chrisvoncsefalvay/vaers-outcomes huggingface dataset:
parkinson's disease; This spontaneous case was reported by a patient and describes the occurrence of PARKINSON'S DISEASE (parkinson's disease) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 045B21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Concurrent medical conditions included Diabetes and COPD.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2022, the patient experienced PARKINSON'S DISEASE (parkinson's disease) (seriousness criteria hospitalization and medically significant). At the time of the report, PARKINSON'S DISEASE (parkinson's disease) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: something was done with his arms,diagnosis of Parkinson's happened in MAY2022.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient had no allergies. No concomitant medication were reported.  The patient stated that for about a year, he has been suffering from Parkinson's disease. It started when patient was in rehabilitation towards the end of APR-2022. This prompted the healthcare provider at the rehab to check blood work and he mentioned that something was done with patient's arms. The diagnosis of Parkinson's happened in MAY2022. Patient saw a neurologist the day after he was discharged from the rehab. His neurologist didn't positively confirm the diagnosis but she was 99 percent sure that patient had Parkinson's. Patient was in detox for a couple of weeks when his hands started shaking real bad. From the blood work, they determined that patient had Parkinson's. Patient stated that, neurologist was doing some additional testing and trying to eliminate other diagnoses.  Company Comment:   This is a spontaneous case concerning a 56-year-old, male patient while in rehabilitation (probably for detox) experienced the unexpected serious (hospitalization and medically significant) event of Parkinson's disease. The symptoms began approximately one year after the administration of the second dose of mRNA-1273 vaccine (Patient also received a booster dose but it is unknown if it was before of after symptoms began). Patient stated he was diagnosed by a lab test, but no details have been shared. Investigations are being done. No further information was disclosed. Queries are being raised. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
30JAN91 vomiting-0 fever; 31JAN91 fussy-diarrhea-seen ER dx Bil ear infect started on Amoxicillin; 2FEB91 Developed rash med changed vomit resolved-diarrhea persists now had fever tc MD med changed to Ceclor; diarrhea & poor appetite cont.
Tinnitus. Volume is really loud and has not diminished over time. I now live with it every day and it is debilitating, painful, and creates hearing loss
Redness, erythema, swelling of upper arm surrounding injection site. 5 inch x5 inch.
pain, redness day of inj;severe h/a, fever to 101, lightheadedness, prostration, muscle  spasms in quadriceps 20FEB-21FEB98;still mildly dizzy, sore & red inj site 23FEB98;
In approximately October 2000, the patient experienced a mild rash on her abdomen. Unspecified medical attention was sought. It was reported that the patient's brother had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
vial was punctured/opened on 2/23/23 and not discarded after 12 hours. Patient was given vaccine on 2/28/23 several days after vial was to be discarded\. Pfizer safety team deemed vaccine no longer good. CDC stated patient may be revaccinated with repeated dose with no minimum interval.
temperature of 100.8; feeling sick; muscle aches; fever; achy; feels cold/freezing like crazy; didn't want to eat or drink; tired; headache; chills; shaking/the shakes; Nausea; lightheaded; arm was sore; This is a spontaneous report from a contactable consumer (patient) from medical information team. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8727, expiration date was not reported) via an unspecified route of administration, in right arm, on 23Mar2021 13:30 (at the age of 58-years-old) at dose 1, single for covid-19 immunization. Medical history included neuropathy of the feet from 2007 and ongoing, ongoing diabetes (2003-2004) and gastric bypass surgery and lost 80 pounds. Concomitant medications included iron; ergocalciferol (VITAMIN D), gabapentin for neuropathy from 2007, metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR) for diabetes; since early 2019 about 5 years, glimepiride for diabetes mellitus from unspecified date (about 5 years) and ongoing, fenofibrate from 2012, Simvastatin from unspecified date (2006-2007) for cholesterol, losartan potassium (about 3 years). All therapies were ongoing. The patient previously took potassium, insulin shots for diabetes. Historical vaccine included flu shot (INFLUENZA VACCINE) years ago and she got the flu virus. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient experienced feeling sick, temperature of 100.8 on an unspecified date, nausea, lightheaded, arm was sore on 23Mar2021, headache, chills, shaking/the shakes on 25Mar2021, muscle aches, fever, achy, feels cold/freezing like crazy, didn't want to eat or drink, tired on 26Mar2021. The patient underwent lab tests and procedures which included blood sugar was ok (as reported) on 23Mar2021, body temperature: 100.2 Fahrenheit on an unspecified date, body temperature: 100.8 fahrenheit on 26Mar2021, A1c: 12 on an unspecified date, glycosylated hemoglobin: 5.1 on an unspecified date, covid- test negative on an unspecified date. Therapeutic measures were taken included Tylenol for temperature of 100.8, muscle aches, fever and achy. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Tightness in neck/throat and hard to swallow, chest and severe heart pain, headaches, dizziness and lightheaded, stroke symptoms, extreme weak spells, fatigue, symptoms that keep persisting.
2/5- received 2nd dose of Gardasil - later that night he started feeling light-headed -not dizzy. Over the next few days he says it started to feel this way over his whole body, his mind now feels "fuzzy" and as if he is "stuck in a dream".  Trouble focusing.
Back pain; Caller asked how long can she can take taking Aleve or other pain relievers without it interfering with the vaccine?; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for covid-19 immunization. The following information was reported: BACK PAIN (non-serious) with onset 02Apr2021, outcome "unknown", described as "Back pain"; POTENTIATING DRUG INTERACTION (non-serious) with onset Apr2021, outcome "unknown", described as "Caller asked how long can she can take taking Aleve or other pain relievers without it interfering with the vaccine?".  Additional information: She asked if she can take Tylenol & Ibuprofen. She asked how long can she can take taking Aleve or other pain relievers without it interfering with the vaccine. Offered to transfer to Safety (back pain and potential interactions with medication), but Caller declined. Preferred to e-transmit information instead, because Caller said she is not sure if the back pain would be from the shot or from her (has happened before). Response: Spoke from attached documents. Checked the Pfizer-BioNTech COVID-19 EUA PI (LAB-1457-6.0, Revised: 25Feb2021), mentioned no information found on the timeframe before being able to get medications after vaccination, and referred to HCP for guidance. It was unknown if the reporter's contact information available a sub-contracted party. The patient had her 2nd dose of the vaccine yesterday at 11am and she is currently experiencing back pain. She's asking if she can take Tylenol or Ibuprofen. Warm Transfer and created Manual AE Form.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a female junior high school student who about six months ago, in approximately March 2007, was vaccinated with 0.5 mL, booster shot, of varicella virus vaccine live (Oka/Merck). On an undisclosed date the patient developed shingles. At the time of reporting the patient was recovered. Unspecified medical attention was sought. There was no product quality complaint.
Information has been received from a certified medical assistant concerning an 18 month old white male who on 10FEB2003 at 2pm was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot 641788/0595M). Concomitant vaccinations that day included a dose of measles mumps rubella vaccine (MSD) administered in the left thigh. ON 22FEB2003 the child broke out in a "chicken pox type rash" which cleared up. The reporter indicated that "today", 31MAR2003, the child presented with "new chicken spots" and a fever off and on. It was noted that unspecified medical attention was sought, however the reporter indicated that the child underwent no treatment or interventions and no prescription drug was required. Follow up information received form the certified medical assistant indicated that on 22FEB2003 at 1.45pm, 12 days after vaccination, the patient had an "outbreak". The outbreak then scabbed over. It was reported that "he seemed to be getting over it then on Monday , 31MAR2003, new spots started." It was noted that the patient came to the hospital where the reporter met him in the parking lot. The patient was diagnosed with chickenpox. No relevant diagnostic tests or laboratory data were reported. Additional follow up information received from the certified medical assistant indicated that the patient was referred to a dermatologist and "we don't think it's chickenpox anymore."  Additional information form a dermatological consultation was received from an advanced registered nurse practitioner which indicated that the patient was seen on 02MAY2003 for concerns of an erythematous papular eruption that involved the upper posterior neck, the cheeks bilaterally, the anterior neck and the upper and lower extremities. This was most prevalent on the lower extremities, however. These were erythematous crusting lesions. It was noted that the patient's chest, abdomen, mid-lower back and buttock area were completely spared. These did appear to be suspicious for an insect bite and the mother stated that she had an indoor/outdoor cat in the house and that she had seen fleas on the animal, as well as in the home. An assessment revealed erythematous papular dermatitis, most likely related to fea bites. The plan was to prescribe desonide ointment 0.05%. The patient's mother was to apply to the affected areas sparingly one to two times for the next seven to ten days. Steroid precautions were discussed at length. Additionally, it was recommended that they have the cat, as well as the house, treated for fleas. On 23JUN2003 the nurse practitioner telephoned the patient. Per the telecommunication, the mother reported that she had the house "bombed" for fleas and the papular eruption resolved. They have since however noted a reoccurence of some fleas and are now noting increasing bites again. It was recommended that she follow up with an exterminator regarding this. The nurse practitioner noted the patient's rash resolved with "bombing" for fleas in the house.
is aching after rsv shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain (Verbatim: is aching after rsv shot). The outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Arexvy.  It was unknown if the company considered the pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2023 The case was received from the patient via (Open field AE monitoring) interactive digital media. The patient stated that it was aching after the RSV shot. Follow-up would not be possible, as no contact details were available.
Local symptoms- pain-discomfort. General symptoms- headaches, took Acetaminophen Narrative:
syringe that was found to be leaking during administration, may not have received full dose; received the second dose from a syringe that was found to be leaking during administration; A spontaneous report  was received from a pharmacist concerning a patient, unknown age, who received the Moderna's COVID-19 vaccine (mRNA-1273) from a syringe that was found to be leaking during administration, patient may not have received the full 0.5ml dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On 09 Feb 2021, a pharmacist reported a patient received the second dose of the Moderna COVID-19 vaccine from a syringe that was found to be leaking during administration and the patient may not have received the full 0.5ml dose. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcomes of the events were considered resolved.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Device connection issue and Underdose without any associated adverse events.
Patient received a dose of Janssen on 3/11/21. Then the patient received a 1st dose of Moderna on 5/13/21 and then a 2nd dose of Moderna on 6/11/21.
Classic COVID arm. Red swollen hot at site swollen lymph node in arm pit slightly itchy.
On  12/17 tested positive for Covid results positive. After the vaccine exp tightness of chest, running fever. On 12/31 I  went to ER  was prescribed Prednisone/Inhaler. I went to PCP on 12/31 and 1/5 about my symptoms. I usually run 5 miles a day as of today can't run my daily routine. For some reason still exp shaking in my hands and tightness of chest not certain if this is from inhaler or steriods. I have a another appt scheduled with my PCP.
Started coughing heavily and couldn?t stop coughing. Throat started feeling like it was swelling. Shortness of breath and chest/throat pain .  I took Zyrtec and an old inhaler because that is all I had. Symptoms subsided within 30 minutes. Around 9:30pm of the same day, I started feeling short of breath, lightheaded, nauseous, had a bad headache,  and my whole body ached. I was at a sporting event so I powered through my match. When I got home, around  11pm, I took more inhaler and Flonase because I already took the maximum dose of Zyrtec.  I also took DayQuil  to help with body aches and throat pain (I assume the throat pain was from the initial coughing fit). I fell asleep  And only had fatigue, a small headache, and minor body aches the next day. Everything was fine the following day.
I received my second Pfizer dose on March 29. I had pain at the injection site, a fever, chills and nausea for a few days but have recovered since then. However, as of last week, I have noticed dull pain in the injection area at time accompanied by itching. My arm still feeling mildly sore at times. It doesn't stop me from going about my day-to-day duties, but it is annoying at times the range of movement is limited as it feels like my muscle is being stretched. I don't work out and haven't lifted anything heavy recently.
I felt fine after the injection but months later I had a car accident & was banged up pretty bad & i couldn't move around much after the wreck and now i have blood clot in my left knee.
10 min after vaccine, started feeling like mouth was dry and hard to swallow, developed palpitations and chest tightness
After receiving his vaccine client stated his throat felt "Itchy" and he was "light headed".   Reclined in car seat and seen by EMS and Dr on site.  Client reports he does carry and Epi Pen for a shell fish allergy that causes anaphylaxis.  Blood pressure 132/88 Pulse 80 and oxygen saturation 100%.  Released by Dr  once feeling better,  Advised to seek medical attention later if needed. Client verbalized understanding
This spontaneous report as received from a medical assistant refers to currently 11 year female patient. The reporter stated that on an unknown date, the patient was administered the GARDASIL that was exposed to a temperature excursion (30 degrees Fahrenheit for 2 hours) (lot number and expiration date unknown), dose, route, anatomical location and dose number were not reported for an unknown indication. No adverse effect was reported. At the time of the report, date administered, vaccine lot number and expiration date, any treatment received, or possible hospital stay were not available. This is one of several reports from the same source. Additional information has been requested.
Adverse events: Temperature, chills, headache, extreme aches and pains, sweating, sore/heavy arm, stomachache, hair loss  Treatment: Attempted sleep, Tylenol  Outcome: Improvement after a day with some lingering effects
Injection site pain, swelling and redness.  Tiredness, headache.  Muscle and joint pain, fever and feeling unwell.  I also experienced shooting pain down left arm and what feels like electrical jolts throughout my body.
This case was reported by a consumer via out of hour services and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included acetylsalicylic acid (Baby Aspirin). On 22nd May 2018, the patient received the 1st dose of SHINGRIX. On 22nd May 2018, several hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling, injection site itching, injection site lump, influenza-like symptoms, feeling unwell and chills. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling, influenza-like symptoms, feeling unwell and chills were recovered/resolved and the outcome of the injection site itching and injection site lump were recovering/resolving. The reporter considered the injection site erythema, injection site pain, injection site swelling, injection site itching, injection site lump, influenza-like symptoms, feeling unwell and chills to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient and was not reported to anyone previously. The patient received OTC probiotics as concomitant medication. The patient experienced injection site reactions consisting of redness, pain, and swelling. The patient also experienced flu like symptoms described as not feeling well, and chills. The symptoms began on the same day, a few hours after receiving the SHINGRIX vaccine and lasted for about 10 days. The patient stated that, the injection site still itches and had a lump under the site.
Dizziness, Headache, Fever, NauseaVomiting, chills, fatigue Narrative:
Mild nausea 1st 24 hours. Injection site soreness. Right foot discolored and extremely swollen going up right leg into calf. This occurred 07/22/2021. Went to urgent care . Blood work and x ray were negative for infection or break. Sent to hospital ER for ultrasound to determine if it was a blood clot. Negative. Put on clindamyacin as precaution if there was an infection. I also have runny/stuffy nose/chills/fever ranging from 99.2 to 100.4/ headache/joint pain/loss of appetite. Covud test performed 7/26/2021 results pending. Saw PCP as followup from ER visit..chest sounds tight and foot and calf still swollen and foot discolored. Chest x ray ordered..flu swab..and Blood test. Chest x ray shows some form of possible viral reaction..flu swab negative. Blood count good. Being sent for repeat ultrasound andcheck arterial blood flow
Information has been received from a physician's assistant concerning a 65 year old female with no medical history or allergies who on 13-Sep-2007 was vaccinated SC with a single dose of Zostavax (Lot #658208/0886U).  Concomitant therapy included estrogens, conjugated (+) medroxyprogesterone acetate (Prempro) and levothyroxine Na (Synthroid).  On approximately 14-Sep-2007, within 24 to 48 hours of vaccination the patient experienced joint pain, muscle achiness and muscle pain.  It was reported that the injection site area was pretty bruised and there was spreading of erythema and swelling.  Unspecified medical attention was sought.  At the time of report the patient had not recovered.  No diagnostic laboratory tests were undertaken.  A product quality complaint was not involved.  Additional information has been requested.
Patient reported a vaccine reaction from 1st dose and was advised by her physician not to take 2nd dose.  Her reaction was severe swelling of the upper extremities where her rings had to be cut off.
3-9-21 12:20PM  'DIZZY - ONLY ATE A BANANA TODAY'.  A/O, W/D, RESP WITH EASE, NO PAIN, NO DECREASED LOC.  FAMILY AT SIDE.  12:51 'FEELS BETTER' AMBULATORYTO EXIT WITH FAMILY, GAIT STEADY.  NO ACUTE DISTRESS NOTED. 3-17-21 8:49AM 'STILL FEELS LAITTLE DIZZY'.  ADVISED TO CALL PCP FOR FOLLOW UP.
Approx 36 hours after the vaccine, I experienced fast heart rate (100bpm), high blood pressure (165/ 110), anxiety, and flushing and went to the ER. High blood pressure sustained over the next few days with episodes of very high bp (197/113) and additional ER visits. I was put on 3 blood pressure medications and anti-anxiety medications. I was able to come off anxiety medications after 3-4 weeks and off bp medications after approx. 4 months. I also experienced weight loss (17 lbs in 3 weeks), nausea, and headaches which may have been related to bp medications/ anxiety. I was also diagnosed with autoimmune Hashimoto's thyroiditis at the time of the first ER visit. Unsure if vaccination was related to health events but it is possible it set off an immune reaction due to already present autoimmune condition.