chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had gout days after receiving the vaccine; A spontaneous report was received from a consumer, concerning a male patient who received Moderna's covid-19 vaccine (mRNA-1273) and had gout days after receiving the vaccine.  The patient's medical history and concomitant medication was not provided.  On 11 Feb 2021, prior to the onset of event, the patient received first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of covid-19 infection.  On 14 Feb 2021, the patient developed gout days after receiving the vaccine.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event had gout days after receiving the vaccine was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested as patient's medical history, clinical presentation and diagnostic results are lacking.; Sender's Comments: 24 Feb 2021: The start date of event was captured as 14 Feb 2021, as per narrative (kindly reassess)
Information has been received from a physician referring to a 2 month old infant patient of unknown age. On 12-FEB-2015, the patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX (lot#, dose and route not reported). No adverse effect was reported. Additional information has been requested.
pt recv vax 15MAY98 & 1JUN98 mom noticed rash;pt was seen by MD;MD noted 5-6 vesicular lesions on face, legs;MD noted chickenpox rash/secondary to vax;resolving;
Received Fluval vaccine at 12:30 pm 11/2/2009. At 6:00 pm noted chest tightness and throat tight. Refused to go to ER. 9:30 pm felt better. No treatment. Not further problem.
The needle came apart from the hub when injection was being given.  Patient received a partial dose.  A second dose was given on 11/3/21.
Information has been received from a health professional concerning a 4 year old male who on 02/02/98 was vaccinated with one dose of varicella virus vaccine live (site unknown). Subsequently, it was reported that on 05/30/01, the patient was diagnosed with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the Spring of 2001, there was a very large chicken pox outbreak. It was not specified whether or not the patient had an exposure to these cases. The reporter also indicated that the vaccines was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases. Subsequently the patient recovered. No further information is available.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received Shingrix for prophylaxis. On 5th October 2018, the patient received Shingrix. On 5th October 2018, unknown after receiving Shingrix, the patient experienced extra dose administered. In October 2018, the patient experienced fever, general body pain, headache and fatigue. On an unknown date, the outcome of the fever, general body pain, headache, fatigue and extra dose administered were unknown. It was unknown if the reporter considered the fever, general body pain, headache and fatigue to be related to Shingrix. Additional details were provided a follows: The patient reported that a couple days later after receiving Shingrix vaccine the Medical doctor office called to tell her that they mistakenly had given her a third dose of Shingrix at that time, which led to extra dose administered. Less than a week after receiving vaccination, the patient had experienced headache, extreme fatigue, body ache and fever. The reporter was unable to provide phone number or address for a physician since she was driving. The reporter was also unable to give dates of the first two doses of Shingrix.
Next day developed chills, diaphoresis, stabbing pain in fingers and toes, joint pains in shoulders and hips, pain at prior surgical scars/sites, generalized muscular pain and stiffness. Fever.
pt recv vax 1130AM; mom called 1225PM; pt had been crying for 45mins-unable to be consoled & refusing bottles; mom instructed to give APAP; checked w/mom @ 1PM pt less fretful, taking bottle; 430Pm pt sleeping;
Client reports that at 10 days post vaccination he became "sick" sx included nausea, vomited and fatigue - denied fever. States missed a week of work, but "I'm fine now." Injection site without any visible redness or blistering.
I had a swollen mass on the right side of my neck, near where the jaw and neck meet. It was tender for a couple of days before I sought treatment. It was determined that I had an infected lymph node and I was given antibiotics.
PT recd a series of 3 Engerix-B vaxs, 1cc, IM, deltoid, on 22NOV89, 3JAN90, & 20MAY90; PT did not seroconvert;
fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and MYALGIA (body aches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FATIGUE (fatigue) and MYALGIA (body aches). At the time of the report, FATIGUE (fatigue) and MYALGIA (body aches) outcome was unknown.           It was reported that patient was on concomitant medications for years. Treatment medication was not reported.   This case was linked to MOD-2021-407115, MOD-2021-407241 (Patient Link).
Pt w/allergic rhinitis was skin tested w/rubella vax because of "unstated problem" w/MMR vax as child (WAES91021329); A prick test & an intrademal skin test were conducted & both were positive w/local swelling, redness & itching;
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. An adult female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 18Aug2021 12:00 (Lot number: ew0196) as dose 2, single and administered in arm left, administration date 28Jul2021 12:00 (Lot number: ew0191) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "recovered with sequelae", COVID-19 (medically significant) with onset 25Aug2021 14:00, outcome "recovered with sequelae" and all described as "I also contracted Covid"; HERPES ZOSTER (non-serious) with onset 25Aug2021 14:00, outcome "recovered with sequelae", described as "shingles"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 25Aug2021 14:00, outcome "recovered with sequelae" and all described as "Lost of taste and smell". The events "i also contracted covid", "i also contracted covid", "shingles", "lost of taste and smell" and "lost of taste and smell" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, herpes zoster, ageusia, anosmia. Clinical Information: Patient developed shingles exactly 10 days after the second vaccine. She also contracted Covid and had well pronounced symptoms that lasted longer than 5 days. Lost of taste and smell. AE treatment was Valtrex. Device date was 13Jan2022. No follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine, on or about 06-JUN-2011, at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and subsequently the patient contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2017, the patient was treated at a medical center for a blistering vesicular outbreak that 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.
Fever, difficulty swallowing, general allergy symptoms: itching, sneezing, cough.  Heat feeling from site up into neck, and down upper arm X24 hours  All of these occurred even after taking antihistamine and ibuprofen every 4 hours after injection.
patient developed localized reaction of 8.5 cm by 3 cm after administration of the pneumonia 20 vaccine and the influenza vaccine on the same day
4/25/07 Rash ? chickenpox on face, trunk, back and feet.
A non-serious spontaneous report of gave H1N1 LAIV to person >49 years old was received from a registered nurse/healthcare professional concerning a 55-year-old male. No relevant medical history was reported for this patient. On 23-Nov-2009 the patient inadvertently received H1N1, Intranasal. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
SORE THROAT AND BY THE THIRD DAY HAD SWELLING OF FACE AND LIPS I  IMMEDIATELY STARTED BENADRYL  THE SWELLING TOOK ABOUT 3 DAYS TO COMPLETELY GO DOWN DOCTOR RECOMMENDED NOT TO RECEIVE ANOTHER DOSE
Injection site reaction-quarter sized redness, swelling, redness warm to touch, some pain/discomfort; No shoulder pain; No fever/chills. No numbness
Fever is really high like 100 and 101 constantly; Bedridden and can't move; Really in pain in her head, body and eyes; Really in pain in her head, body and eyes; Really in pain in her head, body and eyes; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date was unknown), via an unspecified route of administration on 04May2021 at 12:00 (at the age of 33-years-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Other products and patient history not provided. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunization. The patient was calling about the Pfizer vaccine she clarified the COVID vaccine. The patient received her dose yesterday, at 12 in the afternoon and it had been about 26 hours since she got the second dose. Attempted to clarify what caller had said due to call being inaudible for a moment. She got a fever last night after 12 hours and the fever was really high like 100 and 101 constantly. The patient wanted to ask if it was normal or if she should do something about it and she had been bedridden and could not move. She was really in pain in her head, body and eyes. The patient was on a different call. That call got dropped. The patient was waiting to talk to a medical representative through Pfizer. Attempted to clarify with caller which department caller was talking with at time of disconnect. Caller clarified that it was a constant message being played then the call dropped. The patient underwent lab tests and procedures which included body temperature: high (100 - 101 constantly) on 04May2021. The outcome of events was unknown.  PSCC Communication: Asked caller if she would like to complete a safety report and stated if that helps in reporting official, to get her help, she would complete the report. Made caller aware that she does not have to fill out the report and that she could be directed to medical information if she would like further information regarding side effects of the vaccine. Informed caller that we would not be able to give her medical advice over the phone and that we suggest she contact her primary health care provider if she had further questions about what she should do next. Caller asked to be sent back to the line where she was holding for her questions. Re-attempted to explain to caller that we suggest she reach out to her doctor with any medical questions she may have. Medical information may only be able to provide her with information regarding side effects in relation to the vaccine.   No follow-up attempts are needed. No further information is expected.
Needle inserted into patients L thigh, but vaccine was not administered.  Patient slapped the syringe and the needle bent.  RN was able to remove entire needle.  Small scratch noted on L thigh.
pt reports tremors & nystagmus 1wk p/vax;pt also recv flu vax somewhere in close proximity to that date;
Tenderness at injection site; Body ache; Burning sensation on feet; A spontaneous report was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness at injection site/ vaccination site tenderness, body ache/myalgia and burning sensation on feet/ burning sensation.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.On 16 Feb 2021, the patient experienced the event(s) tenderness at injection site for 2 days. On an unknown date, the patient experienced body ache and burning sensation on feet. Treatment details included paracetamol and ibuprofen.  Action taken with mRNA-1273 in response to the events was unknown.  On 18 Feb 2021, the outcome of event tenderness at injection site was resolved. The outcome of events  body ache and burning sensation on feet were unknown.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 17-year-old female patient who received MENVEO (batch number X15019, expiry date 30th October 2017). On an unknown date, the patient received MENVEO .5 ml. On an unknown date, an unknown time after receiving MENVEO, the patient experienced injection site pain and inappropriate preparation of medication. On an unknown date, the outcome of the injection site pain and inappropriate preparation of medication were unknown. It was unknown if the reporter considered the injection site pain to be related to MENVEO. Additional details were received as follows: The patient received only the diluent portion of the MENVEO vaccine in left thigh, which led to an inappropriate preparation of medication.
Arm soreness, runny nose, body aches, fatigue, lump in left arm pit
hemiparesis on the right side she couldn't feel the entire side of her body including tongue her face and her nose; crushing chest pain; bilateral weakness of the hands and arms weakness on the legs; extreme exhaustion; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  An 8 year-old female patient (age from 6-10) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEMIPARESIS (medically significant), outcome "unknown", described as "hemiparesis on the right side she couldn't feel the entire side of her body including tongue her face and her nose"; CHEST PAIN (non-serious), outcome "unknown", described as "crushing chest pain"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "bilateral weakness of the hands and arms weakness on the legs"; FATIGUE (non-serious), outcome "unknown", described as "extreme exhaustion".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the event Hemiparesis and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
It was basically a Rosacea flare up. I have been getting them on and off. On June, I finally called the doctor, and in September I got referred to a Dermatologist, who diagnosed the Rosacea. He prescribed a cream, which is Azelaic Gel, and it seems to be helping. I just got prescribed that in September.
Information has been received from a 59 year old female with asthma, high blood pressure, migraines, heart problem and penicillin, tetracycline, contrast x ray dye, "neuvain", morphine and spiriva allergies, who on 06-APR-2009 was vaccinated with a dose of PNEUMOVAX. Concomitant therapy included azithromycin prescription give to her the same day since her cat bit her, and many other medications which were unspecified. The consumer reported a couple hours after receiving PNEUMOVAX she experienced redness at the injection site that went into the soft tissues of her arm, chills that were so bad she went to bed with every warm thing she had plus a heating pad, had bone aches that hurt so bad she took pain pills, and she also had a headache. The consumer reported that she saw her physician on 08-APR-2009 and the physician stated that the patient experienced an allergic reaction to PNEUMOVAX, but since she took azithromycin later that night on 06-APR-2009, it helped her experience. Consumer reported that on 08-APR-2009 she still could not write,  but she was improved. No laboratories studies performed. The patient was recovering. Additional information has been requested.
Patient received Meningococcal Polysaccharide A,C,Y,W-135 TT Conjugate vaccine, vaccine leaked out from the syringe during administration. Per PCP she recommends that we give the patient a second dose. Manufacturer was called after incident and they stated that 76.9% of patient that did not receive a second did not have a reaction to the vaccine and the 30 % that reported a reaction was  fever,pain and redness at the site of the injection. Patient will be scheduled to receive a second dose of the vaccine. All needles with the same lot number were pulled from the clinic-Multiple 25g needles were assessed and tested and were unable to pull up liquid or administer liquid.
sharp shooting quick quick pain to left collarbone and red itchy blotch at vaccine site delayed 8 days after 1st Moderna vaccine
Patient had a 8 1/2 cm by 12 cm size reaction to DTaP vaccine 2 days after given.  BENADRYL and MOTRIN for pain.
vaccination site swelling; Vaccination site erythema; Had flu like symptoms; Tingling in one arm for several days, then tingling in other arm and recently in legs above the knee, upper thigh; Very bothersome and annoying; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Had flu like symptoms), PARAESTHESIA (Tingling in one arm for several days, then tingling in other arm and recently in legs above the knee, upper thigh), FEELING ABNORMAL (Very bothersome and annoying), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant medication information not provided.  Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) and SIMVASTATIN for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Had flu like symptoms), PARAESTHESIA (Tingling in one arm for several days, then tingling in other arm and recently in legs above the knee, upper thigh) and FEELING ABNORMAL (Very bothersome and annoying). On an unknown date, the patient experienced VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Had flu like symptoms), PARAESTHESIA (Tingling in one arm for several days, then tingling in other arm and recently in legs above the knee, upper thigh), FEELING ABNORMAL (Very bothersome and annoying), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-071105 (Patient Link).
This spontaneous report was received from a pharmacist refers to an approximately 68 year old patient (gender unknown). No relevant medical history of the patient was reported. On 24-JUL-2014 (also reported as 10-APR-2014) the patient was vaccinated with ZOSTAVAX (lot # J000432, expiration date: 10-APR-2014) 0.65 ml, subcutaneous. There were no concomitant medications reported. It was reported that on 24-JUL-2014, the patient inadvertently received an expired dose of ZOSTAVAX that had an expiry date of 10-APR-2014. There were no adverse effects reported. It was unspecified whether the patient had sought any  medical attention. There was no product quality complaint involved. The outcome of inadvertently received an expired dose of ZOSTAVAX was unknown. Additional information has been requested.
Daughter called said mom had Rxn to shot at the site -swollen, red, elevated, hot to touch and painful. M.D. prescribed antibiotic, oral steroid and antihistamine. (If gets worse MD told pt to go to hospital. Pt. Daughter called 10/27/16 9pm).