chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ear ache; Sore throat; swelling of lymph nodes on left side; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear ache), OROPHARYNGEAL PAIN (Sore throat), LYMPHADENOPATHY (swelling of lymph nodes on left side) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced EAR PAIN (Ear ache), OROPHARYNGEAL PAIN (Sore throat), LYMPHADENOPATHY (swelling of lymph nodes on left side) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EAR PAIN (Ear ache), OROPHARYNGEAL PAIN (Sore throat), LYMPHADENOPATHY (swelling of lymph nodes on left side) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included were tremor medications.
after about 10 seconds of getting vaccinated, the patient kind of rolled her eye a little bit and lips became pale and vomited later too.
Immediately reaction after vaccination. 1) Swollen and redness at site. Followed by hives around the site. 2) Swollen gland under arm. 3) Bumps and burning sensation on the back between shoulder blades. 4) Hips pain. Recommend see MD.
This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOVAX 23 for prophylaxis. Previously administered products included PREVNAR (1st dose received in 2002) and PREVNAR (2nd dose received in 9th March 2008). On 11th March 2019, the patient received SHINGRIX and PNEUMOVAX 23. On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, headache, fatigue, feeling cold, nerve pain, back pain, pain in thigh and weakness. On an unknown date, the outcome of the influenza-like symptoms, headache, fatigue, feeling cold, nerve pain, back pain and pain in thigh were recovering/resolving and the outcome of the weakness was unknown. It was unknown if the reporter considered the influenza-like symptoms, headache, fatigue, feeling cold, nerve pain, back pain, pain in thigh and weakness to be related to SHINGRIX. Additional details were provided as follows: Within 24 hrs after vaccination, the patient had flu like symptom headache, fatigue, feeling freezing cold, brief sharp nerve pain in her mid thigh and mid back radiating to the front body aches. The worst part was profound weakness where she could barely stand could not even make it to be seen at physician's office. The events was worst on 12th March 2019 into 13th March 2019. By 14th March 2019, the patient felt somewhat better. On 15th March 2019, the patient was seen in office day 5 back to herself. The reporter agree to follow up from GlaxoSmithKline.
17NOV95 pt felt ill was in bed sick w/a temp, nausea, & chills;started to feel better on 20NOV95;no treatment did not call A MD & took nothing;
Patient received the vaccination and was told to sit down in a waiting chair to be observed for adverse reaction for 15 minutes. Patient fainted and fell off the chair but remained conscious. Patient felt lightheaded and was sweating.
Migraine chest pain rapid heart rate 140-160 high blood pressure 157/102 dizzy  nauseous  had to go to ER
This spontaneous report as received from a physician via a company representative refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ZOSTAVAX. Dose, route, lot number and expiration date were not reported. On an unknown date the patients developed shingles after receiving ZOSTAVAX. The outcome of shingles was unknown. Additional information has been requested.
i had shingles. I had a shingle shot / suspected vaccination failure; shingles; pain was unreal; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had Shingles, the pain was unreal. The patient said that he or she never would like to want to go through that again. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Excruciating pain in chest.  Chest felt like it was going to "explode".  Took a few days for pain to subside.
Information has been received from a pharmacy student concerning a 67 year old female with urinary tract infection who on 25-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (lot number 659761/0157X). Concomitant therapy included MACROBID. On 25-APR-2008, the patient experienced extreme headache, aches in her neck, aches in her shoulders, aches in her wrists, inflammation of her knees and nausea. At the time of the report, the outcome of the events were unknown. The patient sought medical attention by calling the pharmacy. Additional information has been requested.
Went to the doctor on 12/21/2021; Diagnosis: cough and chest pain; Treatment plan: Wanted me to let it pass, but I  still feel achy; Did a Teledoc on 12/27/2021. Diagnosis: Bronchitis. Also developed diarrhea No F/u
gave an adult a pediatric vaccine; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (gave an adult a pediatric vaccine) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (gave an adult a pediatric vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (gave an adult a pediatric vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (gave an adult a pediatric vaccine).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Hospital Course and Significant Findings: Patient is a 89 Y female with history of HTN, urinary incontinence, history of COVID-19 in January 2023, who presented with generalized weakness, fall, who was admitted with severe sepsis with lactic acidosis due to pneumonia/aspiration. Sepsis resolved with antibiotics, fluids. Will finish course of antibiotics for pneumonia. Urine culture contaminated. Weaned off oxygen. PT recommending SNF
Bleeding/spotting between periods - currently 5 days of continuous, light bleeding 2 weeks before period should start.
forgot  second dose, initial vaccination in October 2021; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date in october 2021).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date: 17-MAY-2022 Reporter's comment: This case was reported by a consumer via call center representative. The patient received first shot of Shingles vaccine in October 2021 and completely forgot about the second vaccination. The patient said never received a reminder from the doctor office. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Pleural effusion, stomach/pelvic pain - ER visit - no treatment. Nausea, headaches, weight loss, anxiety, pericarditis, light sensitivity, sore muscles, back pain, no recovery, swollen lymph nodes, acid reflux - no treatment. Chest pain, confusion, rashes, fatique, fevers, migrains, bruises, neck pain, and vomiting. 7/23/10 swelling, insomnia, blood clots, and intestinal problems and earaches.
High fever, Tmax 105 degrees. Febrile seizure. Total symptoms 48 hours. Medical records state viral infection, agitation. msv
Pt. received flu vac on 9/16/10. She developed difficulty swallowing on 9/19 the awoke with red, raised rash on torso. It was pruritic. She is unable to think of another cause & has no constitutional symptoms. She took 2 BENADRYL on 9/21 & has significant improvement today.
Day 1 - HA, pain, Joint pain, constipation; Day 2 "more painful"; 14 days - chills, sweat, constipation. Narrative:
Migraine; Dizziness; Very low level of iron; very low level of vitamin; Pain; Fever; Body aches; Vomiting; Nausea; Tiredness; Chills; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Migraine), DIZZINESS (Dizziness), BLOOD IRON DECREASED (Very low level of iron), HYPOVITAMINOSIS (very low level of vitamin) and PAIN (Pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine), DIZZINESS (Dizziness), BLOOD IRON DECREASED (Very low level of iron), HYPOVITAMINOSIS (very low level of vitamin), PAIN (Pain), PYREXIA (Fever), MYALGIA (Body aches), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Tiredness) and CHILLS (Chills). At the time of the report, MIGRAINE (Migraine), DIZZINESS (Dizziness), BLOOD IRON DECREASED (Very low level of iron), HYPOVITAMINOSIS (very low level of vitamin), PAIN (Pain), PYREXIA (Fever), MYALGIA (Body aches), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Tiredness) and CHILLS (Chills) outcome was unknown.            No treatment medication provided. No concomitant medication provided.   Reporter did not allow further contact
25APR97 h/a PM;26APR inc temp, body aches, nausea;27APR sl redness on chest-described by pt-joint aches worsening;28SEP vomiting, fever 103.2-eval by MD AM;1MAY itchy rash;13MAY tired;
I got both vaccine less than one year I got the Shingles\ suspected vaccination failure; Shingles; suffering with nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got both Shingles vaccine less than one year got the Shingles. The patient was still suffering with nerve pain after three years. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Soreness at injection site, going on day 3 post injection. Extreme body aches starting at 9:00pm on day of injection up until morning of 3/5. Still some back soreness on 3/5
On 5/24/2021, Health Dept. was doing a vaccine clinic at facility. A 17 year old inmate was given Janssen vaccine.
This spontaneous report as received from a physician refers to a patient of unknown age. On 03-MAY-2013 the patient was vaccinated with the second dose of GARDASIL (lot# unspecified). On 05-MAY-2013, the patient developed a rash (described as a contact dermatitis) on the hands and face that had spread down to the knees. The outcome of the event was reported as not recovered. The patient contacted the physician. Additional information has been requested.
Fatigue; Stiff joints; achiness; This is a spontaneous report from a contactable consumer or other non-health care professional. A 51-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration, administered in arm left on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included root canal, dental pain from 06Jan2021 to 06Jan2021. Concomitant medications included azithromycin (AZITHROMYCIN) from 06Jan2021 to 10Jan2021. Vaccine administration at Military Facility. The patient was not been visit emergency room, physician room. The patient previously took BNT162B2, dose 1 single, for COVID-19 immunization. The patient experienced fatigue, stiff joints, achiness after 2nd dose for 3 days 12Jan-14 all day. For 2nd dose of COVID Vaccine, patient felt quite fatigued for 3 days. She missed work 2 days dur to extreme fatigue for 2nd Vaccine. The outcome of event was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Patient is describing a radiating pain down arm and numbness, also having difficulty using the arm. Can pinpoint to exact spot of injection.
no reaction to dose #1. Dose 2 date: Med Cen Feb 17 LOT # EL9262  side effect was fatigue. no missed work
Swollen red arm Dyspnea on exertion.....difficult to climb flight of stairs
Client vaccinated for Covid with J&J vaccine in February 2021.  Developed Covid symptoms on 11/4 - chills, nasal congestion, cough.  Received transfusion of monoclonal antibodies on 11/6 at home.
Sick from first 2 shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An adult female patient received BNT162b2, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick from first 2 shots".  Additional information: Patient stated that she got so sick from the first 2 shots  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reports rash on upper back, chest, arms. Multiple <1cm macular erythematous lesions on upper back, chest, arms, no pustules.
Patient received Shingrix and Prevnar 20 in the same arm on 4/4/23. Patient called the pharmacy on 4/10/23 stating that her arm had a red rash that was itching and burning. Patient went to urgent care and was told it was an infection from vaccination and was given Keflex.
Fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The pharmacist stated that the patient complained of fever after receiving the first dose of the vaccine. It was reported that in spite of having a fever, the patient came back and got the 2nd dose.  The pharmacist recommended Tylenol immediately before receiving the 2nd dose. No patient demographics were provided. This case has been linked with the case US2019109631, reported by same reporter.
ED visit to hospital admission for Community acquired bacterial pneumonia.  At the time of admission he was also requiring 4 L supplemental oxygen versus chronic 3 L supplemental oxygen at home to maintain oxygen saturations greater than 90%.  On 10/4/2021 WBC remained elevated but stable, CRP continued to trend down, and oxygen requirements returned to baseline 3 L/min.  Patient was transition to oral Augmentin and azithromycin, IV steroids were decreased in frequency, and patient continued on scheduled and as needed breathing treatments. He will be discharged on oral azithromycin for 1 additional day to complete a 5-day course, as well as an additional 6 days of oral Augmentin to complete a 7-day course. This visit was within 6 weeks of receivingthe COVID vaccine.
This case was reported by a nurse via sales rep and described the occurrence of vesicular rash in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 15th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vesicular rash and crust. The patient was treated with amoxicillin trihydrate (Amoxycillin). On an unknown date, the outcome of the vesicular rash and crust were unknown. It was unknown if the reporter considered the vesicular rash and crust to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX at the pharmacy. The patient developed a reaction crusted and fluid filled rash. The patient was seen in the office on 19th June 2018 and 25th June 2018. It was also stated in her (patient's) chart that the reaction could have been due to poison ivy. The reporter was unsure.  The patients was prescribed Amoxycillin. The reporter did not agree to follow up from GlaxoSmithKline.
Redness, swelling, itching, pain, and induration of left arm at injection site
BEEN IN BED SINCE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced bedridden. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bedridden was not reported. This report was non-serious.
Aside from common headache, pain at injection site and fatigue. Woke up from sleep unable to breath. I had a large amount of mucus blocking my throat and nose. Coughed up the mucus and was able to breath relatively normal but lungs still felt heavy and breathing was labored. Symptoms have mostly subsided for now.
body aches, chills, fever, diarrhea. Treatment- Tylenol, Ibuprofen Outcome- resolved
she gets sick after as she assumed that they are carrier of the virus; she gets sick after as she assumed that they are carrier of the virus; booster; 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 68 year-old female patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:01), administration date: 19Mar2021, for Covid-19 Immunization; Bnt162b2 (Dose Number:02, she got deathly ill for 2 days), administration date: 11Apr2021, for Covid-19 Immunization, reaction(s): "she got deathly ill for 2 days". The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "booster"; EXPOSURE TO SARS-COV-2 (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "she gets sick after as she assumed that they are carrier of the virus".  Additional information: Caller just wanted to know if she can receive another dose of the booster shot. She mentioned that she has underlying conditions. She said that when her grandchildren visit her, she gets sick after as she assumed that they are carrier of the virus. She also mentioned that, before the vaccine, she got deathly ill for 2 days, but she did not go to the hospital as she did not want to be "put on that machine or whatever". She just wanted to make sure she is protected as she mentioned that every time her grandchildren visits her, she is the only one who gets sick in her family. clarified that she just has a MI regarding receiving a 2nd booster dose, she had no adverse events. She wanted to have another visit with her grandchildren who are 7 years of age and 6 years of age, she calls them her COVID babies because every time they come over to visit, she gets sick after they leave, the next day or two. She declined to complete a report regarding getting sick after her grandbabies leave and stated that she just wants to know if she can get a 2nd booster shot. She did not get sick with the vaccines; she was happy with them, and she would get sick without them. She has not been sick, and she has not had any side effects. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Date and time adverse event started: 3/14/21, rash to right hand he has seen nurse for wound care/antibiotic therapy and have recommended hydrocortizone cream and triple antibiotic cream.
Patient called provider today to state she has had pain in the left arm since the vaccine and she has pain when she tries to lift her arm, for example pain with combing her hair. she denies swelling or redness at the site and denies numbness or tingling.