chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was brought to the ED by EMS on 3/1/23 from his assisted living facility for weakness. Normally he is able to ambulate with a walker but on that day required a heavy assist of 2. In the ED, he was noted to have an elevated temperature at 100.5F. A COVID-19 PCR test performed in the ED resulted positive. Ultimately, the patient was admitted 3/1/23 - 3/9/23. During his admission, he developed some cough and hypoxia, and required supplemental O2 for a short time. He was eventually weaned off oxygen. Additionally, he was started on dexamethasone. Of note, the patient has received the primary COVID vaccine series and one booster dose.
Patient had pre-medicated with about 75 mg of benadryl because of a prior reaction with her first vaccine (generalized rash). After about 2 minutes after receiving the vaccine patient complained of lightheadedness and chest tighness, also difficulty breathing. Her difficulty breathing and chest tightness worsened over the next 2 minutes. Patient's pulse was assessed, she had a 2/2 radial pulse. An epi-pen was administered to the patient (0.3 mg) Im in the right thigh, patient felt significantly better over the next 2 minutes. Patient refused medical treatment and left the pharmacy against my advice, citing that she had to take her mother to a doctor's appointment.
extreme fatigue; Extremely painful to the touch on bones/ribs around left breast thinking swollen lymph nodes. Same side as injection site/ left arm; Extremely painful to the touch on bones/ribs around left breast thinking swollen lymph nodes. Same side as injection site/ left arm; Extremely painful to the touch on bones/ribs around left breast thinking swollen lymph nodes. Same side as injection site/ left arm; Sore throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 20Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included asthma, anxiety, depression; known allergies: sulfa and pineapple, bananas. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), levothyroxine, tramadol, paracetamol (TYLENOL) and alprazolam (XANAX). On 23Jan2021 11:00 AM, the patient experienced extremely painful to the touch on bones/ribs around left breast thinking swollen lymph nodes. Same side as injection site/ left arm. Sore throat only a day. Day 5- extreme fatigue. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the event sore throat was recovered on 24Jan2021, while recovering for the other events.    Information on the lot/batch number has been requested.
Headache, chills, hot flashes, severe injection are pain, swelling at injection site that spread to lymph nodes near site, nausea.  Unable to work.  Stayed home, iced arm, and took Ibuprofen for pain.  Symptoms gone within 24 hrs.  Arm still sore but better.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. In 2016 between 22-NOV-2016 and 14-DEC-2016, the patient was vaccinated with a dose of improperly store PEDVAXHIB, lot number M025194, expiration date 22-MAR-2019, (dose, route and anatomical location were not reported) for prophylaxis. The PEDVAXHIB was exposed to 34.8 Fahrenheit for 35 days and data logger was reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA005346: US-009507513-1701USA005345.
Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 20-APR-2011 at a health care facility, by a licensed practical nurse (LPN) as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 29-MAR-2016, the male patient was treated by a certified occupational therapist assistant (COTA)(Also reported (O.T.A.)), for a vesicular outbreak that was diagnosed as herpes zoster (shingles) causing secondary fatigue syndrome. On or about 27-APR-2016, the male patient was treated by physician for herpes zoster dermatitis. The male was prescribed valacyclovir (VALTREX) and acyclovir (ZORIVAX) for management of his painful symptoms.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Site erythema and swelling hot to touch. No systemic involvement. Tx with MEDROL dose pack - 6 days.
Vertigo; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), CHILLS (Chills) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VERTIGO (Vertigo), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, VERTIGO (Vertigo), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment of the events included paracetamol.
September 2021 months after my 2nd vaccination, I was starting to experience delayed orgasm for over an hour. It started to get worse to the point where I then was diagnosed with anorgasmia. I went to the clinic and they stated verbally saying that I should try to utilize a vibrator. I then found a physical therapist to help with pelvic floor exercises and is trying to aid me in that sense. P.A. diagnosed me with anxiety mid November 2021, I then saw  Dr. (Privacy) on November 30th 2021 and was diagnosed with severe depression. I was prescribed Bupropion HCL XL 300mg once daily, Buspirone HCL 10mg 3 times daily. I met with a urologist, and he recommended Yohimbine, and he also suggested a six week abstinence. I was also given Trazodone to help with sleep as well however I have tapered off using it and quit that, and I wake up sometimes in the middle of the night.
Phone call from client states he had 2nd post exposure (Rabies) vaccine on 01/13/2005. Pt c/o severe headache 3hr after vaccine. Next morning had temperature of 101 degrees Fahrenheit, flu-like symptoms, slight edema in extremeties progressing to midline chest pain and bi-lateral arm pain. No ER or DR. visit was made. Symptoms resolved in 3 days.
Random chest pains on either side; pain in lower left quadrant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 15:30 (Lot number: FA7484) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Generalized Anxiety" (unspecified if ongoing), notes: other medical history: Generalized Anxiety; "Major Depressive Disorder" (unspecified if ongoing); "Exercise Induced Asthma" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; SINGULAIR; GINKO BILOBA [GINKGO BILOBA]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0186, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 23Aug2021, when the patient was 26 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 20Sep2021, outcome "not recovered", described as "Random chest pains on either side"; ABDOMINAL PAIN LOWER (non-serious) with onset 20Sep2021, outcome "not recovered", described as "pain in lower left quadrant". The events "random chest pains on either side" and "pain in lower left quadrant" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of chest pain, abdominal pain lower.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected
Shaking; Aching; Slept for a really long time; fatigue/ tiredness; Bad Headache; Chills; 105 Fahrenheit Fevers/ 106 Fahrenheit Fever; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 95252, expiry date 18-JUN-2024) for prophylaxis.   The patient's past medical history included shingles and rash.   On 24-APR-2023, the patient received the 1st dose of Shingrix (left deltoid). On 25-APR-2023, 1 days after receiving Shingrix, the patient experienced fatigue (Verbatim: fatigue/ tiredness), headache (Verbatim: Bad Headache), chills (Verbatim: Chills) and fever (Verbatim: 105 Fahrenheit Fevers/ 106 Fahrenheit Fever). On 30-APR-2023, the patient experienced tremor (Verbatim: Shaking), pain (Verbatim: Aching) and sleep excessive (Verbatim: Slept for a really long time). In MAY-2023, the outcome of the fatigue, headache, chills, fever, tremor, pain and sleep excessive were resolved.   It was unknown if the reporter considered the fatigue, headache, chills, fever, tremor, pain and sleep excessive to be related to Shingrix.     It was unknown if the company considered the fatigue, headache, chills, fever, tremor, pain and sleep excessive to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2023 As per the patient's physician, the patient recently had shingles and the physician wanted the rash cleared before vaccine.  The physician advised to wait 30 days after rash had gone away before vaccine.  Registered pharmacist reported that the patient administered the dose of Shingrix. The next day the patient experienced, tiredness, headache, fatigue, chills and a 106 Fahrenheit fever.  Registered pharmacist stated that they know that this was common after Shingrix, and patient felt better for next couple of days.  Then a couple of days later, on 30th April 2023, 6 days after vaccination, the patient experienced shaking, chills, 105 F fever, bad headache, aching and tiredness and the patient slept for a really long time.  It was like the patient had 2 reactions within a couple days.  Since then, it had resolved over the weekend, but the patient was kind of hesitant in getting the second dose. Registered pharmacist stated that he thought that the patient did not wait long enough after having Shingles for the vaccine.  The reporter inquired if any information was available if this was common. The reporter did not consent to follow up.
Vaccines received 5/28/03; presented to office for fever to 101 degrees F on 5/30/03. Received one dose of Rocephin 5/30/03. Mom reported lower vocalization at visit 7/29/03, but exam was normal.
Trouble breathing, chest tightness, diarrhea, nausea, approximately 12 to 24 hours after flu shot administration hives, fever up to 103, O2 sat decreased.
Felt pain in shoulder in PM hours. Pain migrated to elbow and then onto the hand. Numbness in right hand. Index,middle finger and thumb are all numb.
Developed shingles under left arm, next to pit, and above left nipple. Approx 20 vesicles at each area, 40 in total. Developed intense, debilitating headache several days later (Apr 18th) which lessened the following day, but continues to the present day (Apr22)
Armpit and below swollen - itching - stinging. Elbow red and swollen. Used CLARITIN during day and I believe she said BENADRYL at night. Getting better slowly.
Information has been received from a registered nurse concerning a 47 year old male respiratory therapist with asthma, allergic rhinitis and allergies to AVELOX, SEPTRA, LEVAQUIN and a history of pneumonia multiple times, who on 09-OCT-2006 was vaccinated IM into the right deltoid with a first 0.5 ml dose of Pneumovax 23 (lot# 651401/0619F). Concomitant therapy included a dose of influenaz virus vaccine (unspecified) (batch# U2168A) into the left arm, ACCOLATE, ("UNIDUR"), INTAL, albuterol, PULMICORT, and calcium (unspecified). That night he had so much pain in his arm that he could not sleep on it. This was followed by a fever, intermittently to 38 degrees C, redness, and swelling. He began to feel a little bit better in the last 24 hours with no fever since 09-OCT-2006. On 13-OCT-2006, the patient woke up the erythema in the arm was descending down th biceps area toward the elbow. The patient was diagnosed with a severe systemic and local reaction. The patient was advised to continue to use an antihistamine and TYLENOL. The physician also gave the patient a prescription for KEFLEX 500 mg to use only if the patient developed shaking chills or a fever. If he did the patient would take one tablet 4 times day for 7 days and call the physician. At the time of this report, the patient had not recovered. No product quality complaint was involved. The nurse requested a lot check since she has never seen a reaction occur with the vaccine. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
approx 3 days p/ vax pt devel red spots on body, low grade fever & soreness at inject site. ``within 2 wk pt devel lymphadenopathy (strep A)'' w/``lymph nodes swelled up to size of golf ball'' on 3/13 dx w/parvovirus, treated w/amoxicillin
Cried x 2 1/2 hrs approx. night after shot .Okay on Fri and Sat.
I had my right arm turn red and then it became a large bruise. I did not think anything of it, so I did not go to the doctor until May. At that time my right leg had the same issue. The doctor asked if I had fallen and I said no that the only thing that had happened was I took the COVID19 vaccine. My doctor order an x-ray for my shoulder on May 10th, 2021 and nothing came up. Then on May 13th, 2021 my doctor had me take blood, which all of the panels came back normal. The doctor could not explain why that had occurred to me, since my blood was within the normal range. Again in June my left arm had the same issue, so again I went to the doctor and she had me do my blood work for my thyroid, which came out normal again. My doctor also had me do an ultrasound to make sure I had no blood clots and that came back normal. To this day my doctor has no idea why I had this happened to me.
100-101° temperature and night, and on/off the next day. shivers, constantly cold, really bad bodyaches, ear aches, cough which has worsened,, migraine,
Swelling of Left arm at vaccine   site   and  patient experience  fever for  few days   after vaccine Pt counseled  to take  tylenol  for  fever  and  follow  up  with  his  her  primary doctor. The  swelling  has  gone  down  since  the  shot  date.  Also,  pt  just  remembered she  developed  rashes couple days after  1st  shot,  but  she  thought  it  was  unrelated  to  vaccine  at the time. I let  her  know  that  she may  be  allergic  to the vaccine.
Had a slight fever; Was achy; Run down; Was kind of sick for a day; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 52-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included multiple sclerosis (probably since from 2001, but was not diagnosed until 2017), blood pressure high (was on Lisinopril for a while, a couple of years or something) and depression (was on antidipressant). Concomitant products included thyroxine sodium (Levothyroxine), bupropion hydrochloride (Bupropion), lisinopril and ocrelizumab (Ocrevus).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine and an unknown time after starting Levothyroxine and Bupropion, the patient experienced sickness, fever, pain and tiredness. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the fever, pain and tiredness were unknown.   It was unknown if the reporter considered the sickness, fever, pain and tiredness to be related to Shingles vaccine.  Additional information was provided as follows: The patient has been on Levothyroxine since 2004 or 2005. The patient was on Bupropion probably since 2017 at a dose of 150mg extended release capsules or something like that. The patient received the 2nd dose of Shingrix in January or February of 2021 (unsure about the date). The patient was kind of a sick for a day, had a fever, slight achy and run down. No lot number or expiration date was available. The patient received both the doses of COVID vaccine and was negative for antibodies. The reporter consented to follow up.
This spontaneous report as received from a healthcare worker refers to a 16 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 22-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K023432 expiration date 18-JUN-2016. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
HEAVY MENSTRUAL BLEEDING; STOMACH WAS HURTING; NOT FEELING GREAT; This spontaneous report received from a consumer concerned a 28 year old female of unspecified ethnicity. The patient's height, and weight were not reported. The patient menstrual cycle was ended 5 days ago. The patient was received with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  The patient received the Janssen COVID-19 vaccine booster recently (dose number in series 2). The patient's menstrual cycle ended 5 days ago. On 17-DEC-2021, the patient experienced heavy menstrual bleeding at morning, her stomach was hurting and was not feeling great (Dose number in series 2) but at work.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcomes from heavy menstrual bleeding, stomach was hurting, and not feeling great were unknown. This report as non-serious. This case, from the same reporter is linked to 20211240616.
The vial was stored in refrigerator on 23-Mar-2022 and administered on 05-May-2022; no adverse event; Monovalent doses administered after the BUD to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.), PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 23-Mar-2022 and administered on 05-May-2022) and NO ADVERSE EVENT (no adverse event) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J and J (0.5 ml) on 28-Oct-2021. Past adverse reactions to the above products included No adverse event with J and J.    On 05-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 23-Mar-2022 and administered on 05-May-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.), PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 23-Mar-2022 and administered on 05-May-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.) and PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 23-Mar-2022 and administered on 05-May-2022).     The concomitant medication was not reported. The treatment medication was not reported. The information was unknown whether the patient received any other vaccine in the 4th week prior to COVID-19 vaccine. The dose administered to the patient passed 14 days after BUD of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2022: Significant follow up included added reporter, past days and dose details. On 22-Dec-2022: Live Significant follow up: Updated narrative.
I was at work and it came on suddenly that it felt like I was getting a tiny head cold, it just felt like I had a fullness in my head and it could develop into something so I thought I needed to go to bed early and rest up. The next morning when I woke up and I was supposed to go out of town and it really felt like the beginning of a cold and I kept my plans because I just thought it was just a cold with fullness in my head. The same day I was visiting family and when I left their house it felt like a chest cold and not a head cold anymore. I stopped at drug store and got a COVID-19 test and I took the test 2 hours later and it came back positive. I drove home and incredibly thirsty and over the next day or two I developed flu symptoms with fever, headache, cough, and a mild fever. My physician advised to rest and take plenty of fluids the first conversation we had. I spent days on the couch. I had symptoms for 10 days and the last 3 days I had the worst body aches I ever had in my life even my veins ached. I contacted my physician again and they instructed for me to take an electrolyte fluid and it didn't get better so I called back again and they advised for me to get to a urgent care and I was diagnosed with pneumonia and they prescribed prednisone, albuterol, and doxycycline. I had two weeks of pneumonia.