chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel as rough; This case was reported by a consumer and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient felt as rough. The patient was wondering would the second part of the shingles vaccine different then the first injection. Was the dosage the same as the first.
my hematology blood count is higher than it has normally been; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Polycythemia since an unknown date.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been). At the time of the report, BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: High. On an unknown date, Haemoglobin: High. On an unknown date, Red blood cell count: High.         No relevant concomitant medications were reported.   No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Polycythemia since an unknown date.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been). At the time of the report, BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: High. On an unknown date, Haemoglobin: High. On an unknown date, Red blood cell count: High.         No relevant concomitant medications were reported.   No treatment information was provided.
Had raised warm red area at site of injection on Saturday morning, 6/22. Then later that day had papular rash noted to neck, arms, and upper thighs. Patient seen in our office (her PCP) today. Diagnosed as allergic reaction. Given two days of Xyzal 5mg TID. To return to clinic for follow up in two days. No fever. Clear Bilat breath sounds. Area at injection still red and raises, measure 9 x 9.5cm.
Approx 1 wk after getting Flu and Pneumococcal vaccines at PCP began having wheezing, increased SOB, increased amount of coughing especially lying down at night, throat felt sore and on fire.
Knows someone have similar side effect as hers (lower leg numbness); This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Knows someone have similar side effect as hers (lower leg numbness)) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Knows someone have similar side effect as hers (lower leg numbness)). At the time of the report, HYPOAESTHESIA (Knows someone have similar side effect as hers (lower leg numbness)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and medication information provided.  No treatment information provided.
This spontaneous report as received from a nurse practitioner refers to a unknown number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date unknown number of patients were vaccinated with improperly stored PEDVAXHIB (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PEDVAXHIB was unknown. This case is linked to # 1412USA001369 via same reporter link. Additional information has been requested.
C/O right arm pain following Td Booster given on 08/04/2005. Client states the upper arm is very tender to touch. There is considerable pain in the area when she attempts to raise her arm or lift anything. She denies any warmth or redness to the site. She has tried hot/cold compresses but they heave been on help.
A physician reported that subsequent to receiving injections of Acel-Imune and Hib-Titer, pt experienced an unspecified adverse reaction.  The reported attributed the event to Acel-Imune.
Patient's mother called in and reported the patient experiencing a reaction to her vaccines, large erythematous swelling, and warmth on the left thigh. She did not develop hives or other complications. She could not tell if it was from DTAP or IPV.
NASAL CONGESTION, CHEST CONGESTION, COUGH, LOW-GRADE FEVER
Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: bp 90/70; hypotension-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild
Severe Migraine 12 hours later.  It has been on and off since booster (I had the same issues with the first dose)  This has been going on for 6 days.  Standard Migraine symptoms.  Unusual as I have had these under control with only 2 - 3 one day events until I got the injection.
arm hurt after the vaccination for just that day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt after the vaccination for just that day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt after the vaccination for just that day). On 17-Mar-2021, PAIN IN EXTREMITY (arm hurt after the vaccination for just that day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 03-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Anosmia; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Anosmia) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Anosmia). At the time of the report, ANOSMIA (Anosmia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) SARS-CoV-2 test and negative (Negative) SARS-CoV-2 test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
DEVELOPED HIVES WITHIN 5-7 MINUTES AFTER INJECTION. STARTED AROUND EYES THEN DISAPPEARED. THEN HIVES AROUND MOUTH THEN RESOLVED. THEN HIVES ON TORSO AND ALL EXTREMITIES THEN RESOLVED. THEN HIVES ON NECK AND SCALP THEN RESOLVED. IF PATIENT ITCHED THEN MORE WOULD APPEAR. WAS GIVEN BENADRYL X 2 IN OFFICE AND DEXAMETHASONE IM. MONITORED IN OFFICE APPROXIMATELY 90 MINUTES. RX GIVEN FOR EPIPEN AND LABS INCLUDING ALLERGY TESTING WERE ORDERED
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: 301SSBA) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment (Paxlovid) from 10Jun2022 to an unspecified date in Jun2022. patient previously received a COVID-19 Vaccine.
I had headache, fever up to 100.5-101 degree for first 24 hours then 99.5-100.5 degree for next 24 hour. I also had tenderness, redness, and swelling at the injection site, decreased appetite.
Patient developed sweating, chills, and dyspnea within 6 hours of administration. Could not sleep overnight and went to ED in the morning. Med 1 (Lot H547E) is antigen component, L349E is suspension component.
Has bilateral LE edema, reddened areas w/ rashes and exudate or drainage from areas.  Looks like a cellulitis
child given undiluted pfizer pediatric dose.  called father, reports no adverse symptom as of 24 hours later
Severe L arm pain (rated 10 out of 10). Refusal to move L arm away from body more than a few inches.
Information has been received from a pt who on 02/08/2001 was vaccinated with varicella vaccine. The pt reports that the nurse gave her the injection IM instead of SC. Subsequently the injection site has been somewhat sore and wakes the pt with discomfort at night. The pt reports that there is no swelling or discoloration at the injection site. It was noted that the pt received a second injection of varicella vaccine on approximately 03/22/2001. This injection was given SC without any problems. Additional info has been requested.
ACHES; SWEATS; OVERALL GROGGINESS; CHEST FEELS A SMALL HOT TOO; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced aches, sweats, overall grogginess, chest feels a small hot too, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, sweats, overall grogginess, and fever, and was recovering from chest feels a small hot too. This report was non-serious.
COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): AGN277757 (RA).  A 48-year-old female patient received bnt162b2, administration date Apr2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Hysterectomy" (unspecified if ongoing); "double mastectomy", stop date: 2020, notes: 1 year ago. Family history included: "breast cancer" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; prochlorperazine maleate (COMPAZINE) taken for migraine; tizanidine hydrochloride (ZANAFLEX) taken for migraine; erenumab aooe (AIMOVIG) taken for migraine, stop date: 2021; ubrogepant (UBRELVY) taken for migraine. Past drug history included: botulinum toxin type a (BOTOX), start date: Jun2017, stop date: 2019, for Migraines, reaction(s): "Botox didn't work", notes: Route of Administration: Injection, Outcome: Ongoing.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2021, outcome "unknown" and all described as "COVID-19". She gave permission to contact her and her doctor. She was on Botox about 2 and a half years and then it quit working for her and uh, she also had Covid in May2021 and her, she does not have the lot number, does not have the expiration date. She does not have her doctor's name since it was a pretty long time ago. She had the Covid shot, she believes it was Pfizer, first dose Apr2021 and second dose Jun2021. She stated used Botox for a few years and stopped working. Consumer provided treatment meds. She stated she is supposed to start Qulipta in a few days. Consumer stated she had a double mastectomy last year due to family history of breast cancer and she was positive for the genes for breast cancer. Consumer doesn't know the dose or lot number of the Botox. She stated she doesn't want us to contact her doctor.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dose 1 moderna 2/4/2021 lot # 016M20A  patient has a cardiac arrest at home and died in the ED
Dizziness, fatigue, nausea, shaking from 7:30am to 4pm
PT was at work on 12/14/21, she could not see out of right eye around 11 am, at 12:15 pm she lost feeling in right arm. She was having difficulty speaking and could not squeeze with right hand. Gait was normal. Per her employer, she was transported to ICU and reports a clotting disorder.
A fib ....Compression Shot 2/24/21. Also had an Afib.  And received a compression
Phenytoin toxicity, also reported in VA ADERS. 12/29/2008 MR received for DOS 11/25-28/2008 with D/C DX:  Dilantin Toxicity.  Hx of seizure d/o. Pt presented to ER with c/o feeling unwell and tired x 1 wk as well as episodes of SOB.  Seen twice in ER previously. This am pt  was feeling hot/cold, dizzy, shakey and feeling as though would fall. Admitted for observation. On 11/26/08 pt developed substernal chest pain/pressure which resolved on it's own. EKG was WNL. On 11/27 pt developed twitching  of jaw. No new seizure activity.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: 10 minutes after 1st dose - tingling sensation, dizzy, sweating, blacked out vision for a minute. Was still able to move arms and body. Took BP 84/49 HR 79. Gave patient water and sat supported by the wall for over 30 minutes. Before leaving patient BP was taken again 121/71 78 HR.
loss of consciousness; severe hypotension; two episodes of emesis and LOC; severe chills; received the third dose of BNT162B2; received the third dose of BNT162B2; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient (not pregnant) received the third dose of BNT162B2 (PFIZER BIONTECH COVID 19) via intramuscular on the left arm on 08Oct2021 at 09:00 AM (Lot Number: EW0183) at the age of 32-year-old as single dose for COVID-19 immunization. Medical history was none. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Known allergy was none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Concomitant medication was none. The patient previously received the first dose and the second dose of BNT162B2, the second dose on 15Jan2021 at 12:00 PM (Lot Number: EL1283) on the left arm, the first dose on 24Dec2020 at 01:15 PM (Lot Number: EK5730) on the right arm, both via intramuscular at the age of 31-year-old as single dose for COVID-19 immunization. On 09Oct2021 at 12:15 PM, the patient experienced severe hypotension and loss of consciousness. Hypotension lasting about 60 min with two episodes of emesis and LOC. followed by severe chills. No treatment was received. The outcome of booster and off label use was unknown. The outcome of other events was recovered with sequel in 2021.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development loss of consciousness cannot be totally excluded.
No additional AE information provided; the patient was administered the second dose of GARDASIL 9 on 5/20/2020 which was over a year after the first dose; This spontaneous report was received from a nurse prescriber referring to a 14 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On an unknown date (reported as over a year ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, vaccine dosage detail, route of administration, lot# and expiration date were not reported) for prophylaxis. On 20-MAY-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, vaccine dosage detail, route of administration, lot# and expiration date were not reported) which was over a year after the first dose (inappropriate schedule of product administration). No additional adverse event information was provided (no adverse event).
2 days after the vaccine - flu like symptoms and low grade fever 4 days after - L armpit lymph node swollen and pain 6 days after - vaccine site redness, swollen, appeared like cellulitis. Large area of raised, warm and itchy and painful.
Breakthrough case admission after 2 vaccines Pfizer 5/21/21 Lot# Ew0183;  Pfizer 6/11/21 Lot# EW0180
chills; body ache; foggy; not able to focus better; sluggish; right sinus cavity aching pain that went back of her head; whole thing was blur; woke up with cold sweat; flu like symptoms continued; no appetite; lethargic; tired; fell asleep on the couch; cold chills; uncontrolled shaking; running fever; headache; massive body ache; flu like symptoms; extreme nausea; throwing up; dry heaving; arm hurt for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), SOMNOLENCE (fell asleep on the couch), CHILLS (cold chills), TREMOR (uncontrolled shaking) and PYREXIA (running fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced FATIGUE (tired), SOMNOLENCE (fell asleep on the couch), CHILLS (cold chills), TREMOR (uncontrolled shaking), PYREXIA (running fever), HEADACHE (headache), PAIN (massive body ache), INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (extreme nausea), FEELING ABNORMAL (throwing up), DRY MOUTH (dry heaving) and PAIN IN EXTREMITY (arm hurt for 3 days). On 02-Apr-2021, the patient experienced VISION BLURRED (whole thing was blur), NASOPHARYNGITIS (woke up with cold sweat), INFLUENZA LIKE ILLNESS (flu like symptoms continued), DECREASED APPETITE (no appetite) and LETHARGY (lethargic). On 03-Apr-2021, the patient experienced SINUS PAIN (right sinus cavity aching pain that went back of her head). On an unknown date, the patient experienced CHILLS (chills), PAIN (body ache), FEELING ABNORMAL (foggy ), FEELING ABNORMAL (not able to focus better ) and SLUGGISHNESS (sluggish). At the time of the report, FATIGUE (tired), SOMNOLENCE (fell asleep on the couch), CHILLS (cold chills), TREMOR (uncontrolled shaking), PYREXIA (running fever), HEADACHE (headache), PAIN (massive body ache), INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (extreme nausea), FEELING ABNORMAL (throwing up), DRY MOUTH (dry heaving), PAIN IN EXTREMITY (arm hurt for 3 days), VISION BLURRED (whole thing was blur), NASOPHARYNGITIS (woke up with cold sweat), INFLUENZA LIKE ILLNESS (flu like symptoms continued), DECREASED APPETITE (no appetite), LETHARGY (lethargic) and SINUS PAIN (right sinus cavity aching pain that went back of her head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 04-MAR-2013, the patient was vaccinated with an expired dose of ZOSTAVAX, (lot number reported as 1599AA, expiry date 13-JAN-2013). No adverse event was reported. Additional information has been requested.
Case number PHEH2012US015400 is an initial spontaneous report received from a nurse on 02 Aug 2012: This report refers to a female patient of unknown age group. She was given only the CYW-135 liquid component of MENVEO vaccine  (batch number: M11046) intramuscularly on an unknown date. No other adverse reaction was reported following this administration error.
pt recvd vax 10-15 mins later, fell to floor w/eye glasses falling; father & sisters present & do not appear alarmed; given ice for sm, cut to tongue; moved to gurney & left w/family approx 20 mins laster feeling beter;