chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sensitive to touch; Couple spots were tender; Rash on right arm; Very red; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Sensitive to touch), VACCINATION SITE INDURATION (Couple spots were tender), VACCINATION SITE RASH (Rash on right arm) and VACCINATION SITE ERYTHEMA (Very red) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination.     Concomitant products included PRIMIDONE, BACLOFEN, PROPRANOLOL and TRAZODONE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced SENSITIVE SKIN (Sensitive to touch), VACCINATION SITE INDURATION (Couple spots were tender) and VACCINATION SITE ERYTHEMA (Very red). 13-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash on right arm). The patient was treated with CORTISONE (topical) at an unspecified dose and frequency. At the time of the report, SENSITIVE SKIN (Sensitive to touch), VACCINATION SITE INDURATION (Couple spots were tender), VACCINATION SITE RASH (Rash on right arm) and VACCINATION SITE ERYTHEMA (Very red) outcome was unknown.            Treatment details included use of ice pack and antihistamines.    This case was linked to US-MODERNATX, INC.-MOD-2021-048253 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up - Email id updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048253:Crosslinked with dose 1
My right eye became completely red in the following day morning which lasted two weeks. The red color faded from 3rd week.  I started to feel chest pain, heart burning and tightness from time to time, every two or three days that really bothers me. When I have the chest/heart symptoms, I can't function my daily work and it is not gone yet.
Slight itching around injection site directly after injection. Pain began a few hours later. The next morning the entire bicep was sore and swollen. As the day progressed swelling in a 2-3" diameter around the injection site occurred. By the evening there was numbness in entire arm from bicep to wrist and immense pain. Pain continued for 2-3 days as swelling subsides by 2 days later.
change in menstrual cycle. Have had 3 IUD's for the last 15 years or so. Last one inserted a year ago. With my IUD I am lucky enough to not  get a menstrual period.  After the first Pfizer shot 8.24.21 (FC3182) I started a period that lasted for 4 days. 3 weeks later I had my second shot 9.14.21 (FF2588) and the next day started a period that is till going now for 8 days. I feel it important to report this affecting hormones and menstrual cycle after not having one for 15 years. Obviously this vaccine made my body react hormonally. Not only did I get a period but I got it both times next day after the shot.
Gout flare up after 1st dose of Moderna COVID 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout flare up after 1st dose of Moderna COVID 19 vaccine) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Gout.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced GOUT (Gout flare up after 1st dose of Moderna COVID 19 vaccine). At the time of the report, GOUT (Gout flare up after 1st dose of Moderna COVID 19 vaccine) outcome was unknown. Unknown      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.   Concomitant Colchicine
This spontaneous case was reported by a non-health professional and describes the occurrence of PRESYNCOPE (Felt like he was going to pass out after the 2nd dose), FEELING HOT (Felt hot), FEEDING DISORDER (Couldn't eat ), NAUSEA (Nausea ) and PYREXIA (Started to feel like he had a fever) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028c21a and 037a218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRESYNCOPE (Felt like he was going to pass out after the 2nd dose), FEELING HOT (Felt hot), FEEDING DISORDER (Couldn't eat ), NAUSEA (Nausea ), PYREXIA (Started to feel like he had a fever) and CHILLS (Chills, shivers). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (Felt like he was going to pass out after the 2nd dose), FEELING HOT (Felt hot), FEEDING DISORDER (Couldn't eat ), NAUSEA (Nausea ), PYREXIA (Started to feel like he had a fever) and CHILLS (Chills, shivers) outcome was unknown. No relevant concomitant medications were reported.
I got a headache around 6:00 PM the day of the vaccine which did not go away. I got cold during the night and felt discomfort in my abdomen. By the next morning, I was tired and achy all over. I still had the headache which was about 6 on a 1-10 scale. I didn't start to feel relief until around 4:00 PM on Wednesday, the day after the vaccine. By evening I felt fine.
Patient began to feel nauseous and faint shortly after administration of vaccines. She laid supine on exam table for a few minutes and then felt well enough to go to school and leave office. Began to feel faint and nauseous again in waiting room while checking out at front desk. Returned to exam room and laid supine with feet elevated. Drank 5.5oz of apple juice, declined crackers, cool compress applied to forehead. Blood pressure and HR monitored, initially hypotensive and returned to normotensive after laying supine for approximately 30 minutes. Also had a popsicle before NP evaluated patient.
Subsequent to receiving one dose of varicella virus vaccine live, the pt experienced a diagnosed chickenpox outbreak and was covered head to toe with approximately 50 lesions. Pt also experienced pox in his throat and an increased temperature.
still sick; she was diagnosed with Covid-19; This is a spontaneous report from Pfizer-sponsored program Pfizer First Connect. A contactable female Other HCP (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she received the first dose of Covid 19 vaccine shot on 19Jan and 1 week later she was diagnosed with Covid-19. She has a schedule for the second dose next week and she stated that she is still sick, asking if she can take the second dose of vaccine. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Light blotchy rash developed in upper right arm neck and chest 30 approximately 1 hour after vaccine with intense itching. Later in evening red with purplish color rash developed on bilateral arms and back with intense itching. I have photos
Diarrhea onset after check in. Ongoing. No exposure to allergens or known exposure to covid-19.
For both doses, 2 months apart, I experienced a mild fever of about 99.8, and related chills on the evening of the shot. And mild body aches and a headache the next day. All of this was an annoyance, but tolerable and managed with ibuprofen and ?acetaminophen. I was able to fully function at work the same day and the next day. But I did not challenge myself with exercise.
Patient came in for second dose of Covid vaccine to a different site than first dose. Pharmacist verbally confirmed first dose info and date with patient as patient forgot vaccine card at home but  did not check system to confirm manufacturer or date of administration.  Pharmacist administered Moderna vaccine at approximately 11:45 AM , Due to a billing/ adjudication issue, system wasn't checked until around 4 PM. The error was then determined. System documented  first dose of Pfizer vaccine on 4/19/21. Immediately contacted patient to confirm system information. It was then patient stated she really wasn't sure what she had received for first dose and her vaccine card was not accessible. Notified patient of both the error in manufacturer and of early administration (14 days after first dose). Patient stated she wasn't experiencing any adverse effects at this time. I reviewed with her possible side effects and course of action (self treat vs contact MD/ urgent care).
The pharmacist gave the patient the MMR vaccine IM instead of Subcutaneously. The patient has had no side effects from this.
Started with fever and progressive swelling at injection site. It kept swelling over the next couple of days with a hot fever. I woke up with a headache the next morning, 8/15/21. Today is 8/20/21, my symptoms have not subsided. Fever, headache, extreme fatigue, extreme muscular pain, chills, hot sweats, nausea, diarrhea, coughing, sneezing.
No adverse effects reported; improperly stored doses of VARIVAX and PROQUAD; This spontaneous report was received from an administrator referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-MAR-2019 or 31-MAR-2019 or 02-APR-2019 or 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot# R023736 with expiration date on 20-AUG-2020 or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot numbers R008697 and R000551, for prophylaxis (dose and routes of administration). The administered doses of the vaccines experienced temperature excursion -12.85 degrees Celsius for 15 minutes. There was no adverse effect reported.  This call was because of a data logger and there was not previous temperature excursion.   No product quality complaint was involved.   Lot number R008697 and R000551 are invalid lot numbers for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) .  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1904USA003556:Original Case : 1904USA003556 US-009507513-1904USA004743:Original Case : 1904USA003556 US-009507513-1904USA004744:Original Case : 1904USA003556 US-009507513-1904USA004739:Original Case : 1904USA003556 US-009507513-1904USA004740: US-009507513-1904USA004742:
This spontaneous report as received from a licensed practical nurse refers to a 32 year old female patient (nursing student). The reporter reported that on 16-JUN-2014 she administered the second dose of VARIVAX (Merck) (lot # H010958, Exp date: 31-MAY-2014, 0.5 ml) subcutaneous in the left arm. However, the VARIVAX (merck) was expired. No adverse events reported at this time. Additional information has been requested.
Stroke - Cerebral Vascular Accident. Hospitalized 5 days. In patient physical therapy 3 days. Outpatient physical therapy 2 months.  Visual field cut, Cognitive impairment. Stroke was 19 months ago. I have improved since then, but still have some impairment.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756560A, A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Very severe skin rash covering the entire body. Itchy skin, some sneezing scratchy throat. Headache, stomach ache overall feeling of being unwell. After 4 days rash not gone. Treatment: Benadryl every 5 hours, Aveeno baths.
Seven hours after the vaccine I had a fever of 101 with a headache and chills. An hour later I had a fever of 106.5 degrees. Nothing seemed to work to bring the fever down and I had a very sever headache. I was advised to take a combination of Ibuprofen and Acetaminophen which finally brought it down to 102-103 which lasted three days. I threw up on the third night and I experienced nausea. On the fourth day I went to work, and I was exhausted when I came home, and I had a fever of io2 degrees. I had to take off work for the whole week because I had trouble keeping my fever down to normal. I was fever free after seven days and I was able to go back to work on the tenth day. I have been diagnosed post-concussion syndrome at the end of 2019 and I don?t know if that had an influence on the headaches. The headaches that I got after the vaccine caused similar pain to some I have had before but they did not cause the same symptoms of vertigo.
received pfizer covid vaccines 3/29/2021 and 4/19/2021  as of 10 Dec 2021 Admission summary in 10/ 2021- This previously healthy young man with a history of sensorineural hearing loss approximately 10 years ago first developed some arthralgia following coronavirus 19 vaccination in April 2021 however he and his father report that the symptoms resolved and he returned to normal health before starting to feel poor again in the summer 2021.  He has developed intermittent myalgia and arthralgia and has been experiencing fevers.  He did develop fatigue and has been coughing for weeks.  He was admitted on 10/15 with left hemiparesis and found to have a subacute right lacunar infarct of unstated location and narrowing of bilateral external carotid arteries on CT. On 10/17, he developed right hemiparesis and acute dysphagia and found to have a right lateral medullar infarct. He was transferred another medical facility on 10/17. Rheumatology was consulted for evaluation of a rheumatologic process contributing to presentation in setting of reported ANA positive serology.    He does have unexplained fevers, inflammatory "arthritis", dry eyes (positive Schirmer's test on R eye, negative on L eye), dry mouth, neurologic symptoms (stroke), cytopenias, hypergammaglobulinemia, elevated Immunoglobulin level, positive ANA, weakly positive anti-SSA which could be explained by Sjogren's symptoms. People with seronegative (weakly positive in his case) Sjogren's tend to have neurological manifestations.    Received IV cyclophosphamide 500 mg/m2 (900 mg) (first dose on 11/6/2021), IV methylprednislone 500 mg bid x 6 doses. Tapered to equivalent of prednisone 1 mg/kg, Plaquenil 300 mg daily (started on 11/5/21)    Laboratory studies Abnormal - anti-SSA (2.5), ANA 1:640 homogeneous, SPEP consistent with chronic inflammation (hypoalbuminemia, hypergammaglobinemia), anti-smooth muscle, MOG antibody, elevated interleukin 2 receptor, elevated ESR, elevated CRP.   Normal/Negative - antiMPO/PR3, RF, anti-Smith, anti-SSB, anti-Scl70, anti-centromere, C3/C4, anti-CCP, anti-beta 2 glycoprotein 1 Ab, anti-cardiolipin Ab, urine studies, anti-ds-DNA, serum immunofixation, anti-mitochondrial aby, DRVVT, cryoglobulin, Hex lupus anticoagulant Negative NMO in CSF, TB   Pathology: Lip biopsy showed mild focal periductal chronic inflammation with focus score<1 (focus score 0.44).    INTERVAL HISTORY:  He he has noticed improvement after he was discharged.  He is able to walk at home without problem but he still uses walker whenever he goes out.  He denies any new neurologic symptoms. He is currently on prednisone 30 mg daily. He monitors his blood pressure every day and taking beta-blocker for it.  Beta-blocker is managed by primary doctor. His dry eyes and dry mouth do not really bother him.  He has been drinking a lot of fluid for the dry mouth.
arm was a little sore; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore) in a  patient of an unknown age and gender 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, the patient experienced PAIN IN EXTREMITY (arm was a little sore). At the time of the report, PAIN IN EXTREMITY (arm was a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported. No treatment information was provided.    Reporter did not allow further contact
This person was not vaccinated at this clinic so we do not know the dates he received his two doses of  vaccine. He came through our drive through testing clinic and is not an established patient so there is no history on him.   He is fully vaccinated and tested positive today with c/o cough, congestion, runny nose and sore throat
Myalgia & Tachycardia Narrative:  sweats; fast heart rate; chills; fatigue during the 15 mins post vaccine  Other Relevant History:
I got the flu shot and I was sick with the flu the next day; Initial information received on 13-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced i got the flu shot and i was sick with the flu the next day while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect Influenza Vaccine (formulation and strength :unknown)produced by unknown manufacturer(lot & batch number and expirydate: unknown) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious i got the flu shot and i was sick with the flu the next day (influenza) (unknown latency) following the administration of Influenza Vaccine. Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event influenza.  At time of reporting, the outcome was Unknown for the event influenza.
Pt presented to office on 11/5/07 following the 10/26/07 administration of flumist.  Pt presented with a swollen face and neck, as well as swelling in one limb.  Pt seen for second follow up on 11/9/07.  At this time was determined to possibly have a flumist reaction.  Pt's sx improving.
At 3am (Wednesday) the following day after my shot, I began having chills and a fever. My fever started at 100.5 and continued through out the entire day, reaching 102. degrees Fahrenheit. At the same time I was extremely weak and could hardly walk. I had a pounding headache and could not sit up. I had to lay down. I was very nauseous and couldn't eat much. I was dizzy and couldn't even look at my phone. at 9pm on Wednesday I was able to finally eat a substantial meal and finally took some Tylenol. Around 10:30pm my headache lessened and I was able to sit up. My temperature was around 99 degrees. I went to bed, then woke up at 1am (Thursday) freezing again with chills, then the sweats. By 3:45am I was able to sleep until 7am. 7am on Thursday morning my temperature was normal (98.6) but my head was hurting. I had some weakness but was able to stand long enough to shower. The biggest symptom I had all day Thursday was a lot of body aches. Mostly in my hips and back, but all over. My right arm was also extremely red and swollen. Wednesday and Thursday I stayed home from work. Friday I returned to work, but I had a headache, would get over heated easily and had body aches. This is when the injection site and surrounding area began itching. Saturday I had a stomach ache and head ache and continued to feel sluggish. I did not move around much and was exacerbated trying to grocery shop. Sunday I had pressure in my head (top of the head) especially when I would bend down.  It is now Monday. My headache has cleared but my arm remains itchy, though there is no sign of swelling or redness. I do not have a history of Chronic Migraines and I have not had a cold/the flu in over a year.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.