflamed reddened & hard area @ the inj site;
Shingles after Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months 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 case details were reported as follows: The age at vaccination was not reported. The patient developed shingles after first dose of Shingrix. The reporter consented to follow up.
I am the epidemiologist reporting on behalf of 80 year-old male patient.  Patient received one dose of the Pfizer vaccine on 2/04/2021, according to immunization records.  The patient passed away on 2/11/2021 (7 days post first dose, hospital inpatient). The death certificate lists ?Acute Hypoxic Respiratory Failure (3 Days)? as the immediate cause of death secondary to acute heart failure (few days). Other significant conditions contributing to death but not resulting in underlying cause include acute kidney injury requiring hemodialysis, staph bacteremia, chronic systolic heart failure.  No additional information regarding underlying conditions that may have contributed to this death is available.
Fussiness, Tiredness and poor appetite, Non-Stop cry for more than 3 hours, complains of pain in the nose, Difficulty breathing, wheezing, paleness, weakness, hot one minute & ice cold the next or clammy, fast heart beat then slow heart beat, dizziness off & on again, speech impaired, no longer able to focus, impaired sleep
This spontaneous report was received from a respiratory therapist refers to a three unspecified patients, age and gender were unknown. Medical history was not reported. The respiratory therapist informed that between 01-FEB-2014 through 31-MAY-2014 the patients were vaccinated with GARDASIL injection, (route, strength and dosage were not reported), which was improperly stored. The possible lots involved included: H018755 expiration date 21-MAR-2015; T005679, expiration date: 27-NOV-2015 and T007850, expiration date: 07-APR-2016. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 36 hours after receiving pneumococcal vaccine patient developed edema, redness, and pain to left upper arm in deltoid region. Arm x-rayed; no fracture found.
Swelling, erythema, induration left thigh around vaccine site. (IPV#4, DTaP #5).
Swollen lymph nodes under left armpit for more than a week; extreme fatigue; Slight chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 (Lot number: EW086) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Aug2021, outcome "not recovered", described as "Swollen lymph nodes under left armpit for more than a week"; FATIGUE (non-serious) with onset 15Aug2021, outcome "not recovered", described as "extreme fatigue"; CHILLS (non-serious) with onset 15Aug2021, outcome "not recovered", described as "Slight chills". Therapeutic measures were not taken as a result of lymphadenopathy, fatigue, chills.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Stroke on March 24, 2021.  Widespread blood clots discovered on April 3rd, 2021.  Death on April 5th, 2021.
At 7:15 am per mother, pt let out a scream and then had a general seizure lasting 3-4 minutes. Vomited once at about 9 am. Now 9:45 pt acting back to normal.
8MAR99 pt called stated had hives on legs p/2 doses oral typhoid;
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patient of unknown age and gender. The nurse reported that the vaccine PEDVAXHIB underwent a temperature excursion, then on an unknown date unspecified amount of patients were vaccinated with this PEDVAXHIB (dose 0.5 ml, lot number and expiration date not reported) intramuscular. There was no concomitant medication reported. No adverse effect reported. This is one of two reports from the same source. Additional information has been requested.
Information has been received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients were each vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # M020926, expiration date 11-AUG-2018) (route and dose were not reported). The vaccines were stored at 34.7 degree Fahrenheit for 11 hours and 47 degree Fahrenheit for 45 minutes. The temperature excursions were detected by a "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
General malaise, muscle twitching, headache, joint soreness, chills, and swollen and painful lymph node under right auxiliary. Same arm as vaccine administered
Sudden difficulty breathing. Heaviness and tightness in chest followed by an exacerbation of CHF that led to hospitalizations.
Local site reaction to influenza virus vaccine.  Redness, hot and edema from shoulder to elbow of L arm at site.  c/o fatigue x3 days.  Symptoms resolved on their own.
Hives on his neck and mostly his face; Headache; Fatigue; Soreness, and body aches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on his neck and mostly his face), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Soreness, and body aches) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced URTICARIA (Hives on his neck and mostly his face), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Soreness, and body aches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 milligram. At the time of the report, URTICARIA (Hives on his neck and mostly his face), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Soreness, and body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up information received on 23-Apr-2021 contains non-significant information.
Pt reported to the health unit today that she received the vaccine on 3/25/2021 at 12 PM.  She reports that ~5 minutes later her palms became diaphoretic and she started to feel "on edge."  She waited for 30 minutes before checking out with the nurse.  She reports that since the vaccination she has constantly been on the verge of a panic attack and is having difficulty sleeping because she is being "jolted" awake.  However, she admits she has not actually had a panic attack since vaccination, but she believes the vaccination is responsible for her current symptoms since they have not completely resolved. Pt does report an intermittent history of panic attacks dating back to 1997.  She reports her panic attacks started after she started taking mefloquine.  She has had panic attacks as recently as 2017, 2018 and 2020, usually secondary to external stressors.
Pt recvd 2nd dose of vax on 20FEB92 & on 22FEB92 devel serum sickness reaction described as diarrhea, gastrointestinal discomfort, arthralgia, myalgia, chills, fever; 24FEB92 seen by MD had some mild stomach discomfort; poss influenza-like
Very tired with shaking chills and fever of 101.1 from about 9:30 am on 9/15 through until 09/16 about 3 am. My arm is very hard and swollen and a warm bright red down to the bottom of my bicep. Very painfull
Headache, nausea, really bad chills  that woke her out of her sleep
This spontaneous report was received from a register nurse, refers to a currently 13 year old patient. The patient's medical history and concurrent conditions were not reported. The register nurse stated that on an unknown date, the patient was vaccinated with two doses of VARIVAX (Merck) (extra dose administered), (strength, dosage, frequency, lot # and expiration date were not reported). Concomitant therapy was not reported. No adverse symptoms reported. This is one of two reports received from the same reporter. Additional information has been requested.
soreness; redness; itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), ERYTHEMA (redness) and PRURITUS (itching) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (soreness), ERYTHEMA (redness) and PRURITUS (itching). The patient was treated with CORTISONE at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, PAIN (soreness), ERYTHEMA (redness) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact
Narrative:  Patient received Moderna COVID #1 on 3/13/21 and #2 on 4/10/2021. On 4/12/21, family contacted the clinic to report that Patient had a reduced appetite and was sleep a lot. He refused to attend his follow up appt. with cardiology that day. No other notes entered or scanned records available. Date of death is recorded as 5/7/21. No autopsy report available. Time from second vaccine to date of death was 27 days.