chrisvoncsefalvay/vaers-outcomes huggingface dataset:
having lots of back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (having lots of back pain) in a male 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, the patient experienced BACK PAIN (having lots of back pain). At the time of the report, BACK PAIN (having lots of back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
This spontaneous report as received from a nurse refers to a 16 years old female patient who on 15-AUG-2012 was vaccinated with dose 1 GARDASIL injection, intramuscularly (dose, and lot number not provided). It was reported that the patient also received doses of GARDASIL on 25-OCT-2012 and on 04-JAN-2013 respectively (dose, route and lot number not reported). No adverse effect reported. Additional information has been requested.
About two hours after receiving the booster shot, I began to get a really intense headache. I do not normally get headaches, so I drank a lot of water and tried to wait it out. The headache continued to intensify to the point of needing to lie down in a dark room. Over the next four days, I had symptoms of a classical migraine (even though I had never had one before in my life). I had photosensitivity, was very nauseated, and often had to go lie in a dark room. I took the maximum dose of OTC Aleve but it did not alleviate the headache. On the fifth day, Dec 28th, I woke up with an intense headache but it did not have the same migraine-like quality to it. Later on that day, it progressed to a migraine again and I was back to bed. Since Dec. 29th, I have had a non-stop headache that ranges from moderately severe to debilitating (back in bed in a dark room). I continue to take the recommended dosage of OTC NSAIDs or ibuprofen. Today, as of reporting this, it is Saturday, Jan. 8th and I continue to have a severe headache.
COVID-19 infection (tested positive on 02/01/2023). Symptoms (sore throat, headache, fatigue, cognitive impairment, nasal congestion) began 01/25/2023.
First shot attacked every nerve in my body that was ever injured. My thigh and leg are still hurting since 5/02/21. Second shot in right arm I through up for 2 days, became very tired and my digestive system has not been good. I'm having diarrhea still. Wish I never became a lab rat for second stage vaccination. I was living quite well with the germs around me. Wearing a mask, social distancing and hand washing.
About 2 hours after being vaccinated the patient cried, had swollen (red edema) of the left thigh that expanded. She also had bruising after the edema decreased.
Patient complained of a burning and tight feeling in her throat.  In the ED, she had no hives, no itching, no difficulty swallowing, and no fever.  Her airway was patent, no wheezing, and her pulse oximetry was 100% on room air.  She was given 125mg of Solumedrol, IV.  50mg of Benadryl PO.  Her vital signs remained stable throughout her stay.  After observation, she was released.
7/6/2021 began painful breathing followed days later by low grade fever, chills, and fatigue.  Diagnosed on 7/9/21 with pleuritis.  Symptoms resolves by 7/12/21. 8/13/21 began same pain with breathing as in July followed by fatigue and low grade temperatures through present. Virtual appt with provider set for 8/17/21 pm.
28YM with no past medical history who presented to the emergency department on 7/28  complaining of 2 days of numbness and burning pain in his right axilla, right hemithorax, right arm and leg. He also noticed weakness in his distal right leg.  Imaging consistent with MS.  Neurology was consulted and he was started on high dose steroids with improvement, but not resolution of symptoms.  He will follow up closely in the outpatient setting with Neurology.  He is very hopeful to get back to his regular activities including fishing/hunting.  On the day of discharge, he remains anxious but wants to get out of the hospital.  He still had some sensory changes in the right axilla and RLE slight foot drop, but overall was feeling much better than at presentation.    #Multiple demyelinating lesions consistent multiple sclerosis, relapsing-remitting.  Symptoms improving, not resolved by dc.  -CT of the head and neck was unremarkable.  -MRI of the brain demonstrates findings consistent with demyelinating disease such as multiple sclerosis including a masslike region in the subependymoma white matter adjacent to the right lateral ventricle.  MRI of the cervical spine demonstrates multiple cervical spine cord lesions including an enhancing focus at C7 most in keeping with demyelinating process. MRI of the thoracic and lumbar spines is unremarkable.  -HIV and syphilis are nonreactive. CRP is normal. Vitamin B12 level is normal. ANA screen negative.  ANCA were not sent.  -LP not indicated given that already meets criteria for relapsing-remitting multiple sclerosis with both enhancing and nonenhancing lesions demonstrating dissemination in time.  He also has lesions that are periventricular, juxtacortical and spinal cord demonstrating dissemination in space. -Completed solumedrol, dose 5/5. Discharged home on 8/1/21
This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation) and COVID-19 (COVID-19) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa and Crohn's disease.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced INFLAMMATION (Inflammation). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, INFLAMMATION (Inflammation) and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: Inflammation.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. A 25-year-old female patient, in treatment with Adalimumab for Crohn's disease, received a dose of mRNA-1273 vaccine and experienced non serious events of COVID-19 (AESI) and inflammation. Vaccination date and onset date of the events were not provided, latency cannot be assessed. In 2021, Magnetic resonance imaging showed Inflammation. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 25-year-old female patient, in treatment with Adalimumab for Crohn's disease, received a dose of mRNA-1273 vaccine and experienced non serious events of COVID-19 (AESI) and inflammation. Vaccination date and onset date of the events were not provided, latency cannot be assessed. In 2021, Magnetic resonance imaging showed Inflammation. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Tachycardia, irregular heart, chills, body aches, spine pain, neck pain, unable to go to work or perform normal activity due to s/s.
PAIN IN LOWER BACK; CHILLS; FEVER; HEADACHE; NAUSEA; OVERALL WEAKNESS; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies, no any history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204a21a, expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced pain in lower back. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever. On 25-JUN-2021, the subject experienced headache. On 25-JUN-2021, the subject experienced nausea. On 25-JUN-2021, the subject experienced overall weakness. Laboratory data included: Body temperature (NR: not provided) 102.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, nausea, chills, pain in lower back, and overall weakness. This report was non-serious.
ED to Hosp-Admission Discharged  3/26/2021 - 4/5/2021 (10 days)    Last attending ? Treatment team Sepsis  Principal problem Discharge Summary    Inpatient Discharge Summary   BRIEF OVERVIEW Admitting Provider:  Discharge Provider:     Admission Date: 3/26/2021     Discharge Date: 4/5/2021   Discharge Diagnosis Severe sepsis COVID-19 pneumonia Acute hypoxic respiratory failure Atrial fibrillation/atrial flutter with RVR   DETAILS OF HOSPITAL STAY   Presenting Problem/History of Present Illness/Reason for Admission patient is an 70 y.o. female with a past medical history of atrial fibrillation chronically anticoagulated with Xarelto, S/P ablation x3 at the Medical Center, and sinus bradycardia who presented to the ED for evaluation of general malaise, shortness of breath, loss of taste and smell, coughing, and shortness of breath and was found to have sepsis due to COVID-19 pneumonia in the ED.   Patient states that over the past week she has been extremely weak, with nausea, diarrhea, but denies vomiting. She also reports that her appetite has decreased and noted that the symptoms has worsened and as a result she presented to the ED for further evaluation.Patient denies abdominal pain, lightheadedness, or chest pain.   Upon further evaluation and tests in the ED, she was noted to have severe sepsis as indicated by vital signs and chest x-ray imaging indicating groundglass pneumonia typical of COVID-19 infection. She also had COVID-19 swab which returned  positive result. Additionally, patient was noted to be hypoxia with SPO2 of 88% requiring oxygen supplementation.    Hospital Course patient was admitted to a Hospital due to shortness of breath, with fatigue and weakness, and was found to have severe sepsis with endorgan damage of acute hypoxic respiratory failure due to COVID-19 pneumonia on admission.  Imaging study showed no evidence of PE, but did show evidence of bilateral pulmonary infiltrates.   Pulmonary was consulted, she was started on remdesivir with Decadron.  She had an increase in oxygen requirement to the maximum of 10 L via specialty nasal cannula during the admission.  With the treatment of remdesivir and Decadron she had improvement in her hypoxia, and was ultimately weaned to room air by the time of discharge.   She underwent a desaturation study on the day of discharge and determined that she did not need any supplemental oxygen.  She completed her entire steroid and remdesivir course during the admission.  She had no evidence of superimposed bacterial pneumonia.   Her hospitalization was complicated by atrial fibrillation/flutter with RVR, that improved with metoprolol administration.  This was thought to be precipitated by her severe hypoxia with acute illness.  She was kept on metoprolol 25 mg twice daily on discharge, and will need to follow-up with her cardiologist at  Medical Center to determine if she can come off of this again.  She will continue to take her Xarelto as previously prescribed.   She was medically stable for discharge on 4/5 in stable condition, and will need to follow-up with PCP within 7 days, with cardiology within 2 weeks at the hospital, and pulmonary within 2 weeks as well.
Injection site became enlarged; Injection site became red; Injection site became inflammed; Injection site became hot to the touch; Injection site became tender, and sore; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th January 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site inflammation, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site inflammation, injection site warmth and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site inflammation, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and injection site became enlarged, red, and inflamed, hot to the touch, tender, and sore. No flu-like symptoms occurred The reporter stated their HCP was not aware of the reactions. The reporter consented to follow up. Not all information was available.  The reporter gave permission to follow up with HCP.
This case was reported by a healthcare professional and described the occurrence of lifeless in a 2-year-old female subject who was vaccinated with INFANRIX, (GlaxoSmithKline), HIBERIX and PREVNAR.  There were no concurrent medications.  On 25 February 2010 the subject received 4th dose of INFANRIX (.5 ml, unknown, right thigh), 2nd dose of HIBERIX (unknown), 4th dose of PREVNAR (unknown).  On 25 February 2010, 12 hours after vaccination with HIBERIX, INFANRIX and PREVNAR, the subject experienced lifeless, blue hand, blue feet and limp body.  The subject's hands and feet turned blue, she became limp and lifeless 12 hours after receiving vaccinations.  The subject was taken to the emergency room but the events resolved before getting there.  The subject returned to the physician's office for follow-up.  At the time of reporting the lifeless, blue hand, blue feet and limp body were resolved.  The healthcare professional considered the events were possibly related to vaccination with INFANRIX, HIBERIX and PREVNAR.
Swollen, red & hot @ inject site, tx Benadryl, slowly improving.
Left side of face (cheek-area) started tightening (swelling), tingling inside mouth, tingling (swelling) of tongue within 10 minutes of vaccination.  Administered EpiPen and went to ER.  At ER, Benadryl (50 mg), Pepcid and prednisone were administered orally.  Evaluated for 3 hours, vitals good and released from hospital.
Extremely painful and tender swelling and redness at site of shot and beyond down to wrist and across to chest. Pain and swelling lasted for 5 days. This was worse than the reaction the previous year, which was similar but not quite as extensive or long lasting.
rash on my torso; This case was reported by a consumer via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Patient wanted to know that the rash on torso that patient had to the 1st Shingrix shot was considered an allergic reaction. No further information was reported.
patient presented for 2nd booster of Pfizer. CMA administered dose taking patients word for how many doses he had previously received. When she went to chart it after administering it she discovered that he had previous doses on 1/1/21, 2/24/21, 3/17/21, 9/24/21, & 4/1/22. Dr. was notified of this and so was the patient. Patient had no concerns and reported feeling ok
Breakthrough case admission after 3 vaccines Pfizer 3/25/21 lot# ER8727;  Pfizer 4/15/21 lot# EW0162;  Pfizer 12/18/21 lot# FJ8762
Light-headed; Fallen several times; I have missed all work and I don't know if I am going to be able to go because I am upset and not feeling good; I am also drinking over 2 gallon of water a day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Apr2021 (Batch/Lot number: unknown) as dose 1,single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Light-headed"; FALL (non-serious), outcome "unknown", described as "Fallen several times"; MALAISE (non-serious), outcome "unknown", described as "I have missed all work and I don't know if I am going to be able to go because I am upset and not feeling good"; POLYDIPSIA (non-serious), outcome "unknown", described as "I am also drinking over 2 gallon of water a day".  Additional Information: When probed for the concern, consumer stated, "Patient concern is that patient had first Pfizer one (shot) almost 2 weeks ago patient had it on April 22nd on Thursday morning. patient had been Light-headed, patient had collapsed, fallen over several times and this is almost 2 weeks later and still very Light-headed whether standing or sitting like going to fall. Patient also drinking over 2 gallon of water a day never done that. Patient had been to "ER" (not clarified) twice, had been to primary care and neurologist. Patient lab work is good, vitals are good, and they are saying that vaccine (unspecified vaccine) has did some reaction to some people. Patient missed the work all last week, missing work all this week and don't know if going to be able to go back because it's not going away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a male 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.            No concomitant and medication information provided. No treatment information provided
(R) arm erythema 10 x 5 cm, (+) warm, (+) edema. Symptoms started few hours after vaccines were given 2 days ago.
Shortness of breath and chest pain upon exercise but unusal for patient, prescriber aware and following up with care.
Client reports he had numbness and a film coating in his mouth, onset at 1-2 minutes post vaccination.  This lasted total of 3 days then resolved without intervention.  Client also reports fevers at night.  Client denies any shortness of breath, trouble breathing or trouble swallowing.  Client did not follow up with primary care provider.
High fever (103.8) for 3 days, 1 day of diarrhea, no appetite/no desire for liquids, extremely agitated/grumpy (not himself), and onset of red rash on scalp, hairline and upper body after fever broke.  Rash still present.  Lack of appetite still present.  Agitation/grumpiness still present.  Difficulty sleeping.
patient developed an unprovoked (no antecedent ccause) multisegmental Pulmonary embolus.  He developed chest pain, Shortness of breath, and tachycardia on Wednesday 19 May 2021 which continued to worsen until he was hospitalized on May 21 and diagnosed with the PE and possible pneumonia.
Mother called health dep. to report child had high fever, 104 degrees and higher, took child to local ER, states almost had seizure.
Redness, warm, tender, rash occurring on the outer portion of the redness.  Lasted about 10-11 days
six months old patient received a dose of pneumovax23; no adverse effect; This spontaneous report was received from a registered nurse referring to a 6-month-old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.     On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route of administration, lot# and expiry date were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported. No product quality(PQC) complaint was filed.; Sender's Comments:  US-009507513-1909USA002286:
1.  Significant discomfort around the left chest, heart area. Feel null and pain around the armpit, upper left arm and left back area.  The discomfort and pain reached peak a day after the 2nd shot. When writing this report, 48 hours have passed. The discomfort is not completed gone. 2.  Accelerated heart beat rate (90-100 a minute) for 2 nights, with 38.5 deg C fever. 3. Elevated blood pressure (135/95).
Pt received vax and the pt stated she felt nauseated. Stood up sat back down and convulsed x 4 and went limp for 1-2 mins. Slowly became alert and oriented x 3 (approximately 5 min. of disorientation, neg. lasting effects after 1 hour of observation.
A164 to a 75 y/o F c/c near syncope after receiving a Johnson & Johnson COVID vaccine. Pt St she has not had a vaccine since grade school due to having syncope type reactions and fear of needles. History of cardiac arrhythmia, no other medical issues. Upon arrival,  Pt laying on floor with FD vaccination team members attending her. Pt a/ox4, GCS 15, St near syncope 10 minutes after injection. Pt St she is feeling much better now. FD vaccination team members St Pt was very nervous about the injection, became pale and sweaty 10 minutes post injection and had a near syncope. No falls reported today. Pt hemodynamically stable by our arrival with negative postural findings. Pt St she is feeling much better. Pt does not feel the need for TRX and agrees to wait with vaccination team for 30 minutes or until she feels 100%. Pt left in care of vaccination team. Near syncope after COVID vaccination injection Exam, vitals, history, Pt left with vaccination team.
Pt has pictures of hive like rash that appeared Sunday morning 3/1/15 on her left arm, near site of injection and right leg.  States rash spread over her entire leg and most of arm.  Rash was gone by Sunday night.  Rash reappeared the next morning, Monday, on leg and lasted for several hours and this morning, 3/3/15, as well.