chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 big blotches; very Itchy; breakout on stomach above waist; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), RASH (breakout on stomach above waist), RASH MACULAR (2 big blotches) and PRURITUS (very Itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.  No Medical History information was reported.  On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), RASH (breakout on stomach above waist), RASH MACULAR (2 big blotches) and PRURITUS (very Itchy). The patient was treated with CORTISONE (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm), RASH (breakout on stomach above waist), RASH MACULAR (2 big blotches) and PRURITUS (very Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment also includes Ice.
The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17.
This spontaneous report was received from a registered nurse via company representative regarding a female patient of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of HPV (manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medications reported. On an unknown date, the patient had genital warts. It was reported that it could not be determinate if the patient developed the warts before or after the HPV vaccine (manufacturer unknown). At the time of the report, the outcome of the genital warts was reported as not recovered. The relatedness between the event and therapy with HPV (manufacturer unknown) was not reported. Additional information has been requested.
THE WHOLE ARM IS BRUISED AND HURTING. PT SAYS SHE CAN'T LIFT HER ARM. HER LEFT ARM IS NOT AS BAD BUT RIGHT ONE IS STILL HURTING.
At 11:50 AM, after receiving vaccination, patient fainted and became incontinent of urine.  Patient kept in office for 30 minute observation and given oral re-hydration solution.
rash on upper right-hand side of back between spine and shoulder blade; redness around rash has a branching effect; rash as bleeding and scabbing over, in a small area, and the redness around rash has a branching effect.; rash as scabbing; not eating much; Severe flu-like symptoms; Lethargy; Chills; feeling off; Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 7th January 2020, the patient experienced influenza-like symptoms, lethargy, chills, feeling abnormal and decreased appetite. On 18th January 2020, the patient experienced rash, red rash, rash hemorrhagic and scab. On 8th January 2020, the outcome of the lethargy and chills were recovered/resolved. On 9th January 2020, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the pain in arm, feeling abnormal, rash hemorrhagic, scab and decreased appetite were recovered/resolved and the outcome of the rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, lethargy, chills, feeling abnormal, rash, red rash, rash hemorrhagic, scab and decreased appetite to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in upper left arm and had pain in vaccinated arm. The patient had severe flu-like symptoms described as severe lethargy, chills, and feeling off. The caller reported eventually staying in bed remainder of that day to be underneath covers and stay warm. Caller describes flu-like symptoms escalating and not eating much, and then going to bed early. The caller reported still feeling off but flu-like symptoms clearly diminishing and getting better.  The patient reported an additional 12 hours later still not quite feeling right but symptoms almost gone.  Symptoms reportedly lasted 48 hours to 2.5 days. Approximately 4-5 days ago, the caller noticing a rash on upper right-hand side of back between spine and shoulder blade.  The patient had no past dermatology history and no major history of health issues.  The caller describes rash as bleeding and scabbing over, in a small area, and the redness around rash has a branching effect.  The caller has pictures and suspects rash was a mild or healed version of shingles based upon shingles pictures observed online.  The reporter consented to follow up.
pt recv vax & 6-7hr later went to ER c/o n,dysphagia, h/a, shoulder neck pain;rash @ neck red pap, h/a & shoulder & leg pain;c/o blurry vision;warm & sl sweaty;speech slow in articulation but coherent;mouth dry, acute allerg rxn, myalgia
Information has been received from a registered nurse referring to two patients of unknown age and gender. On 09-NOV-2015, RECOMBIVAX HB was stored under 32 F for 39.5 hours. Then on 03-DEC-2015 the patients were vaccinated with the improperly stored dose of RECOMBIVAX HB (lot # L018501, expiration date 22-JUN-2017, dose and route unknown). No adverse effects were reported. There was no previous temperature excursions and it was not called because of a "data logger". This is one of several reports received from the same source. Additional information has been requested.
Strokes in the medulla and cerebellum. Hemoglobin struggles to stay above 7. Multiple blood transfusions. He's developed anemia with high levels of ferritin, persistent fever, with no sign of inflammation or infectious disease. He also has complete muscle atrophy. He's had multiple scans, blood tests, surgeries, and biopsies. 3 months, 2 hospitals, and multiple physician and specialist intervention with no determinization of diagnosable cause of symptoms.
Shoulder pain; Neck pain; Pulled a muscle; Blisters appeared on the arm; Shingles; Some residual pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266; Expiration date was not reported) on the upper right arm on 13Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included acid reflux, anxiety, insomnia, and was stressed out. Concomitant medications included pantoprazole for acid reflux; and hydroxyzine HCl for insomnia and anxiety. On 21Feb2021, the patient had shoulder pain; neck pain; had pulled a muscle; blisters appeared on the arm; had shingles; and some residual pain. The patient had received prednisone and valacyclovir as treatment for shingles. The outcome of the evens was recovering for blisters; was recovered on an unspecified date in 2021 for shingles; and was unknown for all the other events. The patient wanted to make sure if it would be safe to receive the second dose of vaccination.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was not information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 06-JUN-2016, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # M004885 with expiration date 23-OCT-2017 or lot # reported as M014544 with expiration date 27-NOV-2017 (dose was not reported), as part of immunization series. There was no adverse effect reported. Administered doses of vaccine were stored in a freezer and experienced the temperature excursion of 34.1 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax; devel hives on face, swelling eyes; spread all over the body
02/05/19 pm swelling at the site, blotchy, warm / painful to touch-- advised ibuprofen and cool compress and see am if no better. 02/07/2019  seen by Dr; Left arm swollen red / tender. Diagnosed as local allergic rx to influenza vaccine. Prescribed benadryl, Ibuprofen, ice pack compress. 2/08/2019 f/u phone call; Doing better / improving with medical treatment of above per mother.
At first just very tired then headache, vomitting, 102 temp, chills, entire spine very painful especially sacrum with pain radiating down both legs, burning at injection site but arm isn't sore, rash (small red dots over entire body), tips of toes and fingers bright red,  This was yesterday and last night. Much better today with slight headache and rash. Headache and spine pain was very painful. Vomitted bile all night. I'd drink water and few minutes later get sick. Looked like antifreeze or bright Gatorade. I was too sick to call anyone. My friend came by and gave me a bucket and water. I dint have energy to get up much less go anywhere.
9/18/18, approximately 4:45 PM: vaccine administered; approximately 11 PM: pulsing headache, throat tightening, difficulty breathing. Patient reports not taking any medication for the issues, nor seeking medical attention. He went to bed, slept soundly, and woke up about 10 AM on 9/19/18. He came to pharmacy where vaccination given at 2:30 PM on 9/19/18 reporting these issues. Patient's head felt better, but his throat still felt "funny," like it was slightly closing in. Patient drove self to pharmacy and felt well enough to drive back home, so didn't want any treatment in store. He was given diphenhydramine and instructed to take 50 mg upon arriving home and repeat in 4 hours. He was instructed to go to the emergency room if he had difficulty breathing again. At about 4:20 PM, pharmacist called patient's grandparents' home (where patient was staying at the time) to check on patient; patient's grandfather reported patient said he felt fine and had been napping.
8 days p/vax pt had fever of 102, sl tremors, 2 days later (10th day) had rash on torso, then face & limbs;given APAP & calamine lotion;rash gone 3 days later
Stem red, slightly smaller than a tennis ball swollen area. Raised ?bump? at injection site. Slightly improved after 10/29 injection date, on 11/1. Very itchy, warm to touch area. Achy joints.
Pt was administered Moderna Covid-19 3rd dose on 10.22.21. Vial had an expiration date of 10.21.21, which was extended by Moderna to expire on 12.21.21 on 10.22.21 (via e-mail from management). This morning new guidance was received stating only vials that were frozen are to be used with new expiration date. The vial used for patient was previously thawed-out.
VACCINE WAS GIVEN ON MY RIGHT ARM WHICH AFTER VACCINE WAS ADMINISTERED I FELT A SORE ARM AND TO THIS DAY I STILL FEEL SORENESS ESPECIALLY IN THE MORNING WHEN I WAKE UP
Information has been received from a registered nurse concerning a patient "over the age of 65 years" who was vaccinated on 09-FEB-2006 with pneumococcal 23v Polysaccharide vaccine (.25 cc), intradermally. "Within 8 hours post vaccination", the patient had local site reaction of swelling. It was noted that most clients injection site was left arm. At the time of the report the patient had not recovered. Additional information has been requested.
Severe headache and development of idiopathic intracranial hypertension. Progressive and worse after 2nd dose. Underwent lumbar puncture and optic nerve fenestration. Permanent peripheral vision loss in right eye. We were assured there was no link to COVID vaccine. Had the booster (3rd dose) and symptoms returned, underwent lumbar puncture one week post 3rd /booster.  Continues with IIH and unknown course of action at this point.
About three days after my second does, my heart was pounding, beating rapidly and was fluttering. This happened mostly at night when I was trying to go to bed. It lasted for about three weeks. It was very scary, but I did not report it at the time.
She developed a rash starting at the injection sites and spreading down her arms, to her face, to her legs, and eventually to her back over the course of 3 days.  The rash was hot to the touch and blotchy red.  While it didn't cause a fever, we did notice some lethargy.
1400 - hives on left arm, back, and upper thorax, pruritus. Hives and pruritus persisted until Sunday morning 13Jan19.
Raised red itchy rash on left palm of hand, evaluated by pharmacy, diagnosed as Shingles onset same day as Covid-19 vaccine obtained.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Vomiting-Severe, Systemic: Nausea-Medium
Localized redness and swelling 5 x 5 cm on 10/04/12.
Initially experienced dizziness and nausea 5 minutes after the shot that dissipated after the 15 minute wait time concluded.  Approximately 10 hours after injection I began to have cold chills, fever,  stomach pains with nausea, diarrhea, severe body aches particularly in the spine, and pain at the injection site. I was unable to keep food down and progressing to a horrible migraine. Severe symptoms lasted approximately 24 hours and then began to slowly  dissipate. The symptoms I experienced were similar to a very severe flu with a stomach virus.
Severe hives on back, thigh, butt, face/legs, feet/hands and arms swollen red. Also had some trouble breathing.
approx 1030AM wheezing-dyspnea-sl cyanosis upon returning to clinic-MD gave DPH;
Fever, body aches, chills, severe headache, arm pain, shortness or breath, weak symptoms lasted 4 days
Patient presented to the ED and was subsequently hospitalized for atrial fibrillation with RVR within 6 weeks of receiving COVID vaccination.
This case was reported by a healthcare professional and described the occurrence of pain in a female subject of unspecified age who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). On an unspecified date more than 10 years prior to the report, the subject received 1st dose of Hepatitis B vaccine (details unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced aches (pain) and feeling unwell. On an unspecified date more than 10 years prior to report, the subject received 2nd dose of Hepatitis B vaccine (details unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced fever, "severe" myalgia and headache. Hepatitis B vaccine course was discontinued. At the time of reporting the outcomes of the events were unspecified. The healthcare professional reported that the subject was alive and 33 years old at the time of the report. She had no further information as the vaccine was administered by a different facility.
Myalgia, Fever & Diarrhea Narrative: WOULD HAVE MISSED WORK WITH THESE SYMPTOMS, HAPPENED OVER THE WEEKEND WHEN HE WAS OFF
called ofc p/hrs;had one episode in which became pale following vax;no resp distress, no rash, no fever;
weakness; tiredness; This is a spontaneous report received from a contactable consumer.  A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 77 years as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 23Mar2021, outcome "unknown", described as "weakness"; FATIGUE (non-serious) with onset 23Mar2021, outcome "unknown", described as "tiredness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I began feeling lightheaded about 5 minutes after receiving the injection. The feeling continued to get stronger and I began sweating and feeling nauseous. I felt like I was going to throw up and/ or pass out. I was about to go get someone and let them know, but then it started easing back off again. It came and went all within about five minutes. I hung around the site a little longer than instructed to be safe, but felt fine and left. Two hours later, I've had no other symptoms besides soreness in my arm and a slight headache.
Patient discovered unresponsive in cell, blue coloration to skin, vital signs, undetectable.  CPR initiated, Ambulance summoned.  Following EMS arrival with additional unsuccessful attempts to revive patient, patient was determined to have expired.
Medical Complaint: Employee. I got my 2nd COVID vaccine on 01/29/2021. Feeling warm, low grade fever, congestion, runny nose, cough-clearing my throat. Had chills, not over 100.0 for my fever. What should I do? Got tested for COVID on 01/08/2021
Had shortness of breath and accelerated heart 60 minutes after vaccine.  The about two hrs later numbness on left side of face, neck shoulder, arm, hand, hip, leg and foot, which got worse as the day wore on.  Excruciating pain in left leg and arm  for two days, and numbness in left side for two day but numbness in left side of face is still present.  Numbness around the left eye is also present and my eye is cloudy and have trouble focusing on reading material and I've not had this problem before the vaccine.
Initial report received on 10 February 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 12-month-old male subject (initials not collected) was identified by the investigator based on review of data from a State Electronic Disease Surveillance System database. The subject had previously received 3 doses of PENTACEL; administered on 08 February 2011, 08 April 2011 and 06 June 2011 (lot number, route and site of administration not reported). The subject developed cold-like symptoms on 01 January 2012, approximately 7 months after the last dose. On 08 January 2012, the subject developed a cough with whoop and posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 11 January 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 11 January 2012. The subject was not hospitalized. At the time of final contact on 23 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Prevnar (PCV-13) Injection given IM Right anterior Lateral Thigh. A reddened raised nodule appeared opposite to and inferior to the injection site. Warm to the touch. No fever noted. Otherwise doing fine per parents.
Within 3 minutes of injection, my pulse became tachycardia, my throat and tongue started to swell. I started to cough. It never progressed beyond that. I felt well enough to leave after the 15 min observation period. When I got home, I took 25mg Benadryl.
Initial unsolicited report received from a pharmacist via other company (Pfizer) on 05 Oct 2016. This case involves a female patient age unknown who was vaccinated with a dose of TETANUS/DIPTHERIA (batch number, expiry date of the product, dose, route and site of administration was not reported) on an unknown date (about 15 years ago). The patient's medical history and concomitant medications were not reported. On an unknown date and unspecified duration following the vaccination (about 15 years ago), the patient experienced swelling of the arm. The patient's lab tests and corrective treatment were not reported. The outcome of the event were unknown. List of documents held by sender: none.
Purplish blue to black odd spot on the middle 3 toes of the left foot; This spontaneous case was reported by a consumer and describes the occurrence of BLUE TOE SYNDROME (Purplish blue to black odd spot on the middle 3 toes of the left foot) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concomitant products included HCTZ, CLONAZEPAM, ELETRIPTAN, MECLIZINE HCL, ONDANSETRON (ZOFRAN [ONDANSETRON]), LISINOPRIL, PANTOPRAZOLE, SIMVASTATIN and ZOLPIDEM TARTRATE (ZOPIDEM) for an unknown indication, BUPROPION.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced BLUE TOE SYNDROME (Purplish blue to black odd spot on the middle 3 toes of the left foot). At the time of the report, BLUE TOE SYNDROME (Purplish blue to black odd spot on the middle 3 toes of the left foot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by the reporter.
Still a little nausea, very fatigue and foggy, body pain periodically and very cold chills periodically throughout the day. Overall feeling - of consisted unwell feeling all day since the shot. I simply push myself everyday to get out of bed as I have to work. 5 hours after shot ? I felt like all my bones were broken ? severe pain ? Cold chills so bad I was shaking ? Fever ? Nausea ? Migraine ? sensitive to lights ? Could not walk (barely can take 2 steps) ? Severely weak ? Chest tightness and heart racing ? Simply felt I was going to die ? of course I didn?t but it was the worse feeling in life worst than flu symptoms
NO ADVERSE EFFECT THIRD DOSE OF MONOVALENT MODERNA DOSE GIVEN INSTEAD OF BIVALENT BOOSTER
The patient developed cellulitis around the inject site. The patient was referred to her pcp or an urgent care to receive an antibiotic. The symptoms started appearing 12-24 hours post injection and continued to progress.
h/a, vomiting, neck pain, lightheadedness, dx as aseptic meningitis;
Day 1:  mild diarrhea; headache;muscle ache; mild fever Day 2:  headache;muscle ache; mild fever Day 3: symptoms disappeared
In January I started having some leg pain, I went to my primary care physician who said that it may be venous insufficient, and he would keep an eye on it. They pain kept getting worse, so I took it upon myself to make an appointment with a vein specialist in April. He did a general exam and had me start wearing compression stockings. I will be going back to see him on June 27 to have an ultrasound done on my legs to see if they can find what is causing the pain.