chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 2nd dose of COVID-19 vaccine in vaccine clinic (Pfizer). Patient reports a history of light-headedness/dizziness with medical procedures involving needles. Approximately 5 minutes after injection, patient reported feeling dizzy. She was alert and oriented x3, denied any difficulty breathing or swallowing, no rash or itching, pupils equal and reactive, visual tracking WNL. I elevated her legs and advised her to remain in our observation area for 30 minutes. At 1:46pm, I was advised by vaccinator that patient remained dizzy. This was approx ~20 minutes after vaccination. Patient remained stable, alert and oriented. At 2:01pm I was called by Dr  and advised to come evaluate patient (I was eating my lunch at the time). Patient remained with feet elevated, alert and oriented x3 with equal and reactive pupils. HR 72 BP 138/78. Patient drank some apple juice, No SOB, rash.  I went to urgent care to see if it would be possible for patient to come lay down on a stretcher there to help with dizziness. Urgent care requested that I call rapid response and 911. I advised UC that this was not a medical emergency and the patient is stable, we just don't have any area for her to lay down. Ultimately, I left UC and advised patient that they would not take her unless we call rapid response. Patient declined. I put a blanket on the floor for her and helped her to lay down on the floor. After about 10 minutes of laying on the floor, she was able to get up and go to the restroom. She walked back to the observation area and sat in chair while husband brought car around. Patient ambulated to car without difficulty or help approx 1 hour after vaccine was administered.
This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The nurse reported that the patient vaccinated with the first dose of GARDASIL (injection) (dose, frequency, lot number not reported) on an unspecified date in December 2010, then vaccinated with the second dose of GARDASIL (injection) (dose, frequency, lot number not reported) on 07-MAR-2011 and vaccinated with the third dose of GARDASIL (injection) (dose, frequency, lot number not reported) on 04-AUG-2014. No adverse event was reported. Action taken was not applicable. Additional information has been requested.
8/19/04 pt received DTaP and IPV on right thigh. Pt had a red itchy rash to the left of injection site.
Started feeling dizzy at 10:30pm on 6/25/22 (woke up feeling dizzy) and unable to walk straight. Went back to sleep and starting throwing up in bed at 12:30am on 6/26/22.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), via a Pfizer sponsored program. A female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced pain in extremity/pain in her hand, with outcome of recovered. Additional information: The patient woke up the next day and pain in her hand was gone. She was able to bend her fingers. It was unknown whether the reporter is a healthcare professional (HCP) and reporter the prescribing HCP or not. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Crawling then stopped, staring into space with right eye turned in and upward for 15 seconds, then seemed fine.
pt recv vax 29FEB96 & 10MAR96 pt devel tightness in lower extremities which progressed to weakness in legs & one arm;presently is having diff climbing stairs & needs to use arms to help pick up legs to ascend the stairs;polymyalgia rheumati
Patient reported to family that she began feeling tired and weak after the second dose on 9/3. Passed away in her home on the couch sometime during the night of 9/5
Crying inconsolably for 48 hours. Examined by doctor's office, no other cause of crying determined, considered hospitalization because level of distress of infant. Crying stopped abruptly approximately 52 hours after vaccination.
A few days after taking the vaccine she had a terrible itch in her ear, naval, scalp and arm. Her chest, neck and top of back was covered with bright red pimples and very itchy. She saw her GI doctor who gave her prednisone.
12 hours after my vaccine I had uncontrollably jumping in my leg and went up to my head, I was unable to talk and this went on for several months. Went to a neurologist three weeks later and they prescribed me medicine but it made me suicidal. I then went to the hospital for 3 days to get tests ran and they prescribed me  Regitoni. My iron was also really low but I started to take supplements and It helped a lot.
Immediately post vaccination patient indicated that she was not feeling well.  She started trembling and exhibited mild confusion and irritation, but patient remained aware of self and surroundings.  Patient expressed some anxiety over the long term effects of the vaccination prior to administration.  Upon arrival of the ambulance and until they left with the patient, the patient continued with symptoms.
Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported. On an unknown dates, the patients were administered improperly stored doses of VAQTA lot # M036459, expiration date 18-JAN-2018, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of VAQTA were exposed to a temperature >46°F but <77°F and were out of range for 112 hours. A data logger was not used to track the temperature and there was a prior excursions of 34.20 F for 15 hours. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA002598: US-009507513-1701USA003705:
pt recv vax & devel swollen, reddened lt arm, painful, ROM limited, cellulitis secondary to inj;tx med;
began crying unconsolably 1/2 hr p/vax & cried almost constantly for over 4 hrs; was taken to MD but they left a/was seen by MD because quit crying & started playing;
Approximately 10 hours after vaccination, severe shivering started.  Covered up, went to sleep, and it had stopped by 1am when I woke up.  Upon waking the next morning at 7am, had a slight fever (99.9), took Tylenol, and the fever subsided and I felt fine.
The patient has intractable pain of the sacral area.  This is due to destructive lesion from her metastatic colon cancer. Pt was admitted to the hospital and underwent an MRI. Unfortunately it showed that her sacral lesion has expanded. Palliative care was consulted and they assisted with revising her pain medication protocols. She is still needing to straight cath 2/2 to neurogenic bladder and a script was sent to a medical equipment supply. Pain meds, etc were sent to the pharmacy.   Patient was transitioned off the PCA pump and onto a fentanyl patch prior to DC.  Electrolytes were repleted prior to DC.  She has close follow up next week with radiation oncology and oncology. Hospital admission after clinic visit - same day as COVID booster was given.
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 15-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
This case was reported by a nurse via call center representative and described the occurrence of irritability in a 11-month-old female patient who received KINRIX (batch number 33X9T, expiry date 31st October 2017). Previously administered products included DTaP vaccine (1st dose). On 5th July 2016, the patient received KINRIX .5 ml. On 5th July 2016, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On 6th July 2016, the patient experienced irritability. On an unknown date, the outcome of the irritability, inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the irritability to be related to KINRIX. Additional details were provided as follows: The reporter stated that, a staff member inadvertently administered the 10 months and 20 days old patient with KINRIX as a 2nd dose in DTaP series, which led to inappropriate age at vaccination administration and wrong vaccine administered. The mother of the patient stated that, the patient was irritable. The call center representative did not ask for the lot number and expiry dates.
Sever teeth and gum pain and swelling for 3 days. Spine pain and swelling  for 3 days.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022; No adverse event; patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (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 the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022).    Concomitant medications were not reported.   Patient received half dose. They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions.  Treatment medications were not reported.
Stiff in her joints; Feeling worse; Very fatigued; Joint pain all over the body; Swelling in her lymph nodes in neck and under both arms; Metallic taste in her mouth; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSGEUSIA (Metallic taste in her mouth), MUSCULOSKELETAL STIFFNESS (Stiff in her joints), FEELING ABNORMAL (Feeling worse), ARTHRALGIA (Joint pain all over the body) and LYMPHADENOPATHY (Swelling in her lymph nodes in neck and under both arms) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included CELECOXIB (CELEXA [CELECOXIB]), CEFIXIME (FLEXERIL [CEFIXIME]), VITAMIN D NOS, MULTIVITAMINS [VITAMINS NOS], ATORVASTATIN CALCIUM (LIPITOR) and PARACETAMOL (TYLENOL) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth) and LYMPHADENOPATHY (Swelling in her lymph nodes in neck and under both arms). On 02-Feb-2021, the patient experienced ARTHRALGIA (Joint pain all over the body). On 09-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff in her joints), FEELING ABNORMAL (Feeling worse) and FATIGUE (Very fatigued). At the time of the report, DYSGEUSIA (Metallic taste in her mouth), MUSCULOSKELETAL STIFFNESS (Stiff in her joints), FEELING ABNORMAL (Feeling worse), ARTHRALGIA (Joint pain all over the body), LYMPHADENOPATHY (Swelling in her lymph nodes in neck and under both arms) and FATIGUE (Very fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Tylenol.
Moderna COVID-19 Vaccine EUA: Vaccine recipient reported 2/6/2021 that she received 1st dose of Moderna on 12/29/2020. Within 24 hours she developed a fever (T max 102) and body aches.  She reported that the fever would not break. On 1/1/2021 she went to the ED and was prescribed azithromycin for left lower lobe pneumonia. COVID-19 test was negative on 1/1/21. On 1/6/2021 she went back to the ED for worsening symptoms and was subsequently admitted. Her COVID tests were negative. From 1/6/2021 to 1/11/2021 she was hospitalized at Medical Center for pneumonia. She was ordered antibiotics and steroids.  Her COVID-19 test was negative on 1/11/2021. She was discharged on 1/11/21 to home.
First dose vaccination record says I have 1ml per dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (First dose vaccination record says I have 1ml per dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (First dose vaccination record says I have 1ml per dose). At the time of the report, ACCIDENTAL OVERDOSE (First dose vaccination record says I have 1ml per dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-399918 (Patient Link).
18 month old patient being administered DAPATECL after the expiration date with no reported adverse event; Initial information was received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an 18 months old female patient who was administered Dapatacel after the expiration date with no reported adverse event while receiving vaccine Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB Vaccine CONJ (TET TOX) (ACTHIB); Hepatitis A Vaccine (Hepatitis A) and (PCV 13).  On 29-Aug-2022, the patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (formulation: unknown; strength: standard; batch/lot number: C5765EA; expiration date: 28-Aug-2022; dose number: 4) once after the expiration date (expired product administered) (latency: same day) via intramuscular route in the left vastus lateralis for immunization.  No adverse event was reported after expired product administered.  Seriousness criteria: non-serious  Action taken: not applicable  Corrective treatment: not reported   Outcome: 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 guidelines. 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.
LOCALIZED REDNESS AND SWELLING AT INJECTION SITE OF KINRIX ON RA THAT BEGAN WITHIN 24HR OF VACCINE AND LASTED 2-3 DAYS.
This spontaneous report as received from a 29 year old female patient, refers to herself. On an unknown date in September 2011, the patient was vaccinated with the dose of ZOSTAVAX (route of administration, dose and lot number were not provided) for birth control (off label use). Concomitant therapies included metronidazole (manufacturer unknown). In S2011 the patient experienced product: ZOSTAVAX/therapy reason for use: birth control. The patient stated that she had been having irregular periods since January 2013, continuously with no break. The patient had visited her physician and was diagnosed with bacterial vaginosis (BV) due to the heavy bleeding. The patient was treated for the event (unspecified treatment). Lab diagnostics studies were performed and included vagina smear (reported as Papsmear) (results not provided). The outcome of events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
eyelid swelling, both eyes, bottom eyelid; strange feeling when blinked; Sore; dry eyes; Eye swelling; This case was reported by a consumer via call center representative and described the occurrence of eye dryness in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 11th July 2022 , the patient received 1st dose of Shingrix in left arm).   On 5th January 2023, the patient received the 2nd dose of Shingrix. On 5th January 2023, less than a day after receiving Shingrix, the patient experienced abnormal sensation in eye and pain in arm. On 6th January 2023, the patient experienced swelling of eyelid. In January 2023, the patient experienced eye dryness and eye swelling. The patient was treated with ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)). On an unknown date, the outcome of the eye dryness and swelling of eyelid were not recovered/not resolved and the outcome of the abnormal sensation in eye, eye swelling and pain in arm were unknown.   The reporter considered the eye dryness, swelling of eyelid and eye swelling to be related to Shingrix. It was unknown if the reporter considered the abnormal sensation in eye and pain in arm to be related to Shingrix.  Additional Information: GSK Receipt Date: 09- JAN- 2023 Reporters comment: The case was reported by the patient. She reported that receiving both Shingrix doses in her left arm.  The patient did not know the lot number/expiration dates for the Shingrix vaccines she received.  The patient reported that her left arm had been sore since she received the second Shingrix dose. The patient reported that she started a new face cream 4-5 days before receiving the second shingrix dose.  The patient said she was watching tv (television) after receiving her Shingrix dose and she had a strange feeling when she blinked.  She reported that the next day (on 6th January 2023) she had eyelid swelling in both of her eyes.  She said that the eyelid swelling was not dramatic but there was swelling present, especially in the bottom eyelid.  She also said she had dry eyes in both of her eyes that started sometime after getting the Shingrix dose.  She said that she was using eye drops to treat the eye swelling and dryness. The patient said that she believed the eye swelling and dryness were from the Shingrix vaccine. Healthcare professional consent for follow up was declined. The reporter did not consent to follow-up.
Pt mother states she took pt to ER complaining of difficulty breathing and rash on right arm. Given antibiotic for pharyngitis and Benadryl for rash.
severe back pain; shingle rash; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (severe back pain) and HERPES ZOSTER (shingle rash) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 004C21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced BACK PAIN (severe back pain) and HERPES ZOSTER (shingle rash). At the time of the report, BACK PAIN (severe back pain) and HERPES ZOSTER (shingle rash) outcome was unknown.            Treatment information included pain medication.   No concomitant medication was provided by reporter.  Shingle rash was diagnosed by patient's primary care physician.
I woke up early morning (about 4:00 a.m. but am not sure feeling achy, felt a little sick to my stomach, could not move my head or neck in bed and felt really stiff in my neck and shoulders.  I used my right hand to push myself onto myself and could then use  move my head, sat up and walked around but felt really stiff and achy and lethargic all day.  Also had chills but no fever.  Used a pulse oxy-meter and my oxygen levels were normal.  Next day still felt sick.  I did some yard work and my right hand and thumb started spasming, very painful.  lasted on and off for about an hour.  Next day the spasming was gone (three days after the shot) and then I started to feel better.  I still have a little bit of "weirdness in my right thumb but it isn't spasming anymore.