chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered with IPOL that expired/no AE; Initial information regarding this unsolicited valid non-serious case via Medical Information (Reference number- 00366463) was received from a Other Healthcare Professional and transmitted to Sanofi on 20-Nov-2020.  This case involved a 13 month old female patient who was administered with ipol that expired (Expired product administered), while she received IPV (VERO) [IPOL].  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Immunisation.  On 19-Nov-2020, the patient received a 0.5ml dose of suspect IPV (VERO) lot number- PIE701M and expiration date- 09-Nov-2020 via intramuscular route at left arm site for prophylactic vaccination.  It was a potential medication error due to incorrect product storage (Expired vaccine used).  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 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.
Pt presents with right arm & forearm swollen & red warm streaking & pain. Pt sent immediately to ER.
After receiving the vaccine patient complained of being light headed, having a tingly feeling on her right side, a headache and feeling shaky. Patient progressed and paramedics were called. Patient declined to go to hospital and paramedics escorted her out to her friends car.
Information has been received from a 69 year old female consumer concerning herself. The patient had no pertinent medical history and no known drug reactions or allergies. On approximately June of 2012, "2 months ago", the patient was vaccinated subcutaneously with one dose of ZOSTAVAX, one time injection. There were no concomitant medications. On 15-JUN-2012 she had swollen area around the right arm, after injection. The patient experienced pain in her back, and started breaking out in a rash. Patient stated rash itched and was crusty, and similar to chickenpox. Patient also stated that her physician had not diagnosed it as shingles, which she believed it to be. Consumer also stated that the chest and top part of her arm is where the rash still existed. No treatment was given for the events. At the time of the report, the patient's outcome for itched and crusty rash, similar to chickenpox and pain in her back was unknown. Additional information has been requested.
patient called day of administration (10/7/08 about 11:30 AM)reporting some itching on injection site, resolved with hydrocortisone cream application.  Came in for evaluation 10/9/08.  Site slightly bruised (on aspirin therapy)slightly raised and red about 2 cm x 4cm oval, warm to touch.  Patient has been icing area and applying hydrocortisone to site.  I advised a check by her doctor to r/o possible reaction to bandage, but area looks like possible injection site reaction to vaccine with secondary infection.  Patient is also diabetic and higher risk for secondary infections.  Pending patient follow up after MD appointment.  Patient reports never having a reaction with influenza vaccine in past history, but un-reported number if times received injection in past.
pt recvd flu vax & devel influenza leading to probable death; this pt & 1 other devel influenza following flu vax;
Please see previous notes for outbreak information. (Did have typical symptoms after second and third injections, but they lasted 2-3 days).
Published information indicated that a case of zoster presented in a pt, shown by sequence analysis to be wild type VZV. Secondary transmission was noted. The information also discussed three other cases (WAES0403USA01096, WAES0403USA01097, WAES0410USA01875).
fever,vomiting. Got J&J vaccine yesterday @1400. Sx started since this morning. C/O cold sweats, headache and n/v. vomit x2 this morning. No blood in vomit. Had L temporal headache but not at this moment. No visual changes or dizziness. Not took medication.History:  pt had J&J COVID-19 vaccine yesterday and started feeling sick this morning, with some muscle aches, intermittent headache, vomit x 2 this morning, and slight cough this morning (which stopped afterwards), here for eval.  Pt was doing ok before the vaccine and lives off-post and denies recent COVID-19 hotspot visit or sick contact.  No neck stiffness, runny nose, ear pain, sore throat, visual deterioration, chest/abdominal pain, diarrhea/constipation, History:  pt had J&J COVID-19 vaccine yesterday and started feeling sick this morning, with some muscle aches, intermittent headache, vomit x 2 this morning, and slight cough this morning (which stopped afterwards), here for eval.  Pt was doing ok before the vaccine and lives off-post and denies recent COVID-19 hotspot visit or sick contact.  No neck stiffness, runny nose, ear pain, sore throat, visual deterioration, chest/abdominal pain, diarrhea/constipation, vaginal bleed/discharge, rash, prior surgery, prior co-morbidities.  Has had implanted contraceptive since before 11/2020.
Sick; Coughing; I can't sleep; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 81-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration on 05Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269) via an unknown route of administration on 15Feb2021 as dose 1, single for COVID-19 immunisation. Patient stated, I need to talk to somebody in Pfizer who knows about the vaccine and what kind of ingredients they use. Consumer stated, patient received first injected in February 15 and then I had the second one, and that was injected on 05Mar2021 and since then, on unknown date I have been very sick. I need to call before but I did not and I am coughing and I can't sleep its 3 o clock in the morning its 6 o clock in the morning and I am still up. I went to doctor, my pulmonary doctor and they did all kinds of test and gave all kinds of medicines (Unspecified Medications) and I am not getting better. So, I would like to talk to somebody who will be able to tell me something. I am not coughing in this 3 minutes because patient received codeine treatment and I had taken a lot of stuff since then. Consumer sated, patient heard that they were giving the third shot. Is that true. Do you think I can get it. The outcome of the events was reported as unknown.  Lot/batch number has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
severe headache, nausea, chills, skin pain, dizziness, body aches.  it started as maybe a mild dizziness and progressed to the point thatover the night and following 24 hours I had to hold on to walls and doors and chairs to be able to walk over to get a glass of juice and take ibuprofen.  I felt so queasy that I was afraid if I started to accidentally vomit I would have to call 911.  I had to alter my breathing to control the nausea and try not to move.  this lasted for over 24 hours.  I am finally able to walk today without having to hold onto things to feel stable. yesterday April 23rd I thought I would be better but I ended up having to decrease stimulation to alleviate headache and nausea and skin irritation.  my skin was just very pale no rash..  Today April 24th I still feel a bit dizzy but thankfully no severe pain.   It was the worst pain I have ever had.  I do not think  I have ever in my life been that sick before.  it hurt to breath and even my liver area and maybe my pancreases area and my spleen.  everything hurt very badly.  today just a little residual back pain and neck pain and arm pain.  only a very little bit of nausea today. slight headache still and I feel a little weak this morning I coughed and it was thick and productive.  only one cough.  I was kind of surprised but I am usually very active so maybe being so still for such a long period of time made my lungs have thick secretion.
Immediate swelling to site approx 6 cm x 6 cm. Within 30 min resolved to 1 cm with injection site. Client walking as usual in no distress.
Patient administered vaccine more than 12 hours post puncture of the vial; No adverse event; Patient administered vaccine more than 12 hours post puncture of the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine more than 12 hours post puncture of the vial), PRODUCT STORAGE ERROR (Patient administered vaccine more than 12 hours post puncture of the vial) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022 at 3:25 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Nov-2022 at 3:25 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine more than 12 hours post puncture of the vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient administered vaccine more than 12 hours post puncture of the vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine more than 12 hours post puncture of the vial), PRODUCT STORAGE ERROR (Patient administered vaccine more than 12 hours post puncture of the vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine more than 12 hours post puncture of the vial) and PRODUCT STORAGE ERROR (Patient administered vaccine more than 12 hours post puncture of the vial).    No concomitant medications were reported.  The patient received first dose on 24-Feb-2021 lot number 030M20A and expiration date were not known in left arm, received 2nd dose on 24-Mar-2021 lot number 048A21A and received 3rd dose on 5-Jun-2022 lot number 017B22A in right arm.  Vial size was reported as 2.5ml. The vial was initially stored in the refrigerator on 8-Nov-2022. The vial was first punctured on 9-Nov-2022 at 12 noon. The vial was stored post puncture at room temperature. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Headache, nausea, joint and muscle ache, dizziness and a fever 101.7 and it was rough for a couple of days, I was still in bed on the third day but I was still sore. all I had was itching and soreness on the injection side and that lasted about a week.
stiffness hip joint after dose 2; stiffness deltoids after dose 2/stiffness upper back area after dose 2; muscle aches hip joint after dose 2/muscle aches deltoids after dose 2/muscle aches upper back area after dose 2; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (stiffness hip joint after dose 2), MUSCULOSKELETAL STIFFNESS (stiffness deltoids after dose 2/stiffness upper back area after dose 2) and MYALGIA (muscle aches hip joint after dose 2/muscle aches deltoids after dose 2/muscle aches upper back area after dose 2) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Coronary artery disease.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT STIFFNESS (stiffness hip joint after dose 2), MUSCULOSKELETAL STIFFNESS (stiffness deltoids after dose 2/stiffness upper back area after dose 2) and MYALGIA (muscle aches hip joint after dose 2/muscle aches deltoids after dose 2/muscle aches upper back area after dose 2). At the time of the report, JOINT STIFFNESS (stiffness hip joint after dose 2), MUSCULOSKELETAL STIFFNESS (stiffness deltoids after dose 2/stiffness upper back area after dose 2) and MYALGIA (muscle aches hip joint after dose 2/muscle aches deltoids after dose 2/muscle aches upper back area after dose 2) outcome was unknown.            No treatment details was reported. Patient takes blood pressure medication and heart medication. He is 71.   This case was linked to MOD-2021-363189, MOD-2021-363354 (Patient Link).
1APR92 t102 R 3 hrs p/inject of DTP/HIB/MMR-shaking when asleep referred to ER or MD; TO MD w/instructions to cont APAP, tepid baths for fever control from MD; 2APR92 fever 104-105 R throughout noc; referred to ER by RN lethargic w/n/v;
freckles on upper extremities Started after 1st dose, intensified after 2nd dosen/a
Case number PHEH2016US023853, is an initial spontaneous report received from a health care professional on 14 Sep 2016. This report refers to a 60-year-old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1618901, expiry date: not reported) at a dose of 0.5 ml subcutaneously on 14 Sep 2016. Reporter stated that 3 patients had received FLUVIRIN subcutaneously instead of intramuscularly. Seriousness of the event was reported as non-serious. No adverse event was reported following this maladministration (incorrect route of drug administration).
edematous, reddened area lt deltoid approx 2" diameter;pt c/o pain (arthritic type), hot to touch area 12hr post vax;24-36hr later pt c/o SOB, tightness in chest, sl nausea;
Cellulitis R upper arm injection site. Headache, nausea, myalgias, arm pain, itching. Prescription for hydrocodone and prednisone given.
pain @ site of vax, onset 1 month p/dose; pain severe w/motion; no redness, induration or mass; tx w/NSAI & physical therapy w/o relief; Now devel pain lt ear, radiating down neck; 14MAR94 No response to f/u request;
Chills, and shivers at night. Hot and cold feelings but no fever, the next day body aches for 24 hours. Arm was sore for 7 days and  itches even today.
Patient given Flu vaccine + Pneumovax vaccine on 10/15/07 and developed general weakness/malaise and a rash/ shingles 10/17/07. 12/28/07 Reviewed hospital medical records which reveal patient experienced vomiting & weakness.  Seen by pcp 3 days s/p vax & dx w/mild immunization reaction.  5 days later, had lightheadedness, syncopal episode, fall & head injury.  Returned to pcp for weakness & difficulty voiding.  Admitted 10/25-12/11/2007.  Neuro, urology, GI, Ortho,Ophthal consults done.  TX w/antibiotics & antifungal for asp pneumonia & UTI.  Received TPN x 2 wks & PEG tube placed.  Nectoric areas of left great toe & left heel debrided.  Improved minimally & was transferred to rehab unit at d/c.  It was felt his mental status changes were possibly a result of post concussive syndrome & mild encephalitis from herpes zoster. FINAL DX: syncopal episode w/prolonged altered mental status, etiology unclear.
Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: patient reports pain in arm from time of second injection; pt reported to us on 2/14; 27 days after second injection.  complains of pain in arm at night; he reports it being a nerve pain.  Rph and language speaking technician gave otc recommendations as well as to recommend seeing an md.
She had been sick with a cold; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (She had been sick with a cold) in an 88-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 16-Oct-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (She had been sick with a cold). At the time of the report, NASOPHARYNGITIS (She had been sick with a cold) outcome was unknown. Not Provided      For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient received flu vaccination on 30-Oct-2023. No treatment information was provided.   This case was linked to MOD-2023-748585 (Patient Link).
Pain in Arm, Mild fever, Severe Headache, persistent coughing, sore throat, severe throat congestion (yellow green Phlegm, very Tired, chills (could not get warm for hours).
After patient completed clinical exam at approximately 3:50pm. Patient given flu vaccine. After taking a few steps down hallway to leave at approximately 4pm patient complained of burning, itching and feeling broken out on face. Patient noted to have red, flushed cheeks. Right cheek appeared to have a circular area about dime size with red outer area and white inner area, over Right outer eyebrow noted to be red with a few small bumps. Doctor saw patient and advised to give patient Benadryl. Approximately 4:03pm patient given Benadryl elixir 50 mg (4tsp). 4:25pm cheeks appear more normal with just a few pinkened areas, circular area on Right cheek barely visible. Area over Right eyebrow normal in appearance with only a small bump noted. Patient reported face didn't feel like it was burning or itching anymore. Patient left with mom.
I developed the typical symptoms beginning about 8 hours after the shot.  Soreness at injection sight, muscle aching throughout my body, nausea and feeling feverish.  However, beginning about 8 hours after the shot my nose began turning red and throbbing with pain.  It looked/looks like a severe sunburn, however I haven't been out in the sun for more than a few minutes.  I received the Vaccine on Monday, 9-9-19.  It is now Friday, 9-13-19 and my nose is finally getting a little better.  It is less red and less sore.  I returned to the Pharmacist who administered the Vaccine and she said she had never heard or seen this before.
Pt was approximately three months pregnant, and miscarried shortly after receiving vaccine, this was per mother.  Case reports daughter had problems with pregnancy prior to receiving the COVID vaccine, and after examining following the miscarriage and noted finding huge blood clots.
Within 3 minutes my arm started to turn red, and I started to break out in hives. By 20 minutes my hives went across to my chest and right arm. My BP was 168/108 and pulse 84, they hooked me up to vitals. They wanted to send me to the ER  for Benadryl but I had more own and took Benadryl (20mg) this was about 25 mins into injection.  About 30 mins my arm started to get really warm, you could feel the heat coming off of it.  They monitored me for an hour and re-did my BP 158/97, pulse dropped to  80, my o2 stats were 99. They made me monitor for another 18 mins. BP was  155/103, pulse still at 80. They had me get up and walk around and wanted me to take more Benadryl but I didn't have a ride home.   . My hives started to improve but were not gone.  About 1hr 25mins post vaccine  I got on the phone with Employee Health to ask to leave (clinic was closing) , they wanted me to stay and I told them I had a BP machine at home, if it didn't go down they wanted me to go to the ER. My BP did go down about 4 hours later but my arm was still hurting.  The hives on my chest went away, but hives on my arm was on and off for about a week. My left arm remained red for about 2 weeks and I ended up getting a really bad rash.  When I woke up the next day I had to take a Benadryl and Tylenol. On January 3rd I felt awful like  I got hit by a car.  On that Wednesday (6th) my arm started to hurt really bad in the middle of the night, it felt like day 2 all over again. It was really painful, it was bright red and life a figure eight going down my arm and I immediately called employee health and they  told me to monitor for 24 hours. It got worse and went down my arm to my chest.  I went to Friday night to our immediate care (only place we could go), I was given antibiotics for cellulitis.  It took about 7 days to  go away.  They were telling me I couldn't get the second dose because of my reaction and I had to fight to get the second dose.
Patient in clinic with left arm injection site warm to the touch, swollen, and red. Patient advised by PCP to take BENADRYL.
This is a spontaneous report from a contactable pharmacist. An adult patient of an unspecified gender received PREVNAR 13, (Lot number and expiration date were not reported), with route of administration unspecified, on 25Jan (year was not reported), at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had an injection site reaction; and rash, redness and bumps at the injection site. The outcome of the events, injection site reaction, and rash, redness and bumps at the injection site, was unknown.
Allergies: Prevnar 13; This is a spontaneous report from a contactable healthcare professional. A male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergies: pneumococcal 13-valent conjugate vaccine on an unspecified date. Outcome of the event was unknown.