chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse, who knew it from one of her fellow nurses, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of GARDASIL and a dose of FLUZONE. On the same date the patient experienced an unspecified reaction. The outcome of unspecified reaction was unknown. The causal relationship was not provided. Additional information has been requested.
Two days post vax, the pt developed tiredness and swollen right thigh. Physician's impression was local reaction to IZs.
Information has been received from a physician and an other health professional concerning the physician's 2 year old son who on 04-Aug-2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#654042/0663F).  On 04-Aug-2006 the patient experienced an injection site rash and out of the normal swelling.  Redness was also noted.  Subsequently, the patient recovered.  Medical attention was not sought. No additional information is expected.
MODERN 0.5 ML FOR IM LOT 020B21A EPX:09/23/2021 No known adverse events.
Pt was given flu shot in L delt. said she was fine to leave on her own.  She went to the front desk to check out and apparently became faint- she hit her head on the wall-(I did not witness this event)-911 was called Pt was taken to ER. She vomited.
headache; fatigue; low grade fever; chills, shivering; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 09Apr2021 at 15:45(at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included HPV, spinal issues, acid reflux and COVID-19. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021 at 07:00 the patient experienced headache. fatigue, low grade fever, chills, shivering and diarrhea. On 12Apr2021, the patient underwent DNA genotek oracollect(COVID test) and the result was unknown. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events headache. fatigue, low grade fever, chills, shivering and diarrhea were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
SQ injection site. Left arm very sore for 3-4 days. No treatment.
flu; Initial information received on 20-Feb-2022 regarding an unsolicited valid Social Media non-serious case from a Patient.  This case involves a male patient of unknown age who experienced flu while receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (dose, form, route, strength, batch number and expiry dates: unknown) in an unknown administration site for immunization. Information on batch number has been requested.  On an unknown date the patient developed  flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Periods of involuntary muscle contractions/ twitching in the arm the injection was given in. Three episodes happened over the course of two hours, each lasting for about 1 minute. No further problem after 6 AM.
Felt sick for three days after vaccine and then starting 7 days after vaccine, symptoms began. Speech was affected and words were jumbled and not coming out right. Severe body tremors started affecting walking and doing daily tasks  Severe body and joint inflammation started. Extreme tinnitus and severe headaches with eye issues.  Memory was affected with lapses of time when I could not remember what I was doing or trying to do.  I was very spacey and my brain was in a fog.  Ocular migraines and vision issues started happening.  By June 15th I went to my doctor and admitted to Urgent Care ER for CBC blood work and CT scan.  Results were non conclusive.  Suggested that I get an MRI done. I did on June 20th. Also chest pain + shortness of breath
Extreme fatigue, cold sweats for greater than 12 hours, pain in hips, thighs, and legs, inability to focus, very foggy for greater than 12 hours
Burning and itching at site, increased blood pressure, redness and burning down both arms, redness in face, hot, sweaty, and cold
Large raised red area on arm.  2" x 3"  Very itchy.  Had vaccine on 2/25 and red area began on 3/5 and as of 3/7, is getting bigger.   Skin is warm to the touch and slightly firmer than surrounding skin.     I have also been more tired than usual since shot.
03/18/2022 - 4pm - Slight pain and discomfort in back,chest and was unable to sleep that night. 03/19/2022 - Pain worsened. In the afternoon, I went to emergency care, they referred me to Hospital emergency care. Later they diagnosed that I have developed pulmonary embolism (PE).
Fever; Patient got where patient got a shot is like a little red and it looks like a tiny rash but not itchy; Patient got where patient got a shot is like a little red and it looks like a tiny rash but not itchy; This is a spontaneous report from a contactable consumer (patient). A 32-year-old patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0185), via an unspecified route of administration on May2021 (age at vaccination: 32 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EW0162), dose 1 via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that I just had general question. So I got my second Pfizer vaccine (Further clarification was unknown hence captured as unspecified vaccine) shot last week which is fine I had you know like a normal side effect just having a fever and all that but today I got where I got a shot is like a little red and I know that a little common too, it looks like a tiny rash but not itchy or anything and I know a lot of people who got that too which must go away in few days but my real question is I am about to get a tattoo in two days in the spot that where I got a shot. So I gone an ask you I do not if something you know but I just take a call to Pfizer the number anyway, if the redness is went away on that day I can go ahead and get my tattoo or should I just wait a little bit longer or there is any guideline for anything like that mention. I had tattoo schedule in two days and I do not know how long this rash last but if it go it tomorrow but I just wanted to confirm that how long does redness go away to get a tattoo where I got a shot or should I been waiting longer? If I do that. It should be today but it could appeared yesterday I have no idea and its a very small not itchy its just overall red that you touch it I heard that a lot of people have it and it went away in couple of days. I would just say that its today. The patient reported that when last week i got and then there was no more content, the week later I have this red spot." The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous report was received from a medical assistant concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported. On an unknown date, the patient might have received one improperly stored dose of VAQTA (lot number reported as M033334, expiration date 11-AUG-2018, dose and route were not reported), RECOMBIVAX HB (lot number reported as M033611 and M036459, expiration dates 30-MAR-2018 and 18-JAN-2018, dose and route were not reported), ROTATEQ orally (lot numbers reported as M007307, M031651 and M016918, expiration dates 30-NOV-2017, 30-MAR-2018 and 15-FEB-2018, dose was not reported) or GARDASIL 9 (lot numbers L037554 and M020103, expiration dates 25-DEC-2017 and 15-FEB-2018, dose and route were not reported). The medical assistant reported that she was not sure which of the vaccines received the patient. The temperature exposure was between 32°F and 36°F and the time frame was 14 days. There was not previous temperature excursion, and a data logger was involved. No adverse effects were reported. A product quality complaint was not involved. Lot numbers M036459 and M033611 are invalid lot numbers for RECOMBIVAX HB, and lot number M033334 is an invalid lot number for VAQTA. Additional information has been requested.
Dizziness; Pain in her arm; Felt weak/Didn't feel energetic; Didn't feel good; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in her arm), ASTHENIA (Felt weak/Didn't feel energetic) and FEELING ABNORMAL (Didn't feel good) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in her arm), ASTHENIA (Felt weak/Didn't feel energetic) and FEELING ABNORMAL (Didn't feel good). At the time of the report, DIZZINESS (Dizziness) and PAIN IN EXTREMITY (Pain in her arm) had resolved and ASTHENIA (Felt weak/Didn't feel energetic) and FEELING ABNORMAL (Didn't feel good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was not provided.    This case was linked to MOD-2021-290867 (Patient Link).
Fever, chills, vomiting, muscle aches, headache on day 1. On day 2, fever, fatigue, and headache. Dose site is extremely sore and red and hot and over 3-4 inches. It is still very sore on December 10, 2018.
This case was reported by a nurse via call center representative and described the occurrence of redness of legs in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced redness of legs and swelling of legs. On an unknown date, the outcome of the redness of legs and swelling of legs were unknown. It was unknown if the reporter considered the redness of legs and swelling of legs to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that a pediatric patient had an adverse reaction included redness and swelling from knee to thigh. The reporter did not currently have the patient demographics or vaccine information, but would be available to get the information. The healthcare professional would be submitting follow up with more details. This was one of 4 cases, reported by same reporter for same events.
pt devel an immed rxn p/24hr;it was a bulliform, intensively pruritus less pruritic rash total body distribution sparing the face & palms & soles of hands & feet;appearing measles type rash on body;
pt recv vax & devel a razor type rash, as well as some swelling on lateral upper torso just below armpit;
rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: rash). The outcome of the rash was not reported.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     It was unknown if the company considered the rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient had shingle vaccinated and he/she had the symptoms was bad except the rash cause his/her dermatology detected and prescribed him/her the medication. The patient supposed to have it in December the second dose and he/she forget ready past six month after the first one that still had the chance to have the second one.
Initial information received on 10-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old female patient who was vaccinated with an 0.5 ml expired dose of MENACTRA (Batch number: U5513AA and expired date: 09-Mar-2018) (dose in series and route was not reported) in the right deltoid on 09-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used because patient was administered expired MENACTRA yesterday on 09-Aug-2018. It was unknown if any adverse event was occurred or not following the vaccination. 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 Directive 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. Documents held by the sender: None.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 26-JAN-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
This spontaneous report was received from a female patient of unknown age who is also a physician referring to herself. The patient did not have pertinent medical history and not drug reactions or allergies. The physician reported that she received an unspecified number of doses of unspecified MMR II (manufacturer unknown) vaccines for prophylaxis on an unspecified dates in 1977 and 1978, and due too poor quality documentation in her medical records, the physician was uncertain whether she received separate doses of ATTENUVAX, MERUVAX II and MUMPSVAX (strength, doses, frequencies, routes, anatomical locations, lot numbers and expiration dates were not reported), or whether she received doses of MMR or MMR II (strength, doses, frequencies, routes, anatomical locations, lot number and expiration dates were not reported). The physician did not have her medical records and was required to have titers drawn on an unspecified date in May 2015, which showed that her titers were "too low" and therefore negative for immunity to MMR II. As as result, the physician was then administered a dose of MMR II (strength, doses, frequencies, routes, anatomical locations, lot numbers and expiration dates were not reported). There was not concomitant medication. Subsequently, on an unknown date in 2015, 12 to 14 days after she received the dose of MMR II, she experienced severe pharyngitis, rhinitis and conjunctivitis which progressed to sinusitis. The patient sought medical attention on an unknown date through visited her physician and was prescribed AUGMENTIN (strength, dose, frequency and route were not reported). On the other hand, on an unspecified date in June 2015, the physician's titters were re-drawn, which showed she was immune to mumps and rubella, but not to measles described as "0.2 away from being immune". The outcome of measles antibody negative was not recovered/not resolved. The outcome of mumps antibody test negative and rubella antibody negative was recovered/resolved on an unspecified date in June 2015. The outcome of pharyngitis, rhinitis and conjunctivitis was unknown. The reporter considered conjunctivitis, rhinitis, pharyngitis and sinusitis to be not related to MUMPSVAX, MMR, MERUVAX II and ATTENUVAX. The relatedness between measles antibody negative, mumps antibody test negative and rubella antibody negative and therapy with MMR II, MUMPSVAX, MMR, MERUVAX II and ATTENUVAX was not reported. Additional information is not expected because the reported wanted to remain anonymous and her contact details were not provided.
Forgot to get her second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Forgot to get her second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination.     The patient's past medical history included Exposure to COVID-19.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Forgot to get her second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Forgot to get her second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not provided.
Same day  - pain at the injection site, slight swelling 1/1/2021 - headache, fatigue, nausea, diarrhea,
Patient presents to ED w/ chief complaint of numbness.   Symptoms started as back pain with numbness to R middle finger.  Symptoms progressed to  Numbness of bilateral legs and face.  +fatigue, exhaustion, weakness in fingers, mild SOB.
After administration of GPV, patiient expressed feeling weak and nausea. Provider was notified and patient was taken to tx room. Initial BP was 104/69; dropped  94/52; NS 500ml was ordered + bolus: between 11:30-11:40; patient improved, was alert.
Pneumococcal vaccine given on 10-18-08 at approx. 1530.  Associate came back to the Infection Control office on 10-20-08 at 0900 with erythema, warmth, swelling and induration at injection site. Associate also reported a fever on the prev. day.
This case was reported by a consumer via call center representative and described the occurrence of listless in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced listless, fever, injection site pain and influenza. On an unknown date, the outcome of the listless, fever, injection site pain and influenza were recovered/resolved. It was unknown if the reporter considered the listless, fever, injection site pain and influenza to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however it could be 83 or 84 years. Within approximately two hours after receiving SHINGRIX, the patient experienced pain at the injection site. The evening after receiving SHINGRIX, the patient began to feel listless like he had a mild flu, and a low-grade fever. All of the symptoms were resolved within two to three days. The reporter gave permission to contact their physician. The reporter was unable to provide additional information. This case has been linked with cases US2018153593 and US2018153589, reported by same reporter.
She was tested positive with corona virus; she ended up in the hospital and had pneumonia for 7 days.; 2nd dose is supposedly on 21Apr but she missed; 2nd dose is supposedly on 21Apr but she missed; This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer (patient) reported that a 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 21Mar2021 as 1 st dose single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got her first dose of bnt162b2 last 21Mar2021 and second dose was supposedly on 21Apr21 but she missed it because 3 days later (24Mar2021) after her first dose she got sick (chills) and tested positive for the virus on 31Mar2021, she ended up in the hospital and had pneumonia for 7 days. Second dose was supposedly on 21Apr2021 but she missed. On 24Mar2021, the patient had a contact with someone with covid and on 31Mar2021 she was tested positive with corona virus. The patient added that she was experiencing pains and was hospitalized for 7 days. The patient went to her doctor, told her she could already get her second dose. However, a clinic told her she should wait for 90 days after hospitalization before she could get her second dose. Asked if she really needed to wait for 90 days until she could get her second dose, she wanted to reschedule her second dose but did not know who to contact. The patient asked if this was true and if she will start all over again. The patient also asked where she could get her second dose. The patient got out of the hospital on 19Apr2021. The patient received unspecified treatment for pneumonia and pain. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 36-year-old female.  Neither medical history nor concomitant medications were reported.  On 11-Feb-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 12-May-2009:  product complaint investigation results.