chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Nurse Practitioner (N.P.) concerning a 21 year old female patient who in January 2007, was vaccinated IM with a first dose of Gardasil. The patient developed genital warts within one month. Patient was treated with trichloroacetic acid (TCA) 80% on 06-MAR-2007 and on 10-APR-2007. The outcome was unknown. Papanicolaou (PEP) test was performed, results unknown (done at another clinic). The NP reported two other patients who had a similar experience. She verbalized concern that she had seen 3 episodes of genital warts developing soon after Gardasil. She believed the patient's immune system can not handle the viral load. Additional information has been requested.
only tooth ache/tooth sore; nowshe only has half of tooth; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (only tooth ache/tooth sore) and DENTAL CARIES (nowshe only has half of tooth) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 007M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-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 TOOTHACHE (only tooth ache/tooth sore) and DENTAL CARIES (nowshe only has half of tooth). At the time of the report, TOOTHACHE (only tooth ache/tooth sore) and DENTAL CARIES (nowshe only has half of tooth) had not resolved.            Caller stated she has scheduled her booster dose for tomorrow, but she has toothache. She saw her dentist yesterday and they recommend she should get a root canal, but they cannot do the procedure until the 19th, and caller wants to know if she can have her booster shot tomorrow. She has a slight toothache, doctor told her she should take a painkiller and warm water to keep it calm, and caller asks if she should postpone her booster shot or continue with her shot. The pain has been going on for a week, it is sore, and when she chewed, the filling fell out, and now she only has half of tooth. Caller stated she doesn't have fever, only tooth ache, tooth sore. Caller states they're going to do a root canal in two weeks.  No concomitant medication reported.    This case was linked to MOD-2021-374965 (Patient Link).
after 2 days began bed sweats during the night; This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (after 2 days began bed sweats during the night) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced NIGHT SWEATS (after 2 days began bed sweats during the night). At the time of the report, NIGHT SWEATS (after 2 days began bed sweats during the night) had not resolved.            Concomitant medication not reported.  Received latest vaccine for the variant recently and after 2 days began bed sweats during the night which appears to be continuing. Treatment medication not reported.
herpes zoster involving C5-C6 dermatome of rt upper extremity;tx w/7 days Iv acyclovir & 3 days PO;
Patient complains of stiff and painful neck and shoulder. Symptoms started 3 days post vaccination. Patient states he is unable to move his arm upon awakening and it takes 1-2 hours to work out the stiffness. Patient also complains of rash starting 5/19/12.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 23-FEB-2018 and 24-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020; lot# N023828 and expiration date 25-JUN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
On 9/9/14 pt received DTaP-IPV immunization. Phone call from parent 9/10/14. Pt seen within the hour with (R) arm swollen 2 times larger than (L) arm, warm to touch, reddish and pt states hurts to move it. No fever. No shortness of breath. Treatment: BENADRYL 25 mg liquid Q 2-3 times a day, Ibuprofen liquid 100 mg Q 6 hours for allergic reaction. Parent informed to contact if not resolving tomorrow.
Around 3 am following my vaccination, I got extremely lightheaded and nauseous. I was sweating profusely. I threw up a couple of times. These symptoms subsided after maybe 15 minutes.
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. It was reported as unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: The follow-up document includes non-significant information.
A small triangular patch was still swollen under my left eye; a racing heart; severe headache.; Dizzy moments,; feelings of clumsiness; Chills; pain in right knee; pain in left shoulder; mouth and left side of  face felt numb; mouth and left side of  face started swelling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8737) via an unspecified route of administration in the arm left on 03Apr2021 at 09:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and general allergies. Patient had birch allergy (as child) and had reactions (fever) after vaccines as a young child. The patient did not have any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 09:45, the patient experienced numbness, swelling face, dizziness, clumsiness, chills, pain in knee and pain in shoulder and at 3:00 he experienced severe headache. On 04Apr2021, the patient experienced a racing heart and  on 05Apr2021, the patient experienced eye swelling. 30 minutes after the vaccine, the patient noticed his mouth and left side of face felt numb and started to swell as he was driving. The sensation felt similar to dental work. It seemed to improve after 1-2 hours (went for a walk and started to do yard work). General numbness and swelling lasted all day. On day 2, a small triangular patch was still swollen under his left eye. In the night (of day1) he woke up at 3:00 with a racing heart and severe headache and had a restless night thereafter (which is highly uncommon). Heart beat went back to normal after waking up and walking outside. Other less severe and persistent symptoms included dizzy moments, feelings of clumsiness (fell playing sports with son, missed a stair), chills, pain in right knee, pain in left shoulder, The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache, dizziness, clumsiness, chills, pain in knee, pain in shoulder and eye swelling was recovering at the time of this report. The clinical outcome of the event numbness and swelling face was recovered on 03Apr2021 and racing heart recovered on 04Apr2021.    No follow-up attempts are needed. No further information is expected.
Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    No concomitant medications were reported.  This lot number 060B22A of vaccine was administered to patients with a count of in between 75 and 125. There were a total of 82 patients involved. The healthcare provider wanted to know if the vaccine administered on 15-MAR-2023 would be considered as valid for the patients.  It was also reported that there was potentially a second lot number of vials that had expired on 28-Feb-2023 and was administered to patients on 03-Mar-2023, but the healthcare provider did not have any details of that event at that time. The second potential lot was confirmed to not be used.  The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master  case
infection; extremely fatigue; Fever; flu like symptoms; coughing; sneezing; injection site reactions; feeling few lumps around the injection site; Her heart beat dropped from 95 to 50 till about midnight and it will go up and down and up and down; chills; sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (infection), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (coughing), SNEEZING (sneezing) and VACCINATION SITE REACTION (injection site reactions) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (coughing), SNEEZING (sneezing), VACCINATION SITE REACTION (injection site reactions), VACCINATION SITE MASS (feeling few lumps around the injection site), HEART RATE IRREGULAR (Her heart beat dropped from 95 to 50 till about midnight and it will go up and down and up and down), CHILLS (chills) and MYALGIA (sore). On an unknown date, the patient experienced INFECTION (infection), FATIGUE (extremely fatigue) and PYREXIA (Fever). At the time of the report, INFECTION (infection), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (coughing), SNEEZING (sneezing), VACCINATION SITE REACTION (injection site reactions), VACCINATION SITE MASS (feeling few lumps around the injection site), HEART RATE IRREGULAR (Her heart beat dropped from 95 to 50 till about midnight and it will go up and down and up and down), CHILLS (chills), MYALGIA (sore), FATIGUE (extremely fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient went to her health care provider and she got diagnosed with infection and got prescribed antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Event information updated
22Jul90 pt vax 3rd dose; neg titer.  04Oct90 vax 4th dose. titer still neg.
PMH: Vasovagal with injection.  Ambulate to healthcare with assistance. Onset diaphoresis, nausea, lightheadedness. CV: RRR No vomiting, no meds,. Ate prior to vaccination (water and crackers). At 12:43PM  patient feels better, no symptoms. Discharge at 12:45PM BP: 119/78
Patient reports a hot pain that lasted almost 2 weeks. Arm still sensitive, not swollen.
Pain in his left sciatic nerve (on his left leg); This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Pain in his left sciatic nerve (on his left leg)) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 037A21B) for COVID-19 vaccination.     The patient's past medical history included Surgery (Surgery for left sciatic nerve) in 2015.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SCIATICA (Pain in his left sciatic nerve (on his left leg)). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, SCIATICA (Pain in his left sciatic nerve (on his left leg)) had resolved.            No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Non significant follow-up appended as there is no new information added
Productive cough and congestion, headache, sore throat, body aches,chills,low grade temperature; itchy and red eyes, eyes felt painful when touched,had thick white/yellow drainage from eyes, puffy eyelids; fatigued.  Symptoms lasted for approx 18 hrs, then began subsiding.  Most symptoms gone within 36hrs. Took Tylenol, cold medicine, and Benadryl.
Rash on neck, chest, under breast and arm pits. Red, but not raised or itchy. Had same rash in same location after my 2nd dose. Lasted about 24-36 hours.
Fever Tm 105.0 (R) -> started at 12 hrs. after & lasted < 24 hrs. Was given Acetaminophen/Ibuprofen - alternating every 3 hrs. to try & keep fever under control.
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Jan2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient took the 1st dose of Covid 19 Vaccine 2nd of Jan. and then 2 weeks later, tested positive for Covid. He was quarantined at the (Department name) that's why he didn't take the 2nd dose of Covid 19 Vaccine. Now, he was feeling good. They're asking if he can take the 2nd dose now. The patient underwent lab tests and procedures which included sars-cov-2 test: he was confirmed to have covid on 05Jan2021.  Outcome of the events was unknown.    Information on Lot/Batch has been requested.
BODY ACHES, FEVER, HEADACHE, CHILLS,  FATIGUE RESOLVED 48 HOURS Narrative:
Head ace,  chills, joint pain,  nausea,   overwhelming fatigue.   Shortness of breath.
pt  brought to ED via EMS after daughter found pt pulseless with agonal respirations; CPR; obtained ROSC; intubated; found to be positive for COVID; started on Decadron, bronchodilators, ventilator, ABX; severe anoxic brain injury; poor prognosis; family decided to have pt extubated and she passed away in the hospital
Tue May 4th I received my first shot of the Pfizer C-19 mRNA vaccine.   Exactly 5 days later (Sunday May 9th) I started to develop a hive like itchy rash on the inside fore-arm of the opposite arm to which I got vaccinated.  A few days later I developed a similar but more extensive hive like itchy rash on my stomach to the right hand side to the front.  The rash is still visible and itchy now (2 weeks post 1st shot).  As of today I am treating the itchy discomfort with calamine spray and I took Benadryl Allergy antihistamine 50mg to see if that helps.
Event:  approximately 3x5cm area of indented atrophic muscle with hypopigmentation to right thigh (where vaccines administered); Parent noted this began to occur shortly after child received 6 month vaccine series however it was not brought to the provider's attention until the thigh was visualized at 12 month visit prior to administration of vaccines again.
Initial report received from a healthcare professional on 22 January 2014. A patient, whose date of birth, age, gender, medical history illness at the time of vaccination and concomitant medication were not reported, had received a first dose of IMOVAX vaccine (lot number, route and anatomical site of administration were not reported) and also received Rabies vaccine for next dose (manufacturer: other, lot number, route and anatomical site of administration were not reported) both vaccines on an unspecified date. On an unspecified date, after vaccination, the patient experienced unspecified "reaction". Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Vaccine was given more than 12 hours (about 13 hours) after puncture.
BNT162B2 was administered at Left leg; 8 days after receiving the second vaccine I developed a rash.; It started as big red patches on my face; Hives on my neck and torso; The hives cleared up the next day but the rash on my face continued to be present and continues to be present four weeks later. Some days it is worse than others, it is hot and it itches just a little. Its more hot than itchy.; The hives cleared up the next day but the rash on my face continued to be present and continues to be present four weeks later. Some days it is worse than others, it is hot and it itches just a little. Its more hot than itchy.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left leg on 23Mar2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included under active thyroid. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) and bupropion hydrochloride (WELLBUTRIN); both from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 02Mar2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 06:00, 8 days after receiving the second vaccine, the patient developed a rash. It started as big red patches on face and hives on neck and torso. The hives cleared up the next day but the rash on face continued to be present and continues to be present four weeks later. Some days the rash was worse than others, it was hot and it itched just a little. It was more hot than itchy. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with unspecified cream and the patient stopped taking other medications. Since the vaccination, the patient had been tested for COVID-19. On 06Apr2021, the patient underwent nasal swab test and the result was found to be negative. The clinical outcome of the event hives was resolved on 01Apr2021. The clinical outcome of the events rash, big red patches on face and it was hot and it itched just a little were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
8 minutes after I ejection left arm and entire face went numb along with pins and needles throughout all of the body, lightheaded, dizzy. Day 1 minor aches, numbness still present. Day 2 severe chest pain, numbness still present. Went to urgent care, ekg preformed. Day 3 loss of equilibrium, severe vertigo, nausea, dizziness. This continued to get worse day 4 and 5, went to urgent care again. Still numb, tingling, vertigo, nausea. Blood work completed and nausea medication provided. Inability to speak or perform any movement without losing balance. Severe spinning sensation. Went to ER on day 9 all symptoms still remain. Numbness converted to painful tingling and movement throughout body. Vertigo medication, nausea medication provided. Suggested neurologist. Went to neurologist  on day 12. Symptoms still remain. Neurologist suggested seeing a primary care internal dr.
Severe chills, without known fever (temp measured 98.6) lasted about 2 hours. Extreme fatigue lasted throughout the following day.