chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"right hand looked like it had a pillow on top of it" \  "fingers are puffy and it is hard to write"; puffy; "my vision seems to be messed up"; Patient did not get the second dose of the Moderna vaccine and doesn't plan to get it; "I am having a real bad time with my eyes"; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING ("right hand looked like it had a pillow on top of it" \  "fingers are puffy and it is hard to write"), OCULAR DISCOMFORT ("I am having a real bad time with my eyes"), PERIPHERAL SWELLING (puffy), VISUAL IMPAIRMENT ("my vision seems to be messed up") and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose of the Moderna vaccine and doesn't plan to get it) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced OCULAR DISCOMFORT ("I am having a real bad time with my eyes"), VISUAL IMPAIRMENT ("my vision seems to be messed up") and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose of the Moderna vaccine and doesn't plan to get it). On an unknown date, the patient experienced PERIPHERAL SWELLING ("right hand looked like it had a pillow on top of it" \  "fingers are puffy and it is hard to write") and PERIPHERAL SWELLING (puffy). At the time of the report, PERIPHERAL SWELLING ("right hand looked like it had a pillow on top of it" \  "fingers are puffy and it is hard to write"), OCULAR DISCOMFORT ("I am having a real bad time with my eyes"), PERIPHERAL SWELLING (puffy), VISUAL IMPAIRMENT ("my vision seems to be messed up") and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose of the Moderna vaccine and doesn't plan to get it) outcome was unknown. Not Provided      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.   Patient takes other medications but did not provide the names of the medications but stated she takes 3 for her heart, 1 for asthma,1 for bipolar, and 1 for pain.
Diagnosis -  Left forehead shingles with left eye involvement Allodynia of left face and left front scalp about 4/7/21 Left eye soreness and slight redness 4/8/21 Raised red blemishes on left forehead 4/9/21
Patient developed redness and a rash - hot to touch on left arm, 5 inches tall, 8 inches wide around arm. Some small red "spots". This was observed on 3/14/18 at doctors re-evaluation appointment.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 55-year-old female patient who received BOOSTRIX (batch number 9GM3R, expiry date 20th January 2020) for prophylaxis. Concomitant products included SHINGRIX, RESTASIS, Montelukast, duloxetine, citalopram, CARDURA, Metoprolol ER, NEXIUM, nortriptyline, topiramate and trazodone. On 30th May 2018 15:45, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced injection site swelling, injection site erythema, injection site warmth, injection site pain and injection site lump. The patient was treated with prednisone. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, injection site pain and injection site lump were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, injection site pain and injection site lump to be related to BOOSTRIX. Additional details were provided as follows: On 30th May 2018, the patient received 1st dose of SHINGRIX (batch number LT533, expiry date 11 December 2020) on left arm concomitantly with BOOSTRIX on upper right arm. The patient's upper right arm had swelling, and as described by the patient to the pharmacist there was a golf ball size lump at the injection site which was painful, red and producing heat. The time of onset of the event was not known. The patient visited a walk in clinic on Saturday, 2nd June 2018 and was given prednisone to help with the symptoms. The pharmacist was calling to get an extended list of ingredients in BOOSTRIX vaccine per the request of patient. No further details were provided.
Pt said 2 hrs after the shot, he developed chill and dizziness. He tried to go to sleep, hoping these s/s would go away. but later that night, he developed fever and ended in ER. Pt stayed there for 3 days.
Initially felt typical post vaccine flu like symptoms but including more severe shaking chills & extreme tiredness, so took a few day off regular daily activities and wor ; night of day three about 15 minutes after going to bed my back, both sides and then shoulders began to itch uncontrollably & got red. I was unable to relive it with cortisone creme or itch X so orally took 25 mg Benadryl but a half hour later itching still bad so took a second oral .25 Benadryl & finally a third .25 oral dose on the hour . After a total of 75mg Benedryl & a third topical itch x, application I was able to sleep.  This occurred night of day four  also -same topical treatment plus .50 mg benadryl got me to sleep. Day five  again same topical  treatment and only .25 Benadryl. Day six  .25 mg Benadryl also. Saw PCP  about 4 days later and we agreed I must stop all famvir or similar drugs to see if this would lessen this effect. Additionally from day four on,  if I took a shower even with cool water my arms & legs where water hit itched & burned badly as if many needles being jammed into my skin.  I remain off all famvir type meds but now  12.31.2019 a lukewarm to cool shower made arms burn itch & tun so red I had to get out of shower &rinse off with pitcher slowly in tears from pain & itching.  I am  unable to resume all normal daily activities  due to generalized itching on neck arms back & legs.
This spontaneous report as received from a nurse practitioner refers to an approximately 14 years old male patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot# unknown, dose/frequency and route unknown). No other vaccine was administered at the time GARADSIL was administered. The nurse practitioner reported that on an unspecified date "in the fall", the patient experienced an episodes of syncope after receiving his first GARDASIL. Action taken was not applicable. The outcome of the event "episode of syncope" was unknown. Additional information has been requested.
66 YO F w h/o COPD, atherosclerosis, esophageal varices, HLD, MDD, cerebral atrophy,  and GERD who presents with itching a few days after vaccine and a redline going up her arm to her shoulder. Denies pain or fever. 2/23/21 prescribed Keflex for possible cellulitis. Med picked up 2/24/21. Follow up planned with PCP
I am having excruciating pain in my ankle; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 05Mar2021 (at the age of 54-years-old) as a single dose for covid-19 immunization. Medical history included cholesterol, High blood pressure. Concomitant medications were not reported. On 05Mar2021, the patient stated "I had a covid shot yesterday around 10 and I am having excruciating pain in my ankle." The patient did not receive any treatment. Outcome of the event was unknown  No follow-up attempts are possible. No further information is expected.
HX OF OLD MI W STABLE ANGINA HYPOTENSION CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/20/2022,  12/21/2022,  2/2/2023 --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Administered dose more than 12 hours after vial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: New reporter added.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 1:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 1:44 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 73.42.  Concomitant products were not provided.  For Lot no : 027L20A on 11-Jan-2021, excursion time was 9 AM and 2 PM and temperature was 34 and 35 respectively, total doses given for the day was 98, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Jan-2021 and was moved to clinic on  08-Jan-2021. 02 vials was sent to clinic. Vaccine BUD date was 04-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Case number PHEH2013US024308 is an initial spontaneous report received from a nurse on 18 NOV 2013. This case refers to a 35-years-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: not reported) intramuscularly a month ago (date unspecified) and received another intramuscular dose of FLUVIRIN 2013/2014 (batch number: 1309001) on 18 NOV 2013. No adverse event was reporting following this administration error.
When I got the injection, I took two Tylenols.  I noticed after my arm got hot and swelled a little.  About 2-3 days later I had a bad rash spread from around the injection site.  I went to see my doctor after a week of having that and they told me to take Benadryl.  I also was taking cortisone cream.  I went back to the doctor because it would not go away.  My doctor prescribed me two different pills, the rash and swelling went away a little.  I had to back to the doctor and he prescribed a different pill, and the itching and swelling went away.
Information has been received from a consumer concerning a 15 year old female with thyroid condition and no drug reactions/allergies who on 17-AUG-2007 was vaccinated with her first dose of GARDASIL and her second dose of GARDASIL on 17-OCT-2007. Concomitant therapy included propranolol HCl. The patient had been very anxious and had trouble focusing since she was given both doses of GARDSASIL. As of 04-DEC-2007, the patient had not recovered. Additional information has been requested.
Pt came in c/o pain to L side of face from nose to L ear and L scalp - tender to touch.  No lesions noted except for small macule on L upper eyelid and some shotty L nodes.  Sx occurred approximately 5 days post ZOSTAVAX.
appeared to be having a sz (arms, legs);occurred 24APR98 AM;pediatrician referred pt to neurologist;no appointment made as of 27APR98;no fever;
rash that itches like hell all over my body/rash that itches intensely; Nauseated for 10-12 days; got tired just going to the bathroom; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash that itches like hell all over my body/rash that itches intensely), NAUSEA (Nauseated for 10-12 days) and FATIGUE (got tired just going to the bathroom) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tracheostomy. Concurrent medical conditions included Heart failure.    On 31-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (rash that itches like hell all over my body/rash that itches intensely), NAUSEA (Nauseated for 10-12 days) and FATIGUE (got tired just going to the bathroom). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash that itches like hell all over my body/rash that itches intensely) had not resolved, NAUSEA (Nauseated for 10-12 days) had resolved and FATIGUE (got tired just going to the bathroom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported as patient was very short winded.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Patient tripped and fell due to loose shoe. One inch laceration on forehead. BP 143/81, pulse 70, 99% O2 sat.
Headache. More likely due to high BP than vaccine, but had headache for 3 days after first vaccine dose.
recurrent corneal erosion.  I also developed a tingling in the tip of my tongue, and shedding of the epidermal layers on my lips.  This slowly improved (helped by an eye procedure) but again deteriorated 2 days after I received the booster 15th November 2021
Discrete, Agminated, blanchable, slightly raised 3-5mm erythematous, slightly raised papules, some with pale haloes. Lesions were located on extensor knees, elbows, dorsal hands, and ventral wrists. slight associated pruritus.
Had 4 mo vaccines 1/8/16 in the days following was increasingly fussy and difficult to console. Seen in our office 1/11/16 for abdominal pain sent for KUB which was concerning for intussusception transferred to ER for further imaging which was unremarkable.
elevated heart rate, elevated blood pressure. headache ,.wheezing for 3 days, dizziness, weakness, chills, fatigue,  constant nausea,, muscle aches, extreme joint pain.
Only 17 years old when received the Moderna vaccine. No actual adverse effects except for experiencing some nausea has been reported since receiving the vaccine. No follow up medical attention was needed.
No additional AE reported; Nurse call to report that GARDASIL 9 was stored improperly and administered; Information has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 29-JUL-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis, lot number 1637651 with expiration date in 09-JUN-2022 (dose, route of administration, strength and anatomical location were not reported).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a temperature range of 50 degrees Fahrenheit (degrees F) for the time frame of 1 hour and 46 minutes. There was no previous temperature excursion and the call was because of a data logger.  No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA000316: US-009507513-2008USA000266:
This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 19-JUL-2013, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot number 0151Z, expiry date 28-MAR-2011, route was subcutaneous). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
@1055 Post vaccination, pt complained of not feeling well, dizzy. Pale. Assisted to the gurney and pt had a syncopal episode, which lasted for about few seconds. No injuries noted. Placed on supine position with feet elevated. Pt became diaphoretic, pale. VS 109/60 HR 70 RR16 100%RA. Left in supine for few minutes. Gradually sitting pt up. Denies nausea. Started introducing PO fluids. Tolerating well. Pt started feeling better, diaphoresis stopped. Per pt, dizziness is better and starting to go away.   @1110 Pt drank a juice box and full bottle of water. Pt's color is better. Denies dizziness. Looking at the phone. Instructed pt to let wife know to meet him by the entrance. Wife is waiting in the parking lot.    @1120 Sat pt at the side of the bed with feet dangling. Pt feeling back to baseline. Skin WNL.    @1123 Ambulated well. Denies any symptoms. Pt is confident on going home. Wife waiting by the entrance.
69 Y/O male, BMI 39.9, PMHx of DM, hyperlipidemia, and HTN, admitted with SOB. Pt tested Covid19 positive on 7/29/21 and received Regeneron. Chest x-ray completed on 8/3/21 indicated bibasilar pneumonia. Pt was not a candidate for remdesivir due to renal insufficiency. Covid19 was treated with supportive care. Pt was discharged home on 8/7/21.
Child complained on Saturday, 1/23/2010 that he had a sore throat and headache with 100.7 fever. On 1/25/2010, child looked flushed all over body (like sunburn) and broke out in a full body rash with blisters.
48 year old female client arrives to led vaccination site and wants to receive Moderna Booster.  Client reports that 1 day after receiving the second dose of Moderna vaccine, she experienced heart rate of "about 160" with "flu-like symptoms" and went to the Emergency Room.  Client reports that Emergency Room labs were within normal limits. Client reports history of "issues with heart and mitral valve".  Client denies other cardiac issues, and reports that her Primary Care Physician (PCP) was made aware of incident and still recommended that she receive booster dose of COVID-19 vaccine. Elevated issue to Clinical Supervisor who received approval from Dr. for administration of Moderna booster dose.  Client provides verbal consent to receive Moderna Booster.  Moderna booster dose given in left arm, administered by RN.  No adverse symptoms noted during observation period.  Client was advised to follow up with PCP if adverse symptoms or cardiac issues arise.  Client verbalized understanding.
A dose of Moderna Covid-19 vaccine was administered to a patient at 10a today (21Jul2022) from a vial that was punctured at 11:45a on 20Jul2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was administered to a patient at 10a today (21Jul2022) from a vial that was punctured at 11:45a on 20Jul2022) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022 at 10:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was administered to a patient at 10a today (21Jul2022) from a vial that was punctured at 11:45a on 20Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was administered to a patient at 10a today (21Jul2022) from a vial that was punctured at 11:45a on 20Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. Number of doses/vial was Single dose The vial was initially stored in the refrigerator on 14-Jul-2022 Vial was first punctured on 20-Jul-2022 at 11:45 am Vial was stored in the refrigeration post puncture Vial did not undergo any temperature excursions
malaise, vomiting, diarrhea occurred w/in12 hrs of vax & have persisted @ least 4 days;
BUMPS HIVES ALL OVER BODY RED ITCHY BRUISED ON INNER THIS AND ARMS SORE AND TENDER