chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 13:45 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing); "Known allergies: Statins" (unspecified if ongoing); "Known allergies: Contrast dye" (unspecified if ongoing); "Mild tinnitus (ringing) of 10+ years" (ongoing). The patient took concomitant medications. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". Vaccination history included: moderna (Dose 1, Location of injection: Arm left), administration date: 01Feb2021, for COVID-19 immunization, reaction(s): "A day of body ache", "Arm pain", "Fatigue"; moderna (Dose 2, Location of injection: Arm left, Vaccine administration time: 16:00 pm), administration date: 15Mar2021, for COVID-19 immunization, reaction(s): "A day of body ache", "Arm pain", "Fatigue"; moderna (Dose 3, Location of injection: Arm left, Vaccine administration time: 16:00 pm), administration date: 12Nov2021, for COVID-19 immunization, reaction(s): "A day of body ache", "Arm pain", "Fatigue"; moderna (Dose 4, Location of injection: Arm left, Vaccine administration time: 02:30 am), administration date: 22Apr2022, for COVID-19 immunization, reaction(s): "A day of body ache", "Arm pain", "Fatigue".   Additional information: The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. All previous shots were Moderna. All Moderna shots caused a day of body ache, arm pain, fatigue. The Pfizer shot did too but a day or two after the shot the patient noticed that her usually mild tinnitus (ringing) of 10+ years increased significantly. It was ongoing and very loud- loud enough to distract from all activities incl. TV, working outdoors, conversations, working indoors, reading, and writing this description. It decreased the quality of life. If she had known, she would have found the Moderna somewhere else. She emailed her primary who suggested seeing an audiologist which she declined b/c their remedies were few and were not very effective (counselling, masking devices). She knew educated older people who won't get latest booster b/c of severe tinnitus that appeared immediately following a COVID shot. The case was assessed as non-serious.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Possible defective syrigne Vantage Point 1" ml. Complete vaccine sprayed from tip of syringe and not administered. Patient given complete dose in opposite arm.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. On 23rd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, tremor, shivers, influenza-like symptoms and sickness. On an unknown date, the outcome of the pain in arm, tremor, shivers, influenza-like symptoms and sickness were recovered/resolved. It was unknown if the reporter considered the pain in arm, tremor, shivers, influenza-like symptoms and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at approximately 9:30 AM in the right arm. The patient claimed that his arm killed him for the first week and he experienced pain at the injection site. The patient also reported shivers the first night and shakes which he described like getting the flu or being sick. The patient also reported that he had many friends with similar experiences (refer case US2018GSK176619). The patient had denied permission to contact their physician.
Patient received an second and unnecessary dose of the flu (Fluad) on 10/15/21 -- previous dose was 9/10/21 -- when they were meant to get their Pfizer booster dose (3rd dose). Patient did receive their requested immunization of Pfizer the same day (10/15/21) on the opposite arm.  Upon recognition that the wrong vaccine was administer patient was informed and received the correct vaccination, informed patient that there should be no additional risk of adverse effect to receiving two flu shots in one flu season.
About six or seven hours after the shot I started to feel bad, first some in my chest, then a scratchy throat with swollen glands, then mild body aches.   The next day the sore throat was gone, and body aches got worse. All my joints ache. I felt chilled in spite of outdoor temperature of 79, and a hot bath, blankets and sitting in front of a fire. It was 74 inside the house. I started to get a bit of a headache but it never developed into a full headache. At about 6pm (day 2) I started to get  hot. Anything touching my skin bothered me.   At about 7pm (day 2) I took two Tylenol and the symptoms improved by about  8:30pm.
pt states arm was swollen whole bicep about a 1/4 inch around. It was sl red and warm as well, after swelling went down entire area was bruised. Pt took 2 Benadryl and cortisone cream. Redness and swelling was gone in 3 days.
With the FLUZONE High Dose, patient had a 2 inch red, inflamed circle around the injection site. With the SHINGRIX, patient had a 3 inch red, inflamed circle around the injection site. Started the day after immunization (9/11/18) and patient reported it to us on 9/13. Was told to seek advice from a doctor if it doesn't begin improving.
This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may have been vaccinated with a dose of GARDASIL (strength, dose unit, route, lot# and expiry date unknown). On an unknown date GARDASIL was improperly stored. Registered nurse reported that she was unsure if improperly stored vaccines were administered and no adverse effects reported, but she does not think so. Registered nurse also reported that another nurse at facility handles the issue. The outcome of unsure if improperly stored vaccines; GARDASIL, VAQTA, PEDVAX HIB, were administered and no adverse effects reported was unknown. This is one of several cases from same source. Follow up information was received on 11/MAR/2014. All telephone attempts to obtain follow up information has been unsuccessful. Additional information has been requested.
About 1pm after receiving the vaccine I broke out in hives 2 on my left arm, around 3pm in hives one on my face, about 4pm I got 2 hives on neck. The next day I broke in 2 hives one on each leg. Then I broke out 2 (hives) on wrist. Today 01/26/2021 2 more hives one of wrist and one on the back on my hand. They start out little red circles about the size of a dime, then grow to the size of quarter or dollar.  On 01/21/2021 I went to the ER (Virtual Hospital). They looked at the hives, and told me it was an allergic reaction to the vaccine. They gave me Benadryl. They also gave me the number to VAERS to make a report.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (slight flu symptoms), VACCINATION SITE ERYTHEMA (where I got the shot, there's a red circle), VACCINATION SITE PRURITUS (slightly smaller than a tennis ball), INJECTION SITE NODULE (3 red little bumps) and PRURITUS (itchy) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. Concomitant products included ATORVASTATIN, QUINAPRIL, FENOFIBRATE and NIACIN for an unknown indication. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (slight flu symptoms), VACCINATION SITE ERYTHEMA (where I got the shot, there's a red circle), VACCINATION SITE PRURITUS (slightly smaller than a tennis ball), INJECTION SITE NODULE (3 red little bumps) and PRURITUS (itchy). At the time of the report, INFLUENZA LIKE ILLNESS (slight flu symptoms), VACCINATION SITE ERYTHEMA (where I got the shot, there's a red circle), VACCINATION SITE PRURITUS (slightly smaller than a tennis ball), INJECTION SITE NODULE (3 red little bumps) and PRURITUS (itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. concomitant medication: Metoprolol ER. Treatment information was not provided.
Dose 1:  4/10/21, Dose 2: 5/3/21 hx obtained 6/24/21: per wife: was out of town, came home 6/13. 6/17 went to casino, came back 6/18. ate a bag of sausage. dog bite that Friday. stomach felt weird. 3 days of HA, stomach ache, vomiting started Monday, went to urgent care the 21st - noticed some nystagmus, given tdap, given meclizine. was told if still not better, to ER.  ER yesterday - was told dehydration, got IV fluids, got zofran IV, no imaging, had bloodwork and urine (WBC normal, h/h normal, abn neutrophils/lymphocytes. normal CMP), per wife was told blood in urine. since yesterday, continued HA, nausea, vomited in ER x 1. after zofran no vomiting today was ok, was getting out of car, felt like tripped, then almost fainted. no head trauma, no LOC. heaving. no chest pain, no shortness of breath, has not eaten today. Did take Tylenol today. 325 mg x 1. and ibuprofen 200 mg x 1. 730 am.  since out of town, has been drinking couple drinks per day. marijuana gummies. marijuana from dispensary. no other drugs, no cigarettes. no hx of HA or lightheadedness sometimes when flying gets sinus HA on landing. no fever did have 99F when sleeping/hot, normal since then no blood in stools. primary sx is HA - constant throbbing 10/10 (currently 6/10) b/l frontal HA, nonradiating, better with lying down. +light sensitivity. no sound sensitivity. +nausea, +vomiting, several times per day. 2 episodes in 24 hours. no abdominal pain. has had lower back pain. tolerating PO. has had zofran and Tylenol. 2 days ago also had meclizine x 1.  per pt always had low HR. no other changes to diet/medications. no facial droop, no one-sided weakness no speaking nonsense. several weeks ago "my heart felt like constant adrenaline" thought was stress - felt like something scared you adrenaline, lasted several days, coming on for several minutes at a time. last dose tadalafil was 1 week ago  Pt sent to ER after this visit, but was then discharged home. pt presented to urgent care couple days later and was transferred to hospital after findings below
CHIEF COMPLAINT:   Per EMS, "coming from Health Center. pt was lethargic and febrile 103 F orally. Received 650mg tylenol from facility & additional 160mg tylenol. Lung cancer pt, receiving chemo. Pt is oriented to person, disoriented to place and time."   HISTORY OF PRESENT ILLNESS:     63-year-old male presenting to the emergency room for fever up to 103 orally.  Patient is currently a resident at the Health Center and is currently on chemotherapy for lung cancer.  Denies any chest pain.  Reports difficulty breathing.  Denies any known history of PE or DVT.  Denies any exacerbating or alleviating symptoms
Aches and chills beginning 10-12 hours post dose.  Also some weakness and fatigue.  Persisted for about 24 hours.  Moderately managed with acetaminophen (500 mg Q 6 hrs).  Patient is breastfeeding; her 7 week old baby was somewhat lethargic and had significantly increased frequency and volume of spit up during the same 24 hour window, but did not appear to be uncomfortable.
Patient was given Pfizer Covid 19 0.3mL IM.  It was noticed 1 hr later that the drug had expired (it was in the fridge Beyond Use Date: 11/29/21) Leadership notified.  Pt and her mother were returning, as they forgot to bring their cards and wanted all info on the same card.  She is asymptomatic.  No adverse reaction.  She was offered Pfizer Covid 19 vaccine and she accepted.
Patient is a 69 y.o. male with h/o- HTN, CKD, prostate cancer, who presented from home on 1/31/2023 with fever, generalized weakness, hypoxia, found to have COVID-19 pneumonia with possible superimposed bacterial pneumonia.  Pulmonology was consulted, patient completed course of remdesivir, started on Decadron and will complete 10-day course outpatient.  He was given Rocephin and azithromycin to cover for possible bacterial pneumonia.  He has been weaned to room air.  He will follow-up with PCP for imaging to ensure resolution of pneumonia.   COVID infection Acute hypoxic respiratory failure - Presented with: fever, generalized weakness - Symptom onset: 1/30/23 - Positive COVID-19: RMH ER on 1/31/23 - Vaccination status: vaccinated and boosted with Pfizer - CXR on admission showed left basal infiltrate - Oxygen status: Increasing oxygen, required non-rebreather then weaned to Oxymizer and now on room air - Decadron: Yes, started 2/1, will complete 10 days - Remdesivir: Yes, started 2/2 after seen by Pulm with renal function at baseline, can be stopped on day - Ceftriaxone, Azithro added 2/2 per Pulm for suspected secondary bacterial infection; sputum culture with gram-positive cocci, no growth, they state okay to discontinue 2/6 - DVT prophylaxis: - Serial COVID labs ordered: Yes- CRP is down trending  - supportive care with limited IV hydration, PRN antipyretics, PRN antitussives, IS - PT/OT and mobility encouraged - Pulmonology signed off   Throat pain, laryngitis - FEES by ST performed 2/3 with pharyngeal and laryngeal structures appearing edematous-see separate procedure images - Suspect this is related to acute COVID infection, treatment as above  - Continue supportive care   Essential HTN - BP acceptable; resumed home med Nifedipine - initially held hydralazine given soft blood pressures, now resumed   Hyperlipidemia - stable, resume statin   CKD- Stage 3 - follows with Dr. - Cr stable range, avoid nephrotoxins as able   Prostate cancer in remission BPH - follows with Urology/Dr. - s/p radiation, now on Xtandi - resumed Flomax
Redness swelling pain at injection site starting 4 hrs after injection.  Fever chills neck and head pain unrelieved by OTC Tylenol, Motrin or excedrine.  Fatigue  Lasted until 11am on 4/8/21 with residual fatigue.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 3/7/2023 Discharge Date: Mar 10, 2023 PRESENTING PROBLEM: Hypoxia [R09.02] Acute respiratory failure with hypoxia COVID-19   HOSPITAL COURSE:   Patient is a 73 y.o. male with a past medical history of essential tremor, chronic back pain with implanted morphine pump, non insulin-dependent type 2 diabetes and depression who presents today with cough, dyspnea and anorexia.  Symptoms started on 02/27.  The patient states that it started with a sore throat and cough.     In the ER the patient was noted to be hypoxic on room air with an SpO2 of 87%.  He remained hypoxic on nasal cannula and required non-rebreather with 15 L of oxygen.  He did receive an albuterol inhaler and 6 mg of Decadron.  He was able to be weaned down to 6 L by nasal cannula.  His other vital signs were unremarkable.  Labs significant for hemoglobin 12.7.  Procalcitonin was negative.  Viral PCR positive for COVID-19.  Chest x-ray with new mild left basilar atelectasis or pneumonitis.  CTA thorax showed mucous plugging w consolidation. Pt was started on remdsivir and decadron. 02 req improved and after 48 hrs was on 3L. On the 3rd day he was able to be weaned off 02. Labs and VS stable throughout stay. Did become bradycardic in the 30's, believe it was due to remdesivir and this was discontinued. Stable for discharge on 3/10. Discharged with decadron to finish 10 day course.
(L) deltoid site of injection red, hot, swelling also at site, knot developed at site also.
Several hours after vaccination, vomiting, diarrhea, headache, low grade fever.
Pt recvd vax & exp myalgia & paresthesia; pt seen by MD & no further details were provided;
Dizziness; Weakness; This is a spontaneous report from a contactable consumer. A 83-years-old female patient (mother)  received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced dizziness and weakness on an unspecified date. Caller stated that her mother got her second Vaccine shot a week ago and experienced dizziness and weakness. Caller asked if this is the reported side effect 7 days post vaccination for the second shot of the vaccine. Response: Spoke as per document attached and also stated that they don't  have specific information on the difference of the side effects people have gotten for either the first or second doseThe outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received via a company representative, from a nurse, concerning a patient (age and gender not reported) at another office, who was vaccinated in the arm (date not specified) with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported), and possibly with a dose of influenza virus vaccine (unspecified). Following the vaccinations (duration to onset not specified), the patient developed an elevated temperature, possibly of 103 degrees, and felt arm where the vaccinations were administered "was going to fall off." At the time of this report, it was unknown if the patient recovered.  Additional information is not expected.
Patient came into the pharmacy just before 4 pm on 10/16/2021 to report that they believe that they may be experiencing an adverse reaction to the second dose of the Pfizer vaccine for COVID 19. They stated that they have been experiencing a persistent headache since about a day and a half to 2 days following vaccination. Patient states that nothing seems to make it either better or worse and I informed the patient that headache is a know side effect to the vaccine, but that it typically dissipates within a few days. Patient denies any history of migraines or other headaches, stating if they've ever had one, it was minor and went away within a day or so. Vaccine was administered at 10:47 am on 9/26/2021 in the left deltoid. Advised patient to follow up with provider as it has now been going on for a week and a half to 2 weeks. Patient stated they will follow up with their doctor and gave me verbal permission to include their information including address and phone number to the CDC in my accompanying VAERS report to be filed with this report.
arm pain; headache; muscle pain; nausea; vomiting; fatigue; joint pain; fever of 100ºF; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), HEADACHE (headache), MYALGIA (muscle pain), NAUSEA (nausea) and VOMITING (vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C71A or 038C91A and 007C21A or 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain), HEADACHE (headache), MYALGIA (muscle pain), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), ARTHRALGIA (joint pain) and PYREXIA (fever of 100ºF). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 UNK. At the time of the report, PAIN IN EXTREMITY (arm pain), HEADACHE (headache), MYALGIA (muscle pain), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), ARTHRALGIA (joint pain) and PYREXIA (fever of 100ºF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Body temperature: 100 (Inconclusive) fever of 100ºF.
Fever, chills, and sweats the night of injection for two days. Redness and warmth at injection site the next day and persistent redness and warmth 4 days later.
Shortly p/shot was given pt c/o nausea, dizziness; pt was also very pale; pt took drink of water & layed down; pt reported felt better; pt did not have LOC;
History of presenting illness: PMH significant for hypertension, hyperlipidemia, hypothyroidism, anxiety, depression, COPD, obstructive sleep apnea, and morbid obesity with BMI greater than 40, presents from home with worsening respiratory symptoms. The patient was found to be COVID 19 positive. Family nurse to test positive as well. The patient was fully vaccinated in September. She currently denies any fever, chills, nausea, or vomiting. She does admit to diffuse generalized weakness. She states she is not due really much of anything. She does wear CPAP at home at night, but no oxygen during the day. She is currently requiring some oxygen. ID consultation requested. Patient will be started Remdesivir, steroids,  Anticoagulation medications. She is encouraged to ambulate, and continue to prone when able.her most recent vitals show temperature 99.4 degrees, heart rate 77/m, respirations 18/m, and a blood pressure 112 or 57. SPO2 saturations 94% on nasal cannula. BMI is 46.  Her blood work is within normal limits. Her hepatic function panel is stable. No leukocytosis or anemia. Chest x-ray does show bilateral infiltrates, suggestive of pneumonia. Continue current treatment plan. Seen by infectious disease, started on COVID 19 protocol. She did slowly improve, and was on 4 L nasal cannula. She did have a home O2 evaluation prior to discharge. She will continue her steroids, and supplements for allotted time.  She is encouraged to follow-up with her primary care physician within one week..  All questions and concerns were answered and addressed prior to discharge with patient/family.  Prescriptions were provided.
Pt states she felt fatigue and nausea the day after getting vaccine. 3 wks post vaccine, started feeling neck pain- April 27.
Pain and weakness, fatigue, dizziness, difficulty with coordination and balance. Started in March 2021. Episodes  increased in July 2021.