chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: CIJ3277) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient received ritonavir (PAXLOVID) from 23Dec2022 to 28Dec2022 for covid-19 treatment.  No follow-up attempts are possible. No further information is expected.
The following account is per RN -- The patient came to the pharmacy to receive the flu and pfizer bivalent booster and received both vaccines in the left deltoid region per patient preference (vaccine administered by RN.) Shortly after receiving vaccine while patient was getting up to stand the patient fell. Per RN., "I went down with the patient while he was getting up to make sure he wouldn't get hurt." Per RN, he did not hit his head or get injured on the fall. Per RN, "I called for RPh right away who then came by immediately." RN and RPh, then proceded to help the patient off the floor and into a chair where his legs were then elevated. Patient appeared pale. RN then proceded to take his vitals and patient had a blood pressure of 121/74 mmHg and heart rate 83 bpm. Several minutes later this was retaken and found to be 126/71 mmHg and heart rate 81 bpm. Per RN after a few minutes the patient began to regain color.  Patient called his mother to come sit with him and was observed for 30 minutes before leaving. Per RPh the patient reported having eaten and didn't have any medical conditions of concern and no prior history of fainting after receiving a vaccination. Patients mother stated "I think he just got overwhelmed".
No adverse event at this time, but patient is 10 years old and was give the adult dose of vaccine. Parents were made aware and are monitoring for adverse events.
febrile rash, face bright red, fine red rash, T 100 AA P120 R20, Tx-Atarax and Tylenol. Observed x1 hr, released.
Arm pain with increasing weakness and loss of range of motion. Though patient said she had some symptoms the day after, she did not report it until 10/11/18 (3 days later) after symptoms got worse.  Patient went to doctor, received x-ray, and was prescribed high dose steroids.
Narrative:  6/22/2022 Pt had primary care appt. today, during which patient became unresponsive to sternal rub shortly after receiving Tdap vaccination. likely vasovagal response however will document for future vaccinations. Labs have returned and the only significant abnormality is the hemoglobin which has dropped just under a point since the last one. Is not significant enough to cause the symptoms today. Provider will request a Holter monitor through cardiology and have the patient follow-up with his PCP. Son agrees Pt is at baseline and agrees with care plan. Patient does have a history of blood clots and he is on apixaban twice a day and son states that he has not missed any doses. Patient has had no tachycardia here or respiratory distress I do not feel a chest CT is indicated today. Pt discharged and cardiology consult placed.
Severe tinnitus that resulted in almost complete loss of hearing in left ear for 2 days, headache, fever, body aches for 3 days.  I will NEVER take Moderna vaccine in the future, and will probably never take another covid vaccine.  Vaccines shouldn't make you sick for 3 days.
pt with hx MS received Tdap generalized weakness extreme fatigue, debilitating headache numbness weakness tingling in legs and arms x 1 week
Patient had normal side effects of low grade fever, chills, headache, but then developed a swollen lymph node under her right arm. (Right Axillary Node) Patient is retired healthcare worker. She said upon palpitation the node feels "golf-ball" sized. She stated it does seem to be shrinking in size by this morning. We felt it may be an important symptom to document due to her Lupus diagnosis and lack of studies in patients with this disease.
Felt no systems on the first shot, on the second shot on 3/24 I felt dizzy and nausea when first out of bed the following day,  went back to bed for 2 hours, got up had coffee and toast, back to bed for another 2 hours,  felt better but head ache and muscle aches over entire body, and fatigue.  Had better strength at times through out day.   Went to bed and woke up Friday and felt fine.
That night (Sunday) and all the following day, I had a  sick feverish feeling without an actual temperature.  Also even three days later, I have a 3 1/2 knot on my arm that is hot to the touch.  The feverish feeling did go away by Tuesday.
p/vax pt exp a high fever & inj site redness, swelling & severe pain;
About 2 hours, post vax, the pt developed chills, nausea, "eyes felt hot", legs and arms tingled and late in the day, temperature was 101F. Also arm was swollen and hard. Rx'd with Tylenol; next day all signs and symptoms had subsided.
About an hour an a half after the shot - I started to feel nauseous due to inner ear issue. I could not hear well out of my right ear. There was no ringing - things just sounded like they were in a tunnel.  Even when I was in bed I still did not have full hearing back. I felt like I had to lay very still do to the nausea.  I had once had a bout of vertigo and I also knew that a sudden movement can feel awful.  The vertigo incident resulted in some hearing loss in my right ear.  Anyway, I finally fell asleep and by 9 a.m. was fine. It is 11:30 and everything seems fine. I am only writing this as I googled hearing loss with vaccine and it seems like quite a few people are reporting this as well as tinnitus.  I think this is gone but too early to tell.
Rash/Hives all over body starting on the torso.  Over the days and weeks it has spread to legs arms and back to torso
SORENESS IN RIGHT NOSTRIL; CHILLS; MINOR HEADACHES; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced soreness in right nostril. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced minor headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in right nostril, minor headaches and chills was not reported. This report was non-serious.
Patient had an appointment for their 3rd Pfizer (booster due to age) but was given the Moderna vaccine mistakenly. Patient had not had any problems with the vaccine so far.
Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes. Upset stomach with vomiting and diarrhea. Body was shaking and didn?t have a fever. Skin felt like it was burning whole body felt swollen. Started around 2:30am with the cramping. It woke me up. Once I got up everything came so fast. Was rushed to hospital where I was admitted very quickly. I was blacking out on the drive there and blacked out while in their care. This was from one dose of Pfizer vaccine for Covid. I was put on a GI, Allergy, and steroid medications. I was hooked up to an IV and 3 drugs were injected. I passed out numerous times but was discharged at 5am.
9 hours after the second shot, I started feeling achy. I didn't sleep well that night. The following day, I ran a low-grade fever (99.6) and was tired and achy. I took Tylenol and ibuprofen to control symptoms along with rest and lots of fluids. I felt better that evening. Monday, I was fatigued. I had little appetite but otherwise felt better until about 7 pm (more than 48 hours after). I started feeling nauseated and started vomiting 30 minutes later. I vomited every 10-15 minutes for the next three hours. I couldn't keep even sips of water down. Even when I didn't drink anything between bouts of vomiting, I vomited every 10-15 minutes. I was finally able to fall asleep around midnight. Tuesday, I felt better and gradually was able to eat. Wednesday I was back to normal.
Moderna vaccine was given to a pediatric patient. No ADE was noticed at this time. Patient and parents are informed.
Ringing and preasure in right ear increased. Mild ringing started in left ear.  Dizziness  Off-balance Vision changes
Approx 4 Hours after receiving flu shot felt achy, which lasted thru the night. Face was red, on 11/18/2005 called Dr told to take Benadryl. She did so and redness went away. No redness on 11/19/2005. Did have facial redness on 11/20 and 11/21. Called Dr on 11/22. Told to take Benadryl. Do so and no redness since.
About one week post vaccination, the patient complained of additional swelling, whelps, redness, and fever at the injection site that she did not experience immediately after the vaccine
Pharmacist on duty has verifies the immunization for a Pfizer shot and the administering Nurse (RN) has administered the wrong vaccination (Moderna) to the patient.
Fuzzy headed, head ache, tired, fever for a short time, easily out of breath
As soon as vaccine received patient had headache. Later in the day, took 3 Ibuprofen later on; it helped for a couple of hours. By 7pm palm of hands went numb for a couple of hours; went to bed and back to normal by the morning. Patient still has headache now--progresses between headache and migraine. Taking Ibuprofen as needed for headache. Patient mentions pain, stiffness on neck and shoulder blades, and spine is very sore. Today, left side of face went numb for about 30 minutes. Patient called the doctor but was directed to make an appointment. Patient had a little shortness of breath during choir practice; was told to go to the ER if got worse. Has also noticed loss of appetite, stomach pain, pain on left footpressure around the top and side of foot; most issues on left side of body. Patient is on the last day of her period; patient has noticed thinner and excessive discharge. Patient has developed a cold but over the weekend exposed to someone that was sick. Patient reports mood swings are not common.
product storage error; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (product storage error) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (product storage error) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The vaccine was placed in refrigerator on 21 Oct 2021. The vaccine did not go any temperature excursion and does not experience adverse event. No treatment information was provided.
pt recv vax & devel chickenpox w/over 50 lesions all over the body;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-JAN-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # J013345, expiration date: 11-JAN-2015), dose and route not were reported. No adverse effects reported. Additional information has been requested.
driving to work began to have tingling in lips and around lips.  Lips became numb and Benadryl taken in car.  Continued driving and began having trouble swallowing, started to feel very nauseous and pulled into a parking lot. Difficulty speaking and called 911.  Benadryl began kicking in and husband drove me to the ER and later to personal physician
Dehydration; Dry mouth; Unquenchable thirst; Urine that stayed yellow after drinking a lot of water; Dry stool and anus.; Dry stool and anus.; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 01May2021 at 15:00 (at the age of 18-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 22May2021 at 12:00 (at the age of 18-years-old), both as a single dose for COVID-19 immunisation. Medical history included depression. Concomitant medications included drospirenone (SLYND) for unspecified indication from unknown date. 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. The patient had no known allergies to medications, food or other products. The clinical course was reported as follows: on 02May2021, the patient experienced dehydration and dry mouth, unquenchable thirst, urine that stayed yellow after drinking a lot of water, dry stool and anus. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dehydration, dry mouth, unquenchable thirst, urine that stayed yellow after drinking a lot of water, dry stool and anus was not recovered at the time of reporting.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Case number PHEH2014US021227 is an initial spontaneous report received from a consumer on 20 OCT 2014. This report refers to a 57 years old male patient. Her medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml intramuscular FLUVIRIN 2014/2015 (batch number: not reported) in his arm on 14 OCT 2014. Three days later on 17 OCT 2014, he started feeling weakness and tiredness in his legs. On the same day he also had soreness in his legs that lasted a full day. There was no fever. The feeling of weakness and tiredness in his legs was followed by tenderness on 18 OCT 2014 (the fourth day after vaccination) and he experienced tenderness and soreness in thighs (Symmetrical, inner aspect and up to top and around hips). His arms were fine except that he had soreness in his vaccination site which was expected. Soreness at vaccination site lasted about 2 to 3 days. He had difficulty in lifting his arm which went away. The event outcome of weakness and tiredness of legs, tenderness, soreness in thighs and  legs and vaccination site pain was reported as condition unchanged. The seriousness and causality were not reported.
04/23/2022 vaccination. I took TYLENOL the first 48 hours after. 05/07/2022 About two after vaccination, I noticed I had twisting of my head and the ringing in my ears started. I went to the doctor to check on my neck. They ruled out that scenario and said maybe it was something else that had happened to my body.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A 50-year-old female patient (not pregnant) received the first dose of BNT162B2 (Comirnaty, batch/lot# FJ1620), at the vaccination age of 50, right arm, on Dec 2, 2021, at 15:00, single dose, for COVID-19 immunization. Medical history included hypertension, acid reflux (unspecified if ongoing); and COVID-19 (unspecified if ongoing). Prior to vaccination, was the patient diagnosed with COVID-19? Yes. Concomitant medication(s) included telmisartan and pantoprazole. The patient reported lymph node pain/arm pit lymph node pain, onset Dec 4, 2021, at 06:00, with outcome of not recovered; and arthralgia/elbow pain, onset Dec 5, 2021, with outcome of not recovered. No therapeutic measures were taken as a result of lymph node pain and arthralgia. Additional Information: Two days post injection, patient had arm pit lymph node pain. Now, had extreme elbow pain (day 3 through present day 9). The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts possible. No further information expected.
First symptom noticed was flushing/warm feeling in the chest radiating outward, followed by feeling lightheaded.  Upon check by healthcare worker in the clinic, BP was 195/123 (within 10 minutes of immunization).  Heart rate elevated to above 100.  While being monitored, also experienced flushing/warm feeling in the lower facial area.  Monitored at clinic for 1 hour observation with BP rechecks.  At some point during observation, also experienced problems concentrating and cold fingers.  After 1 hour most of symptoms had resolved except for slight flushing and BP 150/101.  O2 SATS remained at 100%, no shortness of breath, tongue or lip swelling or dysphagia.
Patient admitted with aphasia secondary to acute CVA/lacunar infarcts. Patient did not develop any focal deficits during hospitalization.  His speech has improved.  No previous hx of CAD or HTN.  Blood pressure has been elevated in the hospital.  Started on ASA, Plavix, statin and multiple blood pressure medications.  Patient feels fine on the day of discharge even though his blood pressure remains elevated. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Tested positive for COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Coronavirus test: positive (Positive) Tested positive for COVID-19.     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.   No concomitant medications or treatment details reported.
ON SECOND DOSE 2 DAYS LATER WIDER SORENESS AND BLOCTHY RASH WHICH WAS SORE ON 04/10/2021 AND STILL BLOCTHY ARM STILL SOMEWHAT SORE . HAD CHILLS SWEATING BUT STARTED THE NEXT DAY AFTER SECOND DOSE CHILLS BUT WENT AWAY WITH IN 48 HOURS
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) and (batch number 5S34K, expiry date 13th March 2021) for prophylaxis.  On 22nd March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain, influenza-like symptoms, joint pain, injected limb mobility decreased and activities of daily living impaired. On 22nd March 2019, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, joint pain, injection site warmth, injected limb mobility decreased and activities of daily living impaired were unknown. It was unknown if the reporter considered the injection site pain, influenza-like symptoms, joint pain, injection site warmth, injected limb mobility decreased and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received the SHINGRIX vaccine into the left arm.  The patient experienced joint pain on left arm above elbow and could not move her arm past her shoulder or head, loss of functions such as, bra fastening and driving. The patient experienced warmth at injection site at time of the shot and it later ached, she had flu-like symptoms to progressing pain on the top of the injection site. The expiry date of adjuvant batch number (5S34K) was reported as 13-MAR-2019, however it was captured as 13-MAR-2021 as per sales database. No additional details were provided.
Numbness,tingling in both upper and lower extremity, especially left foot and hand which began several hours after vaccination. Day 6 post vaccine, numbness and tingling began in right hand. Associated symptoms include heaviness, mild weakness of extremities described above.
She got positive to COVID-19 right after her first dose; This is a spontaneous report from a Pfizer Sponsored Program . A contactable female consumer (patient herself) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) on 27Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Feb2021, the patient tested positive for covid-19 right after her first dose and she mentioned that she had mild symptoms. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Hives developed within 24 hours of receiving the vaccine. No other new exposures. Improved with benadryl.
I experienced body aches, sore throat. I ended getting treatment because my blood pressure elevated for one month. I went to ER due to a bad headache and blood pressure elevated. I had lab work and EKG done. I also got monitored for a heart attack.  I still feel sick and feel very tired and have not recovered from my symptoms.
A serious spontaneous report of Bell's Palsy has been received from a registered nurse concerning a 43-year-old male patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. On 28-Sep-2009, the patient received FLUMIST. On 01-Oct-2009, the patient presented to the emergency room and was diagnosed with Bell's Palsy. The outcome for the reported adverse event was not reported.
Patient stated he felt uncomfortable the day he got his vaccine. In the next few days, he had facial drooping, slurred speech and muscle sensitivities in legs. His face is still slightly drooped as of today 3/6/21.  Per the patient, his doctor advised not to get the second dose of the vaccine.