chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an administrator and vaccine coordinator and refers to a patient of unknown demographics. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M038717 with expiration date on 24-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 1 degree Celsius for 3 minutes and 56 seconds. Data logger was involved in recording of the temperature excursions. There was a previous excursion of 1 degree Celsius for 1 hour and 22 minutes reported.
This case was reported by a nurse via sales rep and described the occurrence of general body pain in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, malaise and fever. On an unknown date, the outcome of the general body pain, malaise and fever were recovered/resolved. The reporter considered the general body pain, malaise and fever to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on an unknown deltoid. The field representative was the original caller, however, she had limited details regarding the adverse event, so she asked that someone from global response center reach out to the nurse who reported the adverse event to her, to obtain more details. Outbound call was placed to the nurse to obtain additional details. The nurse reported that a patient received the SHINGRIX vaccine in their office and reported to the nurse that she experienced body aches and overall malaise for more than 7 days. The nurse stated that the patient also experienced a fever, but she was not sure how long the fever lasted. The reporter had limited information at the time of call and stated that she might call back in to provide additional details.
I did not have an adverse reaction to the vaccine. I began not feeling well 03/14/2023 with weakness and hyperthermia. I was admitted to the hospital two days. I was recently diagnosed with a viral upper respiratory infection. I am not on any prescriptions to clear the infection.
Patient did not report until 11/13/2018 but said she had soreness in her shoulder and that the pain radiated up to her neck and down her arm to her thumb. She was seen by Dr on the 13th and he thinks it may have been shoulder impingement.
Pain at site of injection, but also could feel pain in my humerus.  The soreness eventually went away, but I continue to have stabbing pain in my shoulder with any movement overhead.  It is painful to take my shirt off, get things out of cabinets.  If I attempt to throw a ball with my son, my arm is so sore that I can barely use it for the rest of the day and into the next.  I have tried applying heat to the site, but this only seems to make it worse.
Patient said 2 hours after the shot she got nauseous and developed a fever (ranging form 101-103 degrees).  She said the next day she developed a seizure (not a grand mal) but lasting about 15 minutes of shaking.  Her md said because of this reaction...no more vaccines for her.
Passed out after received shot with brief tonic/clonic activity of upper extremities lasted 3-5 seconds. No loss of bladder control.
Patient received vaccination on 5/2.  Patient presented to pharmacy 5/6 with red upper left arm and stated it was hot to touch.  Referred patient to her PCP.
I was violently ill, almost went to E.R. my husband called my doctor after hours. I was vomiting, in EXCRUCIATING pain over my whole body. freezing cold. temp of 102. I literally felt like i was poisoned. If there is a booster down the road, i dont feel i can get it. I would like to know why i got so sick from the vaccine.
3PM Right arm (where flu and PNEUMOVAX-23 was administered) become very sore. 6PM patient's throat began to swell/become tight, entire body ached, weakness, difficulty focusing & walking, visual problems, face and eyes became red. 9PM chills and low grade fever. 9/21 Patient states arm is no longer sore, temp normal, normal facial color. Throat still feels restricted. BENADRYL helped.
Soreness at injection site Cough Fever between 99 and 102 for 16 hours Fatigue
Throat tightened, chest pain, chills, vomiting. Patient took antihistamine, went to sleep and felt better after awakening.
Next day post vax, the pt developed local redness, swelling, and warmth four inches by six inches. Three days post onset, the pt recovered.
Soreness at site, day 1,2, & 3. Reddened rash surrounding site w/approx 8 dime-quarter sized patches, slightly raised. No itching sensation noticed at this time. No tx given since pt. already takes Zyrtech daily.
Extreme chills / uncontrollable shaking.  Slight Fever. Terrible headache.  Muscle Aches throughout my body. Fatigue with coughing.  Diarrhea.
Positive for Covid-19; achiness; headache; blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurred vision), COVID-19 (Positive for Covid-19), MYALGIA (achiness) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VISION BLURRED (blurred vision), MYALGIA (achiness) and HEADACHE (headache). On 25-Jan-2021, the patient experienced COVID-19 (Positive for Covid-19). The patient was treated with PARACETAMOL (TYLENOL) 22-Jan-2021 for Adverse event following immunisation, at a dose of UNK dosage form. At the time of the report, VISION BLURRED (blurred vision), COVID-19 (Positive for Covid-19), MYALGIA (achiness) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
This case was reported by a pharmacist and described the occurrence of optic neuritis in a 15-year-old male subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), DTPa (with small D + P), HPV vaccine, meningococcal acwy vaccine (non-gsk) and varicella virus vaccine (non-gsk). Concurrent medications included Gentamicin + dexamethasone. On 26 July 2011 the subject received unspecified dose of Hepatitis A vaccine (details unknown), unspecified dose of DTPa (with small D + P) (details unknown), unspecified dose of HPV vaccine (details unknown), unspecified dose of Meningococcal ACWY vaccine (Non-GSK) (details unknown), unspecified dose of Varicella virus vaccine (Non-GSK) (details unknown). On 22 August 2011, 27 days after vaccination with DTPa (with small D + P), HPV vaccine, Hepatitis A vaccine, Meningococcal ACWY vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK), the subject experienced optic neuritis and vision loss. The subject started experiencing right eye vision loss on 22 August 2011. On 29 August 2011, he started experiencing vision loss in both eyes. The subject was hospitalised for 6 days from 06 September 2011 to 11 September 2011. At the time of reporting the outcome of the events was unspecified. The pharmacist reported that the subject had been discharged from hospital, but was not sure whether he had completely recovered.
About 20 minutes after vaccine given, complained of discomfort, face flushed, facial and upper arms with paresthesias.  Vital signs normal aside from mild hypertension.  Improved.
Information has been received from a nurse practitioner concerning a 6 y/o male who on 07Aug1997 was vaccinated with a dose of varicella virus vaccine live. On 04Jun2003 it was reported that "several days ago" the pt developed a rash which was determined to be breakthrough chicken pox with less than 50 lesions on the neck, chest, leg and groin. Medical attention was sought and the pt was treated with diphenhydramine hydrochloride (BENADRYL) and colloidal oatmeal bath (AVEENO). No additional information was provided. No diagnostics studies were performed. No product quality complaint was involved. Additional information has been requested.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: NNI
Patient's arm turned a whiteish color from the site of the injection down to her wrist.
I had nausea, random muscular aches in legs, arms and fingers that night. It continued to get worse the next day. I was incapacitated. It ended with a migraine later that night. Acetaminophen  didn't help. The next day the symptoms had gone. I also had some small itchy spots on my upper left arm that have disappeared.
Got a large lump, soft ball sized in left arm pit. Lump very discomforting and painful. Had malaise, body aches, & extreme tiredness.
Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided. Patient was put on an antibiotic for sinus infection.   Reporter did not allow further contact
Information has been received from a health professional concerning a 17 year old female who on approximately 12-MAR-2008 was vaccinated with her first dose of GARDASIL (lot number 658556/1060U).  On approximately 12-MAR-2008 the patient experienced nausea, vomiting, diarrhea and gastroenteritis.  The symptoms began within 24 hours of vaccination.  The patient's nausea and vomiting and diarrhea and gastroenteritis persisted.  The patient sought unspecified medical treatment when her mother called the office.  Additional information has been requested.
Next day presented with redness and swelling of the entire arm (not just localized to the injection site). Developed fever >99 degrees F as well as chills and body aches. Symptoms resolved after approximately 48 hours.
Roughly 45 minutes after receiving dose 2 of the Pfizer vaccine, my face began to feel funny and then became itchy. This is the same thing that happens when I eat shellfish. It didn't last for more than 45 minutes, and I didn't need to take anything for it.   I also woke up in the middle of the night with horrible pain throughout my entire left arm, from my shoulder down through my hand. This lasted a couple hours and then returned to just moderate soreness at the injection site only.
expired vaccine administrated / Expired vaccine >24 hours post puncture administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administrated / Expired vaccine >24 hours post puncture administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administrated / Expired vaccine >24 hours post puncture administered). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine administrated / Expired vaccine >24 hours post puncture administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that a punctured vial was kept at room temperature more than 24 hours, then administered to a patient.  No concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2022: Follow-up received with information vaccine administered to a patient and event verbatim updated.
Information has been received from a licensed practical nurse concerning a 68 year old female who on 29-JUN-2007 was vaccinated with a dose of Zostavax (Lot# 657676/0619U). "Approximately three months later" the patient developed shingles. The patient called the pharmacy to report the issue. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
While PT was in her 15 minute observation period PT began to experience weakness with a near syncope, later complaining of chest pain. PT was found to be hypertensive BP 200/100. PT advised she has a PMH of HTN but did not take her prescribed medication in the morning. PT remained hypertensive and was found to have an irregular heart rhythm with no history of cardiac issues. IV was established, 325 mg of aspirin via PO was and 0.4 mg of nitroglycerin was administered via sublingual with PT chest pain improving from 8 of 10 chest pain to pain completely subsiding.  Run #21-0766
Swelling (left arm edema), redness, soreness of upper left arm from Pneumovax23 injection. Pt iced left arm. She also took Aleve. Symptoms were not worsening after 24 hours and she felt ice and ibuprofen helped. She also noted she developed cough overnight, but the cough is not worsening and she had no shortness of breath or swelling of airways associated with it.
Patient was given Moderna instead of Pfizer for her 2nd Covid-19 vaccine dose.
13hr of cerebral screaming immed p/vax;foaming @ the mouth, saliva, bubbles emitting from mouth;Md stated pertussis allergy;Annual follow-up dated 01/29/01 provided an additional vaccine and that the pt has autism and and suppressed immune  system. The pt also has gi inflammation and permeability from food allergies. He has tactile defensiveness issues, speech delay, sinus and ear problems, viral infections, and pneumonia. After each subsequent vaccine his gi system and sleep got worse until he had only diarrhea and was screaming most of the day and night for 2 years. Now he is on a special diet and medications and is better but brain damage is done.
Fever  Unable to hold down food.  Vomiting  immediately after eating or having a bowel movement after 3-4 hours.
Patient began feeling ill within 24 hours of getting second COVID19 vaccination. Presented to our hospital the evening of 1/28/21 with generalized weakness, fevers, near syncope. Extensive workup revealed likely hemophagocytic lymphohistiocytosis syndrome attributed to reaction to vaccine. Patient treated with blood transfusions, corticosteroid (dexamethasone 20mg) and folic acid 1mg daily. Patient also developed rectus sheath hematoma attributed to vaccine/reaction. Patient continues to remain hospitalized 15 days later. Clinically stable, yet critically ill with no significant / some worsening of laboratory results.
Pt came into pharmacy on 9/5/2019 and reported soreness, redness, and warm to the touch the night of vaccination on 8/27/19. She took Aleve and it went away after 3 days. Then she developed red spots from her ankle going up her knees. She was not itching  or in pain.  Recommended Benadryl also just to see if it could be an allergic reaction. She will take 25 to 50mg every 4 to 6 hours. If it doesn't get better, she will see a doctor.
diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated, "I received the first dose of the COVID-19 vaccine last 19Dec2020 and unfortunately was exposed to COVID-19 in the evening. I was diagnosed with COVID-19 on 22Dec2020 or 23Dec2020. Should I have my second dose as scheduled tomorrow considering that I have the COVID-19?". The outcome of the event was unknown.   Information on lot number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
This case is a part of 2 cluster cases and is linked to case number 2013-09702 (same vaccine lot number and same reporter). Initial report received from a healthcare professional on 11 September 2013. A 05-year-old male patient, had received an intramuscular fifth dose of DAPTACEL vaccine (batch number: C4431AA and expiry date: 10/16/2015) in the left deltoid on 21 August 2013. The patient had no illness at time of vaccination, no pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient's concomitant medications were not reported. On 23 August 2013, the patient developed vaccination site blister, redness and swelling. No laboratory investigations were done and the patient had received MOTRIN and cold compresses with ice to the site as corrective treatment. On an unspecified date, the patient had recovered from the events. Documents held by sender: none.
the worst pain I have ever had; my underarm lymph node swelled up to the size of a grapefruit; I felt like I was about to vomit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GJ2524) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (3rd dose), administration date: 09Nov2021, when the patient was 49-year-old, for COVID-19 Immunization, reaction(s): "the worst pain I have ever had", "my underarm lymph node swelled up to the size of a grapefruit", "I felt like I was about to vomit"; Covid-19 vaccine (2nd dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 11Oct2022 at 16:00, outcome "recovered" (Oct2022), described as "I felt like I was about to vomit"; LYMPHADENOPATHY (non-serious) with onset 11Oct2022 at 16:00, outcome "recovered" (Oct2022), described as "my underarm lymph node swelled up to the size of a grapefruit"; PAIN (non-serious) with onset 11Oct2022 at 16:00, outcome "recovered" (Oct2022), described as "the worst pain I have ever had". Therapeutic measures were not taken as a result of pain, lymphadenopathy, nausea. The clinical course was reported as follows: with this shot (4th dose) and with the last booster I had on 09Nov2021 my underarm lymph node swelled up to the size of a grapefruit and was the worst pain I have ever had. I happen to have a high tolerance for pain but this came in constant waves for 48 hours and every time it hit a 10 in pain I felt like I was about to vomit. Follow-up attempts are completed. No further information is expected.
In the evening if the injection and through the following day I started to have brain fog or forgetfulness and the inability to concentrate. I also had occasional sharp but temporary pains in my chest and in my toe joints. Very minor headache.
dizzy, sick to stomach, ran temp of 101, vomit and diarrehea.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "hx of afib" (unspecified if ongoing), notes: hx of afib. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.
Received Td vaccine at 3:53pm on 4/2/01, client developed dizziness @ 3:58pm, itching, tingling around her mouth @ 4:05pm also c/o nausea. Epinephrine 0.3ml sq administered @ 4:09pm. Denied any SOB respiration even and unlabored. To Baylor hospital @ 4:24pm by paramedics.
10/27/2022 developed soft cough and low grade fever (99) late afternoon/evening 10/28/2022 tested positive at home for Covid 19 mild upper respiratory signs poor appetite, muscle aches, increasing fever peaked at 101.4.  began tylenol late afternoon. 10/29/2022 fever, headache responsive to tylenol q 8h. Received bebtelovimab IV infusion at home @ 3PM.  Flonase nasal spray used BID. 10/30/2022 continued OTC medications increased sneezing, little cough, less tired, some GI cramping and diarrhea 10/31/2022 no significant fever, took tylenol prn for muscle aches, minimal URI signs but ongoing diarrhea and poor appetite 11//2022 progressive diarrhea, poor appetite
Patient said that about one hour after receiving the ZOSTAVAX shot, he had difficulty breathing and his abdomen got swelling. He went to the hospital, got IV treatment for bowel obstruction.