chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 65 year old retired male with no illness at the time of vaccination, polyarthritis, peripheral vascular disorder, hypertension and a history of non-specific abnormal liver function studies related to hyperlipidemia who on 19-MAR-2007 was vaccinated with a first dose of Pneumovax 23 (lot # 655290/0959F) 0.75 to 0.8 ml subcutaneously in the right tricep area at 10:30 AM. Concomitant therapy included enalapril maleate (MSD), warfarin, DEMADEX, amitriptyline hydrochloride (MSD), OMACOR, meclizine and VIAGRA. The nurse withdrew 1 ml. from a multi-dose vial of Pneumovax 23. During administration, the nurse realized the recommended dose, stopped administration of the 1 ml dose and 0.75 to 0.8 ml was administered to the patient. On 20-MAR-2007 (previously reported as 19-MAR-2007), the patient experienced chills and fever. At the time of reporting, the patient had not recovered. No further information was available at the time of reporting. Follow-up information was received from the licensed practical nurse. On 20-MAR-2007, the patient experienced fever, chills, muscle aches, and erythema of the right tricep. No diagnostic tests were performed. The patient was treated with rest, fluids, and TYLENOL. On 23-MAR-2007, the patient reported feeling much better and had recovered. No additional information is expected.
Patient received FLUVIRIN (Novartis) and PNEUMOVAX 10/03/2008 at 15:58. Her temperature was 103.5 on 10/4 with extreme dizziness. She saw Dr. 10/7. Dr reported to me that she had temp of 102.5, dizziness and 2nd degree cellulitis at site. He prescribed Cipro 500 twice a day for 10 days. On 10/12 patient reported to me she was better, still running a low-grade temperature and still very weak but no dizziness. Dr's phone number is 325 690 1500.
BODY PAIN; FEVER; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, anxiety, hiv positive, cigarette smoker, half a box daily, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and  expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body pain. On 10-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, and fever on APR-2021. This report was non-serious.
Forgetful; Very tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Forgetful) and FATIGUE (Very tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (Forgetful) and FATIGUE (Very tired). At the time of the report, MEMORY IMPAIRMENT (Forgetful) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Pharmacist had multiple vaccines on clinical counter.  Pharmacist was preparing to administer vaccine to intended patient and another family.  Pharmacist picked up Janssen vaccine in error and administered to adolescent instead of the intended parent. Error was acknowledged and family was advised that error occurred and would be reported to supervisor and other appropriate individuals within the Company. Parent was given updated receipt listing what product family had received and advised that Company would stay in communication with family as further information arose.
Muscle twitching/fasciculations  (10-14 days post vaccine, remains unresolved) Stiffness/achiness/pain in thighs and knees worse on the left ( 10-14 days post vaccine, remains unresolved) vibrations/shakes in chest (10 days post vaccine, within 3 weeks) numbness/pins and needles in upper thigh, and fingers (resolved after 30-45 days) Dizziness and fatigue (began 10-14 days post vaccine, and is intermittent, but unresolved) Overpowering anxiety and depression which I had never treated for or experienced, including extreme emotional distress and thoughts of suicide (resolved gradually after 2 months, began after 2-3 weeks after vaccine.  I am unable to walk significant distances or stand for more than a few minutes. Subjective weakness in legs, but not clinical weakness. No current neuromuscular/vascular issues above waste. Muscle twitching occurs primarily in calves and thighs but is widespread.
Mother states "bumpy rash" to both arms & legs 1 day after vaccine. Followed up with pediatrician & dermatologist who Rx cream & rash subsided temporarily but came back after the cream & prednisone was complete. Now is seeing allergist who is running tests.
Patient was wheeled in on a rolling chair(no wheelchair available at time) from nurse that administered vaccine because of anxiety and a needle phobia that put the patient into a kind of shocked state. Patient was sweating profusely, white to the face, and not speaking very much but would answer questions correctly. EMT was speaking with the PT before walking away to continue other monitor duties when he turned back to see patient limp in chair, head back, eyes rolled back, and some twitching movements of the body. EMT called for rapid response  because first thought of seizure and seizure like activity with the twitching movements. EMT got to patient, supported head up straight, and opened jaw to ensure airway was clear. Patient had no response to EMT trying to communicate. Sternum rub was performed where patient came back conscious nearly instantly. PT was unresponsive for roughly 10-15 seconds. Patient was told of what happened and vitals were taken on her, response team was cancelled with most them already on scene. PT was feeling better, sweating stopped, color to the face returned, and PT was speaking and understanding more clearly than before. PT was given a snack and water and was monitored by EMT for an additional 15mins before patient and staff were confident with her leaving.
Very sore arm, fever/chills/shakes, headache, extreme tiredness, achy that lasted for 2 days.  Much worse than expected since this was my second shot.
The pt cried hard and stopped breathing, turned blue, passed out and recovered spontaneously. Occurred 4 days post vax in August and the same day in October. However this pt has had similar episodes unrelated to vaccines.
Rash on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No prior medical history was reported.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash on injection site). At the time of the report, VACCINATION SITE RASH (Rash on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included antihistamines for product use of unknown indication.  Reported treatment medication including antihistamine. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No prior medical history was reported.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash on injection site). At the time of the report, VACCINATION SITE RASH (Rash on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included antihistamines for product use of unknown indication.  Reported treatment medication including antihistamine.
I am experiencing awful muscle pain in my upper right arm that radiates down to my elbow each time I move it.  In the mornings I can barely move my arm without experiencing pain. I was taking Ibuprofen or Advil to gain relief and movement.  At the direction of my physician, she recommended Voltaren to alleviate the possibility of harming my liver due to taking Advil/Ibuprofen daily.  The shot has truly impacted my quality of life.  It is very doubtful that I will take the shot again.
Pain to left deltoid; swelling to left neck on set 24 hours after injection, no temp, swelling is painful.
At the time of the injection I felt immediate pain and burning. The next morning when I woke up I was unable to move my shoulder without excruciating pain. I had almost no range of motion. I had absolutely no strength. I started to take ibuprofen and cycle with Tylenol. I treated with heat, ice, icy hot and salon pass patches. My pain is located where my joint or rotator cuff would be located. I had no deltoid pain this time. My shots were both from the same lot. It is now eight days and I have some relief but still some pain, loss of motion and loss of strength. When I reported it to health programs they asked me to fill out this form. I am going to continue on the same regimen and hope it resolves itself. I have been doing a lot of things one-handed and trying to avoid use of my left arm.
No additional AE reported.; a dose of PROQUAD was administered after a temperature excursion; This spontaneous report was received from a health bussiness professional (HBP) responsible for vaccines and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 19-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # W017570, expiration date 29-NOV-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis. The suspect vaccine was improperly stored at a temperature of 5.7 Fahrenheit (F) for 30 minutes. The vaccine was previously improperly stored at a temperature of 6 F up to 14 F for 1 hour 6 minutes and at a temperature of 6 F up to 14 F for 1 hour and 8 minutes. No adverse events were reported.
Guillain Barre Syndrome post Twinrix. Immediately after the injection he "felt like it went straight to the base of my neck and down the spine, felt like a worm." He reports he asked the vaccinator "am I supposed to feel like this?" 24 days later on 30JAN04 he reports his "back became numb and I had a sensation in my legs and was weak. " The next day these sxs continued as well as he developed numbness in the hands and feet bilaterally and had difficulty walking Also his "throat felt tight" but denied shortness of breath. On 2FEB04 he presented to the emergency room and was admitted to the ICU for Guillain-Barre syndrome. On admission he denied any recent hx of URI, diarrhea, fever or chills. The initial problem list included generalized weakness, autonomic instability and transaminitis. Sxs quickly progressed to complete immobility although he was fully alert and responded to yes an no question with a slight squeezing of the left hand. On 5FEB he was intubated secondary to an aspiration episode. He had a gastrostomy tube insert4ed. He received 5 treatments of IVIG with little improvement. He remained intubated in the ICU for several weeks with telemetry, sequential compression devices, tube feeding and UE peripheral IVs. Eventually he was extubated and made slow progress toward regaining mobility. On hospital day 45 physical medicine and rehabilitation was consulted to assist in pt's rehabilitation. He then began intensive physical therapy, occupation therapy and speech therapy. At the time he had diffuse neuropathic pain and had become incontinent of urine and stool. He was unable to ambulate and had developed glaucoma following extensive steroid use. He developed a reactive depression with insomnia, anxiety and depressed mood. He was receiving DVT prophylaxis. He continued to improve and was discharged from the hospital on 5JUN04 and allowed 30 days convalescent leave. At the time of this writing his hands are numb to temperature and light pressure. Fine motor movement is improving and he is able to ambulate a few steps independently. He has full sensation in the thighs but it is markedly reduced below the knees. he has constant throbbing neuropathic pain in the lower extremities and frequent feelings "like an electric shock or on fire". His bladder control had returned and bowel function is improving. He is pending medical board separation form the military. Per the follow up report-Spoke to SM. Has greatly improved. Is walking now with a cane, no longer wheelchair bound. Has neuropathic pain in feet only, no longer in legs. Feet are painful only with contact, not continuosly. Still has numbness in fingertips, but no longer in hands. His smile is asymmetrical. Bowel and bladder function has returned to normal. Is receiving care. Is medically retired from the military and received 50% disability. VA claim still pending. Is applying to school now to acquire new skills.
Patient was happy that she got her 1st dose.  She did not report any adverse reaction.
Arm pain, unspecified, has been increasing since the shot was administered; arm is sore/ feel worse; arm is sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported, NDC number was not reported) dose 2 via an unspecified route of administration on 15Jul2021 as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Historical vaccine reported bnt162b2 on an unspecified date as dose 1, single for COVID-19 immunisation. The patient concomitant medication was not reported. Investigation assessment was not provided. On unspecified date of 2021 the patient experienced arm pain/unspecified has been increasing since the shot was administered, arm was sore/ feel worse, arm was sore. Caller stated that it seemed unusual to have the pain, lasting six weeks after injection. The clinical outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
A patient was given a more heavily concentrated dose of the Pfizer COVID-19 vaccine when the vial was improperly diluted with 0.8mL instead of 1.8mL. No acute reaction occurred. The error was identified prior to additional patients being affected. Clinic staff are currently attempting to contact the patient and parent regarding this error.
This is an initial spontaneous report from a non contactable physician. This physician reported for a patient. This 4 year old, patient (gender, race unknown) received PREVNAR 13 intramuscularly on an unknown date. Relevant medical history and concomitant medication of the patient were unknown. It was reported that on an unknown date in Jan2012 the patient experienced large red area with puffiness and tenderness at the site of injection in arm being administered with PREVNAR 13. Relevant laboratory tests were unknown. Therapeutic measures taken in response to the event reported were unknown. The patient had recovered from the event tenderness after 10 days of experiencing it and had not recovered from the event large red area with puffiness.
Accidently administered Pfizer-BioNTech on 01/15/192.  Patient wanted an additional dose of Moderna. Patient was notified of the error immediately.
This is a spontaneous report received from contactable other HCP (the patient). A 40-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3182) at the age of 40 years, in right arm), on Sep 21, 2021, at 17:00, single dose, for COVID-19 immunisation. Medical history included hypertension (unspecified if ongoing). Concomitant medication included carvedilol. The patient had a headache(s) and eye pain/right eye pain, onset Sep 23, 2021, at 00:15, with outcome of not recovered. These events required a physician's office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache and eye pain. Additional information: Reportedly, patient experienced headaches within days of receiving first dose Sep 21, 2021 and right eye pain. Patient had most days out of the week, most hours of the day with headaches, despite never having a history of headaches. Patient had to visit ophthalmologist and had MRI performed on brain. The patient received MRI and daily medications for headache/pain. The patient has no known allergies. No COVID-19 reported prior to vaccination. Sender's comments: Linked report: US-PFIZER INC-202201114674 (same patient/vaccine/event, different vaccine dose); US-PFIZER INC-202201114673 (same patient/vaccine/event, different vaccine dose).
Got the shot Friday March 5th. Sore arm and muscle aches like the first dose on 2/5. Woke up March 7th with swollen lips/throat/tongue. went to urgent care and received an EpiPen and steroid. Monitored for a couple of hrs and went home for a nap. (refused the ER at this time as I felt better). Woke up around 2:30 and my symptoms worsened . We to ER and received another Epipen for anaphylactic shock. Remained at the hospital for 5 days. Had 5 episodes while there. Also, had tightening in chest and what felt like a heart attack. Been resting, still very tired and swollen nodes in my neck and sore throat as well as aches. Also, might be developing thrush. Didn't run a fever and Ive never had an allergic reaction  before this.
Janssen COVOD-19 Vaccine EUA. I had a fever, terrible headache, muscle aches, tired, chills, soreness in upper abdomen and not being able to take a very deep breath.  These lasted for a little over 24 hours, but I still have some tenderness in upper abdomen and cannot take a deep breath.
PAINFUL, RED, HOT INJECTION SITE. PT REPORTS TONGUE AND CHEST TINGLING.
Patient reached out in May to share concerns that he had shoulder pain.  Said he did not seek medical treatment until recently when he obtained health insurance.  Patient said he was referred to a neurologist and the neurologist thinks the injection was given into the nerve and caused damage.  The pain was in the right arm, despite the dose administered on the left.  The patient yesterday shared that he also thinks he has nerve damage with his feet and has unusual coldness in his feet.  He also added that recently he has had chest pain, like a heart attack.  He shared that he knows others that had similar adverse events from the Covid vaccine.  Patient is under the care of a provider and is evaluating further.
Fever; Lethargic; Tired after 1st dose/Tired after 2nd dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (Tired after 1st dose/Tired after 2nd dose), PYREXIA (Fever) and LETHARGY (Lethargic) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Hemochromatosis.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (Tired after 1st dose/Tired after 2nd dose). On 01-Apr-2021, the patient experienced PYREXIA (Fever) and LETHARGY (Lethargic). On 05-Mar-2021, FATIGUE (Tired after 1st dose/Tired after 2nd dose) had resolved. On 02-Apr-2021, PYREXIA (Fever) and LETHARGY (Lethargic) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.       Reporter did not allow further contact
Red, swollen, painful infection sight reaction within 24 hours. Hives on upper body and neck within 48 hours lasting greater than one week.
Headache, weakness, dizziness. Severe hives from head to toe. Headache started 5/21. Weakness and hives started 5/23 and lasted for 4 days until 5/26.
dry tongue; white spots in the tongue; burning, tingling sensation in the tongue; burning, tingling sensation in the tongue; swelling of the tongue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TONGUE DISCOMFORT (burning, tingling sensation in the tongue), PARAESTHESIA ORAL (burning, tingling sensation in the tongue), SWOLLEN TONGUE (swelling of the tongue), TONGUE DISCOLOURATION (white spots in the tongue) and TONGUE DRY (dry tongue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029L20A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included LORATADINE (CLARITINE), LEVOTHYROXINE and VITAMINS NOS for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced TONGUE DISCOMFORT (burning, tingling sensation in the tongue), PARAESTHESIA ORAL (burning, tingling sensation in the tongue) and SWOLLEN TONGUE (swelling of the tongue). On 21-Feb-2021, the patient experienced TONGUE DISCOLOURATION (white spots in the tongue). On 25-Feb-2021, the patient experienced TONGUE DRY (dry tongue). At the time of the report, TONGUE DISCOMFORT (burning, tingling sensation in the tongue), PARAESTHESIA ORAL (burning, tingling sensation in the tongue), SWOLLEN TONGUE (swelling of the tongue), TONGUE DISCOLOURATION (white spots in the tongue) and TONGUE DRY (dry tongue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
About 30 min after vaccine was given, I felt strange, as if my torso and eyes were burning, and it continued into the evening, along with extreme fatigue, which I was told would go away after 48 hours.  That night was the first of many I was unable to sleep.  My heart raced and the burning sensation continued, as if my chest, or heart, and eyes were on fire.  For one month I was unable to fall asleep on my own through the entire night, so that I had to take a sleep aid.  I've NEVER had trouble sleeping and do not believe the sleep trouble was a coincidence. Then I slept fine for about a week and a half, but it started all over again, this time with the burning sensation not as prevalent. It seems to be slowly disipating, as some nights are better than others.