chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of HIV viral load increased in a adult patient who received SHINGRIX. Concurrent medical conditions included HIV infection. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced HIV viral load increased (serious criteria GSK medically significant), influenza-like symptoms and tiredness. On an unknown date, the outcome of the HIV viral load increased, influenza-like symptoms and tiredness were unknown. It was unknown if the reporter considered the HIV viral load increased, influenza-like symptoms and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient complained of flu-like symptoms, very tired and did not go to work for 1 week, and his viral count was increased. The pharmacist refused to provide additional details.
Swollen right arm, 2"x2", dark red, hard, painful. Increased in size since Friday. No fever, no SOB, only site specific sxs.
WITHIN 2 DAYS, HIS ARM WAS REALLY SORE, RED IN COLOR, WARM TO THE TOUCH, SWOLLEN.  HE HAD AN INDURATION THE SIZE OF A GOLF BALL.  SOFT TISSUE SWELLING 2-3 INCHES ABOVE THE INJECTION SITE ALL THE WAY DOWN TO HIS ELBOW.  LOW GRADE FEVER 2 DAYS POST VACCINATION.  VACATIONED 2 DAYS POST VACCINATION.  HE SAW A PHYSICIAN THERE.  PHYSICIAN GAVE HIM KEFLEX AND A PROBIOTIC.  HE PUT ICE AT THE INJ SITE FOR A FEW DAYS, THEN SWITCHED TO TAKING A WARM SHOWER.  NOTHING HELPED HIS PAIN.  HE IS NOW BACK TO NORMAL WITH NO LINGERING SIDE EFFECTS.  NOTE: THE INJECTION WAS GIVEN IN THE OUTER ASPECT OF THE TRICEPS NOT IN THE DELTOID REGION AS RECOMMENDED BY THE ACIP.
Pneumovax23 was administered first and the Prevnar 13 dose has been delayed and has not been given to the patient al this time; This spontaneous report was received from a pharmacist via Pfizer and refers to a 59-year-old male patient. The patient's concurrent condition included being immunocompromised. The patient's medical history included recent heart transplant. His concomitant therapies were not reported.  On 21-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, intramuscularly in the left arm, frequency was reported as once, lot # S029265, expiry date 31-MAR-2021, for prophylaxis. It was reported that he used pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) because of post heart transplant vaccination check list.  The patient was prescribed with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) and then a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was supposed to be administered 8 weeks later. However, the vaccines were administered backwards and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was given first. The dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) was delayed and was not given to the patient at the time of the report. Action taken with both suspect vaccines was reported as unknown.  The pharmacist considered the event to be medically significant as it had the potential to be very significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
received expired dose of Pentacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Medical Information (Reference number- 00722325) and transmitted to Sanofi on 12-Aug-2021.  This case was linked to case-2021SA270105 (cluster).  This case involves a four-month-old female patient who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 10-Aug-2021, the patient received a second dose (0.5ml) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ325AA; expiry date: 13-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported, "Caller states that 2 patients received expired doses of PENTACEL in the practice on 10AUG2021 and 11AUG2021 respectively. Caller asked about how to proceed after administering expired doses to these patients."  No adverse events were reported at the time of this report.  At the time of this report, the outcome of the event was 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
10 hours after administration, arm became swollen and patient developed syncope. Patient also experienced tinnitus, although not 100% sure this was connected to the vaccination.
Administered booster dose of Moderna (blue top).  Person should have received Moderna Bivalent booster (blue top).  No adverse event occurred,
Narrative:  Pt was a 68 YO female with PMH of ascites, hep C, HCC, HTN cirrhosis of the liver, PVD, and CVA. No details available in chart regarding cause of death.
She got a shot on Sat and later had a red mark. This was still there this morning and was swollen.
(R) lateral thigh 3x3.5 cm mildly erythematous area with induration and mild swelling, no warmth, nontender.
I experienced extremely excruciating pain constantly in my right foot;on the second day of taking the second dose of Moderna! I was unable to find any relief and was unable to sleep or do anything for 3 days and nights! The pain was unbearable and the gabapentin did not help any at all. On the forth day, the pain finally subsided.
abdominal pain/Her pain is still ongoing; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain/Her pain is still ongoing) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Urinary infection.    On 05-Oct-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 October 2022, the patient experienced ABDOMINAL PAIN (abdominal pain/Her pain is still ongoing). At the time of the report, ABDOMINAL PAIN (abdominal pain/Her pain is still ongoing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: They had done many tests including blood tests and a CT scan. Her pain is still ongoing today. On an unknown date, Computerised tomogram: They had done many tests including blood tests and a CT scan. Her pain is still ongoing today.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  Patient did not other vaccines in the 4 weeks prior COVID-19 vaccine. In the middle of Oct patient went to emergency room with abdominal pain. Patient received first dose in may-2021. Second dose and first booster at unknown times.  Treatment medications were not reported.
Diarrhea, eye infection, congestion, bloody diaper rash, irritability.
"pt recv vax 5AUG97 & 12AUG97 it was reported that pt on 6AUG97 ran fever of 103.5, diarrhea, small 4 or 5 bumps on diaper area;no local rxn from either shot noted per mom;pt sent to pediatrician to r/o vax rxn vs viral, ear etc;"
patient BP shot to 166/97 and he was experiencing severe chest pain. ambulance was called and the checked his heart and found no abnormalities. patient did not go to hospital, but said he would if the chest pain continues
3 weeks post Right deltoid Moderna  Vaccine the patient developed lymphadenitis. Infectious Disease physician was consulted. Patient  to take  naproxen 550mg po bid for 5 days and Prednisone 20mg po daily for 5 days Patient was  instructed that he may proceed to 2nd dose Moderna but would defer administation until lymphadenitis has resolved and he is not taking prednisone
41 yo female received second dose of Moderna COVID-19 vaccine on 1/26 @1747. Approximately 15 minutes after time of administration, patient had s/s of tongue swelling and dryness as well as an anterior chest wall erythematous rash. No airway involvement based on assessment by physician. Reaction was treated with diphenhydramine 25 mg, famotidine 20 mg, and IM epinephrine 0.3 mg. Patient transported to ED. Improvement noted: "slightly swollen tongue, but had no SOB/dyspnea". Given prednisone 40 mg. Observed for 4 hours. @2214 symptoms were completely resolved and patient discharged with EpiPen prescription and allergy referral. Patient advised to avoid current mRNA-type vaccines should subsequent "booster" doses of..
pt recv vax 31OCT96 930AM & 950AM returned pale, no diaphoresis, anxious, BP 160/100, P88, R16;c/o dizziness, tightness in chest, AP 88 regular, resp 24, inc anxiety;sx did not subside by 10:15 sent to ER via ambulance;BP 150/102, AP 92
Sudden onset of "marble in my throat" hoarse drippy nose, eyes, nauseated and HA. Dx: Reaction to flu vaccine - tx: BENADRYL 25-50 mg and 4-6 hr f 2days EPIPEN given no more flu vaccine in future.
Started having significant twitching under both eyelids on the day after initial vaccination, soon thereafter followed by progressive fluctuating palpitations. Issues persisted through 3/2021.
Patient has had an approximate 1/2 inch square red rash spot at the injection site for over 2 months. She says it itches from time to time, gets a bit redder from time to time, but won't go away. She has been advised to go see her MD.
Pt, 12-Year-old Female was in the office on 6/19/2023 for a Well Child visit. In the appointment notes it stated she was coming in for her "11 yr", with this information, I checked the immunization records to make sure the patient was up to date, I went through past encounters to "confirm" that she did not have an 11 year well child last year (since she was already 12 years old). While checking past encounter's the appointment note for the last well child appointment stated "10 yr well child." I then pended the routine vaccinations for 11-year-olds (Tdap, HPV and Meningitis A,C,W,Y) I then went into the room to complete the rooming process as I normally would. Toward the end of this process, I informed Mom that since the patient was here for an 11-year checkup, there were routine vaccines due, and I asked if she wanted to do the HPV vaccine. Mom agreed to do the HPV. After Dr. was done conducting his examination, the vaccine orders were signed so I prepared them, put all required information in system and entered the patient's room with them. When I entered the room, the patient stated that "getting shots scare her sometimes" and that "last year they put something on my arm to make it so the shot didn't hurt as much" I then asked her if she got her flu shot last year since I, at this point, thought she missed her 11 yr well child last year and that would have been the only routine vaccine that she should have gotten. She said "yes" and there was no further mention of her getting other vaccinations last year. I proceeded to administer the vaccinations, using the numbing spray as requested by the patient. Mom stated afterward that she forgot her vaccine card that she keeps for her record of pt's vaccinations, but she would add them to it when she got home. I then advised that the information for these would be located on her after visit summary. Patient and mom exited the office. Approximately an hour and a half later, Patient's mom called the office stating that she went to write in the vaccines given at the appointment that day and noticed that she was given these vaccines last year (Meningitis A,C,W,Y and Tdap) and wanted to make sure this was not harmful to the patient. At this time, Dr. was informed of what occurred and advised that there were no ill effects from receiving these again. I looked back in the patient?s chart to see if I missed something and at this time is where I then noticed that there was documentation of the Meningitis A,C,W,Y and Tdap vaccines given last year. When I looked at the immunization record prior to pending these vaccines, I did not realize these were documented from last year. Mom was given reassurance of Dr. advice that there are no ill effects from receiving these twice and mom verbalized no further concern. This incident was then documented in her chart. No reactions have occurred at this time.
This case was reported by a consumer via call center representative and described the occurrence of bone pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (experienced after receiving 1st dose on 25th November 2018, refer case US2019027684). On 1st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In February 2019, less than a month after receiving SHINGRIX, the patient experienced bone pain, pain in arm, muscle pain and pain in elbow. On an unknown date, the outcome of the bone pain, pain in arm, muscle pain and pain in elbow were not recovered/not resolved. It was unknown if the reporter considered the bone pain, pain in arm, muscle pain and pain in elbow to be related to SHINGRIX. Additional details were provided as follows: Last few days from the date of reporting, the patient experienced bone pain in her left arm, the pain was also in her forearm and she cannot tense her muscle because of the pain. The patient push on her elbow and it hurts. The patient felt that the pain was getting worse. The patient was wondering if it could be related to the second dose of the SHINGRIX.
Approximately 121 hrs after Hep B vaccine given, patient noticed facial swelling and erythema. No respiratory distress or hives. TX: observation.
Patient had swelling and redness at site of injection. Patient did not treat herself prior to notifying pharmacy staff on 31 Oct 2015.
PANCREATITIS; MYOCARDITIS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity.   The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced pancreatitis, and myocarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis and pancreatitis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221215194- pancreatitis and myocarditis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
puffiness on the back of tongue near the throat; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (puffiness on the back of tongue near the throat) and NAUSEA (nauseous) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced SWOLLEN TONGUE (puffiness on the back of tongue near the throat) and NAUSEA (nauseous). At the time of the report, SWOLLEN TONGUE (puffiness on the back of tongue near the throat) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were  provided by Reporter No Treatment Medications were  provided by Reporter
This initial spontaneous case, was received from other non-health professional on 18-Oct-2017, concerning a female patient of an unspecified age. The patient medical history and concomitant medications were not reported. On an unspecified date (yesterday) (as reported), the patient was administered with influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date, manufacturer and trade name: not reported. On unspecified date, after several hours of vaccination, the patient had headache, queasiness and general body aches. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious.
In the patient's words: "I got the vaccine on Thursday 01/21, I was fine that day but Friday I started feeling arm pain. And chest pressure that was increasing after lunch time, SOB. Took nitro pill at around 1:30PM. Waited and took another one an hour later or so. Left 2 hrs early that days. Went home and rest. Felt a little bit better. On the weekend I felt weak, tired SOB. And pain on my shoulders. Just doing the things like making my bed in the morning. I decided to go to hospital on Monday 01/25 right after work cause I wasn?t any better. And stay over night for observation until Tuesday 26 .  "
1st Dose: fever, aches, very painful joints, could not walk for one day due to severe knee pain. 2nd Dose: COVID arm, sharp stabbing pain beginning in left armpit to left breast nipple and entire breast, Dramatic increase in heart palpitations. Both of the latter two symptoms lasted until April 1st @ 1pm when the both subsided at the same time. I visited my breast care center and 6  weeks after the vaccination an ultrasound was completed revealing a swollen lymph node at level 3 - still within normal limits. A second ultrasound is scheduled 1 month after the first ultrasound. No further palpitations other than what I usually experience - very few.
Starting about 20 hours after vaccine area of warmth and redness was noted centered around the site of one of the vaccines that was given on the right arm.  I evaluated her on 3/22/2012 around 8:30 pm and noted an area 11cm x 13 cm deeply erythematous plaque that was warm to the touch centered around what appeared to be a vaccine site.  No drainage/pus.  No fevers.  No pain.  Well appearing overall with stable vital signs.
After the second dose my injection site was painful and around 8 pm I started getting a headache  then came the chills which I then went to bed my sleep was awful I woke up every 5 minutes with a terrible headache. At about 4:40 am I ended up vomiting.  Since then I have just been lethargic and the headache is consistent
Arm was only slightly sore; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm was only slightly sore on an unspecified date. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Patient tested positive when she had her rapid test today; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on 22Aug2021 as dose 1, single for COVID- 19 Immunisation. Relevant medical history and concomitant medications were not reported. It was reported that patient tested positive when she had her rapid test on 28Aug2021. Patient asked what she would do if she tested positive after her 2nd dose also. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
22JAN93 lt thigh puncture mark w/1 cm area redness small knot non tender, poss cellulitis;
This spontaneous report as received from a medical assistant refers to an unspecified number of unspecified patients. On an unspecified date in 2015, the patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # L013429, expiration date 21-JUL-2017). No adverse effects have been reported. This is one of several reports received from the same source. Additional information has been requested.
Stomach Pain , Metal taste,intestinal problems , black stool, Lower back Pain , fatigue.  The patient schedule an appointment to have test done due to the side affects of the vaccine
2 days after getting vaccine developed bronchial asthma; This is a spontaneous report from a contactable consumer (patient herself, reported as other HCP-nurse).   A 57-year-old non pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot Number: unknown) via intramuscularly on 04Feb2021 at 11:45 AM in right arm (at the age of 56 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included hyperparathyroid and hypothyroid. The concomitant medications included levothyroxine sodium (THYROX). Historical vaccine included first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Batch/Lot Number: unknown) via intramuscularly in left arm on 09Jan2021 at 11:45 AM (at the age of 56 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 2 days of vaccination the patient developed bronchial asthma. The patient visited emergency room and physician office due to the event. The patient did not diagnose with COVID-19 prior to vaccination and tested COVID-19, since the vaccination. The lad data included nasal swab was negative on 06Feb2021. At the time of this report outcome of the event was recovered.  No follow-up attempts were possible; information about lot/batch number cannot be obtained.
Gardasil vaccinations administered @ 4:30 p.m. 9/2/2009, was taken by ambulance to Hospital, @ 7:00 am on 29/3/2009.  Diagnoses, seizure. 10/7/09 ER record received for date 9/3/09. Pt presented to ER with complaint from Mother that pt had 3 seizures while in shower  and was "odd" for 5 minutes. Had HPV vaccine previous day. 12/17/09 GYN records received for DOS  9/02/09. Pt. presents for routine exam. YAZ prescribed. Gardasil Vax provided. Assessment: dysmenorrhea.