chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced vaccination site pain (pain at injection site), with outcome of not recovered; chills (non-serious) and fatigue, with outcome of unknown. Additional information: The female patient experienced pain at injection site, along with chills and fatigue about 36 hours after her dose. She stated she was still experiencing pain at injection site. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Redness, heat , swellling ,soreness down whole arm,  hot, itching ,  acheing, tired, arm is still sore.  Pt stated Reaction much worse on 2nd Vaccination
dose given 1/13/21, patient hospitalized with high blood sugar, hyperkalemia, hypernatremia on 1/15/21 after being lethargic with shallow breathing. Patient still hospitalized as of 1/19/21 and diagnosed with Diabetes
Pt recvd vax 3 to 5 wks later, devel muscle aches, fever & tachycardia; f/u it was reported that exp was hypothetical;
Approximately 10 min after receiving 4 yr immunization pt had syncope with L.O.C x 30-40s also had upper extremity stiffening and Bil eye deviation.
Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers 1995-00224, 2003-02926, 2006-03086, 2006-03230, 2011-03827, 2013-02288, 2013-05188, 2013-05251-05260 and 2013-05262-05263 and 2013-05268-05269. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. This case involved a 66-year-old male patient who had received Trivalent inactivated influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and 36 days later reported the onset of GBS. No further information was provided. Outcome was not reported. Documents held by sender: None.
No adverse effect reported.; the patient (...) was inadvertently administered a dose of PROQUAD (...) and a dose of VARIVAX; pro-rHa This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, past medical history, concomitant medications and drug reactions or allergies was provided. On 03-MAY-2019, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R026350, expiration date 15-MAR-2020, albumin status rHA (recombinant Human albumin) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R030485, expiration date 22-OCT-2020 (exact dose and route of administration were not provided for any of the suspect therapies). No adverse effect was reported.
First thing I noticed was a pain like my humorous was going to snap in half while moving in bed. Within a few more days I started to lose range of motion and constant pain in my shoulder. I was unable to put my bra on or reach across or stretch my left arm out. By the time week 2 rolled around, I struggled to be able to prepare dinner plates for my children. I sit with a heat pad on my should constantly for some relief. Finally went to my dr and he gave a cortisone shot. This was roughly a month after the vaccine. Cortisone shot was great at first. I finally was pain free and able to move around. My dr recommended physical therapy. First cortisone shot lasted 1 week. Went to physical therapy. Physical therapist agrees that there was something going on with the lose of range of motion. Went bad to dr to follow up with report from PT. Was given a second cortisone shot. Lasted 2 weeks. Dr ordered xray, which came back clear. Requested MRI. MRI shows tear in Labrum and an adjacent 1cm cyst. Referred to pain management and to an orthopedic surgeon. Appt with Orthopedic Surgeon is June 23 2022 for next steps. Possible surgery to repair tear.
Fever of 101; body aches like the flu; headache; like the flu; This is a spontaneous report from a contactable health care professional, the patient.  A 53-years-old female  non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK 9231), via an unspecified route of administration in the right arm on  25Jan2021 at 14:30 (at the age of 53-years-old) as a single dose, for COVID-19 vaccination. Facility where the most COVID-19 vaccine was administered was a Nursing Home/Senior Living Facility. Medical history included breast cancer on an  unspecified date (Breast cancer survivor) and Covid-19 on an unspecified date (Prior to vaccination, the patient was diagnosed with COVID-19).  Concomitant medication included escitalopram oxalate (LEXAPRO), tamoxifen (TAMOXIFEN). The patient had no known allergies. No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. On 26Jan2021, The patient experienced fever of 101,  body aches,  like the flu, headache. The events were considered non serious.  The patient underwent lab tests and procedures which included body temperature:101 fahrenheit (fever 101) on 26Jan2021. No treatment was given for the events.   The clinical outcome of the events Fever of 101, body aches like the flu, headache was recovering.
Swollen, greyish tongue and thrush on the back of the tongue; Spontaneous report received on 20FEB2020.  A nurse reported that a 70-year-old female consumer who developed swollen, greyish tongue and thrush on the back of the tongue (PT: Oral candidiasis) while being on Vivotif for immunisation and doxycycline for an unknown indication. The consumer took first and second dose of Vivotif on 15FEB2020 and 17FEB2020 respectively. It was reported that she had taken the doxycycline from 05FEB2020 to 12FEB2020. On 18FEB2020 after second dose of Vivotif, she developed swollen, greyish tongue and thrush. The nurse stated that he was not sure about the location of the thrush but assumed it was in the back of the tongue. Moreover, the consumer stated that thrush could have been caused by doxycycline. Action taken with Vivotif with respect to the reported event was unknown while action take with doxycycline with respect to the reported events was not applicable. The outcome of the reported event was unknown at the time of report. The consumer took treatment for thrush which included nystatin and was started on 19FEB2020.  Concurrent medical conditions included atrial fibrillation, thyroid cancer-remission and sleep apnoea.  Allergy history included allergy to Demerol (meperidine) which caused nausea.  Concomitant medication included rivaroxaban (20 mg daily), Crestor (rosuvastatin, 20 mg daily), metoprolol (25 mg daily), and levothyroxine (125 microgram daily).  Company Comment: A consumer developed swollen, greyish tongue and thrush on the back of the tongue (Oral candidiasis) after second dose of Vivotif. This consumer completed one week of doxycycline course a few days before starting Vivotif. The consumer was then started on Nystatin for treating thrush. The causality of oral candidiasis is unlikely with Vivotif (Doxycycline course could have caused oral candidiasis).; Sender's Comments: A consumer developed swollen, greyish tongue and thrush on the back of the tongue (Oral candidiasis) after second dose of Vivotif. This consumer completed one week of doxycycline course a few days before starting Vivotif. The consumer was then started on Nystatin for treating thrush. The causality of oral candidiasis is unlikely with Vivotif (Doxycycline course could have caused oral candidiasis).
BRAIN BLEED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no other kind of brain difficulties bleeding or clots ever before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, three days after receiving the vaccine, the patient experienced brain bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brain bleed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230913855-Brain bleeds. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
wound; received a Tdap(Adacel) when he was 9 years of age; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a physician and additional information received on 15-May-2019.   This case involves a 09-years-old age patient who experienced wound while he/she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route.  On an unknown date, The patient developed a non-serious wound following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of actual medication error due to Inappropriate age at vaccine administration. As per PI: Adacel vaccine is not approved for individuals less than 10 years of age.  No lab test was reported.  Final diagnosis was received a tdap(adacel) when he was 9 years of age and wound.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for wound.  Information on the batch number was requested:  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 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.
Myalgia, NauseaVomiting, left arm hurts, Narrative:
Pt vax w/ 3rd dose of hep B vax approx 4 days p/ vax,p/ being in the sun for approx 20 min, devel itiching, redness & edema on rt side of face.Seen by MD who felt rash not D/T vax but benzophenone & PABA acid in suntan lotin.
Pt received vaccine and had symptoms: SOB, Itching, and redness within 10 minutes
Ii have had recurrent aphthous ulcers every week since mid Jan, without any respite.  Previosly I would have 3-4 per year but it is now a weekly occurrence.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: LOSARTAN; ESCITALOPRAM. Past drug history included: Bactrim, reaction(s): "Known allergies: bactrim", notes: Known allergies: bactrim. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case narrative, reported events drug ineffective, Covid 19 with BNT162B2 are possible
This spontaneous report as received from a pharmacist via Company Representative refers to a patient of unknown age. On an unknown date a dose of expired ZOSTAVAX (lot # reported) (start date, dose and route not reported) was administered to a patient. Additional information has been requested.
Got the first dose the injection made me so sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 57-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had in 30s).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-APR-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient got the first shot, the injection made him/her so sick that the patient never got the 2nd one. It was horrible. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Rec'd 2nd Rabies vaccine on 4/26/08. Went to ER on 4/27/08 w/reports of high blood pressure and constant vomiting.
inappropriate age at vaccine administration; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration) had resolved. Not Provided      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.   No Concomitant medication provided.  No treatment drugs were provided.
PATIENT GOT RASH THE NEXT DAY IN GROIN AREA UNDER ARM PITS ON HIP AND SIDE AND HAD SWELLING OF THE LIPS
04/05/2021 - Inflamation in neck and shoulders. 04/06 to 04/09/2021 - Began experiencing double vision and felt pressure behind right eye. Slept nearly all day during this time frame. 04/12/2021 (12:20pm) - Phone appointment with primary care doctor to discuss symptoms experienced after receiving Pfizer vaccine. Office vist scheduled for 04/22/2021. 04/22/2021 (11:50am) - Office visit to Dr. Continued to experience double vision and pressure behind right eye in the interim. Referred to opthamologist and ordered MRI. 04/27/2021 (3:15pm) - Office visit to Dr. No evidence of detatched retina, eye pressure normal. Agreed that MRI needed.
she "literally got woken up" with her heart pounding and racing; heart rate was 110-120 bpm; literally got woken up / wake up from her sleep; felt more tired than usual; had a headache; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported.   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 02Feb2021 at 16:00 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. It was reported that, enquired on auto-call back, caller started off by saying she was fine. She had the second shot of the Pfizer BioNTech COVID-19 vaccine yesterday on 02Feb2021 at 4PM. On 02Feb2021 at 10PM, last night she felt more tired than usual. She also had a headache. She was feeling tired and had a bad headache, but she didn't take anything. Stated that, she didn't drank any medication for that. Stated that, on 02Feb2021, at around 11pm of the same day, she literally got woken up with her heart pounding and racing. It was like a pounding heart rate and It was a hard beat. It may hit 110 when exercising. It made her wake up from her sleep. She monitored her heart rate and the lowest was at 110 bpm and the highest was 122 bpm. It was on 117 most of the time. This event lasted for 30-40 minutes. Stated that, she had no problem breathing. She tried to do breathing exercises to calm her heart down, but it didn't work. Stated that, she was a healthy person with no issues and her normal heart rate is at 61 bpm (generally a very calm person). Reporter had a question that She had a weird thing happen last night. She got her second shot of the COVID vaccine. She had a weird thing happen. She is wondering if it is connected. She mentioned that her doctor asked her to call Pfizer. Offered caller to be transferred but due to long hold time to Med Info (about an hour), she declined. The patient underwent lab tests and procedures included heart rate, resulted as resting heart rate was 60-61 on an unspecified date, on 02Feb2021, heart rate was resulted as 110-122 bpm, for about 30-40 minutes, this has never happened before and on 02Feb2021, heart rate was resulted as 115-120. The outcome of the events for fatigue, headache and disturbed sleep were unknown while for the other events were recovered.   Information of lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of an unknown age and gender. Medical history was not reported. The medical assistant informed that on 30-OCT-2014 the patients were vaccinated with improperly stored doses of GARDASIL injection , lot # K006117, expiration date: 14-JAN-2017, (route and dosage were not reported). No symptoms reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
left arm was moderately sore throughout the day yesterday; This is a spontaneous report received from non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing). Concomitant medication(s) included: SYNTHROID; OMEPRAZOLE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Dec2022, outcome "recovering", described as "left arm was moderately sore throughout the day yesterday". It was unknown if therapeutic measures were taken as a result of vaccination site pain.  Additional information: The patient has no reported allergies. The patient did not receive any other vaccines within 4 weeks prior vaccination. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Neck Pain; Left Arm Pain; This case was reported by a nurse via sales rep and described the occurrence of neck pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 95LX9, expiry date 22nd February 2021) for prophylaxis.   On 17th July 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced neck pain and pain in arm. On an unknown date, the outcome of the neck pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the neck pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient experienced neck and arm pain that lasted for approximately 2 months.  The patient was not sure which limb was involved with the 1st dose. The reporter did not provide any additional details. For tolerance after 2nd dose of Shingrix, refer case US2019129916.
About 6 hours after receiving my vaccine, I all of a sudden felt extremely fatigued. I noticed I was having headaches and general aches and pains running up and down my body. I felt this way for about 3 days. My right arm also felt very heavy, but that only lasted for one day.
fever, chills, restlessness, alertness lasting from 11:00 PM to 3:00 PM.  Spoke to patient at 3:40 pm on 11/24/2010 and pt reported chills, no fever, no increased heart rate.