chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Breakthrough Case  Moderna Dose 1 2/1/21 (031M20A) Moderna Dose 2 3/11/21 (040A21A) COVID Positive 7/31/21  8/7/21: The patient is a 73-year-old female who presents to the emergency department today with worsening shortness of breath and hypoxia at home and tested positive for COVID-19 on 08/01.  The patient has a past medical history significant for relapsing polychondritis and ulcerative colitis on immunosuppression, hypertension, diverticulosis, history of colon polyps, depression, Barrett's esophagus, and osteoporosis.  Of note, patient received her COVID-19 vaccinations in February and March.   On arrival to the ED, the patient's temperature is 99.9° F, heart rate 96, respiratory rate 25, saturating 76% on room air requiring supplemental oxygen at 6 liters/minute to maintain saturations greater than 90% with blood pressure 133/71.  The patient's laboratory studies were significant for Na 133, K 3.2, Cl 94, CO2 30, calculated osmolality 268, AST 44, phosphorus 2.2, CRP 18.7, ESR 75, WBC 10.68 with a neutrophil count of 9.54 and lymphocyte count 0.32.  Blood cultures were obtained x2.  CT chest negative for PE shows ground-glass airspace disease involving all 5 lobes with lungs consistent with viral pneumonitis.  EKG showed normal sinus rhythm, heart rate 77, QTC 473 with left axis deviation and prolonged QTC. The patient was administered 1 L IV NS in the emergency department.   The patient was seen in the emergency department laying in bed on 3 L supplemental O2 via nasal cannula.  She reports that she was tested on 08/01 because she had been exposed since she had been around family members who had tested positive including her great grandson and granddaughter, as well as her husband.  She reports she started feeling short of breath 2 days ago and today at home she was hypoxic with her saturations reading 79% on room air.  She complains of a severe cough, fatigue, sweats and chills, loss of taste and smell and some fevers.  8/26/21: Patient is a 73-year-old female with history of ulcerative colitis on azathioprine, sulfasalazine, and prednisone 5 mg, presented to the emergency depart with the shortness or breath admitted for acute hypoxic respiratory failure secondary to COVID 19 pneumonia, was also treated with Zithromax and Rocephin cover for bacterial component. Patient received remdesivir, Decadron and was switched to Solu-Medrol, she required intubation and was successfully extubated in August 25th, had NG tube for feeding and failed swallow evaluation.  Was evaluated by select and found appropriate for admission.  Will be transferred to select in fair condition.
This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a male patient who received SHINGRIX (batch number LT533, expiry date 10th November 2018) for prophylaxis. This case was associated with a product complaint. On 12th July 2018, the patient received the 1st dose of SHINGRIX. On 12th July 2018, immediately after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and allergic reaction. On an unknown date, the patient experienced wound oozing, laceration of arm, injected limb mobility decreased, activities of daily living impaired, pain in arm and pharmaceutical product complaint. On an unknown date, the outcome of the extensive swelling of vaccinated limb, wound oozing, laceration of arm, pain in arm and pharmaceutical product complaint were unknown and the outcome of the injected limb mobility decreased, activities of daily living impaired and allergic reaction were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, wound oozing, laceration of arm, injected limb mobility decreased, activities of daily living impaired, allergic reaction and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received SHINGRIX in the left arm. Shortly after receiving SHINGRIX, the patient's left arm was doubled in size from shoulder to fingertips. The patient could not bend his arm and still could not bend it completely. He still could not put his wedding ring, watch or wear certain shirts because the sleeves were too tight. They have contacted the pharmacist who have administered the vaccine. The patient was seen by family physician and both have informed that the patient was having severe allergic reaction to vaccination and they could do nothing. Recently the patient's swollen arm split open about 3 inches and starting to ooze fluid. His arm was drained constantly for days and he has to continually blot the drainage. This drainage caused him embarrassment and kept him at home and curtailed his activities. The reporter asked that whether there were any reports of this severe reaction to the vaccination and how this arm could be restored so that the patient may resume his normal activities. The reporter asked for any remedy or medical advice. It was frustrating and worrisome as we wait for relief. The reporter requested to investigate production facility of lot number LT533 for contamination and to study the enclosed photos that substantiate which severe reaction. They had spent money for the vaccination and could not anticipate the future costs before the arm would be at normal size. They hope GlaxoSmithKline would give serious consideration to their concern. They requested for monetary consideration for patient's medical expenses, pain and suffering once his arm returns to normal. At the time of reporting time they were only giving notice of this severe allergic reaction and were looking for assistance in the patient's arm to be normal.
patient experiencing pain in shoulder - hurts when Lifting - hurts when sleep on it. pain when lifting she was going to follow up with us in January 2020.
Vaccine expired on 10/28/2022, administered past expiration date on 11/03/2022.
Client received Flu vac. at 2:30 PM 8/31/12. On 9/1/12 she noticed a 3 inch area below the bandaid was red and warm. On 9/2/12 she called b/c area was still red. No treatment offered. Told to watch area.
RN administered COVID vaccine dose of 0.5mL instead of 0.3mL. No adverse reactions were reported.
Information has been received from a published literature article. Vaccination with attenuated varicella zoster virus (VZV) could lead to infectious complications in immunodeficient patients. It was reported two immunocompromised patients who developed initial or reactivated vaccine strain varicella, leading to unique vesicular rashes involving the vaccinated limbs, without becoming wide-spread or remaining limited to a single dermatome. Case 1 - A 5 year old female presented with fever, jaundice, epistaxis and petechiae which began 2 weeks after receiving a second VARIVAX vaccination. Diagnostic testing revealed pancytopenia and hepatitis with a peak ALT of 1712 unit/L. A liver biopsy showed diffuse portal and lobular hepatocellular inflammation with prominent lymphohistiocytic infiltrate. A bone marrow aspirate and biopsy revealed hypocellularity and hemophagocytosis. She soon developed vesicles on her right arm and shoulder in a non-dermatomal pattern. The lesions remained localized to the entire right upper extremity, which was the site of the earlier VARIVAX vaccination. A vesicle was unroofed and the fluid tested positive for VZV by PCR. Further analysis revealed the virus to be vaccine strain varicella. She was hospitalized and treated with intravenous acyclovir and the lesions crusted over 21 days from presentation. Outcome of events were unknown. These two cases highlighted unusual presentations of vaccine strain varicella in immunocompromised patients. Vaccine strain varicella could cause a vesicular rash in a non-classical distribution. It was also notable that vaccine strain virus can trigger hemophagocytic lymphohistiocytosis in immune deficient patients. This is one of two reported received from the same literature. Additional information has been requested.
Reported on 11-15-10 by employee. Reported arm swelling, site redness, and pain in area surrounding vaccine. Onset 24 hrs post vac. lasted 48 hours.
Receive doses number one and number two of Maderna with zero issues. Received my booster December 1, 2021 and right at one month started having rashes/hives/itches all over my body. From head to toe. My daughter experienced the same thing at one month after her booster. Went to doctor and they told me to take Zyrtec one pill a day and take Benadryl one pill at night. I am still doing that. Stopped taking Zyrtec four days ago to see if I would begin itching again and I did. Started back up on Zyrtec yesterday . Itching has subsided. The rashes would occur not at the same spot but just everywhere different.. I have photos.
Left cheek and jaw swole within 1 hour of vacc. Hot and hard to touch. Swelling responded to massage and dissipated within 18 hours. Sore jaw for about 24 hours.
Pt. received Enegix-B Hepatitis B vaccination #1 on 01/09/04.  When asked if he had any problem with initial vaccination on return visit on 02/23/2004 pt. stated he had nausea, dizziness, and slight SOB several hours after receiving vaccine.  Also pt. states he broke out in a "bumpy rash" on face only, 1-2 days after starting doxycline; did not seek treatment; dis not contact.
22SEP fever, ST;2OCT lesions 100, face & trunk;3OCT covered w/chickenpox everywhere, n/v, severe h/a;
sore arm; couldn't really move it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "couldn't really move it".  Additional information: Reporter stated that last Thursday 29 APR 2021 she got her first dose of Pfizer COVID-19 vaccine and she had a really really sore arm for two days after the vaccine, she says its okay now, she couldn't really move it, but she is very active busy person. She stated that Saturday night she could feel something was changing in her body. She states that her husband called 911 and she went into the hospital. She states that her blood pressure was through the roof.  She ran into her son-in-laws chiropractor and he stated that he had a similar reaction to the caller but didn't have a reaction until Saturday either. She stated that the got his vaccine the same date as she did and he had the same symptoms except for the blood pressure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
felt like her heart was pounding out of her chest/High heart rate; tenderness underarm; redness at the injections site; had intense pain in head, body/ body aches, aches from the shot/felt like somebody beat her up; severe headache/m intense pain in head and body; 102.6 fever; chills; some nausea; a lot of swelling; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (felt like her heart was pounding out of her chest/High heart rate), TENDERNESS (tenderness underarm), VACCINATION SITE ERYTHEMA (redness at the injections site), MYALGIA (had intense pain in head, body/ body aches, aches from the shot/felt like somebody beat her up) and HEADACHE (severe headache/m intense pain in head and body) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020. Concomitant products included LISINOPRIL and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEART RATE INCREASED (felt like her heart was pounding out of her chest/High heart rate), TENDERNESS (tenderness underarm), VACCINATION SITE ERYTHEMA (redness at the injections site), MYALGIA (had intense pain in head, body/ body aches, aches from the shot/felt like somebody beat her up), HEADACHE (severe headache/m intense pain in head and body), PYREXIA (102.6 fever), CHILLS (chills), NAUSEA (some nausea) and VACCINATION SITE SWELLING (a lot of swelling). At the time of the report, HEART RATE INCREASED (felt like her heart was pounding out of her chest/High heart rate), TENDERNESS (tenderness underarm), VACCINATION SITE ERYTHEMA (redness at the injections site), MYALGIA (had intense pain in head, body/ body aches, aches from the shot/felt like somebody beat her up), HEADACHE (severe headache/m intense pain in head and body), PYREXIA (102.6 fever), CHILLS (chills), NAUSEA (some nausea) and VACCINATION SITE SWELLING (a lot of swelling) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: NNI (non-significant follow up is added)
A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a patient concerning a 37-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Patient presented with nausea, mild flushing, some palor and light sweating at approximately 12:30 pm. Zofran was administered. Patient with nausea, patient presents with mild flushing, some palor and light sweating at 12:30 pm. Sublingual zofran was administered. BP 117/55, HR 102, O2 99%, RR 18.
I had fever, aches, extremely sore arm, hives under the left arm, tingling in the left arm and still occurring.
Patient has red area that is warm to touch extending around vaccination area and halfway down upper arm mostly to outer area but some extension to inner arm.
Upper arm swollen, itchy, recent vaccine on 07/14/2005.  Appoint in office on 07/16/2005.  Stated went to ER during the night, was given Prednisolone and Benadryl.
Vomiting, migraine increase, dizziness, nausea, unsteadiness, ?brain fog?.
Had "cold" approx 1 1/2 wks prior to immunizations. No fever. 3-6 hr after vaccines had chest tightness and "ache in lungs". Used inhalers, some relief. Sx continued with lessening affects to 10/24/13. Did not seek medical attention.
Information has been received from a pharmacist concerning a 40 year old female, with sleep apnea, hypertension, obesity and no allergies, and a history of migraine headaches, and a skull fracture on her left side twenty years earlier when she fell of a horse, who, on 14-DEC-2006, was vaccinated with a first intramuscular dose in the arm of MMR II (Lot# 654685/0987F). On 21-DEC-2006 the patient had a headache and numbness on her left side. The patient was seen in the emergency room on 22-DEC-2006 and was sent home. The patient had a plain computed axial tomography of her head on 22-DEC-2006, which was negative. The patient was back in the emergency room on 23-DEC-2006 with an increased headache and no problem swallowing. On the evening of 23-DEC-2006 the patient had numbness in both legs which was progressing to her face and mouth. The patient was then admitted to the hospital on 23-DEC-2006 with headache and diarrhea, plus numbness in her legs that was worsening. On 24-DEC-2006 the patient had a computed axial tomography scan of her head without and with contrast which was negative with no definite enhancing vascular mass or definite aneurysm. The patient was transferred to the intensive care unit on the third day of her stay. On 27-DEC-2006 the patient had an electromyography nerve conduction study done which showed evidence of generalized predominately motor demyelinating secondary axonal neuropathy. The patient was treated with intravenous immune globulin daily, for five days, followed by plasmapheresis for four days. The patient was then treated with plasmapheresis again for three days. The patient was started on physical therapy due to swallowing and speech difficulty. The patient never required ventilator assistance. A diagnosis of Guillain-Barre syndrome was made early in the patient's hospital stay. The patient was discharged from acute care on 12-JAN-2007. As of 24-JAN-2007 the patient remained in the hospital on a unit with a lower level of care for physical and speech therapy. The patient was able to move her arms and legs. She still had weakness in her legs, and was mostly in a wheelchair. Her facial muscles remained weak, however she had regained her swallowing ability. At the time of the report the patient had not recovered and her date of recovery was pending. No product quality complaint was involved. No other information was provided. The patient's Guillain-Barre syndrome was considered to be disabling by the reporter. Additional information has been requested.
CLAIMANT ALLEGES THAT AFTER A FLU SHOT WAS ADMINISTERED AT THE PHARMACY THAT HE WAS NOT FEELING WELL. THE CLAIMANT LOST HIS URINE. EMS WAS CALLED AND HE WAS EVALUATED ON SCENE. CLAIMANT REFUSED TO BE TRANSFERRED.
Fever; My body is aching so bad; I can't walk; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 second dose on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was having reaction to the vaccine, patient had fever, body was aching so bad, can't walk, going to the bathroom is so painful. Patient feel like need to go to the emergency room or don't know. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Vaccinator educated pt's parents to properly hold pt, but the pt was very strong. Pt was thrashing around and when the nurse inserted the needle, the pt jerked away and no vaccine content given. Consulted with vaccine team. Dose wasted and  continued with a different dose following parents permission. administered fully without issues.
Tingling; Numbness; A spontaneous report was received from a 47-year-old female patient who is a nurse and received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, tingling and numbness.  The patient's medical history was not provided. Concomitant medications were not reported.  On 23 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number:039K20-2A) in her left deltoid muscle for prophylaxis of COVID-19 infection. She experienced tingling and numbness on left side of her face 30 minutes after the injection and was still experiencing the event at the time of reporting.  Treatment for the events was not reported.  Action taken with mRNA-1273 vaccine in response to the events was not provided.  The events, tingling and numbness, were considered not resolved.; Reporter's Comments: This case concerns a 47-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 039K20-2A), and who experienced the unlisted events of tingling and numbness.  The events were considered possibly related to the vaccine due to the temporal relationship.
Patient came from nursing home.  She was diagnosed with COVID-19 couple of weeks ago.  She has been on 2 L oxygen since the onset of COVID-19.  Has cough but has a weak cough and not able to bring up any sputum.  Has low-grade fever today morning. Received antibiotics. Not able to take p.o. well and patient not much improved so it was decided that patient would go on to hospice Is also noted that she had collapse the lower lobe of left lung
blisters on back, arms and legs; rash; This case was reported by a nurse via call center representative and described the occurrence of blister in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number 24DP5, expiry date 8th April 2022) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix. In September 2020, 1 week after receiving Shingrix, the patient experienced blister and rash. On an unknown date, the outcome of the blister and rash were not recovered/not resolved.   It was unknown if the reporter considered the blister and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and experienced rash and blisters. The patient experienced rash and blisters on back ,arms and legs. The patient reported they would come and go. The patent was not recovered. The reporter consented to follow up. No further information was available.
Palpitations Palpitations on/off since the; headaches, chills and  muscle ache Narrative:
Red-mild induration right upper arm. 10 x 14cm, no pain on palpation. Children's Motrin and cool compresses as needed.
Pt states 10 days following vaccination, he developed gas and constipation and lack of appetite.  Denied any fever, chills, diarrhea, vomiting, skin rash.  Wife had a little gas, but not to degree of pt.  He had one prior vaccine in 1965 denied any problems with same vaccine.
Approximately 7 min after giving MENVEO, GARDASIL and TDaP, mom informed RN that patient was sweaty, dizzy and felt weak. Patient was extremely diaphoretic, pale and listless. Taken to lie down with feet elevation 3 sets of VS were taken in 10 min intervals sips of H2O given. Pt went to sitting, standing answering appropriately instructed to drink fluids and not to go to soccer at 3PM. 2:11 84/, 216 90/60, 227 94/60, 240 90/64 P74, RN
Pt recvd vax 26SEP89 & on 27NOV89 pt anti-HBs was pos; however, on 4FEB93 anti-HBs was neg; No further details were provided;
I received my vaccine on 08-04-2021 and experienced terrible, bad headaches. For five days I could not get up from bed. I also vomited on the day of the vaccine. I went to see my PCP but he was not taking any appointments. I then started to take Tylenol for pain. When I take the Tylenol medication my pain goes down a bit but I have to be taking the Tylenol every 4-6 hours. I can not lie flat on my bed, and my head pain is located at the back of my head and base of neck region. I also apply Vicks vapor rub for the pain. My left arm is hurting and I also have numbness sensation that radiates to my hand. I had lab work done, and all my results were normal. An MRI of the brain was performed yesterday and I was put an IV intravenously. My doctor called me and told me for me to continue taking the two mediations for my migraine headaches, which are Amitriptyline and Topiramate. I also have the sensation to vomit but I can not vomit. I have nausea that does not go away. I will see my doctor on 09-09-2021 for my MRI results.
Dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.