chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body ache; Arm was a real sore and bruised; arm was swollen and red; Chills; Headache; Arm was a real sore and bruised; arm was swollen and red; Arm was a real sore and bruised; arm was swollen and red; Arm was a real sore and bruised; arm was swollen and red; 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, Batch/Lot number was not reported) via an unspecified route of administration on 07Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced body ache, arm was a real sore and bruised, arm was swollen and red, chills, and headache. It was reported that this is my 1st shot, and the patient was just had a little concern, she took the Pfizer vaccine 2 days ago and noticed some side-effects like headache and body ache, my arm is a real sore, and bruised. She asks if there was anything she can do, take for it. This was the second day, today, chills, headache, her arm was swollen and red, she was trying to figure out was there anything she can do or take, and how long it will last. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Pt has a history of ESRD and is on hemodialysis.  She was admitted due to cholecystitis and incidentally was found to be COVID positive.
Patient presneted with redness in arm from shoulder to elbow, multiple bruises; was referred to a physician to determine if this was an allergic reaction (local) or cellulitis
Got the 2nd dose yesterday (26Mar2021) and Caller tested positive for Covid-19 today (27Mar2021); Got the 2nd dose yesterday (26Mar2021) and Caller tested positive for Covid-19 today (27Mar2021); This is a spontaneous report from a Pfizer-sponsored program.  This contactable consumer reporting the same events under the same suspect product for 2 patients. This is one of 2 reports.   This contactable female consumer (patient) of an unspecified age received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported. The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on unknown date (Batch/Lot number was not reported) as COVID-19 immunization. The patient got the 2nd dose yesterday (26Mar2021) and she tested positive for covid-19 today (27Mar2021). She mentioned that she had an exposure to her son who also tested positive after getting the vaccine. Outcome of the events were unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021364392 Same reporter, product and event, and different patient
This spontaneous report has been received from a nurse referring to a 12 years old female patient who was sexually active. The patient had neither medical history nor drug reactions/allergies. On 06-JUN-2016 the patient was vaccinated with the first dose of GARDASIL 9 (0.5 ml, lot # L040164, expiration date 20-FEB-2018) via intramuscular. Concomitant therapies included CLARITIN. On 06-JUN-2016, the patient developed redness the "size of a nickel" at the injection site. On an unknown date in June 2016 (reported as "as the week progressed") after receiving the GARDASIL 9 the patient developed swelling alongside of the redness at the injection site. Currently, the redness and swelling were the "size of a baseball". On 13-JUN-2016, the patient was seen in the physician's office and the treatment was given for the events. On 13-JUN-2016 the complete blood count (CBC) was performed which resulted normal. The outcome of the events were not recovered/not resolved. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to an adult patient of an unknown age and unknown gender. There was no information reported regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date the patient received a dose of a pediatric (25/0.5) VAQTA intramuscularly (lot# and expiration date were unknown by the reporter) instead of the adult VAQTA. The reporter did not report any adverse effects and did not provide further information. The action taken in regards of the event was not applicable. At the time of the report the outcome of the event was unknown.
I went to the hospital for an MRI for another health concern and found they an infection on my back and front hip area and leg. They called me and told me to go to the ER when they gave me my results. When I got to the ER, they did a CT scan and blood work. They sent me to the hospital, and they did more tests and another CT scan, they put in a drain to remove the infection, and gave me antibiotics.
severe itching & swelling @ site of inj;extending beyond site of inj x 3 days p/vax;
Pt. developed high fever 103.1 degrees F, vomited twice & developed a "pimple like" facial rash that lasted 2-3 hrs. Parent gave Ibuprofen every 4 hrs. Fever decreased, was low grade on 12/18 & gone by 12/19. Parents stated pt. slept a lot on 12/17 but is ok now. Parents stated the facial rash was similar to a previous rash pt. developed after using sunscreen. Pt. is feeling fine now no further f/u.
Information has been received from a Registered Nurse (R.N) concerning her 16 year old daughter with juvenile rheumatoid arthritis, and allergies to BACTRIM, ZITHROMAX, CECLOR, potatoes, tree nuts, peaches, pears and apples who in November 2008 was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  It was reported that the patient received the first dose of GARDASIL and has been sick for 6-8 weeks.  It was reported that the patient was fatigued, nauseous, vomited, stomach hurt and lost 8 pounds.  It was reported that the patient's stomach hurting was getting better but she was still fatigued and had not gain the 8 pounds of weight back that was lost. No significant disability was reported however the patient has seen three unspecified physicians and has missed school.  A gastrointestinal work up, allergy work and blood work were performed (results not provided).  It was reported that the patient saw the pediatrician on 10-MAR-2009.  It was reported that the patient took one pill of an unspecified "gastrointestinal medication" that gave the patient a bad stomachache.  It was reported that the "gastrointestinal medication may have been PREVACID or gastrointestinal pills (MSD).  Additional information has been requested.
Early onset of menstrual period when unexpected, increased intensity of menstrual symptoms (fatigue, cramps), ongoing and prolonged menstrual cycle.
side effects; ear ache; sore throat; headaches; aching all over; malaise; fever; CHILLS; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced adverse drug reaction, ear pain, sore throat, headache, fever, chills, muscle pain, general body pain and malaise. On an unknown date, the outcome of the adverse drug reaction, ear pain, sore throat and headache were unknown and the outcome of the fever, chills and muscle pain were recovered/resolved and the outcome of the general body pain and malaise were not recovered/not resolved.   It was unknown if the reporter considered the adverse drug reaction, ear pain, sore throat, headache, fever, chills, muscle pain, general body pain and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient stated that had every side effect but also had ear ache, sore throat and headaches. The fever, chills and muscle aches lasted 4 days. At the time of reporting patient stated that still aching all over and just a feeling of malaise. The patient was not sure if want to take the 2nd dose if will have a reaction like this. The patient cannot take medrol dose pack due to adverse reactions. The patient asked for the suggestions. The patient asked if I do not take the 2nd shot how much of efficacy can I expect from one dose of the Shingrix.
shingles after receiving the first dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix and experienced shingles. Reporter consented to follow up.
respiratory illness  Cough -     benzonatate (TESSALON PERLES) 100 mg capsule; Take 2 capsules (200 mg total) by mouth 3 (three) times a day as needed  for cough for up to 7 days Increase fluids. Can honey and honey tea as needed. Can use OTC allergy medications like Claritin, Zyrtec and Allegra as needed. OTC Tylenol or ibuprofen for fever, discomfort.     Recommended saltwater gargles, nasal saline sprays, humidifier and vapor rub at night.  If symptoms persist without improvement over the next 2-3 days despite above treatment, follow-up with PCP for further evaluation.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with ROTATEQ (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (Same reporter link). Additional information has been requested.
This case was reported by a consumer and described the occurrence of rash in a female subject of unspecified age who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent vaccination included pneumococcal vaccine (manufacturer unspecified) given on an unspecified date in 2002 (same date of flu vaccine administration). In 2002 the subject received unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced rash. At the time of reporting the outcome of the event was unspecified.
Nose Bleeds . Facial Rash . Red blotchy skin. Lump in neck on the right side  Sore throat . Extreme fatique  .
Gave this patient MMR-V (Proquad) in error, instead of giving M-M-R. Also gave varicella. This resulted in a double dose of varicella.
Seen @ ER on 13DEC91 w/fever of 104; Fever started 11DEC91 fever not responsive to APAP, sponging; pt lethargic; recvd APAP;
first vax was arm soreness and about a week of fatigue; first vax was arm soreness and about a week of fatigue; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: er8730) via an unspecified route of administration (At the age of vaccination 57-year) in Left Arm on 25Mar2021 08:45 as 1st dose, single dose for COVID-19 immunization. Medical history included fibromyalgia, hypersensitivity Allergies to codeine, levaquin, cipro, sulfa, antibiotics, shrimp. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced first vax was arm soreness and about a week of fatigue. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 14May2021. The seriousness of the event was reported as non-serious. The clinical outcome of the event was not recovered.  Follow-up attempts are needed. Further information is expected.
I'm not sure if this is the right form for me to report getting Covid. I've had both vaccines and two booster shots. My covid symptoms started on the morning of 6/18/22. I tested positive with an antigen test.
arm hurt a little; fibromyalgia; Shivering; canker sores; felt icky; This is a spontaneous report from a contactable consumer (parent). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunisation. The patient's medical history included auto-immune diseases. Concomitant medications were not reported. On an unspecified date, after vaccination, the patient experienced fibromyalgia, shivering and her arm hurt a little after receiving the vaccine, a week and a half later got canker sores and felt icky for a day or two. The clinical outcome of all the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Patient received expired dose of IPOL vacine with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional and physician via Medical Information (MI) (Reference number- 00567207) and transmitted to Sanofi on 19-Apr-2021.  This case involves a 4-years-old female patient who received expired  0.5 mL fourth dose of IPV (VERO) [IPOL] vaccine (frequency: once, Strength: standard, batch number: R1B25 and expiry date: 13-Mar-2021) via intramuscular route at the right thigh (expired product administered) on 13-Apr-2021 for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  List concomitant or no other vaccines reported as DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and CHICKENPOX.  It was a case of actual medication error due to expired vaccine used.   At the time of reporting, reporter questioned that, what do to if 8 patients got expired IPOL vaccine.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
She got her vaccine, (previous cancer patient with no involvement in lymph nodes).  It didn't hurt, she felt nothing.  About 3-4 days later started having vertigo.  It was really bad for about 4 weeks after the first shot.   Two days after the 5th week she was feeling a little bit normal, but has the lynching forward feeling but has to use a walker to get around, and used to walk all the time in the neighborhood but cannot now.  She had lifted up her left foot and fell over and did not know if she had blacked off or not, but had fallen on the street and had to holler for help.   She went to the pharmacy at an outside window about 3 1/2 to 4 weeks later as somebody mentioned Meclizine was for dizziness, and he gave that to her.  She has been taking that and that has not helped and took it for 5-6 days.  Her ears felt stopped up badly.  She also started taking Claritin with the Meclizine to help with the stopped up ears, which has  helped.  She did not take any OTC medicine until 4 weeks after the vaccine.  She has an APT with an ENT tomorrow.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 08-JUNE-2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also knows as shingles and other complications. On or about 27-NOV-2015, the patient was treated at a medical facility for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Injection site pain Headache with ?brain zaps? for a period of 2+ hours Joint pain over entire body Chills with severe trembling  Fever Vomiting for a period of hours Severe itching on my back, shoulders and upper arms for two days
Headache, Myalgia, Dose 1: body aches and extreme fatigue
redness, tenderness, swelling over rt deltoid 6x8cm;subsided over the following days;
On 8/21/18, patient experienced fever, chills and "white spots near injection site." Pt was counseled on management - antipyretic PRN, topical BENADRYL, ice pack, and to monitor.
Extreme thirst for 3 days; Extreme energy/hyperactivity for 2 days; Insomnia for 3 nights
Patient was found deceased as reported via phone call by a member of the police department. No details were provided by the individual.
Pt said liquid hurt when it went in her arm. Swollen in 2 days - MD said to treat w/ heat called RpH on 8/24/12 & we told her to ice the area.
Vaccine administered 10-11. On 10-16 woke with (R) upper arm (deltoid) swelling, warmth, tenderness. Rx warm packs and Keflex. Improved by 10/18.
Steady degradation into flu-like symptoms, very noticeable starting around April 4th.  Intermittent fever feeling, muscle pain (chest, neck...) congestion in ears and nose, runny nose, tearing eyes, coughing, sneezing... somewhat similar to reaction following last immunization round in June 2013.  No formal treatment to date, but strongly considering a visit to an urgent care clinic.
Had them after Shingles shot/Suspected vaccination failure; Had them after Shingles shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles prior to the vaccine).   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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had them twice. The patient had second time after shingles shot. No near as severe as the first time. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sore arm x1 day; day of onset= 1 day post vaccine  sore throat x 2 days; day of onset= 1 day post vaccine  cough x 4 days; day of onset= 2 day post vaccine; cough worsened on day 3 fever x3 days; day of onset= 1 day post vaccine  congestion x 4 days; day of onset= 1 day post vaccine  headache x 2-3  days; day of onset= 1 day post vaccine  fatigue x 2 day; day of onset= 1 day post vaccine
Redness and warmth in the region of injection site, drew line around it 2/28 and then another line drawn by ARNP as redness had advanced on Friday at appointment. Prescription for antibiotics issued and filled 3/2 (today) with request to patient to follow up on how it resolves in the coming days.
Soon after vaccine rash on face , next day entire face covered in rash and red certain spots looks like mini hives but not itchy; Soon after vaccine rash on face , next day entire face covered in rash and red certain spots looks like mini hives but not itchy; Soon after vaccine rash on face , next day entire face covered in rash and red certain spots looks like mini hives but not itchy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Jan2022 15:45 (Lot number: 33036bd) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 10Jan2022, outcome "not recovered", ERYTHEMA (non-serious), URTICARIA (non-serious) all with onset 11Jan2022, outcome "not recovered" and all described as "Soon after vaccine rash on face , next day entire face covered in rash and red certain spots looks like mini hives but not itchy". Therapeutic measures were taken as a result of rash, erythema, urticaria.  Additional information: No covid prior vaccination. No known allergy. No other vaccine in four weeks, no other medications in two weeks. Ae treatment: Applied Benadryl day 1 and hydrocortisone cream day 2. No covid tested post vaccination.