chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt dizzy; received / vaccine in 2018 / not gotten the second dose; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced dizziness and incomplete course of vaccination. On an unknown date, the outcome of the dizziness was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: Reporter was patient's wife. The age at vaccination was not reported. In 2018, the patient received the 1st dose of Shingrix and he felt dizzy and had to sit down in the pharmacy for 20 to 30 minutes before being able to walk to the car. Till the time of reporting, the patient still had not gotten the 2nd dose of Shingrix, but reporter said he was getting it soon, which led to incomplete course of vaccination. The reporter did not consented to follow up.
PASSED OUT FOR 2 HOURS - THEN PASSED OUT AGAIN - BODY WAS IMMOBILE - LACK OF OXYGEN - AMBULANCE BROUGHT TO A LOCAL HOSPITAL - TREATED FOR PULMONARY THROMBOSIS IN HOSPITAL 8 DAYS THEN REHAB FOR 7 DAYS.
Nonstop high pitched crying 24 hours after getting IZ. Crying lasted for 5 hours. Evaluated at hospital ER, admitted to hospital x 2 days. IV given (per mom).  03/27/2007 MR received for an ER admission for fever, decreased appetite, refusing to eat and continuous high pitched screaming which occured the day following vax. PMH:  Seizures.  Allergies:  None.  Meds:  Phenobarbital and Keppra. PE:  Child sleepy but otherwise WNL. Admitted for hydration. Diagnosis: Dehydration.  Fever.  History of Seizures.
Itchy rash on skin of arms (worse on upper area and equal on both left and right) and thighs to side of hips. I had a steroid injection for carpal tunnel on Monday April 12, 2021, which helped temporarily heal the rash. It then returned soon thereafter (timeline unknown, maybe a month later) and sought care with my PCP on May 24th, 2021. I was then treated with a steroid injection  in office, methylprednisolone pack, and antihistamines. This treatment resolved the rash entirely.
autoimmune thyroiditis associated with amenorhea within the month, weight gain, left upper quadrant pain and multi nodular goiter. Persistent symptoms for over 1 year.
The Hib portion of the vaccine was reconstituted with sterile; Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a health care professional (nurse).  This case involves a 20 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past vaccination(s) included HIB VACCINE in 2017 and HIB VACCINE in 2018.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 22-Jan-2019, the patient received a first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number of  HIB: C5591AA, expiry date: 15-Nov-2019, dose and dose in series not reported) via unknown route in the left thigh.  It was a case of actual medication error due to inappropriate reconstitution technique because the Hib portion of the vaccine was reconstituted with sterile water rather than IPV and the IPV was not given. The administering nurse did not had IPV component at hand.  It was unknown if any adverse event occurred or not following the vaccination.  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 Directive and Module VI of the 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.
Forty minutes of prolonged crying (unusual to our child) and figured that she was hungry.  Tried to nurse her and she would not eat.  This was the first time that she would not eat and it alarmed us.  We figured she was in pain from the vaccinations and gave her infant Tylenol as directed by her doctor.  She calmed down about 5-10 minutes later and put her in the carseat to go home.  Around 5-10 minutes after that she vomited clear liquid.  This was alarming because se had only had breast milk in her life.  She immediately turned white and became very lethargic.  She had a blank stare and trouble staying conscious.  We put her in the car and started to the ER.  On our way she became completely unconscious and turned blue/purple.  At this point we called 911 and got her in an upright position and waited for the ambulance.  She was beginning to regain consciousness when they arrived yet was still blue.  The paramedics gave her oxygen in the ambulance on the way to the ER.  She was admitted immediately.  While at the ER nobody knew what had happened.  They thought it might have been a febrile seizure but while at the ER she was not convulsing or showing any other signs of a seizure at that point.  Her temperature was ok and they monitored her heart rate for a while.  Within a month an EKG and an EEG were administered with normal results.  It was not until her current doctor that our concerns regarding the correlation to the vaccinations were validated.  The nurse at the ER immediately disregarded our concerns saying that vaccinations do not cause any side effects.
Extremely tired, arms and legs felt like lead. Sharp pain top of ankles. Tireness, achiness, joint pain, muscle pain, headache. Feeling unwell.
Extreme swelling upper leg and knee - not warm or tender, mild, patchy erythema.
Patient was dizzy and weak after the vaccine was administered. After 10 minutes later she passed out. EMS came to take care of her. All the tests were normal. Her glucose level was low. She was given glucose oral gel to take before she left with her dad.
Heart rate went from a normal rate to 144-150. At same time I took a serious cold and achy joints and muscles. Doctor has me taking Digoxin, Diltiazem and Eliquis to try and bring the heart rate down.
P/ shot,woke up w/ horrible screams,not hi pitched but painful screams.Eyes bulged out&face turned purple.Gave APAP w/codeine.Pt's eczema got worse p/ shot & w/in 2 wks body oozy raw red.Has become allergic to many foods.Sensitive/emotional
pts neck started swelling after taking the vax.  she was having a hard time breathing due to the swelling. she went to  Hospital ER.  pt was triaged and then left due to the situation at the hospital.  Pts mother gave her Advil and was monitored all night.  The swelling seemed to be better the next day.   She had fatigue that lasted about 3 days.  Parents called the Pediatrician.  They were advised to call her Endocrinologist.  They recommended her back to Pediatrician due it being a immune reaction. They called an infectious disease specialist which recommended her to an allergist.  Pt has follow up appts next week for thyroid.
Early on Day 2, dermatitis close to site of injection (Left arm); approx. 2" diameter, redness, swelling, pain, itching.  Rx: Desoxymethasone ointment. used topically, twice/day. Day 7 Pain & itching worse, dermatitis ring increased to approx. 4" in diameter.  Pain & itching worse.  Red bumps noticed at site of rash.  To Dermatologist.  Confirmed it was a side effect of vaccine.  Desoxymethasone continued.  Day 10 Rash subsiding, much less pain & itching.
p/vax pt exp varicella w/greater than 50 lesions;had scattered erythema vesicles on trunk, head & face;visit to ER required or MD visit required;
Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm). At the time of the report, VACCINATION SITE PAIN (Pain in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-036540.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Patient updated event outcome as Resolved. and declined for further follow-up on this.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This case was reported by a pharmacist via call center representative and described the occurrence of back pain in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced back pain, scapula pain, breast pain and leg pain. On an unknown date, the outcome of the back pain, scapula pain, breast pain and leg pain were recovered/resolved. It was unknown if the reporter considered the back pain, scapula pain, breast pain and leg pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that after vaccination, the patient experienced pain in the back, scapula, breast area and the pain ran down her leg. The patient was foggy in thinking. The event lasted for 7 to 8 days. The health care professional called MI for advice on administering the 2nd dose. No additional information was provided.
Brought to drive up clinic by Grandfather (guardian). Child completed forms himself. Vaccine dose was given.
severe arm pain 13 days post injection,  completely unable to use arm that vaccination was given in at this point.
3/7/23  I started having diarrhea. I had tests run. They tested for digestive disorders. Everything was negative.  On 3/27/23 I had an appointment with a PA at the center. I gave a stool sample. I have severe pancreatic insufficiency. I was dehydrated and was sent to the Hospital. I had more digestive tests done and the diagnosis for pancreatic insufficiency was confirmed. I still have the diarrhea. I was prescribed a binding medication and Creon. I have a CT scheduled for next week.
3 AM CHILLS, MUSCLE PAIN, JOINT PAIN, NAUSEA, FATIGUE RESOLVED BY NOON Narrative:
Given Varivax, Hep A and Fluzone 10/10/2006. Shingle like rash downL5-S1 dermatome about 48 hours later. Have HX of previous chicken pox.
Adult received pediatric dose; Adult received pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult female patient who received HBV (Engerix B pediatric) (batch number P49X7, expiry date 7th December 2023) for prophylaxis.   On 9th February 2023, the patient received Engerix B pediatric. On 9th February 2023, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 9-Feb-2023 Reporter's comment: The only patient information the reporter had at the time of the call was that the patient was an adult female. At the time of reporting, the patient had not been re-dosed. The reporter gave permission for follow-up. Additional supportive information: An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Pain at injection site/ Injection site soreness (in left arm) overnight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 12:15 (Lot number: EL3248) at the age of 34 years as dose 1, single and administered in arm left, administration date 24Mar2021 12:00 (Lot number: EL3248) as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic rhinitis" (unspecified if ongoing), notes: allergies. Concomitant medication(s) included: CLARITIN [LORATADINE]; FLONASE [FLUTICASONE PROPIONATE]; VITAMIN D [COLECALCIFEROL]; MULTIVIT [VITAMINS NOS]; ALIGN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Mar2021 19:00, outcome "recovered", described as "Pain at injection site/ Injection site soreness (in left arm) overnight". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: The facility where the most recent COVID-19 vaccine was administered in a workplace clinic. The patient has no allergies to medications, food, or other products and prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant therapy included birth control. The patient also experienced injection site soreness (in left arm) overnight after the second dose on 24Mar2021 at 18:00 which resolved within 24 hours of receiving shot. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Patient said it turned red and was warm to the touch almost immediately. She thought it may go away but it got worse. She went to the ER department that evening and they gave her antibiotics. She said it was cellulitis.
This spontaneous report was received from a certified medical assistant via company representative regarding an adult patient of unknown gender. There was no information about concurrent condition and historical medication. On an unknown date, the adult patient was vaccinated with pediatric dose (0.5 ML) of RECOMBIVAX HB INJ 5/0.5 mcrg/ml (drug administered to patient of inappropriate age). Reporter stated that only 0.5 m. of RECOMBIVAX HB was drawn up into the syringe, rather than the entire contents of the vial. No adverse effects reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Narrative: Patient states he recieved 2nd dose of Covid vaccine on Feb 26 and on March 11 he had fever, chills, and diarrhea that lasted for about 24hrs then went away. He wanted to document that he had a reaction to the vaccine.
I26.99 ACUTE PULMONARY EMBOLISM 3/9/2023 BILAT PNEUMONIA I82.409 ACUTE DVT, UNSPECIFIED VEIN 3/21/2023 BILAT PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/4/2023 BILAT PNEUMONIA R09.02 HYPOXEMIA 4/7/2023 BILAT PNEUMONIA
Mother states child presented to ER five hrs after imunizations with hives on neck, ears, red and swollen, difficulty breathing with wheezes and temp of 100 deg. F. Treated with Epinephrine, Benadryl and Prednisone. Sent home with instructions to continue Tylenol and Benadryl. Mother states symptoms better this morning.
Right thigh at injection site 3" diameter hot, red and swollen. Keflex 250mg Qib x 10 days
for wks p/recvd Td booster pt c/o pain going down both arms esp rt arm;
Redness, swelling to injection site right leg; fever, discomfort.  Treated with KEFLEX 250 mg/ 5 ml 4 cc QID.
acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7 minutes then stopped - 30 minutes after injection given blurry vision - 30 minutes after injection given mild shaking - following morning lasting for about 2 hours extreme fatigue - lasting for 48 hours - Sunday evening through Tuesday evening
4/34 (12%) aSOTRs reported infection 6-12 months post-D3; 4/34 (12%) aSOTRs reported infection 6-12 months post-D3; This is a literature report.  An adolescent patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Adolescent solid organ transplant recipients" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "4/34 (12%) aSOTRs reported infection 6-12 months post-D3". The patient underwent the following laboratory tests and procedures: Antibody test: Positive; Antibody test: 1275 IU/ml, notes: At 3 months, those infected 6-12 months post-D3; 927 IU/ml, notes: Mean 6 month antibody titers among those infected 6-12 months post-D3; SARS-CoV-2 antibody test (1927-2500): Unknown results, notes: (maximum: >2500 U/ml).at 1-, 3-, and 6-months post-D3.; Sender's Comments: A causal relationship to the suspect drug bnt162b2 (BNT162B2) cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-PV202300180965 Same article/ drug/event and different patient;
p/vax pt devel chickenpox w/approx 20 to 30 lesions;1wk later pt recovered;
Employee began to complain of nausea, weakness, and dizziness. Employee felt better when she laid down but would complain of feeling as if she would vomit upon movement. This occurred over a period of fifteen minutes. Patient recovered on her own and was sent home for the day.
Vesicopapular lesion at site left deltoid. Pink, scattered papules face, trunk and extremities.
Patient presented to clinic with mother (MOC) to receive 4 month vaccinations.  During the screening process MOC stated that infant became extremely irritable and became constipated  following receipt of vaccinations on 12/17/08.  MOC stated that infant did not have bowel movement for 5 five days post-vaccination.  Infant taken to urgent care center for assessment; no treatment provided.  Infant is breastfed.  Explained to MOC that breastfed infants can go for several days without having a bowel movement.  This is not reason for concern unless the infant appears to be uncomfortable.  MOC went on to state that when infant did have a bowel movement it was "black and tar-like".  MOC also stated that the stool had a very foul smell.  Current stool pattern has returned to normal and infant no longer appears to be in distress.  On 02/5/09 RN made determination to proceed with administering HIB dose #2 and PCV dose #2; withheld Rotarix dose #2 due to concerns regarding potential adverse reaction to Rotarix vaccination.
After administrating Dtap #3 within seconds childs face got very flushed, warm to touch. Temp 100.8 Tylenol given by mom.
I woke up with a sore throat, throughout the day I just wasn't feeling right, I started feeling really tired. I took a home COVID-19 test, that came back positive. The next day I woke up feeling even worse, I started getting a fever. I called my doctor to the Paxlovid. I was able to get the antiviral medication and start it that day. Although I have recovered, I have a lingering cough.
Patient  had a stroke on 11-28-22 and was taken to a hospital.  While at the hospital patient had a second heart attack.
Pt and two siblings were administered a dose of Pfizer 5-11 (Orange Top) that was discovered to be undiluted.  The doses were drawn up by RN who had discovered she was unable to draw more than 3-4 doses from the vial.  Pt and siblings had observation period and no adverse effects were observed or mentioned.  Mother was contacted about the discovery and said her children were experiencing sore arms, severe nausea, and headaches.
Patient sent to hospital 1/2 and 1/5.  Returned both times to nursing home covid unit without a hospital admission.  Resident had been diagnosed with COVID later in the day on 12/30, when routine testing PCR results returned to facility, after resident had already had her first covid vaccination on 12/30/20 in the morning.  Resident continued decline, was again sent to hospital on 1/24/21, and expired in hospital 1/25/21.
Got the second shot still have diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Got the second shot still have diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Got the second shot still have diarrhea). At the time of the report, DIARRHOEA (Got the second shot still have diarrhea) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.   This case was linked to MOD-2021-168393 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received on 25 May 2021 included no new information.
2nd dose of Gardasil administered on 12/18/07.  Patient experienced syncope after 1 minute.
I had my first Pfizer vaccine on March 27th.  Around April 9th I began to feel chest pain.  I went to the ER on April 13th and they initially thought I was having a heart attack.  Ultimately I was in the ICU overnight with pericarditis, which effected my heart rate.  I had several EKGs, blood tests and an Echocardiogram.  I was sent home with meds for three weeks.  I had my second doze of Pfizer vaccine on April 24th.  I was back in the ER on May 24th, sent home yet back again on May 31st after a week of heart rate issues.  I started in the ICU, stayed overnight in the hospital and then send home with meds for four weeks.  The diagnosis was a return of the pericarditis.  I?m now in recovery mode.  My concern is basically a healthy sixty-six year old male with no heart issues ended up in the ICU with pericarditis just over two weeks after the Pfizer vaccine and then back again the next month after I had received the recommendation to go live life with no needs of a follow-up appointment needed from the cardiologist.
Within 24 hours of the vaccine, Patient started to experience pain in her left axilla and swelling of her face, and fatigue.  Within 72 hours she had a worsening of her headache
Information has been received from a health professional concerning a female employee in her 60's, with no history of shingles, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006.  It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck).  Subsequently the patient was diagnosed with shingles by her physician and treated.  No product quality complaint was involved.  No other information was provided.  Follow-up information indicated that the patient had a VZV PCR test and no VZV DNA was amplified.  This is one of several reports from the same source.  Additional information has been requested.