chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received first dose of Moderna COVID19 vaccine on 29Jan21.  She states the day following her vaccination she had approximately a sand dollar size area of erythema, induration, and warm located on her left arm.  Pt denies any numbness, tingling, pain or swelling down her arm.  The swelling remained localized. Denied any bruising at the site.  Patient states upon awakening on 03Feb21 she felt the left lower lip was tingling/numb and slightly swollen.  Over the next hour noticed that the numbness/tingling then started moving over to the right lip.  Pt took benadryl and symptoms subsided.  Pt states she has equal movement of both sides of her mouth, denies any drooping.  Able to eat and drink without dribbling.  On 09Feb21 patient went to UCC again due to chin swelling.  She was diagnosed with topical bacterial infection and prescribed antibiotic ointment.  Denies any lymph node swelling.  She no longer had erythema or pain at the vaccination injection site.    As of 17Feb21 all symptoms have resolved.
This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age who on 02-JAN-2013, was vaccinated with a dose of ROTATEQ, oral (lot number 0777AA) (dose not reported) that was expired. The vaccine expired on 14-NOV-2012. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
A non-serious, spontaneous report of Influenza B has been received from a physician concerning an 10-year-old male patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 26-Sep-2009. A few days later, the patient experienced sore throat, cough, fever, decreased appetite, watery green stools, and dizziness. On 28-Sep-2009, the patient tested positive for Influenza B. The outcome for the reported adverse event was not reported.
I begin having upper respiratory infection cough, tightness in the chest, mucus, sore throat, sinus pain, runny nose, and a headache all within the course of a week. I did at-home COVID-19 test on 04/21/2022, and it came back positive. I called my doctor and prescribed cough syrup and informed me to rest. After 5-6 days of taking the syrup and quarantining, my symptoms began to go away and I recovered shortly after.
arm was a little sore for a couple days, sore arm; felt like I had a spasm in my leg it was horrible; muscles in my legs were just killing me, muscle pain; every joint in my body are killing me today, joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore for a couple days, sore arm), MUSCLE SPASMS (felt like I had a spasm in my leg it was horrible), MYALGIA (muscles in my legs were just killing me, muscle pain) and ARTHRALGIA (every joint in my body are killing me today, joint pain) in an 82-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) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MUSCLE SPASMS (felt like I had a spasm in my leg it was horrible), MYALGIA (muscles in my legs were just killing me, muscle pain) and ARTHRALGIA (every joint in my body are killing me today, joint pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little sore for a couple days, sore arm). At the time of the report, PAIN IN EXTREMITY (arm was a little sore for a couple days, sore arm) and MUSCLE SPASMS (felt like I had a spasm in my leg it was horrible) outcome was unknown and MYALGIA (muscles in my legs were just killing me, muscle pain) and ARTHRALGIA (every joint in my body are killing me today, joint pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood thinners, medication for blood pressure and heart medication. No treatment information was provided.
3 hrs after injection eyes began with red and itching. Redness to injections. Fever 101.6 began about 6pm. Body aches until Monday 10/6/14. Fever until 10/5/14
Info has been received from a pharmacist concerning a 27 y.o. male PT w/NKDA, who on unspecified date, was vax'd w/Hep B vax recombinant. There was no concomitant medication. Subsequently, 4 days post vax, lab work showed the PT developed "AST and LST" levels at 3 times their normal value. Unspecified medical attention was sought. Add'l info has been requested.
Information has been received from a physician concerning a male who was vaccinated with a dose of varicella-zoster virus vaccine.  Subsequently the patient developed a rash around the injection site.  Unspecified medical attention was sought.  Subsequently, the patient recovered. There was no product quality complaint involved.  Additional information has been requested.
Information regarding PREVENAR 13 was received from a physician regarding a patient who experienced rash. The patient received a dose in 2010. The patient experienced rash in 2010. The outcome was unknown. No additional information was available at the time of this report.
Patient described having GERD, diarrhea, vomiting night after injection and al over muscle cramps ( hands, back, legs) at least 8 to 10 times a day every day since injection. Arm was sore for 3 days
Mild reaction lasting 48 hours - achy arm at injection site, brain fog, congestion, slight sore throat, fever: 98.9-99.9, fatigue
Caller 'felt woozy' after her injection but was unable to quantify, that resolved the day before yesterday, then yesterday noticed her injection site was a bit itchy and she had an odd bull's eye type rash over the area, area is also red/tender, she is finding this quite bothersome.    As patient was rather upset about the bull's eye rash and the redness/tenderness advised her to seek tx, not sure if she did actually go.
arm soreness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "arm soreness"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient was diagnosed with measles; Secondary measles due to vaccine failure.; This literature marketed report has been received from the authors of a published literature article, referring to a 59-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On an unknown date, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.    On an unknown date, the patient experienced cough, fever, weakness from diarrhea, diffuse maculopapular rash, and facial skin peeling. The initial diagnosis for this case was reported as Influenza-likebillness and viral syndrome. There was no clear history of a measles exposure for this patient. Additionally, it was reported that on day11 of symptoms and day 6 of the rash some samples were collected for testing.   On an unspecified dates, reported as day 11 of symptoms and day 6 of the rash the samples were collected for the following tests: a measles IgG (chemiluminescent immunoassay [CLIA], LIAISON XL) was performed to the patient and showed a result of high positive at >10 X the cutoff, a measles IgM (laboratory-developed immunofluorescenceassay [IFA]) testing that was negative, a measles real-time reverse transcriptase PCR (RT-PCR) that returned positive (cycle threshold 27), an additional measles IgM testing that resulted Positive (5 X cutoff), and finally a IgG avidity test that was high. At the time of the report, the outcome of the events was not reported.   The authors considered that while the majority of measles cases are primary infections in persons who had not been vaccinated, measles can also occur in previously vaccinated individuals. In 2019, a record number of measles cases were reported as a result of suboptimal vaccination rates and a loss of herd immunity. Moreover, measles cases due to secondary vaccine failures are more common than previously thought, comprising approximately 11% of cases reported in 2019. Attenuated or modified presentations, lack of overt epidemiologic risk factors, and false-negative IgM and strong-positive measles IgG results may mislead clinicians to favor alternate diagnoses, creating delays in identification and increasing the risk of transmission. Due to this, clinical laboratorians and clinicians should be aware of the pitfalls in diagnosing measles in previously vaccinated persons by serology alone and be proactive in obtaining nasopharyngeal (NP) or throat swabs for measles real-time reverse transcriptase PCR (RT-PCR) in addition to serum samples.  In conclusion, testing by both RT-PCR and serology is especially important for the diagnosis of index cases, which may occur in the absence of clear epidemiologic risk factors.  Upon internal review, measles was considered to be medically significant.   Literature Report. Sender's Comments:  US-009507513-2011USA011191:Original Case : 2011USA011191
Pt had "grand mal" seizure per EMS, found post ictal having had a witnessed 2 minute seizure after a period of feeling ill and left arm weakness.
1st round:Headache  chills loss of appetite( 2 days 2nd Round: (april7th) chills headache weak loss of appetite incontince  sore muscles  shortness of breath
PATIENT HAD SWELLING UNDER THE ARMPIT AND PAIN IN THE SHOULDER BLADE FOR MORE THAN A WEEK. PATIENT TOOK IBUPROFEN 800MG OVER THE PERIOD AND SWELLING SLOWLY SUBSIDED.
Severe menstral bleeding, breakthrough bleeding; Severe menstral bleeding, breakthrough bleeding; inflammation; joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 14:30 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NUVARING. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 14:30, Manufacturer unknown), administration date: 30Mar2021, when the patient was 34 years old, for COVID-19 Immunization. The following information was reported: INTERMENSTRUAL BLEEDING (medically significant), HEAVY MENSTRUAL BLEEDING (medically significant) all with onset 10May2021, outcome "not recovered" and all described as "Severe menstral bleeding, breakthrough bleeding"; INFLAMMATION (non-serious) with onset 10May2021, outcome "not recovered", described as "inflammation"; ARTHRALGIA (non-serious) with onset 10May2021, outcome "not recovered", described as "joint pain". The events "severe menstral bleeding, breakthrough bleeding", "severe menstral bleeding, breakthrough bleeding", "inflammation" and "joint pain" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of intermenstrual bleeding, heavy menstrual bleeding, inflammation, arthralgia with ablation and tubal ligation, medication used was NSAID . The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
No adverse effects reported; Incorrect product storage; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot #R032766, expiration date on for prophylaxis (strength, dose and frequency were not reported). The temperature of storage and time frame of the excursion were above 47°F (92.3° F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA007468: US- 009507513-1907USA007439: US-009507513-1907USA005368: US-009507513-1907USA005362: US-009507513-1907USA010550: US-009507513-1907USA010551: US-009507513-1907USA010552: US-009507513-1907USA010553: US-009507513-1907USA010554: US-009507513-1907USA010555: US-009507513-1907USA010557: US-009507513-1907USA010558:
This spontaneous report was received from a female patient of unknown age who refers to herself. The patient had no pertinent medical history and drug reactions or allergies. She was not administered any concomitant medications. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot#, expiration date were not reported) to prevent shingles. On 20-SEP-2017, the patient experienced redness at the site of injection (also reported as insertion). The patient did not seek medical attention. The outcome of the event was unknown. The relatedness between the event and the suspect drug was not reported.
tightness in chest, congested, achy, joint pains;persists as of 9OCT95;
Fever greater than 102 for two days then it has been low grade ever since. Very lethargic, fatigued, muscle weakness, stomach pain. She is still symptomatic and it has been 5 days.
On 3/1/2019 - Patient had a Hep B vaccine on 2/25/19. She stated with previous hep b vaccine, she has had some arm pain, but with this vaccine, she is experiencing back pain, in some places worse than others. Patient is wanting to know if she can take something for relief. She has already tried OTC pain relief without much help. I tried to return her call, but it went right to voicemail. A letter was sent out for her to call the clinic on 3/5/2019. On 3/8/2019, the patient had an office visit with her provider. She stating that 2 days after she received the Hep B vaccine she has had a sharp pain on the left side of her spine in the middle of the back. The doctor noted it was not related to the Hep B vaccination, but rather the pain was musculo-skeletal, and not in any way consistent w/any side effect to the hepatitis vaccine that she was aware of or could find in the literature.  On 3/11/2019, the patient continued to have shoulder pain and now jaw pain, which ibuprofen helped alleviate symptoms, and the patient had also lost her appetite.  On 5/16/2019, the patient presented to the clinic with c/o bilateral tingling in her foot/ankle/shoulder/neck, numbness, reduced appetite and didn't feel well enough to eat and constant feeling tired. She stated at this office visit she recently had loss of motor function of bilateral lower extremities . The physical exam was benign.  A referral to neurology was done and labs were drawn.  on 7/3/2019 - The patient was seen in neurology -
This spontaneous report was received from a nurse practitioner an adult female patient of unknown age. There was no information regarding concomitant medications and historical medication. On an unknown date the patient was vaccinated with 2 doses of GARDASIL 4 and 1 dose of GARDASIL 9 (interchange of vaccine products and wrong drug administered. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Reporter did not provided the age of the patient but stated that she was well over the age of 26 years. This is one of several reported received from the same reporter. Additional information is not expected as reporter does not wants to get contacted.
Narrative:  Patient reported that he was hospitalized at hospital overnight after his first covid vaccine (did not notify primary care) and for 2 nights after the second one. Hospital records indicate he was tx for "COPD exacerbation" and symptoms resolved with steroids, nebs, antibiotic.
Patient presents to the ED on01/20/22 with a Chief Complaint of Shortness of Breath after receiving covid vaccine 01/10/2022. Per guidelines, all hospitalizations are reported.
pt recv vax 14MAY96 & 19JUN96 pt devel full blown chicken w/about 40 scattered lesions;tx w/DPH & calamine;pt recovered w/in 2wk;
nasal congestion; Diarhhea; cough; fever; chills; Muscle aches; headache; This spontaneous case was reported by a physician and describes the occurrence of NASAL CONGESTION (nasal congestion), DIARRHOEA (Diarhhea), COUGH (cough), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-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 NASAL CONGESTION (nasal congestion), DIARRHOEA (Diarhhea), COUGH (cough), PYREXIA (fever), CHILLS (chills), MYALGIA (Muscle aches) and HEADACHE (headache). The patient was treated with ZINC (oral) from 24-Jan-2021 to 07-Feb-2021 for Adverse event, at a dose of 25 mg once a day; VITAMIN C [ASCORBIC ACID] (oral) from 24-Jan-2021 to 07-Feb-2021 for Adverse event, at a dose of 2000 mg once a day and VITAMIN D3 (oral) from 24-Jan-2021 to 07-Feb-2021 for Adverse event, at a dose of 1000 mg once a day. At the time of the report, NASAL CONGESTION (nasal congestion), DIARRHOEA (Diarhhea), COUGH (cough), PYREXIA (fever), CHILLS (chills), MYALGIA (Muscle aches) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, SARS-CoV-2 test: positive (Positive) positive and positive (Positive) Positive.     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 medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up was received. Additional events- pyrexia, nasal congestion, chills, headache, myalgia, diarrhea and headache were added. Treatment medications were added.
Pt complained of fever, stomachache, light headache, and sore throat, it was reported also that the pt experienced bloating for 1 month post vax.
This spontaneous report as received from healthcare worker refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L027076, expiry 25-MAY-2017 (dose and route not reported). No adverse effects reported. No additional information was provided. Temperature: 32F Time frame: 3 minutes and back in range. No previous temperature excursions reported. Data logger was used. This case is one of the 3 reports from the same source. Additional information has been requested.
Redness, swelling at injection site (lower deltoid at left arm). Recommended Diphenhydramine 25mg and Ibuprofen.
Extremely weak; lethargic; chills; fever of 101.2; very sensitive to light and touch; This is a spontaneous report from a contactable other hcp (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 16:30 (Batch/Lot Number: EW0158) as dose 2, single (age at vaccination 26-year-old) for covid-19 immunisation. Medical history included rheumatoid arthritis and covid-19 from an unknown date and unknown if ongoing (If covid prior vaccination: Yes). There were no concomitant medications. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 29Mar2021, administration site (Left arm), administered at 04:30 PM (age at vaccination 26-year-old), lot number ER8727 for covid-19 immunisation. On 19Apr2021 21:00, the patient experienced extremely weak, lethargic, chills, fever of 101.2, very sensitive to light and touch. Adverse event: Extremely weak and lethargic, having chills and running a fever of 101.2 very sensitive to light and touch. Missed two days of work. The patient underwent lab tests and procedures which included body temperature: 101.2 on 19Apr2021(fever of 101.2). The patient did not received treatment. The outcome for all events was recovering.  No follow-up attempts are possible. No further information is expected.
cough, fever (Tylenol needed to keep temp from going up to 102), covid (+) test last Friday., body aches, headache, loss of taste, loss of smell starting on 10/6/21
Moderna - Redness, warmth, pain, and swelling noticed at injection site the day after injection. Redness is about the area of 3 quarters side by side. Headache and fatigue also noted.
Pt became lightheaded, sat pt in reclining chair. He had not eaten much or had much fluid. He took po fluid and ate. Vitals were all stable. He denied sob, cp, n/v, recent illnesses, itching or mouth swelling. He felt better after eating and drinking.
sore at injection site (upper left arm) up to my ear, tired, nausea, headache
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 15Jan2021 as dose 2, single (Lot number: EL1283), in left arm, on 20Sep2021 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 years, in left arm for covid-19 immunisation. Patient had no Known allergies. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL, start date: 21May2022, stop date: 22May2022; TUSSIN DM, start date: 22May2022, stop date: 23May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course :Treatment start date: 21May2022. Treatment stop date: 26May2022.