chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (REACTION TO COVID VACCINE), PAIN (NO RESPONSE YET/NO IMPROVEMENT IN PAIN) and RASH (RASH with RINVOQ (UPADACITINIB) and HUMIRA (ADALIMUMAB)) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Psoriatic arthritis and ADALIMUMAB (HUMIRA) solution for injection for an unknown indication. Concurrent medical conditions included Psoriatic arthritis. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form, UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (REACTION TO COVID VACCINE), PAIN (NO RESPONSE YET/NO IMPROVEMENT IN PAIN) and RASH (RASH with RINVOQ (UPADACITINIB) and HUMIRA (ADALIMUMAB)). At the time of the report, IMMUNISATION REACTION (REACTION TO COVID VACCINE) and RASH (RASH with RINVOQ (UPADACITINIB) and HUMIRA (ADALIMUMAB)) had resolved and PAIN (NO RESPONSE YET/NO IMPROVEMENT IN PAIN) had not resolved. No concomitant medications were reported. There was no reported medical history. The patient experienced reaction to Covid vaccine, no response yet/no improvement in pain from Rinvoq and rash with Rinvoq (Upadacitinib) and Humira (Adalimumab). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of reaction to Covid vaccine, no response yet/no improvement in pain from Rinvoq and rash was not provided. The reporter's causality for the events of no response yet/no improvement in pain from Rinvoq with Rinvoq (Upadacitinib) was a reasonable possibility. The reporter's causality for the events of reaction to Covid vaccine, no response yet/no improvement in pain from Rinvoq and no response yet/no improvement in pain from Rinvoq was not provided. The reporter's causality for the events of Rash with Humira (Adalimumab) was a reasonable possibility. No treatment information was provided by the reporter.
severe headache for the first three nights; diarrhea; before she threw up she started sweating; throwing up for a day after receiving the 1st shot of vaccine; didn't feel good; feeling of tiredness, fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "severe headache for the first three nights"; DIARRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "diarrhea"; HYPERHIDROSIS (non-serious) with onset Apr2021, outcome "unknown", described as "before she threw up she started sweating"; VOMITING (non-serious) with onset Apr2021, outcome "unknown", described as "throwing up for a day after receiving the 1st shot of vaccine"; FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "unknown", described as "didn't feel good"; FATIGUE (non-serious) with onset Apr2021, outcome "not recovered", described as "feeling of tiredness, fatigue". Therapeutic measures were taken as a result of headache.  Additional information: The patient experienced a severe headache for the first three nights after receiving the 1st shot, and she took low grade aspirin to ease it off. (Name) had fatigue, a feeling of tiredness and she mentioned that she still has it, she also experienced diarrhea, throwing up for a day after receiving the 1st shot of vaccine on 07Apr2021. (Name) would like to know if she should still get her 2nd shot. She wanted to know the side effects if it is just one side effect or more than one side effect after receiving both doses of covid vaccine. She experienced a headache that woke her up at 1 or 2 in the morning all 3 times and reports that the headache was on the side of her head. She also reports having diarrhea and vomiting one time each, and states that before she threw up she started sweating. She reports "didn't feel good" for 5 days and reports that the tiredness where she just wanted to go to sleep did not go away for 5-6 days. She would like to know if it is unusual for someone to have this many side effects all at once after receiving the vaccine. Caller also mentions that her aunt, who is in her "70s", had all the same symptoms she did and "got really bad with her for a couple of days" after her first dose, but reports that after her second dose, she did not have any symptoms. Caller also mentions that her daughter, who is 30, received her vaccine at the same time as the caller did and did not have any problems.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
/PATIENT CAME INTO PHARMACY ON 8/23/21 TO STATE SHE HAS BEEN HAVING ARM PAIN FROM THE RIGHT SHOULDER DOWN TO THE RIGHT ELBOW SINCE SHE GOT HER SHINGRIX VACCINE ON 7/12/2021.
Patient was here for her Moderna booster 0.25ml IM but received Moderna 0.5ml IM. Patient was notified and did not have an adverse event related to the error
site of inj lt arm reddened & hardened area around site, was sore day p/vax;20NOV96 was sore all over;broke out in a rash;19NOV96 on inside of both legs;22NOV96 started breaking out under arms;itches all over;
Information has been received from a registered nurse concerning a pt who on 3/25/97 was vaccinated with 1 dose of varicella virus vaccine lie. In May 2000, the pt experienced full-blown chickenpox with greater than 100 lesions. Medical attention was sought. The pt's 2 siblings had a similar experience following vaccination with varicella virus vaccine live (WAES00051888)(the other pt's twin) and (WAES00061176). No further information is available.
I had muscle pain in the abdominal and low back areas.  The pain is moderate and is 6 on a 1 to 10 scale.
left arm pain; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number C7B9P, expiry date 27th February 2021) for prophylaxis.   On 21st January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The nurse reported that the patient experienced left arm pain after receiving the Shingrix vaccine into the left deltoid.
But "tested positive for HPV 16 and 18 on 21-JUN-2019; This spontaneous report was received from a 29-years-old, female, pregnant (16 weeks) patient reporting on herself. No information regarding the patient's pertinent medical history, previously drug reactions or allergies, and concomitant therapies was provided.   On an unspecied day in June 2006, the patient was vaccinated with at least one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) in the deltoid arm, for prevent human papillomavirus (HPV) (formulation, strength, lot number and expiration date were not provided; the dose and  frequency were unknown by the reporter, and if could not be established how many doses of the suspect vaccine the patient received), however the patient tested positive for human papillomavirus (HPV) (papilloma viral infection) 16 and 18 on 21-JUN-2019. Also, the patient stated that she was "naive to human papillomavirus (HPV)", when she received the vaccionation. The patient did not receive treatment for the event and did not sought medical attention.  At the time of this report, the  outcome of the event papiloma viral infection was reported as not resolved.  The relatedness between the suspect therapy and all the aforementioned event was not provided.
I discovered that I was having an extremely high heart rate when I went in to give blood. It was over 100 beats per minute at resting and mine is typically at 60. They declined to allow me to give blood. I attempted to give blood again in August and was able to get it down. I began to check my heart rate more after that and noticed the fluctuations. I have reduced my exercise to avoid exacerbating the issue. I have not seen anyone for the heart rate yet but I would like to see someone so that I can get back to normal activities. At one of the visits to give blood, my blood pressure dropped so low that they had to give food and other liquids to get it back up. They took my blood pressure every 20 minutes. My pulse still gets high without explanation.
2015 Shot Effects: Left arm and shoulder pain going on 15 months (Nov 2015 to now). Limited rotation and range of motion, weakened strength, some partial numbness left fingers and hand, difficulty sleeping, physical activities limited or given up such as golf and arm machines at gym. From the time of shot 11/2015 to current date 1/7/17. Treatment for left arm pain 11/2015 to 11/2016: Over counter medication for pain and inflammation. Call to pharmacy to report prolonged discomfort. They said no other reports coming in. Visit to PC physician office, then referred to Ortho. 3 visits to Ortho Doctors: x-rays and 3 cortisone shots over 8-month period. Tendonitis, bursa damage, rotator cuff all explored. Physical therapy Sept and Oct 2016. Discomfort continued, Ortho Arm Dr recommended MRI of neck 11/2016. Then referred to Ortho Spine surgeon and Neurosurgeon and Neurologist for left arm nerve testing. Currently exploring if arm problem could relate to any neck issues. 2016 Shot: Based on possibility pain could be neck related, my PC Dr. and I agreed I should consider a reduced dose flu shot for 2016/2017 season. Shot administered PC office on 12/13/16 in right arm. Has been more than 3 weeks since shot and my right arm is experiencing same issues I had with the prior year's flu shot in left arm. Although not as painful as 2015 there is constant discomfort in upper arm and shoulder, limited range of motion and waking multiple times at night due to pain. Treatment: Back on over counter anti-inflammatory and expecting will need continued Medical attention to both my left and now my right arm. Assumption is now that this is not neck related but direct result of flu shot in 2015 and 2016. Personal observation: I have been taking flu shots for a minimum of 15 years without any issue until the 2015 and 2016 shots. Going forward I will forgo any further flu shots as this has changed my activity level and quality of life substantially. Constant discomfort causing me to reduce the physical activities I used to enjoy. Has aged me prematurely both mentally and physically. I hope this information is helpful in future development of flu treatment and their delivery process.
Information has been received from a Registered Nurse (R.N) concerning an 18 year old female patient who no pertinent medical history and no known drug allergies/drug reactions who on 22-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot # 658558/1061U). On 09-OCT-2007, the patient was vaccinated with the second dose of GARDASIL (Lot # 660618/0572X). Concomitant therapy included ADVIL. It was reported that "three weeks after the first dose" the patient developed inflammatory polyarthritis. The patient developed joint pain, fatigue, shortness of breath, chest pain, rash, headaches, fever, weakness and muscle aches after receiving a dose of GARDASIL. It was reported that the patient also complained that the injection site was sore for two months aft the second dose of GARDASIL. The patient had not received the third dose. The patient saw the physician. On an unspecified date a rheumatoid factor test was performed and it was positive. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
Pre-menstrual breakthrough bleeding, excessive cramping and discomfort during menstruation. No change in timing of menstruation.
BLOODLETTING TO GO WITH IT; PAINLESS VACCINATION HAD SOME PAIN; This spontaneous report received from a patient via a company representative 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 received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced bloodletting to go with it, and painless vaccination had some pain. The action taken with covid-19 vaccine was not applicable. The outcome of the painless vaccination had some pain and bloodletting to go with it was not reported. This report was non-serious.
Pt received 5-11yr (0.20 ML) ,second dose in the series, should have receive adult dose 0.30 ML. Mother of child notified within 30 minutes of the incident. CDC recommend NOT to repeat/administer the appropriate dose.
Patient stated that she was itching slightly the day after her immunization. She was recommended to use Benadryl. Patient stated if anything was to get worse she had a doctor appt the following Tuesday.
PT RECD 1ST DOSE OF MODERNA WHEN HE WAS 16. HERE FOR 2ND DOSE. MOM WAS CONSULTED ON OFF LABEL USE, SIGNED CONSENT. PT RECD 2ND DOSE OF MODERNA.
DIZZINESS; FEELING HIGH; WEAKNESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 167 pounds, and height was not reported. The patient's past medical history included blood clots, and concurrent conditions included flu shot and weed smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced feeling high. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and weakness, and the outcome of feeling high was not reported. This report was non-serious.
Woke up at 2am with sore throat and difficulty breathing. Took TYLENOL on Sunday and gargled with salt water and took lozenges. Monday felt horrible. Ears are plugged, felt chills. Body aches/soreness.
Information has been received from a registered nurse concerning a 10 year old female with asthma and penicillin allergy who on 28-SEP-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 658375/1118U). On 29-SEP-2007 the patient developed redness, swelling and tenderness to the left deltoid. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been received from the registered nurse stated that the patient had recovered on 05-OCT-2007. Additional information has been requested.
Vertigo; Tinnitus; Numbness on left side of face; Numbness in some toes on left foot.; This is a spontaneous report from a non-contactable consumer, the patient. A 35-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 left arm on 18Mar2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had not taken any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies. On 20Mar2021, the patient experienced vertigo, tinnitus, numbness on the left side of the face and numbness in some toes on the left foot. The event resulted in a doctor or other healthcare professional office/clinic visits and in the emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent a nasal swab test and the result was negative. The clinical outcome of the events vertigo, tinnitus, numbness on the left side of the face and numbness in some toes on the left foot was recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna vaccine (NDC--8077-0273-99, lot # 048C21A) was received at a store on 7/16/2021 and placed under refrigerated temperature. 3 vials were transferred to another store where 20 doses were administered beyond use date.
nausea & vomiting w/generalized h/a, malaise, fatigue developing w/in 24 hrs p/vax & tapering off;
Received expired vaccine, Moderna contacted,  and this was the report "Analysis of the vials associated with your storage excursion is complete. The vaccine administered on April 19, 20, 21, 2022 from lot number 016J21-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
SLEPT FOR 18 HOURS; FELT MISERABLE/TERRIBLE; FATIGUE; STAPHYLOCOCCUS INFECTION; This spontaneous report received from a consumer concerned an adult male of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic lymphocytic leukemia since an unspecified date in 2017. There was no other reported medical history. The patient received covid-19 vaccine ad26.cov2.s (dose number  in series 01) (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, 01 total, administered on an unspecified date in 2020 for Covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ibrutinib (Imbruvica) for chronic lymphocytic leukemia. On an unspecified date, the patient slept for 18 hours, and felt miserable for a couple of days due to fatigue, he slept for 18 hours and some days he felt terrible and some days not so bad while he was taking the Imbruvica. He resumed taking the Imbruvica however it was unknown why he was stopped from taking the Imbruvica before and it was not stated also if it was due to fatigue or not. On an unspecified date in 2020, the patient experienced staphylococcus infection and fatigue. Alternative etiology for fatigue was due to chronic lymphocytic leukemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and the outcome of staphylococcus infection, slept for 18 hours and felt miserable/terrible was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211203320.; Sender's Comments: V0: 20211210427-covid-19 vaccine ad26.cov2.s-Staphylococcus infection. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY
About 12 minutes after receiving immunization I heard patient's wife ask him if he was okay, went to patient and saw him keep blinking and looking off. He was not talking as much and seemed confused. I grabbed the NP and patient told her that his vision was blurrier than normal and he did not feel right in the head. Patient then started to experience some chest discomfort. Got BP on patient, it was 158/79. NP listened to his chest with a stethoscope and said he should probably go to the ER. Wheeled patient over to the ER, he had a hard time getting into the chair and prior to immunization he had been getting around just fine. While wheeling over, chest pain was worsening and he was feeling weak. Upon entering ER, they got him right back.
Immediately she had pain when the needle was still in her arm. When the medication got shot in her arm it burned real bad. The next day she started feeling cold all day long. She noticed if she lay on her right side her arm became really sore and it now has a knot on it and is real red.
Developed 8 cm. diameter area described as "very sore, swollen, and hot"  Seen by MD and cellulitis diagnosed.  Placed on Azithromycin for 3 days.
Headache that lasted until 4/14/21, was seen by her provider as a virtual visit and told to treat with flonase and ibuprofen and to go to ED if headache doesn't go away after that treatment.  Headache got better night of 4/14/21, but returned again 4/15/21 in AM.
a few minutes after receiving the vaccine, the patient  became flush and lightheaded. He was lowered to the floor where he never went unconscience, but did get very pale and sweaty.  His blood pressure was low at 99/60.  He reported he had not eaten.  He was given glucose tabs and after 15 minutes began to feel better.  he drank water and was observed for 30 minutes.  He did not report this had happened previously, but did say he did not like needles or blood.
My symptoms started  on August 1, 2021 after I had the second dose Pfizer Lot #ER2613  on March 24, 2021.  It started with TMJ and  then I developed Occipital Neuralgia.  From there I lost weight, lost strength, my color was greyish.  Spent approximately 6 months on the couch.  Went to the Neurologist and did all the neurological test with him finding nothing.  Went to the Hematologist and they did all the blood test...again nothing was found.  They put a pic line in me because my ferritin level was sky high.  And when I was still so weak and aching terribly, they recommended a Rheumatologist.  When I told him all the symptoms I had over the past 6 months then, he diagnosed me with Polymyalgia Rheumatica.  I havent EVER been sick in my life.  I also did receive a third COVID vaccine on October 16, 2021. I am still taking Prednisone steroid to get rid of this. I am still under Dr. care.
pt recvd vax & started fever 5NOV93; mom picked up pt; pt exp rash, itchy, sore throat, runny nose, influenza;
Six hours post vax, Mom called stating baby awoke from nap and was inconsolable. Right thigh red and appears swollen. Baby cried very hard for about 1 hour. Given Tylenol and did quiet down smiling and cooing at times but right thigh very tender/sore to touch. Cry was high pitched.
Patient claims to have developed rash at injection site 3 days after injection and complained of erythema and itching. The rash went away after 5 days (which was approx. 8 days after injection), but came back 4 days later on 5/25. Recommended for patient to see primary care physician.
Patient presented to emergency department on 8/3/2021 with shortness of breath and chest pain radiating down her left arm.  Patient was admitted for further management. She started having a fever and was found to be COVID-19 positive on 8/29/2021 in addition to having a urinary tract infection.  She had a very complicated hospital admission. Patient was discharged to assisted living facility on 10/1/2021.
Mild headache, mild nausea, temperature 99.2; duration of headache and temperature was <2 hours; duration of mild nausea unknown, but resolved before following day.