chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back of my legs are very sore, stiff, I mean I am crippled and difficult to walk; I couldn't walk I couldn't walk but it's very it's pain and it is sore; Back of my legs are very sore, stiff, I mean I am crippled and difficult to walk; I couldn't walk; Back of my legs are very sore, stiff, I mean I am crippled and difficult to walk; I couldn't walk; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142; expiry date: unknown) via an unspecified route of administration, on 08Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated, "I took the vaccine a week ago from yesterday on Friday and it didn't appear right away but now back of my legs are very sore and it's very stiff and it's very difficult to walk. I mean I am crippled; I mean I couldn't walk but it's very it's pain and it is sore. I don't know if it does vaccine or not?" Patient is a healthcare worker, a speech therapist but works with high risk patients. Outcome of the events was unknown.
Initial case received on 19 February 2010 from a physician. A 46 year old male patient received a left deltoid injection of ADACEL (sanofi pasteur Inc. lot number UF451BA, sanofi pasteur Ltd. lot number C3002) on 16 February 2010. On 17 February 2010, the patient experienced a 7 to 8 cm induration at the left deltoid with induration in the left axilla. The patient started night sweats and a low grade fever on 18 February 2010. The patient was seen in the physician's office on 18 February 2010. His medical history included gastroesophageal reflux disease (GERD) and he had no known allergies. The physician also stated that the patient experienced "swelling of the upper arm with 7-8 cm induration, and swelling of the axilla" with the areas being warm and tender. The patient was sweating profusely enough to "wet his clothes." At the time of this report the patient had not recovered. Documents held by sender: None.
I started with a rash and itching all over that worsened over 2-3 days,and resulted in significant inflammation of my right hand and wrist that increased up towards my elbow quickly on day 4 of reaction.  I was seen by my primary care office via telehealth initially was prescribed a tapering dose of prednisone starting with 40mg, told to take Pepcid for a histamine blocker, Zyrtec twice daily and Benadryl as needed. And use hydrocortisone cream.  I was unable to sleep through the night and missed 2-3 days of work over 2 weeks.  The itching only lessened with the use of all medication, with the most relief coming towards end of steroids.  I?m still itchy now that steroifds are completed but it improved; a little nervous it will get worse Now that tapering steroid Cousy is completed.  I felt like there might be inflammation inside my neck around day 5-7 as I would wake in the night unable to swallow my saliva -very weird - I have never experienced something like that before.  Sometimes I felt like I was wheezing, but the  wheezing didn?t feel like it was in my chest but maybe my neck.  The swelling that occurred in my right hand and wrist was concerning and progressed quickly so I went to Urgent Care where they treated me with another 20mg of prednisone on day1.
The wrong vaccine was administered. I filled out the paperwork for my child to receive the Pfizer 5-11 booster shot. She previously received the Pfizer series on 11/13/21 and 12/4/21. The nurse gave her the Moderna shot for 6 month - 5 years. The nurse realized her mistake only afterwards when she was filling out the vaccination record card. She assured me that it was still safe, but I am nervous, as this is not an approved administration procedure.
Patient was given the COVID 19 Bivalent Booster past the Beyond Use Date. The BUD date was 01/13/2023.  The patient received the vaccine on 02/03/2023.
Swelling of left sinus escalating into full left side of face swelling with inability to put food on left side of mouth without pain. Malaise throughout body and inability to sleep for 20 hours. Swelling began dissipating after that and is still slight in left sinus at time of report.
Information has been received from a nurse in physician's office concerning a pediatric patient who may have been vaccinated with a dose of Varivax (lot# not reported). Subsequently the patient developed a mild case of chicken pox, 8-15 lesions. The patient's outcome was not reported. Additional information has been requested.
@1013 Pt stated that he only ate the crackers that he was given upfront.   @1014 Vaccine given. Pt started to feel dizzy and nauseous. Kept pt sitting down at the vaccination site. Cooling measures provided.    @1020 Pt felt better. Moved pt to observation room with supervision and mother. Upon reaching the observation clinic, pt looked pale. Placed on the gurney. Additional juice and crackers provided.    @1025 Pt felt better. Denies any dizziness. SKIN WNL. VS 122/70 77HR 99% 18. Mother and pt are confident going home. Encourage to follow up with MD and ED precautions. Instructed to eat and hydrate prior to next vaccine appointment.
Rash on her chest; A spontaneous report was received from a healthcare professional concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on her chest.  The patient's medical history was not provided. Concomitant medications reported were birth control pills, over the counter allergy medications.  On 22 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 006B21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22 Mar 2021, the patient experienced the event, rash on her chest. It is localized in the top middle part of her chest, underneath the collar bone and is the size of her palm. Follow up with safety given. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, rash on her chest was unknown.
pt recvd vax;10-15 mins later,exp dilated pupils,slow speech,mental status change,pain at inject site;pt states feels far away & is in a cloud;adm to er w/in 40 mins;BP noted to dec;p/2.5 hrs of observation,sxs improved & pt discharged;
dispensed 28 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient had no known allergies.     On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Patient had not been diagnosed with COVID-19 vaccine previously. Patient was not taking any prescription, over the counter medications, dietary supplements and herbal remedies at the time of vaccination. No adverse events were reported by the patient after the vaccination. The vial didn't had any temperature excursion issue. Date on which the vaccine was placed in refrigerator was unknown.  No treatment drug information was provided.
Pt was given vaccine on 12/16/2021 which had expiration date of 12/14/2021
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
This initial spontaneous report was received from a physician referring to a 6 month-old female infant. There was no pertinent medical history, concurrent medications, concurrent conditions or drug allergies/drug reactions described. On 09-SEP-2015 at 08:54 hours, the patient was vaccinated with a dose of improperly stored, oral, ROTATEQ (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostic test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
This spontaneous report as received from Registered Nurse (RN) refers to a 17 year old female non-pregnant patient. The patient's medical history included infectious mononucleosis. There were no drug reactions/allergies. On 16-MAR-2015 the patient was vaccinated with a dose of GARDASIL (lot # K011492, expiry date: 22-JUN-2016), intramuscularly. On 03-FEB-2016, 10 months 19 days after onset of therapy the patient experienced headache, dizziness, syncope and abdominal pain, dizziness, syncope and headache. The causality between abdominal pain, dizziness, syncope and headache and GARDASIL was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
HEAD COGESTION, FEVERISH AND ACHY STARTED 12-36 HOURS POST INJECTION
EMS reported around 3:30 pm, patient started not feeling right.  He had some tingling sensation in his left arm.  Per family patient had slurred speech was not acting right.  He did slide out of the chair he was sitting in.  He was ambulatory on scene.  Symptoms lasted approximately 5 minutes and then gradually resolved.  Upon arrival to the emergency department symptoms had significantly improved.  Patient reports he is feeling a lot better.  Patient did receive his second covid vaccination 2 hours prior to arrival.  His never had a stroke in the past.  Patient was otherwise feeling at baseline earlier today.  No chest pain shortness breath nausea vomiting diarrhea comes patient fever chills headache.
Extreme fatigue after first dose; Can't drive; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Extreme fatigue after first dose) and IMPAIRED DRIVING ABILITY (Can't drive) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     Concomitant products included BUSPIRONE, CLONAZEPAM, PAROXETINE and DONEPEZIL for an unknown indication.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extreme fatigue after first dose) (seriousness criterion disability) and IMPAIRED DRIVING ABILITY (Can't drive) (seriousness criterion disability). At the time of the report, FATIGUE (Extreme fatigue after first dose) had resolved and IMPAIRED DRIVING ABILITY (Can't drive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Additional information was mentioned patient had a First shot done in left arm and second shot done in the right arm., patient don't feel safe for driving also mentioned.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: disability). However, as per medical criteria none of the events was serious (not IME listed and resolved).   This case was linked to MOD-2021-231034 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: disability). However, as per medical criteria none of the events was serious (not listed and resolved).
Headache, fatigue, disoriented, a feeling that I was going to collapse on first day of onset of symptoms. Second day: Headache, fever, chills, runny and stuffy nose.
Patient is having extremely sore arm despite using ice on a daily basis 5 days later.  No heat, redness, or swelling at area of injection
Gave the pediatric Pfizer vaccine to her when she should have gotten the adult dose.  She came with her siblings who are under 12 and asked to be added in.  Pharmacist did not realize that she was 15 and failed to confirm age prior to vaccination.
Late mensural cycle with both vaccines. My whole life I had on time cycles, never late. The last one was 2 days late this one is going on 3 days late. Also had the most painful cramps I have ever experienced.
1st dose 2 years ago, no information on 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient declined to provide patient demographic information. The reporter did not consent to follow up. This case was linked with case US2021230194, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230194:Same reporter
06/04/2003 Grandmother called and said right arm swollen shoulder to elbow. 06/05/2003 Patient seen in clinic by MD: Dx localized heat and swelling, redness at shoulder deltoid. . Lasted 3days- no fever
Initial unsolicited report received from a pharmacist on 31-May-2016. This case involves a 31-year-old male patient who was vaccinated with ADACEL (batch number: U5406AA expiry date: 05-Jun-2018, route of administration was not reported) in left deltoid on 14-May-2016. Patient had no illness at the time of vaccination. Patient had a history of low back pain since 2000 and concomitant medications were not reported. On an unspecified date, some time after vaccination patient developed shooting pan down his legs into his feet. It was reported that the patient required ER/doctor visit. No laboratory investigations were performed. Corrective treatment was not reported. Patient was suggested to seek further medical treatment as needed. The outcome was reported as not recovered. Documents held by sender: none.
24 hours after dose, pain and swelling is experienced in the armpit lymph node on the same side as the vaccination. About 34 hours after vaccination diarrhea set in lasting the day
I test positive for Codvid- 19. I had fever, chills, and a temp of 104*.
Facial tingling around 1:00 PM followed by drowsiness. Around 6:30 PM chills started followed by a headache. Drowsiness continued and then fever of 102 throughout the night. Headache at temples, in between eyes and eyes continued to get worse along with pressure in those areas. Full body aches also developed. Nausea also occurred along with grassiness. Around 9 AM the next day the fever broke but headache continued. Aches subsided but persisted in neck, shoulders and most notably middle to lower back along with stomach aches. Weakness in the arms and hands still noticeable.  Dull headache still exists, aches, and weakness as of 9:00 PM.
Patient stated pain began 4 hours after the immunization was administered on October 6, 2008, and has never been the same since.  She went to her primary doctor who gave her an anti-inflammatory.  Patient stated that did not help.  Her family doctor referred her to an orthopedic doctor who stated the patient has a frozen shoulder.  Patient has been given a cortisone shot by the orthopedic doctor.
MMRV and Varicella were administered on the same day. No signs/symptoms at this time.
On 4/2/2023, I had sore throat and chills in the evening. Later that night, I had a fever of around 100. I got up the morning of 4/3/2023 and went to an urgent care clinic. I was tested for COVID-19, RSV, and influenza A and B. The results on all of the tests were negative, but the doctor urged me to keep testing at home, since I had symptoms that were consistent with COVID-19. I still had the fever and chills throughout the day. I took a home antigen test on 4/4/2023 and got a positive result. I did a video visit with my PCP, who prescribed PAXLOVID. He also told me that I could rotate MOTRIN and TYLENOL to manage the fever and chills. By 4/7/2023, I was feeling better, and the only symptom I had then was fatigue. On 4/10/2023, I took a home antigen test and got a negative result. However, I had a sore throat and an earache, so I stayed at home and didn't return to work until 4/12/2023. At the time of this writing, I feel fine, but I still get intermittent sore throat and earache. Although I tested negative for COVID-19, I still wear a mask while working.
first dose on 21-NOV-2019, not received the 2nd dose; cough; GERD; Body aches; Headache; Swelling of the throat; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles).   On 21st November 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On an unknown date, the patient received the 2nd dose of Shingrix. On 21st November 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain, headache and throat swelling. In November 2021, the patient experienced cough and gastroesophageal reflux disease. On an unknown date, the patient experienced incomplete course of vaccination. On 22nd November 2019, the outcome of the general body pain, headache and throat swelling were recovered/resolved. On an unknown date, the outcome of the cough, gastroesophageal reflux disease and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the general body pain, headache and throat swelling to be related to Shingrix. The reporter considered the cough and gastroesophageal reflux disease to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of Shingrix. The patient received 1st dose of Shingrix in left deltoid at 9 am in Physician's office. The evening after receiving her 1st dose of Shingrix, the patient experienced body aches, headache and swelling of the throat. All symptoms were resolved by the following morning. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Patient came in after receiving these vaccinations. Pt had a large raised cellulitis on her left arm. Injection site was visible in center of Deltoid. Patient was given Cefdinir to treat cellulitis.
This is a spontaneous report from a noncontactable consumer or other non-HCP (patient). A 23-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported, expiry date not reported), at the age of 23, via an unspecified route of administration, administered in left arm, on Feb 10, 2021, at 12:30, single dose, for COVID-19 immunisation. Medical history included penicillin drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient has not received any other vaccine within 4 weeks. The patient received birth control medications in two weeks. On Feb 11, 2021, patient stated lymph node in left armpit was swollen and very sore 5 days following vaccine (starting day after injection). Normal soreness at injection point for about 48 hours following injection. Soreness decreased on days 6 and 7 but still present. The patient did not receive treatment for event. The outcome for the events: recovering. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to a 15 year old female patient with drug reactions or allergy to diethyltoluamide (product reported as DEET). The patient had no pertinent medical history. On 05-JAN-2015 the patient was vaccinated with a first dose of GARDASIL 0.5 ml, intramuscular, lot # K009482, expiry: 06-MAR-2017. There was no concomitant medication. On 05-JAN-2015 within 30 seconds to 2 minutes after receiving GARDASIL the patient experienced ringing in both of her ears, became "hot and sweaty", became dizzy and her vision was blurred. The patient was still at physician's office when the symptoms occurred. There was no treatment given for the events and no lab diagnostic studies were performed. The patient recovered from adverse events on 05-JAN-2015 within 5 to 6 minutes. Relatedness between the events and GARDASIL was not specified. Additional information has been requested.