chrisvoncsefalvay/vaers-outcomes huggingface dataset:
everything hurts; Feels like shit today; his muscles hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (everything hurts), FEELING ABNORMAL (Feels like shit today) and MYALGIA (his muscles hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced PAIN (everything hurts), FEELING ABNORMAL (Feels like shit today) and MYALGIA (his muscles hurt). At the time of the report, PAIN (everything hurts), FEELING ABNORMAL (Feels like shit today) and MYALGIA (his muscles hurt) outcome was unknown.            No concomitant medications were reported   No treatment information was provided
Pfizer COVID-19 booster shot in left arm; He left arm pit lymph nodes swelled up causing pain.; He left arm pit lymph nodes swelled up causing pain.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer COVID-19 booster shot in left arm"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious), outcome "unknown" and all described as "He left arm pit lymph nodes swelled up causing pain.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness and swelling around the injection site, spreading down to the elbow. Some itching and painful to touch.
stroke-like symptoms; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke-like symptoms". The event "stroke-like symptoms" required emergency room visit.  Clinical course: Pharmacist said that a patient has been in the ER for 3 days now after experiencing stroke-like symptoms (ex. headaches). The doctor told the patient it was from the vaccine and patient blamed pharmacy. Pharmacist did not disclose further information  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. 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.
Patient took 3rd dose with full glass of water before breakfast, two hours after taking the capsule patient burped the capsule intact. Capsule was very soft but swallowed it again with water.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 3:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 3:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 41.67 years old. Concomitant products were not provided. On 03 Mar 2021, Excursion time was 09 AM, 10 AM and 01 PM, temperature were 51, 34 and 35, total doses given for the day was 200, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24 Feb 2021, vial was moved to clinic on 03 Mar 2021. 20 vials were sent to clinic. Vaccine BUD date was 26 Mar 2021. On 03 Mar 2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Unknown, 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM: 35, 2 PM: 36, 3 PM: 36, 4 PM: 36 and 5 PM: Unknown. The vials were only punctured right before administration and all doses were drawn from the vial due to high pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Abnormal menstrual cycle pattern. 3 days of spotting after the first injection. Currently 15 days of spotting/light vaginal bleeding after the second vaccine. This symptom has not yet resolved.
Numbness of the right side of face, headache on the right side. Right side of face still numb.
Pt experienced redness with very slight heat at site of injection on right arm. It was apparently worse yesterday.
Normal redness and soreness at vaccination site for the first few days then a 3? circle appeared at the site on the 7th day and caused itch and soreness. It is now fading away with no after effects
Patient fainted after injection. Patient was pale and sweaty. Patient revived in 15 minutes with feet elevated, ice applied to back of neck  and 7-Up given.
Patient having shoulder pain.  Made appointment with doctor.  MRI completed.  Possible SIRVA.
Shingrix 50MCG INJ(IM)SNGDSE VL 10PK      Fever, shaking, teeth chattering for approximately 1 hour.  Nausea and fever for approximately 24 hours.
Floaters in both eyes; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration on 26Apr2021(at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 05May2021, two weeks after the first dose of vaccination, the patient experienced floaters in both eyes and it was still ongoing and was getting worse. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of floaters in both eyes which included treatment with eye drops (MANUFACTURER UNKNOWN). On an unknown date, the patient underwent SARS-CoV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event floaters in both eyes was not resolved at the time of this report.
had my first vaccine in March 20/20, didn't get second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on March 2020).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination The reporter asked could get 2nd dose now.
This literature marketed report has been received from the authors of a published literature article, regarding a 5 year old female patient with recurrent infections since age 2 months, hypogammaglobulinemia and atypical heterozygous Artemis mutations associated with an unrelated gene mutation. It was reported that the patient was immunodeficient. It was also stated that the patient's mother with an isolated similar heterozygous Artemis mutation was asymptomatic. The patient had low immunoglobulin G (IgG), immunoglobulin A (IgA) and immunoglobulin M (IgM), low CD4+ and high CD8+ percent of T cells. On an unknown date, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (PPV23), injection, (dose, route of administration and injection site were not reported) and pneumococcal 13v conj vaccine (crm197) (PCV13), (formulation, dose, route of administration and injection site were not reported) for an unknown indication. There were no concomitant medications reported. On an unspecified date, the patient developed failed antibody responses to Pneumococcal polysaccharide and Conjugate vaccines, PPV23 and PCV13 respectively. Genetics performed on an unspecified date revealed a missense mutation of exon 6 of the DCLREC1 gene I: c.457G>A; p.G153R. Other mutations found on DCLREC1 reported as unlikely association. The outcome of failed antibody responses to Pneumococcal polysaccharide and Conjugate vaccines was unknown at the time of the report. The authors considered the event to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). This is one of two reports received from the same literature article (cross reference with MARRS#1603USA007632). Additional information has been requested.
S & S began 10/25 AM with flu-like S & S chills & fever have abated at present but band-like H/A persists. 10/29/10 4pm Rx TYLENOL #3 for discomf.
RIGHT THIGH: pain, redness, swelling. FEVER: 101.3.
Injection site red 2 x 2 area (dark) arm slightly swollen & red to elbow itching & burning.
I experienced lymph nodes under my left arm and to the back of my left shoulder blade which lasted a couple of weeks. I also developed pneumonia which I did not know I had which resulted in me having a flat lung, right lung base. I do not know if me having pneumonia was in correlation to the vaccine. I do not have the lymph nodes today under my left arm. I still have issues with my right lung which I am currently being treated. I do not have lot# to provide.
Small blister, then crusts in 1-2 days. Itchy and sore rash developed on face, arm and torso on 3-19-17. Was given cephalexin 500 mg 1 Tab BID for 10 days.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 24-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
became non responsive, pale w/shallow resp about 15 mins p/vax given; lasted about 10 mins & responded to shaking;
This spontaneous report was received from a registered pharmacist concerning an approximately 59 year old female patient. On 27-AUG-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J003796 and 28-JUN-2014 respectively), subcutaneously. Concomitant therapies included pantoprazole, pramipexole, sumatriptan, gabapentin, carbidopa, levodopa and folic acid. Approximately on an unknown date in 2013, the patient experienced a rash around the ZOSTAVAX injection site which was described by the husband of the patient as red and the size of a nickel. The patient sought medical attention (saw physician in office). The patient was treated with BENADRYL and cephalexin. It was unspecified if any lab tests were performed. The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. This is one of the two reports from the same source. Additional information has been requested.
PATIENT HAS FEAR OF NEEDLE AND HAD AN ANXIETY ATTACK WITH SYNCOPE. NEEDED TO LIE DOWN 10 MINUTES TO RECOVER.
1st shot: Cramping, bleeding. Started with spotting and continued to get heavier daily. Cramping dulled for a day 7/9 but started again in the evening.
Left leg red, swollen, painful, warm to touch, Cold compresses, Tylenol, Benadryl, if needed, Reaction occurred at DTaP site.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 06-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp 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.
I had a bad head cold. I had phlegm, hot, cold, body ache, and loss appetite. I tested positive for COVID-19 and my doctor prescribed me PAXLOVID. I tested negative for COVID-19 01/09/2023 and I ended up tested positive again on Wednesday. I had the same symptoms as the first time. I also had a cough, congestion, and worse body aches. My doctor gave me prednisone and cough syrup. I still have body aches.
9/26/02 8:10am phone call from mother states pt has red swollen area left htigh size of soft ball in diameter upon arising this am. Has fever today and yesterday. Low grade fever day of injection. C/O leg hurting. States she gave Tylenol  and sent to school.
Weakness, fainting, loss of vision, clammy, seizures, Psychotic break, signs of strokes, slurring of speech, borderline unconscious.
hives on the injected arm/ diagnosed by his physician as shingles; experienced pain and itching near the injection site; experienced pain and itching near the injection site; red splotches under his arm and on his chest; chest that were itching; This is a spontaneous report from a contactable consumer (patient).A 77-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 29Jan2021 (vaccine location: right arm) at single dose for COVID-19 immunisation. The patient's medical history was included Prediabetes. The concomitant medications were reported as metformin at 1000mg by mouth for Prediabetes and blood pressure medication. Patient got his first shot on 29Jan2021, about 3-4 days later (in Feb2021) it started hurting/ pain and itching near the injection site, he found red splotches under his arm and on his chest and chest that were itching. Later, patient developed hives on the injected arm, he was able to get to the doctor today to see him, doctor diagnosed him with shingles and gave him some medicine. Patient wanted to know if it is safe to proceed with the next dose since it was scheduled 20Feb2021. The outcome of red splotches on arm and chest that were itching was recovering. The outcome of other events was unknown.  Information on the batch/Lot number has been requested.
I felt depression after my first dose given on 1/16/21. I was down and more hopeless and self critical than usual. I assumed it was because of the strain of the pandemic coupled with winter. After my second dose, I experienced a buildup of depressive symptoms from the day after the second dose, and it became worse and worse until on day 4 and the morning of day 5, I had a depressive episode that was so bad that I considered going to the hospital. I was having suicidal thoughts, which is not something I have experienced at this intensity.
pain in arm of vaccine, still ongoing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm of vaccine, still ongoing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in arm of vaccine, still ongoing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain in arm of vaccine, still ongoing) had not resolved.      Action taken with mRNA-1273 in response to the events was not applicable     No concomitant medications provided
a congested head cold; had some congestion last Tuesday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Jul2021 (Batch/Lot number: FA6780) 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "a congested head cold"; NASAL CONGESTION (non-serious) with onset 03Aug2021, outcome "unknown", described as "had some congestion last Tuesday".  Additional Information: She reported she had some congestion last Tuesday and she is asking can she get the second dose or should she wait. Adds she think she just has a bad head cold unrelated to the vaccine.   No follow-up attempts are possible. No further information is expected.
Slight headache; pain at injection site; fatigue; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6203), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 at 12:00 PM as DOSE 1, SINGLE (at the age of 33-years-old) for COVID-19 immunisation. The patient's medical history included Known allergies: Penicillin from an unknown date and unknown if ongoing. There were no concomitant medications. On 19Feb2021 at 15:00 hours, the patient experienced slight headache, pain at injection site, and fatigue. The patient received no treatment for the events. The patient had received no other vaccine in four weeks and no other medications in two weeks. The patient did not have COVID prior to vaccination, did not get COVID tested post vaccination. The patient recovered from the events on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Second Moderna COVID19 vaccine administered on 3/22/21 at 10:45 am with no concerning symptoms in post-observation period.  Pt noted tingling down right arm and leg around 11:30 am, and right hand felt cold.  Pt called triage RN line.  No SOB, no swelling of lips or face.  Pt denied any symptoms after the 1st dose.  Triage RN directed pt to present to ED. Pt presented to ED same day at 1:57 pm. Diagnosed with radicular neuropathy.  Recommendation for care included elevation of the arm and OTC ibuprofen.
Information has been received from a female who on an unspecified date was vaccinated with the first dose of MMR II and "had a reaction like stop breathing and fever up to 104 degrees. Caller doesn't remember any information for second dose". Upon internal review, stop breathing was considered to be an other important medical event. This is one of several reports from the same source. No further information is available.
pt recv vax on 29JUL95 & devel full blown case of 22SEP97 w/rash, low grade fever & itching;