chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 65 y.o. male with pmhx with HLD, SNHL(uses bilateral hearing aids), here today for  evaluation of facial nerve palsy. Patient had first shot of pfizer COVID vaccine in March 2021 then  developed shingles on the mentum (L>R) which was treated with anti-virals and steroids. After his  second dose of pfizer COVID vaccine he developed complete facial nerve paralysis. Onset was left sided,  sudden, associated with left sided pain at the lower mandible, complete inability to move any left sided  facial muscles with incomplete eye closure. Improved since. Now with persistent tingling and pain (pins  and needles) on the left tongue, mandible. More noticeable later in the evening. * See Page 2 Is on pregabalin to help with this. Eye dried out and then vision feels blurry. Doctor pulgged left lower punctum but still with intermittent issues. Still feels like left corner of the mouth droops, his left eye corner droops. Left neck tightness when smiles.  (-) trauma; no previous such episodes  PLAN: o The timeline of his left facial paralysis is interesting.  Even though the zoster preceded his facial paralysis with the second dose of his vaccine between the two, I would still classify this as Ramsay Hunt over Bell's palsy.  That said, from a Ramsay Hunt perspective his recovery is remarkably ideal.  He appears to have early facial muscular spasticity most notable in his platysma with smiling.  He still appears to have some weakness, particularly with delaying eye closure and blink as well as oral commissure excursion.  We had a long discussion about the development of synkinesis and facial spasticity. We discussed the fact that recovery is a multiyear process for which she is only in the first 4 to 5 months. o Facial muscle retraining for synkinesis- refer to specialist o Placement into facial nerve disorders multidisciplinary treatment program per specialist. o Plan for future chemodenervation related to facial spasticity related to recovery from facial nerve paralysis on the left.  Plan the following injection pattern: platysma 25u and approx 2 u to dao, 3-5 to oculi, 2u to nasalis/ds, 5 u to mentalis.  This pattern is subject to change as he is currently referred to start therapy which will help the irregular contraction patterns and thus his botulinum toxin requirement.  Injection pattern is also subject to change as there is advancement in recovery, either good or bad, ie worsening of spasticity in the first 2-3 years of recovery. o Discussed tingling.  Cutaneous sensation c/w pattern of vesicles related to shingles.  Oral/tongue tingling likely related to chorda tympanil involvement. o lyrica for neuralgia per pcp
Information has been received from a 22 year old nurse with penicillin allergy and no pertinent medical history who on 21-NOV-2007, 21-DEC-2007, and 21-MAY-2008 was vaccinated IM with the first, second and third 0.5 ml doses of RECOMBIVAX HB. There was no concomitant medication. Within 24 to 48 hours after the nurse received the first does of RECOMBIVAX, the nurse experienced reddish slightly raised rash appeared on inner elbow area right arm and left arm. Rash did not itch. The nurse reported that ever since starting the RECOMBIVAX HB series her rash had not gone away and it only faded in the sunlight and had spread to back. The nurse consulted with physicians but diagnosis remained undermined. The nurse reported that she had used the over the counter creams hydrocortisone and selenium but they did not do anything. No diagnostic study was performed. The patient saw a physician on an unspecified date. At the time of the report, the patient had not recovered. Rash was considered to be an other important medical event. Additional information has been requested.
MOnday 14 July I developed a fever (101.5) and MOnday night a rash started on my face. Tuesday it spread to my arms and body. Wednesday i felt better but the rash was bright and itchy. By Friday it was fading.
First night of vaccine,  excessive chills and tired, with periods of fever.  2nd day, achy, tired, and after going to bed two episodes of waking in a full sweat.
SORENESS AND ITCHING LEFT ARM AT SITE OF INJECTION UPON RETURNING HOME THAT EVENING. NEXT DAY EXPERIENCED SWELLING, DIFFICULTY RAISING ARM & FELT TIRED. THIRD DAY FELT FINE AND ABLE TO RAISE ARM.  REDNESS AND SORENESS MIGRATED TO ELBOW. APPLIED ICE.
pt recvd vax 8JAN96 7PM t99.8 ax APAP given;9JAN96 arm sore & still warm;APAP given & sent to day care;slept most of day;appetite poor;315PM t102;APAP given & through noc;10JAN96 taken to PMD,T102,advil given,ear infect noted;given ATB
Tired for 1 or 2 days (dose 1 and 2)/very fatigued for 1 or 2 days (dose 1 and 2); This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Tired for 1 or 2 days (dose 1 and 2)/very fatigued for 1 or 2 days (dose 1 and 2)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A, 0018(B)21A and 039F21A) for COVID-19 vaccination.     Concomitant products included ACYCLOVIR [ACICLOVIR] and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced FATIGUE (Tired for 1 or 2 days (dose 1 and 2)/very fatigued for 1 or 2 days (dose 1 and 2)). At the time of the report, FATIGUE (Tired for 1 or 2 days (dose 1 and 2)/very fatigued for 1 or 2 days (dose 1 and 2)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug included protonic and supplement.  No treatment drug reported.   This case was linked to MOD-2021-378065, MOD-2021-378110 (Patient Link).
Child waited around after recieving injection and she toppled over and seized for 3 seconds, then opened her eyes and was able to speak and answer questions. Paramedics came and checked her vitals and she was fine. Mother made a Dr. appointment and took her home.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on 08-SEP-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C. No concomitant were reported. No treatment were reported.   This case was linked to MOD-2022-496015 (Patient Link).
10/29/20/21 2:05 pm upper lips started tingling and getting puffy. Same day 2:10 pm both lips tingling and swelling. Went down the hallway to clinic where I had received my covid-19 Pfizer vaccination 2:00 pm the same day. I told the RN my symptoms. I went back to work. About 2:25pm same day I had started coughing  and slight wheezing. Went to RN, told me if I felt my airway closing then go to the Emergency Dept. I'd did not go to ER. I asked the RN for a Benadryl capsule which I took. At 4:00pm I checked in with RN about my symptoms, RN said if I feel my airway closing  then go to our hospital ER. ER was full of many sick people. So i felt that I was not that suck so I returned to work. 5pm went home and monitored my O2 saturation and took more Benadryl. My heart was pounding, pulse was 99 on O2 sat finger monitor, 10/29/2021, 10/30/2021, & 10/31/2021 arm was sore, fatigue, muscle soreness, foggy mind ,
Fever, chills, nausea, vertigo, headache, SWOLLEN LYMPH NODES. Armpit on left side is visually swollen and still huge and sore long after other side effects resolved. Other side effects lasted 1 day lymph nodes swelling and pain is now on day 3 and showing no signs of improving.
sore injection site arm after each vaccine; greater than 36 days between doses of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between doses of Moderna Covid-19 vaccine) and VACCINATION SITE PAIN (sore injection site arm after each vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between doses of Moderna Covid-19 vaccine). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arm after each vaccine). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between doses of Moderna Covid-19 vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (sore injection site arm after each vaccine) outcome was unknown.            No concomitants medications was reported.  No treatments medications was reported.   This case was linked to MOD-2021-402855 (Patient Link).
Information has been received from a registered nurse concerning a 14 month old female with an upper respiratory tract infection, no other medical history and no known drug allergies who on 05/10/2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant therapy included amoxicillin trihydrate (+) clavulanate potassium (AUGMENTIN). On 05/20/2002 the pt had a red rash on her face, trunk, and legs and also had a fever. The pt was seen in the doctor's office, on 05/23/2002 with a "typical rash head to toe," described as slightly raised red macules 2-3mm to 1-2cm. The pt was treated with diphenhydramine hcl (Benadryl) (12.5 mg/tsp 1/2 tsp every 6 hours). It was reported that the physician "does not feel this is a reaction to the antibiotic." Additional info has been requested.
Information has been received from a nurse practitioner concerning a 77 year old female with allergic reaction to antibiotics, clam allergy and egg allergy who on 11-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (657764/0584U), subcutaneously.  Concomitant therapy included lovastatin (manufacturer unknown), and DIOVAN.  The nurse practitioner reported that the patient reported to her via e-mail that she experienced injection site reaction.  As of 15-JUN-2007, the patient had a 3 inch spot on her arm that was hard, warm, and itchy.  The patient sought unspecified medical attention.  At the time of the report the patient had not recovered.  There was no product quality complaint.  Additional information has been requested. Additional information received indicated that the patient recovered after about 1 week.  Additional information is not expected.
Horrific headache lasting 2:00am to 6pm same day.  Worst headache in 61 year life - crushing all four sides of head.  Thought I could die of hemorrhage.    Very scary and painful, level 3 grade
stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a sore throat with chest congestion. I had cough and fatigue. It then moved to my head. I had sinus congestion, runny nose and huge body ache. I had my first positive test on July 23, 2022. I felt absolutely miserable for 5 days. My doctor recommended over the counter MUCINEX for my symptoms. After the 5th day, the body aches and other symptoms began to ween off. I took about 12 days to make a full recovery.
found lying on couch by father-eyes rolled back & frothing @ mouth;no tonic/clonic activity seen-but similar to a prev event 10JUL97 parents did not f/u w/EEG;runny nose-no fever
Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 53-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Sleepiness/i was sleepy all day; Temperature 100, never reaching more than 100.3; very dizzy; Restless; woke up earlier that her usual time; feeling very tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Restless), POOR QUALITY SLEEP (woke up earlier that her usual time), SOMNOLENCE (Sleepiness/i was sleepy all day), DIZZINESS (very dizzy) and PYREXIA (Temperature 100, never reaching more than 100.3) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high (Patient has been suffering from high blood pressure since long term.) since 2007, Allergy and Osteopenia. Concomitant products included LORATADINE for Allergy, BENAZEPRIL HCL for Blood pressure high, ACETYLSALICYLIC ACID (ASPIRINE) for Heart disorder, MULTIVITAMINS [VITAMINS NOS] and CALCIUM for Osteopenia.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (feeling very tired) and CHILLS (chills). On 26-Feb-2021, the patient experienced RESTLESSNESS (Restless), POOR QUALITY SLEEP (woke up earlier that her usual time) and DIZZINESS (very dizzy). On an unknown date, the patient experienced SOMNOLENCE (Sleepiness/i was sleepy all day) and PYREXIA (Temperature 100, never reaching more than 100.3). On 26-Feb-2021, SOMNOLENCE (Sleepiness/i was sleepy all day), PYREXIA (Temperature 100, never reaching more than 100.3) and CHILLS (chills) had resolved. At the time of the report, RESTLESSNESS (Restless), POOR QUALITY SLEEP (woke up earlier that her usual time), DIZZINESS (very dizzy) and FATIGUE (feeling very tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant follow-up: Updated outcome and stop date of the event chills. Added medical history, concomitant medications and additional events of sleepiness, pyrexia.
Joint pain (all joints, back, neck, arm and legs), fatique, anxiet, shortness of breath and sleeplessness growing into decreased mobility and first event to force me to seek medical care was a frozen hip due to severe pain and limited ability to walk on/about 6/19/21; prescribed prednisone (among other prescriptions) which greatly helped and improved some but still had joint pain, back pain, fatique, shortness of breath and mobility issues; next injury requiring medical care occurred on/about was after my legs went out from under me and I fell down stairs. I sought care at facility where they only xrayed my knees. I sought follow up care at another facility with my long time orthopedic Dr for my continued joint and back pain and inability to walk. I have been experiencing shooting pains/sensations up and done all arms/legs/spine from skull to tailbone. Dr watched me limp and stated it appeard that I had inflammation of the spinal cord and he agreed with me that I think it is the result  of my covid vaccine. He said there was no treatment and to see if it got better. I got a flu shot on 9/10/21 and my symptoms all came back and I have struggled with walking ever since. My GP has ordered full MRIs and for me to follow up with Dr, a neurologists for the suspected myelitis.
This spontaneous report as received from a pharmacist via a inside sales representative refers to a female patient of unknown age. The patient's medical history and drug reactions were not specified by the reporter. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (1 vial, route of administration, lot# and expiration date were not reported). The patient's concomitant therapy was not specified by the reporter. On an unknown date (thirty days after the patient received the vaccine), she broke out in a rash. It was unspecified exactly where the rash was at that time. The patient was treated with unspecified oral steroids, with no improvement. The patient sought medical attention by having multiple trips to an unspecified Emergency Facility. The rash was spreading and covered the patient's entire upper torso. The outcome of rash was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of fatigue in a male patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. Concurrent medical conditions included dog bite. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to dTpa vaccine. Additional information was reported as follows: The age at vaccination was not reported. The patient was bitten by a dog and vaccinated with dTpa vaccine by the hospital. The patinet had a visit to the office on the date of reporting and was complaining of lingering fatigue. The reporter was unsure if the event experienced by the patient was related to the vaccine but wanted to explore the underlying causes and was curious if it had been reported or linked in the past.  The patient was also provided with the Medical Affairs number.