chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back pain / Shots of pain in back; Cold chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain / Shots of pain in back) and CHILLS (Cold chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain / Shots of pain in back) and CHILLS (Cold chills). At the time of the report, BACK PAIN (Back pain / Shots of pain in back) and CHILLS (Cold chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Strong pain in the eye from the front to the posterior part of the head.  Blurry vision, very strong pain.  Went to various specialists fo the eye and an MRI was done.  She was hospitalized for a great inflammation of the optic nerve.
Patient's mother snuck patient into pediatric line after being told that this patient did not qualify for the Pfizer 5-11  dose, and needed to received the Pfizer 12+. Dose was given by RN.
Patient called in to public health department to report potential adverse event from vaccine. After Dose 1 reports on Day 13 post vaccination developed rash on arm and headaches/head congestion that lasted x1 week. Self medicated with otc antihistamine. Symptoms resolved. After Dose 2, 12 hours post vaccination, developed again a rash on arm lasting 1 week and had 24 hours of fatigue, weakness, malaise, That resolved, but now today (Day 11 post vaccination) has pain in lower back, cramping in abdomen, aching in legs, generalized weakness. Is afebrile. Is contemplating seeking medical care -- encouraged to do so if continuation of symptoms. At this point she has not sought medical care and has not missed any days of work.
suffering from recurrent zoster reactivation / suspected vaccination failure / breakthrough shingles episodes; developed Rheumatoid arthritis since vaccination; suffering from recurrent zoster reactivation / breakthrough shingles episodes; It has been a living torment; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix and an unknown time after starting famciclovir, the patient experienced vaccination failure (serious criteria GSK medically significant), rheumatoid arthritis (serious criteria GSK medically significant), herpes zoster and feeling bad. The patient was treated with famciclovir. On an unknown date, the outcome of the vaccination failure, rheumatoid arthritis, herpes zoster and feeling bad were unknown.   It was unknown if the reporter considered the vaccination failure, rheumatoid arthritis, herpes zoster and feeling bad to be related to Shingrix.  Additional details were provided as follows: The reporter was a family physician, reported via a webform. The patient (reporter's wife) was a retired nurse. The age at vaccination was not reported. The patient received Shingrix vaccine over 2 years ago and since suffering from recurrent zoster reactivation. The reporter stated that he was not interested in a lawsuit. The reporter was just hoping there was a scientist there that could potentially stop what was happening. The reporter wanted to know that had the adjuvant caused an inflammatory response that had led to this and was there some sort of treatment to reverse this. The patient had also developed rheumatoid arthritis since vaccination. The reporter stated that it had been a living torment. The patient seen specialists and was on high doses of famciclovir on an ongoing basis just to keep it at bay, with breakthrough shingles episodes despite medication. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. This case had been linked with US2020249598, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020249598:same reporter (husband case)
Beginning of Major joint pain, loss of muscle strength, inability to ambulate comfortably, pain. This increased over the next week. I was seeing a physical therapist for my knee and she saw me over the course of the next two weeks and became very alarmed at my increasing debilitation. I went to my physician on June 2 and had labs drawn- CRP and ESR very elevated. Diagnosed with polymyalgia rheumatica. Placed on steroids which I remain on- as yet unable to wean from them. Lost one and one half weeks of work.
I started to get ear pain felt like I had water in my ear, it is so severe it will wake me up. I felt like air through my ear and severe pain. I went to the aftercare service because of the severe ear pain in my left ear only. The doctor gave me 800 mg of ibuprofen. The doctor gave me drops for my ear. I went to an ENT in April and they saw nothing. I was given another ear drop medication that gave me a lot of pain so I didn't take it and I threw it away. All the doctors are telling me they don't see anything with my ear. The side of my face by my outer ear aches, still does on and off. I do not sleep on that left side anymore.
Injection site soreness; Headache; Fever; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Lot 3248), via an unspecified route of administration in the left arm on 23Mar2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El3248), via an unspecified route of administration in the left arm on 02Mar2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 22:30, the patient had injection site soreness and experienced headache, fever and chills. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events injection site soreness, headache, fever and chills. The clinical outcomes of the events injection site soreness, headache, fever and chills were recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Patient had Hep A and HPV immunizations and stated she felt fine, patient dropped head while in chair, I called for help and help patient in chair and woke her. She was reoriented, vitals recorded, patient stayed over one hour and evaluated before she left clinic.
60 year old male died unexpectedly at home, found 04/11/2021. Last known contact was by phone with his brother on 04/10/2021. Cause of death was determined to be MI due to ASCVD due to tobacco dependence, cigarettes. Autopsy was not requested. This medical examiner was later contacted by the daughter of the decedent to report that he had received the Johnson & Johnson COVID vaccine on 04/08/2021, 2-3 days prior to his death.
pt recv vax & devel an inj site rxn characterized by redness, warmth, swelling & soreness;pt instructed to take DPH;
Patient was cold to the touch; Sweating profusely; Became pale; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING COLD (Patient was cold to the touch), HYPERHIDROSIS (Sweating profusely) and PALLOR (Became pale) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced FEELING COLD (Patient was cold to the touch), HYPERHIDROSIS (Sweating profusely) and PALLOR (Became pale). At the time of the report, FEELING COLD (Patient was cold to the touch) and HYPERHIDROSIS (Sweating profusely) outcome was unknown and PALLOR (Became pale) was resolving.        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.   No concomitant medications were reported. No treatment medications were reported.
Pericarditis, chest pain radiating to jaw and shoulder associated with shortness of breath that was confirmed on EKG as pericarditis
Itchy palms (started 9/20), low grade nausea/lack of appetite (started a day after vaccination), diarrhea (started 9/13), extreme fatigue (9/21 - 9/22).
Information has been received from a pharmacy technician concerning a 62 year old female patient who on 09-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669264/1363Z, Exp date 15-JAN-2012, route not reported). The pharmacy technician stated that on an unspecified date, the patient injured her lip after ZOSTAVAX (Merck) was administered. The patient was treated with MEDROL dose pack. At the time of the report, the patient had not recovered. No further information is available.
03/19/2023 I caught a virus probably one of the influenza viruses. It resulted in about 10 days of low-grade fever and significant pain and a limitation of movement in my legs. A little bit of lung congestion for the first couple days, it did not persist. A lot of loss of energy. About halfway through I went to visit the doctor. They looked for respiratory symptoms. They did an X-ray, checked oxygen level. I rested for 5 to 10 days. About day 10 the fever went away, and things started to get better. By day 15 my left calf was swollen. I called my doctor and they told me to come to urgent care. Urgent care checked for deep vein thrombosis, and I did have a deep vein clotted. They did a chest CT scan they saw signs of pulmonary embolism and they admitted me to the hospital. I got standard medical treatment for DVT. I was put on anticoagulants and more test to see if anything else was going on. A lower abdominal CT Scan and echocardiogram to see if anything else was being impacted by the clotted episode. They were concerned that the clots would come up to my lungs. I was there for 2 nights. I was discharged I was put on 5 mg of ELIQUIS, anticoagulant, twice a day and here we are. The cause of the sequence of the blood clots, I would just have to guess, it was the inactivity for 10 days from the series of the flu is my guess.
This spontaneous report as received from a registered nurse refers to an approximately 13 month old patient (gender unknown). On 28-APR-2014, the patient was vaccinated with M-M-R II 0.5 ml once, subcutaneous (lot 007155; exp date on 20-JUN-2015) Albumin Status was HSA, subcutaneous. Other suspect therapies included VARIVAX (Merck) (lot J010252; exp date on 02-AUG-2015) (dose, route not provided). It was reported that the patient detected (at unspecified time) to have a porcine type allergy. At the time of the report, the outcome of porcine type allergy was unknown. Additional information has been requested.
July 16 - Severe muscle pain (sharp, intense) in back and extremities.  Unable to sleep. July 24 - Metallic taste in mouth/partial loss of taste. July 27 - Facial paralysis on left side (diagnosed as Bell's Palsy)
As I was walking out of the vaccine sight on 3/10 after receiving my second COVID vaccine, after my required 15 min wait, I noticed my ears starting to get clogged (similar to being in an an airplane ascending) and they started ringing. I didn't think much of it right at the moment because it was warm and windy thought it might be the storm and pressure change (I've never had an issue with storms/pressure in the past though). The clogged feeling lasted approximately 45-60 minutes and then just stopped. The ringing has been pretty consistent since. It is a lot less noticeable in the day but at night when it's really quiet it's much more noticeable and loud.
Narrative:  COVID infections following completion of COVID vaccine series 12/21/20 COVID vaccine dose #1 01/13/21 COVID vaccine dose #2 02/02/21 Preop COVID test NEGATIVE 05/18/21 Pt reports numbness in right leg that feels like needle pricking; scheduled MRI and nerve conduction test 06/13/21 Pt reports severe pain in right leg; nerve conduction test reveals bilateral S1 radiculopathy and MRI reveals multilevel lumbar degenerative disease/degenerative disc disease with multiple levels of variable neuroforaminal stenosis: Community care consult to Neurosurgery placed 07/26/21 Pt presents to screening reporting chills, cough, muscle pain, nausea, runny nose, shortness of breath, vomiting x4 days; swabbed COVID POSITIVE 07/27/21 Pt presents to ED reporting headache, nausea, vomiting, chills, nasal congestion that started 5 days ago; has slight cough and dyspnea; discharged with rx for zinc, ascorbic acid 07/28/21 Pt reports dry cough with chest tightness after, headache, muscle pain; rx given for DM/guaifenesin 07/29/21 Pt reports going to medical facility for ongoing COVID care and plans to receive Regeneron 07/31/21 Pt reports diminished cough with use of benzonatate twice daily and cough syrup; improving and stable 08/02/21 Pt is improving and reports mild cough 08/04/21 Pt reports dry cough, throat discomfort, and nausea; requests medications recommended by medical facility Dr. (dexamethasone, azithromycin) be provided by agency but based on symptomology, pt does not have an indication for the medications; agency advised pt against the use and that he will need to obtain the meds outside the agency
Shock-collapse; 1140 given HIB TITER vax only; 1148 pt vomited, very pale; 1150 hyporesponsive, resp, slow shallow, pulse thready, tachy, BP 50 palp; Airway clear; 1152 Given Epi; no other meds given in ER; released p/2hrs;
Approximately 25 minutes after vaccination administered patient reported feeling nauseated, dizzy, and flushed. Patient was administered diphenhydramine (dose unknown) in the emergency department. At approximately 60 minutes after vaccination administered patient reported relief of symptoms. Patient discharged to home with after care instructions for allergic reactions. Instructed patient for future vaccines to pre-medicate with anti-histamines.
Information has been received from Pfizer, Inc. (Manufacturer # 2017070827) via a health care provider regarding a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date the patient was vaccinated with PNEUMOVAX23, (route, lot# and expiration date unknown), for prophylaxis.  It was noted on the patient's current medication list that she had an allergy to PNEUMOVAX23.  The outcome of the event was not provided.  Additional information is not expected.
taste buds have been off; This is a spontaneous report from a non-contactable consumer (patient) from a sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date in 2021 at dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient stated that his taste buds have been off since the vaccination. He was asking if this was normal. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache; chills; fever; nausea; sore muscles. Lasted approximately 36 hours. Treated with rest, fluids and Tylenol.
COVID 19 Treatment; COVID 19 Treatment; On the sixth day I tested positive again and symptoms began.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "unknown", described as "On the sixth day I tested positive again and symptoms began.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative; (Aug2022) Negative; (Aug2022) Negative; (Aug2022) Negative; (Aug2022) Positive; (Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 include Paxlovid from 18Aug2022 to 21Aug2022. After finishing the Paxlovid, patient tested negative four days in a row, then on the fifth day patient tested positive with no symptoms. On the sixth day he tested positive again and symptoms began.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
diarrhea; headache; This is a spontaneous report from a Non-contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced diarrhea and headache both on 28Jan2021. The outcome was unknown.        No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A report has been received from a Health Professional concerning an 8 month old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST started on 02-Dec-2013. It was reported that the patient was inadvertently administered expired FLUMIST QUADRIVALENT on 02-Dec-2013. No adverse reaction has occurred. The outcome of the event of inadvertent administration of expired FLUMIST is unknown. The report was considered to be non-serious.
By mother's report - Rec'd MMR II and VARIVAX 4/14/10 at 315 pm, mom noticed 4/15 at 300 child had itching - noted redness around injection site on both arms and gave BENADRYL. The next AM mom noticed redness on her cheeks and a little more on her arms. She gave her BENADRYL and sent her to school. When pt returned home from school at 3 pm - mom noted redness on her cheeks and mom noted what she said was hives/rash/redness from head to toe, called Health Unit and we recommended she see PMD or go to hospital. ER MD gave corticosteroids and BENADRYL. This problem has not resolved yet child stay home from school today.
Pt went limp & began to breath hard & took a few seconds to respond to stimuli. Then did not eat well.
AVA x 5 Feb 1999-May 2000. Joint pains and migraines in 2002. Denied problems with vaccine at that time. Denies any body aches prior to receipt of the vaccine. Joint aches: Inc in AM of elbows, shoulders, knees and ankles, improves during the day. No swelling or redness. Duration of hours to all day. Daily pains since onset in 2002, with intensity usually 6-7/10 but at times higher or lower. Is able to participate in weekly exercise regimen. Evaluated by rheum with no auto immune findings. Headaches ("migraines"): varying onset lasting 3-4 hours, OTC medications help. No aura. Frequency 1-2 times per week, longest period without a headache about 1 month. Pain is usually at level of about 7/10, occas 10/10. Pain resolves on own if OTC medications do not help. Denies photophobia, nausea, vomiting, etc. No neuro evaluation to date and no actual diagnosis of migraine noted in record review. Symptoms: Joint pain, multiple joints, headache, general, muscle pain. Pt doesnot know exact date and time. Reported Sx approx 2 years after last AVA.
Starting at the end of May had groin pain extending down right leg. This progressed to red streaking on both lower extremities with extreme pain and swelling. Seen in ED and Ultrasound, Ct scan, Blood work completed. Diagnosed with pulmonary embolism and Deep Vein Thrombosis. Hospitalized for 4 days and discharged to home on blood thinners. Tried going off blood thinners in October and started with leg and groin pain-seen in ED three times. Re-started on blood thinners end of November after all blood work-up was normal.
extreme exhaustion; flu like symptoms set in; chills; body aches; uncomfortable; a little achy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot/Batch number: unknown) via an unspecified route of administration on 05Feb2021 at 04:45 pm on the left arm as a single dose for COVID-19 immunisation. The patient's medical history included depression. The patient's concomitant medications were not reported. Patient did not take any other medications with in four weeks of vaccination. Patient's other medications within two weeks included Effexor. The patient was not tested for COVID prior vaccination. Patient's COVID past vaccination was none. The patient stated that within the 1st 24 hrs of vaccination on 06Feb2021 at 08:00 am, the patient felt uncomfortable& a little achy. On the second day after vaccination, the patient had flu like symptoms, chills, body aches in joints and lower back. On the third day, the patient experienced chills, body aches and extreme exhaustion. The patient was treated with OTC medication for the events. The outcome of the events was resolving.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
She described her symptoms as: "face became red and puffy, lips blistered, blisters around nostrils, hard to swallow, and throat closing." She went to the ER around 7 pm where she was given Benadryl and prednisone. She came into work today with no symptoms. She was advised by the ER doctor to not get the second Moderna dose, but to follow up with her PCP for further guidance. Her appointment with the PCP is scheduled for tomorrow morning.
Within 24 hours of shots, began fever (100.7) which increased to 103 by 9/16/04. She was irritable.
Patient given 2 doses of influenza vaccine. First during annual PE on 9/30/21 and second at immunization clinic 11/15/21. No immediate adverse effects noted. Reported incident to nursing supervisor and pediatric MD. Educated parent on possible adverse reactions. Called parent 11/16/21 for update and she reported that patient is doing well today, no complaint aside from soreness at the injection site. Invited to call back with any concerns.