chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On  unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # reported as L045955 exp. 17-NOV-2017 or lot # L044525 exp. 09-NOV-2017 (dose, site and route of administration were unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of max 10.2 degrees Celsius for 10 hours 45 minutes on an unspecified date. No product quality issue was involved. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Generalized itching with red blotching and wheals >1mm to upper extremities, trunk and neck.
Sharp shooting nerve pain that radiates from shoulder to wrist, extreme wrist weakness, hip nerve pain that radiates to back - both on right side of body ( side which shot was given) Weakness of wrist and pain that does not allow me to even turn the ignition key on my car  had xrays taken and now MRI scheduled ... extreme difficulty walking and sleeping bc of severe nerve pain
Developed a rash on leg 11/15/13 in evening and went to emergency room 11/17. Patient had leg pain also.
Developed strep throat, was prescribed Amoxicillin it seemed to get better, but then came back. Symptoms came back, thought it could be ear infection and was prescribed Cefdinir symptoms did not improve went to PCP, rapid strep test came back positive was then prescribed Azithromycin and improved. (This was over a course of 3 weeks)
The day after my 3 shoot I had fatigue, headache, fever, severe joint pain, shortness of breath, tachycardia,  swollen lymph nodes in my neck, pain in my right rib cage, neck pain, bouts of vertigo, and IBS.  These systems have lasted six weeks.  I have been to the E.R. 3 times  for shortness of breath and tachycardia  and severe joint pain and  I was send home to rest.  I went to my  primary care doctor and his said lets just wait and see if the systems go away. I can not walk the grocery store without being short of breath.  I exert my self at all and I feel my heart pounding in my chest.
This is a spontaneous report from a contactable consumer (patient). A 21-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 12Sep2021 16:00 (at the age of 21-year-old) as dose 1, single for COVID-19 immunisation at Pharmacy. Medical history included pituitary tumor from an unknown date and unknown if ongoing, non-classic adrenal hyperplasia, idiopathic hypersomnia in long and potassium deficiency related heart arrhythmia from an unknown date and unknown if ongoing. Concomitant medication included JORNAY and prednisone taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. The patient previously took fentanyl and experienced known allergies. Patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Sep2021 16:00, patient experienced racing resting heart rate, bronchitis and continued recurrent upper respiratory illnesses. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received for the events. Multiple medications for bronchitis, EKGs was taken. The patient underwent lab tests and procedures which included EKGs: Unknown Result on an unspecified date in 2021, Nasal Swab on 16Sep2021, 26Sep2021, 20Oct2021, and 22Oct2021 was resulted negative, heart rate racing resting on 12Sep2021. The outcome of event racing resting heart rate was recovered on unspecified date in Sep2021, event bronchitis was recovered on unspecified date in Oct2021, event continued recurrent upper respiratory illnesses was not recovered at the time of reporting.  The lot number for BNT162b2 was not provided and will be requested during follow up.
I expected the sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I expected the sore arm) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I expected the sore arm). At the time of the report, PAIN IN EXTREMITY (I expected the sore arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Antibody test Negative done after 3 months of completing both vaccines. and positive (Positive) antibody test was positive after five month of vaccination.         No concomitant medication provided by reporter.  No treatment medication provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: follow up received on 12-jul-2021. contain significant lab data information ,patient gender also updated.
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure systolic: 200.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medications were reported.  Reporter stated she has been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID.  It was reported that, vaccine was given to patients for long COVID between 21-Mar-2023 and 01-Aug-2023. 42 Patients received bivalent booster with 38 having improvement of symptoms and 50s or more. Patient was treated skin lesions, scary brain, body aches. No adverse reactions occurred.  Tachycardia was greater than equal to 150.  No treatment medications were reported.  This case contains information about patient 14 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
severe chills; severe aches; This is a spontaneous report from a non-contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 12Feb2021, at 10:30 (Lot Number: EL9267, at the age of 56 years old) as dose 2, single for COVID-19 immunisation. The vaccine was received in a hospital facility. The patient's medical history and concomitant medications were not reported. She was not pregnant at the time of vaccination and she did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2, administered in the left arm on 23Jan2021, at 16:45 (Lot Number: EL9267, at the age of 56 years old) for COVID-19 immunisation. On 12Feb2021, at 20:00, the patient experienced severe chills and severe aches. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the events. The patient has not recovered from the events at the time of report.  No follow-up attempts are possible. No further information is expected.
Extremely bad headache, shortness of breath, dizziness lump in throat, chills followed by getting hot flashes and very lethargic and fatigued. Shot was administered at 11:45am on the 9th and by 03:00am on the 10th felt the above symptoms. Today date I am feeling better with minor unsteadiness here and there and a slight pain deep inside the middle of head almost like a headache for a few seconds then goes away, So far so good I think. I did call doctor to note on chart. Thank you!
Employee noticed bilateral hives on her lower legs on 01/05/2021. She took Benadryl and applied steroid cream with little resolution of her symptoms. She contacted her PCP who told her to seek evaluation at the urgent care. She went to the urgent care on 01/05/21 and was tested for COVID (negative) and was given an Rx for steroid cream. CG called me back on 01/07/21 stating that she now has developed a "circular rash" around her injection site, which her PCP was able to assess. The CG reports that her PCP told her she is ok to receive the second dose, but with close monitoring and to pre-medicate with Benadryl.
Pt states recvd Engerix-B series in 1985 (?) & titer was below therapeutic;
Patient returned approximately 20-30 minutes post 2nd COVID vaccination with complaints of throat itching and feeling like her throat is closing. Patient and husband waited 15 minutes in office as instructed but while driving home noticed above symptoms and returned to clinic. Patient states that when these symptoms began she used her albuterol inhaler in her car and states symptoms resolved immediately following this. Upon arriving back at clinic patient was noticeably anxious though exibits no evidence of respiratory distress or difficulty breathing. Patient denies any difficulty breathing, current throat/lip/tongue itching or swelling.  Treatment in clinic included 50mg IM Benadryl.  VS and exam were normal.  Patient monitored for 45 minutes and discharged in stable condition with her husband.
Pt recvd 3 doses of Engerix-B & devel a weak pos titer; recvd a booster dose & had no detectable titer;
Began to feel mild to moderate symptoms (headache, tiredness, feeling cold) before retiring for bed  around 11:00pm on 11/1/21. Around 3:00am 11/2/21 went to bathroom (urinated) felt achey and went back to bed. Around 6:00am got up to go to the bathroom and fainted upon walking into the bathroom. Was on the floor profusely sweating. Bruised my knee, bridge of nose (later developed skinned knee with pain, bruised bridge of nose and under eyes). Contacted my GP and was on a virtual call at 4:00 that afternoon. Related to him the events of adverse reaction. He checked my blood pressure on the call (with my home blood pressure monitor), dehydration - all normal. Concluded that my blood pressure may have dropped upon get. ting up (maybe too fast?) in combination with maybe a fast heartbeat and told to rest and monitor blood pressure, eat and hydrate. The rest of that day and the next I continued to feel body aches, headache. Took Tylenol. As of today knee remains stiff, mild soreness around eyes and nose.
Individual developed shingles on the top of her head around to her left ear on 4/22 She was prescribed an antiviral that she will be on until one month after her second dose, per her MD Gabapentin for the nerve pain
Patient received 1st Moderna dose on 2/5/21.  Came into Health Department today on 2/18/21 and nurse gave dose #2 before client was checked into the system.  There is 13 days between the 2 doses.
Pt received flu shot on 9/25/15. She stated on 9/27 evening her arm started to swell to size of a fist. It was hard knot. She did not take any action and swelling went away after 6 days.
Patient received first dose of Pfizer COVID-19 vaccine on 11/19/2021 and presented to employee clinic for second dose on 12/3/2021. Second dose given on 12/3/2021 at 14 day interval instead of recommended 21 days.
H/A,neck pain. Pt ED EMS; received COVID vaccine this morning with syncopal event, possible head strike. state he was sittig in a chair and awoke on the floor. facility VS: HR48, SPO2 100% RA, A/Ox3. reports feeling better at this time. denies visual. emergency room there is no evidence for intracranial bleed or skull fracture.  The patient had a rapid return to baseline.  As well as laboratory evaluation was normal and he had an unremarkable EKG.  At this time there is no emergent indications for referral or hospitalization.
Patient was diagnosed with Covid-19 on 02/09/2022.  He drove himself to ED and collapsed in the parking lot and was found down, he was taken to ED and CPR initiated, and he was intubated.  Patient was found to have Lacunar Infarct, Pulmonary edema, Afib with RVR.  Patient was admitted to hospital services.  Family eventually elected DNR/Comfort Care.  Patient was extubated.  Patient was transferred to Hospice.  Patient was unresponsive and actively dying.  Patient expired on 03/18/2022.
Confusion, Dizziness & Fever Narrative:  with c/o disorientation after receiving second series. denied other COVID+ exposures.
Patient got 1st dose of vaccine on 22 Jan 2021 and 2nd dose 08 Feb 2021; A spontaneous report  was received from a nurse concerning a 60-year old male patient who received the first dose Moderna's COVID-19 vaccine (mRNA-1273), and received the second dose on 08 Feb 2021 (17 days after the first dose).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   On 08 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) for prophylaxis of COVID-19 infection.  On 09 Feb 2021, a nurse reported a patient received the second dose of Moderna vaccine 17 days after the first dose. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, patient got 1st dose of vaccine on 22 Jan 2021 and 2nd dose 08 Feb 2021, was considered resolved on 08 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
About 9 days (Friday 1/8) post vaccine I developed an area of redness around the injection site. It started off the size of a nickel, was slight swollen, warm, and tender to the touch. The next day (Saturday) the reddened area grew to be the size of a half dollar coin. Still warm and tender to the touch.  The size was never itchy. I did not treat it with anything. The next day (Sunday) the redness was much less, the site not as warm and not tender. This is how the site remains now.
This is a spontaneous report from a contactable Other HCP via Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, at single dose and SHINGRIX, both via an unspecified route of administration on the same unspecified date for immunisation. The patient medical history and concomitant medications were not reported. Pneumococcal 13-val conj vac (dipht crm197 protein) and varicella zoster vaccine rge (cho) were given concomitantly there was more swelling. Information on the batch number has been requested.
My second Moderna vaccine reactions included sore, somewhat swollen deltoid muscle starting at approximately 7:00 PM on 4/6/2021. Then on 4/7/2021 at approximately 9:00 AM I started feeling soreness in some of my joints, especially those of the lower back and pelvic region. I also started having mild chills and felt fatigued. I spent part of the day in bed and felt better (normal) by 4:00 PM on 4/7/2021.
Swelling of face, vomiting, chest pain, and complaining couldn't see, headache.
PATIENT WANTED OMICRON BOOSTER AND RECIEVED UNDILUTED PFIZER PEDIATRIC. PATIENT MADE AWARE. PER CDC PATIENT COULD RECEIVE OMICRON IMMEDIATELY OR WAIT 2 MONTHS. PATIENT CHOSE TO WAIT 2 MONTHS. NO ADVERSE EFFECTS REPORTED.
Patient experiecnced syncope within seconds of vaccine administration. He regained consciousness in about 30 seconds
I still have site pain at the injection spot. I can feel it constantly and it intensifies when I left my part up.  It has been over 5 months.
(L) tricep area swollen, red and warm to touch. Approx. 3 1/2 cm in length 4 cm width. Arm circumference 20 cm (R) arm 19 cm. Mother was told by the school's bus driver that child's arm was swollen.
The patient presented to the Emergency Department today secondary to symptoms which she states started about 1 hour ago prior to arrival after she received her Covid vaccine first injection at 11:40 AM, states that she went back to work as a teacher and started to feel a sensation as if she had some swelling of her throat and a mild sore throat as well, she states that she developed some nasal congestion as well as lightheadedness, she denied any dyspnea, no coughing or wheezing, no chest pain, vomiting or diarrhea, she called her doctor and was told to present here for evaluation, she did not take any medication for symptoms prior to arrival and states that her symptoms are very similar to her previous allergic reactions but has never required epinephrine. Treatment required: NS1L IV bolus, Famotidine 20mg IV, Solu-medrol 125mg IV, and Diphenhydramine 50 IV all x1. The patient will be given a prescription for a short course of steroids at home and has been advised to take benadryl and pepcid at home if needed.
Patient states she has been experiencing significant neuropathic pain in unilateral left arm after receiving Pfizer vaccine. Pain is described as burning and tingling extending from site of vaccination at the deltoid to the tips of the fingers on the left arm. Pain was not present for this patient prior to receiving 3rd dose booster vaccination.
1. Crippling Gout flare 5/22 2. Bells Palsy.  6/11/22
Information has been received from a 48 year old female with sulfonamide allergy and penicillin allergy and a history of shingles, 2 caesarean section, appendicitis, hepatitis b, hysterectomy due to fibroids and "mono about 8 years ago" who on 10-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included occasional alprazolam (XANAX) and "CLARITON D". On 19-SEP-2007 the patient developed "yet another" case of shingles. The patient reported that she had blisters that started inside of the upper right eye lid on the cornea, a spot on her face on the upper left cheek bone, a spot under her right eye, a spot on and in her ear and in her throat, an area acrossed her breast, and a spot on her left leg. It was reported that she conducted few laboratory tests in March 2007 and the physician noted "everything was normal". Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.  01/14/2008 Lot # obtained 0618U. /pc 03/21/2008 MR received for ER visit 9/26/2007 with DX: Herpes Zoster.  Nausea. Pt presented to ER with c/o pain r/t Shingles. Lesions began 1 wk prior. Seen by PMD 3/25/07 but no improvement noted with meds.  Pt also c/o nausea, vomiting and dizziness. Vision and hearing OK.  Lesions noted around R eye.
10 days after vaccine varicella type lesions appeared on stomach, back, face and bottom. Approximately 15 lesions. Low grade fever persisted times 2 days. Given Benadryl-2 doses on day lesions appeared. Infant Motrin given BID times 3 days. Lesions and fever resolved 11/28/01.
Pt felt sluggish and like he wasn't getting a full breath of air. He also experienced ringing in the both ears. He was dizzy and saw spots. He sat down and symptoms diminished but reappeared after standing up. He then couldn't see and then passed out, this went on 3-4 times for a time period of 1 hour. Afterward, pt felt weak and tired so he went to bed. Once he woke up the next morning, he felt fine.
I received the first dose on April 9th, 2021.  On April 17th, 2021 I noticed a red rash and swelling at the injection site.   As the day progressed it kept getting bigger.  April 18th, the rash seems to have gone but the swelling hasn't and it seems to be getting larger.  My arm was really sore for the first three days after vaccine.  Since then I have had no swelling or rash at injections site for 8 days?
On 9/7/18 patient began developing a fever. On 9/8/18, it peaked at 103 degrees. Fever faded by night of 9/8/18. On 9/9/18, he began developing the start of a rash in the creases of his thighs, which on 9/10/18 spread to cover his chest, thighs, feet, hands, and around his nose and mouth. It took 4-5 days for the rash to have no new spots developing and to have the old spots dry over.
Body aches, nausea, vomiting, headache, dizziness, sore throat, asthma flare up, fever, swollen lymph nodes under my arm extending to my collar bone, fatigue. Started with body aches and fatigue at 8 pm after getting the shot. by the next day I had all of the other things going on. Fever ended on the 9th and I felt better by the 11th. The lump under my arm didn't go away until about the 14th. I took lots of Tylenol and rested and I also used my inhaler and took anti nausea medicine, but didn't go to a doctor because I knew the reason I felt bad and din't think there was anything to do about it.
Patient received ADACEL vaccine and shortly after she got spots in her vision then lost vision completely. She then fainted. Her father called 911 and paramedics took over care of patient when they arrived.