chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; Blood pressure went up from 105/65 to 155/80; dull aches in achilles tendons; feeling of stimulation that kept them from sleeping; diarrhea; headaches; neuropathy; Explosion through their body; really dizzy; weak and wanted to lay on the floor; Fatigue; A spontaneous report was received from a consumer concerning a 69-years-old female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an explosion through their body/feeling abnormal, really dizzy/dizziness, weak, wanted to lay on the floor/asthenia, blood pressure went up from 105/65 to 155/80/blood pressure increased, dull aches in Achilles tendons, headaches, nausea, neuropathy/neuropathy peripheral, feeling of stimulation that kept them from sleeping/tendon discomfort, diarrhea, fatigue.  The patient's medical history was not provided. No concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 25 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot number: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, approximately 5 minutes post vaccination, the patient reported she felt like an explosion went off inside her body. She felt really dizzy, weak and wanted to lay down on the floor which last 2 days. Her blood pressure went from 105/65 to 155/80. Approximately 3 hours later her blood pressure was back in normal range. Later that day, the patient reported she experienced headaches, nausea, neuropathy, dull aches in Achilles tendon, diarrhea and had a feeling of stimulation that kept her from sleeping.   On 28 Feb 2021, the patient stated she took zolpidem to help her sleep but it did not work.   Treatment details included pseudoephedrine and zolpidem.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, blood pressure went up from 105/65 to 155/80/blood pressure increased, was considered resolved on 25 Feb 2021  The outcome of event, diarrhea, was considered resolved on 26 Feb 2021.  The outcome of events, explosion through their body/feeling abnormal, really dizzy/dizziness, weak, wanted to lay on the floor/asthenia, were considered resolved on 27 Feb 2021.  The outcome of events, dull aches in Achilles tendons, headaches, nausea, neuropathy/neuropathy peripheral, feeling of stimulation that kept them from sleeping/tendon discomfort, fatigue, were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Patient experienced an ALTE two times in the evening.  He was observed to stop breathing for 10-15 seconds and lips were blue. Throughout the day, child had been irritable and crying. Since the episode, child has been irritable with high pitched screaming.
Rhabdomyolysis; Rhabdomyolysis; This case was reported in a literature article and described the occurrence of rhabdomyolysis in a adult female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.  Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included systemic lupus erythematosus (Family History) (maternal). Concurrent medical conditions included cystic acne, muscle pain and weakness (frequent episodes).   On an unknown date, the patient received Influenza vaccine and Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine and not applicable after receiving Influenza vaccine, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant) and rhabdomyolysis (serious criteria hospitalization and GSK medically significant). Rechallenge with Influenza vaccine was positive. On an unknown date, the outcome of the rhabdomyolysis and rhabdomyolysis were recovered/resolved.   The reporter considered the rhabdomyolysis and rhabdomyolysis to be possibly related to Influenza vaccine and Influenza vaccine.     Additional Information: GSK Receipt Date: 22-Aug-2022 Author's comment: The patient was 46 years old at the time of reporting.  The patient's family history included maternal systemic lupus erythematous. Patient had a history of cystic acne and most notably, frequent episodes of muscle aches and weakness.  In 2006 and 2016, the patient was hospitalized for episodes of rhabdomyolysis after receiving influenza vaccine. Autoimmunemyositis was ruled out. The patient never received statin medication. In late 2017, the patient was admitted for rhabdomyolysis after upper respiratory tract infection. The patient reported dark urine but no rash or arthralgia. Patient had elevated creatinine kinase (CK) 107,737 U/L, Aspartate transaminase (AST) 379 U/L, and alanine transaminase (ALT) 115 U/L. The patient's renal function, sedimentation rate, Thyroid stimulating hormone, Human immunodeficiency virus (HIV), influenza, direct Coombs, protein electrophoresis, and antinuclear antibodies were negative or within normal limits. The patient was treated with intravenous fluids, pain medication, and discharged.  At the time of presentation, she was evaluated for generalized body aches five days after receiving second dose of COVID mRNA-1273 (Moderna) vaccine and was admitted for rhabdomyolysis. Six months prior to that, the patient received her first dose of Ad26 (Johnson & Johnson) vaccine without sequelae. Patient was discharged as she was asymptomatic and CK had dropped significantly. Rhabdomyolysis can be an adverse event to vaccine administration, most commonly influenza vaccination. The patient had a history of recurrent episodes of rhabdomyolysis after receiving influenza and COVID immunizations, as well as viral infection.  Additional supportive information: This article corresponding to this case is not available for regulatory submission due to copyright restriction.
The authorization for Bivalent Covid vaccines ended before we administered the vaccine here. We are in another country and did not receive the notice until 09/13/2023 our time.
No adverse event; Patient received Dose Number 1 on 15-MAR-2021 and Dose Number 2 on 5-APR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose Number 1 on 15-MAR-2021 and Dose Number 2 on 5-APR-2021) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 036A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Egg allergy and Food allergy.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose Number 1 on 15-MAR-2021 and Dose Number 2 on 5-APR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose Number 1 on 15-MAR-2021 and Dose Number 2 on 5-APR-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant products were not reported.  It was reported that patient received dose 3 from Pfizer on 25-Oct-2021 batch number FF2593 at left arm. Dose 4 from moderna on 04-Apr-2022 batch number 027L21A at right arm. Dose 5 from Pfizer on 07-Sep-2022 batch number GH9695 at left arm. Patient received paxlovid from 23-Jan-2023 to 28-Jan-2023 batch number GF317.   Treatment medications were not reported.
Mother noted rash on face, spread to chest and back. Physician said it was possibly immunization reaction (though early) verses a sensitivity reaction. No treatment given.
My blood pressure and it was 200/124; My tongue started to have spots on it; two spots, red spot; I got very flushed; I got metallic taste in my mouth; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 27Feb2021 (at the age of 72 years) as dose 1 single for COVID-19 immunization. Medical history included "Just Vaginal Hormones", allergic to hornet sting. The patient's concomitant medications were not reported. Patient informed since she was allergic to hornet sting. When she went to the clinic to get shot, instead of waiting 15 minutes, they had waited her 30 minutes after the shot well she waited 30 minutes and then she left to go to the parking lot to her truck and while she was walking she got very flushed and got metallic taste in mouth and her tongue started to have spots on it, two spots, red spot so she went back in the clinic and told them and blood pressure was taken and it was 200/124 and that was what alarm them so she have to go in to urgent care then she have to go emergency room (ER) on 27Feb201. The patient underwent lab tests and procedures which included blood pressure measurement which was 200/124 and blood test: normal on 27Feb2021. The outcome of all events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Low cough; Not feeling good; Wasn't feeling good; I ran 99.6 fever; I am still, I am running 100.8 fever; Bad headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received the first shot on Thursday, it was the 29th, and was perfectly healthy. The patient got the shot and Saturday night on the 31st, she started with low cough and not feeling good and then yesterday, the patient ran 99.6 fever, had a bad headache and wasn't feeling good. Patient reported feeling better today but was still running 100.8 fever. The patient underwent lab tests and procedures which included body temperature: 99.6  and body temperature: 100.8 on unspecified date. Patient took Tylenol and Ibuprofen as treatment for event. The outcome of the event not recovered.   Information on Batch/Lot number requested.
Ataxia, high fever, confusion, loss of speech, falling, weakness, shingles- at left forehead and left temple, V1 along the trigeminal nerve x 2 after vaccine.   She was seen in Emergency Room admitted for  1 day, seen by two board certified Neurologists who concur this was Vaccine related/caused.  Remains in rehab with speech therapy
Patient received 2nd Moderna Covid vaccine on 2/9/21 around 2:00pm.  Around 9:00pm she stated she started breaking out in a rash all over body.  She took 50mg benadryl by mouth.  She states she got better.  She came to work at 8:00am on 2/10/21 with a little rash lef but as time went by rash got worse and spread.  Around 9:30am rash started to get worse.  9:50am-She stated throat is getting scratchy.  She took Allegra 180mg by mouth.  Physician in office next to immunization room took over care.  Doctor ordered 50mg Benedryl IVP, Pepcid 20mg IVP, and Solumedrol 125mg IVP.  10:12am-BP 100/70, resp 20, pulse 120, O2 sat 99% on room air.  IV started to right hand.  Benadryl 50mg given IVP over 5 minutes. Lot #070110, exp date 7/20/22, NDC 064107376-21.  Line flushed with20cc NS.  10:22am-pulse 94, BP 114/80, resp 20.  Pepcid 20mg given IVP over 20 minutes.  Lot # 090126, exp 9/22, NDC 0641-6022-01.  Line flushed with 20 cc NS.  10:28am-Solumedrol 125mg given IVP over 5 minutes.  Lot # DF5453082022, exp 8/20/22, NDC 0009-004725.  Flushed with20cc NS.  10:55am-BP 120/82, Pulse 82, resp 18..  No s/sx of distress noted.  Flushing decreasing. Patient states throat no longer itchy.  11:15am-BP 116/80, Pulse 107, resp 20, O2 sat 99% on RA.  11;35am-BP 112/80, pulse 98, O2 sat 98% on RA,   IV dc'd.  Patient discharged home via W/C in stable condition with husband driving.
Pt was negative for COVID on admission on 1/18 when she was admitted for acute respiratory failure, abdominal pain, and alcohol abuse. The pt was tested again on 1/30 prior to SNF placement and the swab came back positive.
2/21 tired, achy legs 2/22 tired achy legs, 6 PM fever 100 degrees chills 2/22 PM fever 101.1  chills 2/23 tired in bed all day sleeping on/ off 2/24 red patch on arm under injection site ( about 4" x 2 ") but otherwise back to normal 2/25 patch fading
Tested positive for Covid-19 on 9/4/2021, admitted for SOB.  C/O cough, sob, ha and weakness since 8/20/2021.  Acute hypoxemic respiratory failure requiring NIPPV, Covid-19 PNA.
Patient had a vasovagal reaction. Became diaphoretic, had syncope. Was alert and oriented within less than 30 seconds. Vitals remained stable throughout. Initially 120/80 pulse of 74 pulse ox 98%.
Left arm Injection site  swelling and discoloration increasing in size 6 days after 2nd Pfizer dose
flushing to face and swollen cheeks; flushing to face and swollen cheeks; nausea; vomiting; This is a spontaneous report from a contactable Other Health Professional. A female patient (non-pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation.  Medical history included anxiety, PCOS (polycystic ovarian syndrome), known allergies: sulfa. Concomitant medication included biotin, cannabidiol (CBD OIL), fish oil, ibuprofen, metformin, famotidine (PEPCID AC), spironolactone, ethinylestradiol; ferrous fumarate; norethisterone acetate (TAYTULLA), calcium carbonate (TUMS [CALCIUM CARBONATE]), colecalciferol (VIT D3). The patient experienced flushing to face and swollen cheeks, nausea and vomiting day 4 after vaccine on 18Jan2021 16:00. Therapeutic measures were taken included cetirizine hydrochloride (ZYRTEC) and omeprazole (PRILOSEC). This event resulted in: Doctor or other healthcare professional office/clinic visit. Outcome of the event was not resolved.  Information on Lot/Batch number has been requested.
Patient reported being very sick for 1 week after 1st dose. The day of 2nd dose patient had numbness under right arm prior to dose, numbness has progressively gotten worse since 2nd dose. Numbness has spread to middle of chest, across right side, and down to upper right hip. Patient is unsure if symptoms are related to vaccine, but requested the event to be reported. Experiences tightness and sharp pain occasionally in the numb areas. Patient saw an urgent care facility about symptoms, which ordered an EKG to evaluate possibility of heart attack. Negative results. Patients primary care doctor did blood work and found some vitamin deficiencies.
Began a second period after ending one just 4 days prior.  This cycle lasted 13  days (out of my norm of 5-7 days) and was nonstop heavy flow, worse than anything I have ever experienced.  I felt  weak and had difficulty concentrating on tasks with forgetfulness.
Fever of 102 degrees f, body aches, chills, headache, nausea
I received the 2021 Influenza vaccine in doctor's office on 9/27/2021.  Three hours later I broke, I felt like I had been bitten by an insect on my leg and arm.  But then these itchy bites grew into larger red rashes over the next days and became increasing red, itchy and painful.  The one on the back of my upper calf (about 3" x 3") was intensely itchy and looked like a red scalding burn with a big bump.   Another appeared on my forearm and then several more spots down the arm and another one smaller one on the lower leg.  The ones on my arm have begun to itch again very intensely even 5 days later.  I showed the rash on the back of my leg to my boyfriend and he said that is more severe than the average rash, you need to report that. I did take a photo of the large one.
I started feeling a headache and a very bad cold. I felt congestion and fatigue I did not feel well. I was having body aches. I did not lose my taste. There was fatigue. I contacted a telehealth service the recommended that take Paxlovid because of my age and history of my asthma returning when having colds. After 5 days of taking the Paxlovid I starting feeling the same symptoms again. I have gotten a rebound COVID-19 positive test again after taking the Paxlovid. I am currently with COVID-19 again. I am just taking cold medicine now.
w/in 10 min p/vax felt sick, like may pass out, dizzy, light headed, lt arm felt strange, hurt @ site & achy down to fingers & up to neck;arm cont to hurt;arm red, swelling @ site;felt bruised;warm @ site;lymph node sl swell & tender;
Headache, Myalgia, Edema to left shoulder with decreased range of motion of left arm; reports "tightness" in left arm, left neck and towards left breast; diaphoretic X1 Narrative: Outcome is undetermined at this point; is being followed by a physician to see if any improvement
This is a spontaneous report from a contactable consumer reporting for the daughter.   A 41-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose maybe the right arm (reporter was unsure) at the age of 41-year-old for COVID-19 immunisation, administered through hospital.  Medical history was none.  There were no concomitant medications.   In Apr2201 the patient experienced she can't hear right now and it won't go away, ringing in ears, she is extremely stressed out and this is affecting her life, she was so upset. The course of events was as follows: She has had ringing in her ears from this, started some time after the shot. She was extremely stressed out and this was affecting her life. She can't live like this. She recently divorced with 2 kids and trying to work. Went to the doctor twice and they sent her to ENT department. This is destroying her life. It was very stressful. Patient was having a severe problem. She had been to the doctor twice, including this week in Apr2021 and once the end of last week in Apr2021. They looked at her medications and sent her to counseling, to therapy. She had definitely not gotten better, has been persistent. She did not know on like a graph scale where it was. She received no treatment for ringing in ears. She was trying to take something for stress because this was horrible. She cannot hear right now and it won't go away. This is a serious problem. Reporter did not want her daughter to go deaf. She received a message from hospital, regarding her being scheduled for the second vaccine on Saturday and she said she was not going for that she wished she had not gotten the first one. Reporter stated she has a good friend who's daughter was a PA whom she has been corresponding to about this and she sent them links of how the Covid vaccine is linked to tinnitus. She has never had anyone report this. She sent it to her daughter and her daughter said can't read this, there is blogs with responses and she just said she can't read this, she was so upset that she can't hear right because of this with this ringing that won't go away. She had gotten a call from the Hospital Department stating that she was ready for the second shot. She was not getting the second shot and was sorry that she got the first one. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Two hours after 2nd vaccine dose, felt lightheaded and loopy, couldn't think straight - almost like I was drunk. Within 12 hours, I had severe muscle, joint, and organ pain that could have been made worse by fibromyalgia. It was an 8 on the pain scale and everytime I attempted to move, I felt nauseous from the pain. Even my skin hurt, and it was impossible to sleep until 10p the day following the vaccination, after symptoms had eased. Since the vaccine, I've felt more fatigued than normal and have been needing to sleep for 9-10 hours per night (7-8 is normal).
Strange tightness on jaw; Couldnt close or bite down completely; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 03Apr2021 at 09:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medications included metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), glipizide (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); all for unknown indications and from an unknown date. The patient had no known allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 13Mar2021 at 11:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine.  On 04Apr2021 at 06:00, the patient had tightness on jaw, could not close or bite down completely. This seemed to dissipate the more as the patient moved the jaw, talked and drank fluids. However, it reappeared the next morning and did not go away like the day before. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event tightness on jaw and jaw movements disturbance was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
LARYNGITIS; SORE NOSE; BLISTERS; SORE THROAT; RED THROAT; BAD INJECTION TECHNIQUE; NAUSEA; MALAISE; EAR BUZZING/(HORRIFIC) IN EARS; SEVERE DIFFICULTY MOVING ARM; SOME PAIN; DISCOMFORT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s for prophylactic vaccination (Dose, route of administration and batch number were not reported) (unspecified manufacturer). The Company is unable to perform follow-up to request batch/lot numbers.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, dose and batch number were not reported), 1 total administered on 22-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-OCT-2021, initially the patient experienced nausea, as week progressed buzzing (horrific) in ears worsened each day. The patient also experienced malaise. Also due to bad injection technique created one week severe difficulty moving arm, some pain and discomfort. On 23-OCT-2021, the patient experienced red throat. On 25-OCT-2021, the patient had sore nose / blisters and sore throat. On 27-OCT-2021, the patient had laryngitis.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 25-OCT-2021, and the outcome of ear buzzing/(horrific) in ears, malaise, red throat, sore nose, blisters, sore throat, laryngitis, severe difficulty moving arm, some pain, discomfort and bad injection technique was not reported. This report was non-serious.
Coughing, throat tightness. BP 155/124 (pulse 115), final BP 183/123 (pulse 96). Given EpiPen, sent to ED. At ED, received Benadryl 50 mg PO, Pepcid 40 mg PO, Decadron 8 mg PO. Resolved.