chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacist reported the patient received first dose of GARDASIL 9 on 10/9/2019. Pharmacist reported the patient is in the pharmacy now,  2/7/2020 and will be receiving second dose ofGARDASIL 9; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 07-FEB-2020, 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, dose, lot # , expiration date and route were not provided). Pharmacist reported that on 07-FEB-2020, the patient was currently in the pharmacy and would be receive the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R005341, expiration 06-DEC-2020) for prophylaxis.
P/vax within 14 hr pt devel t101.9. Pt recovered within 24 hr.
headache; sore throat; swollen glands on right side of throat; This is a spontaneous report from a contactable nurse (patient herself). A 58-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E19261), intramuscularly in left arm on 04Feb2021 at 08:00 as a single dose for COVID-19 immunisation. The patient's medical history included osteoporosis, essential tremor, right hip replacement; All from an unspecified date in 2019 to an unspecified date. Concomitant medications included other medications in two weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E41284), intramuscularly in left arm on an unspecified date in Jan2021 at 14:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation, codeine, and experienced known allergies: Codeine, meloxicam and experienced known allergies: Meloxicam, erythromycin and experienced known allergies: Erythromycin. No COVID prior vaccination. No other vaccine in four weeks. No COVID tested post vaccination. On 14Feb2021 at 06:00 AM, the patient experienced headache almost daily since #2 (just suttle), sore throat and swollen glands on right side of throat 11 days after #2. The patient was treated with over-the counter treatment for the events. The outcome of the events was recovering.
Patient reports a rapid onset of progressive vitiligo. Following a 3-part course of GARDASIL, per dosing schedule. Condition persists. Patient is in treatment through a number of modalities. Sx began within 2-3 weeks of administration of the vaccine.
Two episodes of sudden dizziness, blurred vision, collapsing, unable to stand first on 4/1 and second on 4/2. No history of dizziness or fainting. Not dehydrated at the time. Duration of event was approximately 30-60 seconds with trouble speaking thereafter for 10 minutes. Resumed normal activities thereafter. Made a doctor's appointment.
The night after receiving the vaccine, the patient began having continuous fevers and coughs. It was later discovered that there were blood clots in the lung and legs. Patient health rapidly declined during hospitalization period. Mobility, apetite and overall strength and energy decreased. Patient was fully bedridden and soon lost eye sight.
Sweating real bad; Rapid heart beat; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating real bad) and HEART RATE INCREASED (Rapid heart beat) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating real bad) and HEART RATE INCREASED (Rapid heart beat). At the time of the report, HYPERHIDROSIS (Sweating real bad) and HEART RATE INCREASED (Rapid heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.     Reporter did not allow further contact
Fatigue; headaches; upset stomach; soreness at injection site; body aches; nausea.
Janssen COVID-19 Vaccine EUA Nausea, vomiting, chills, headache, fever, blisters in mouth, swollen gums duration 3 days
Pt reported to NP 2 days after vaccine administration that she was having back pain with inhalation, along with high fever x 1 day, and dizziness. She reports the fever started within a few hours after the vaccine administrations. The breathing issues and dizziness started 1 day after the vaccines. She was instructed to go to ER. She was tested and evaluated and instructed to rest at home, per pt. On 01/28, pt reports she is now having body aches.
3 crazy rashes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (3 crazy rashes) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (3 crazy rashes). At the time of the report, RASH (3 crazy rashes) outcome was unknown.            No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2021-387097, MOD-2021-387461 (Patient Link).
developed shingles; develop a rash that started on her back, went up her side, and onto her chest; Multiple sores are silver dollar size, sores scabbed over, pretty big, rest of sores are dot size; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (developed shingles), RASH (develop a rash that started on her back, went up her side, and onto her chest) and BLISTER (Multiple sores are silver dollar size, sores scabbed over, pretty big, rest of sores are dot size) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Apr-2021, the patient experienced RASH (develop a rash that started on her back, went up her side, and onto her chest) and BLISTER (Multiple sores are silver dollar size, sores scabbed over, pretty big, rest of sores are dot size). On 14-Apr-2021, the patient experienced HERPES ZOSTER (developed shingles). At the time of the report, HERPES ZOSTER (developed shingles), RASH (develop a rash that started on her back, went up her side, and onto her chest) and BLISTER (Multiple sores are silver dollar size, sores scabbed over, pretty big, rest of sores are dot size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient developed papular, puritic  areas on B thighs at injection sites. the areas are nontender wilth no edema no erythema
Swelling and puffy red @ site and all below all way to elbow, and hot and sore. Stayed for 7 days.
The caller was allergic to the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, 30 ug single for covid-19 immunisation. Relevant medical history included: "cancer tumor on the bladder" (unspecified if ongoing), notes: Verbatim: cancer tumor on the bladder, It was removed in Dec2021 via surgery; "just had surgery" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "The caller was allergic to the vaccine".  Additional information: The patient was taking antibiotics (unspecified) as she just had surgery. The patient was allergic to the vaccine so she was hesitant but she did it anyways. The patient had the two doses of the vaccine. Received her second dose on 18Mar2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Narrative:  Pt received 2 doses of Pfizer vaccine in Mar 21. The patient tested positive for COVID 19 on 18 Sep 21 and was hospitalized at another hospital with COVID 19 pneumonia. The patient was discharged with oxygen on 5 October 2021. The EUA requires that any patients that tested positive for COVID 19 and required hospitalization after receiving the vaccine must be reported.
First dose received at 1 year and 2 months; Temperature excursion; This spontaneous safety report was received by the partner on 29-Oct-2021 and forwarded on 1-Nov-2021 from a consumer.  This case was considered non-valid due to no patient identifiers (temperature excursion only).  Due to the nature of the event, the causality between the event and Vaxelis was not applicable.  No further information is expected.  FOLLOW-UP INFORMATION was forwarded on 03-Dec-2021 from a nurse. Case became valid since patient identifiers were provided.  Reporter was not contacted by the patient's parent regarding any adverse event experienced.  No treatment was provided to the patient.  Due to the nature of the event, the causality between the event of First dose received at 1 year and 2 months and Vaxelis was not applicable.  No further information is expected.
This initial spontaneous case, received on 14-Apr-2017, which was reported by other health-professional (nurse) and concerns a male patient of an unspecified age. On 29-Sep-2016, the patient received FLUCELVAX QIV (dose: 0.5 ml, expiry date: 30-Apr-2017, batch number: 185327, route of administration: intramuscular and anatomical location: not reported). On 10-Apr-2017 (Monday), the patient was diagnosed with Influenza A virus infection. This was characterised as vaccination failure. The patient was treated with an anti-viral medication  for influenza. Batch review report (reference number: 1021320) received from quality assurance department on 08-Jun-2017, based on the document review, it was stated that, FLUCELVAX QIV was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. The outcome of the events were not reported. The reporter did not provide the causality of the events in relation to the FLUCELVAX QIV. This case was serious (medically significant). Significant case correction received on 11-May-2017: Company causality was changed from unassessable to related. Batch review report (reference number 1021320) received from quality assurance department on 08-Jun-2017: Based on the document review, it was stated that the concerned FLUCELVAX QIV batch number 185327 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements.
Patient was given the 2nd Pfizer vaccine 5 days before the recommended time between the 1st and 2nd dose.
Knot in right arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Knot in right arm at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE MASS (Knot in right arm at injection site). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE MASS (Knot in right arm at injection site) 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.
6 PM, shooting pain (sting) under tongue, lasted thru night 7 PM, lower back pain, diruppted sleep, took ibuprophen next morning, got better almost immediately night sweats, that night Swollen left tonsil, lasted week General myalgia, lasted 2 days sore injection site, lasted 7 days
No initial side effects from vaccine except sore arm at injection sight.  On 3/22/2021 7pm in the evening, I noticed a small lump in collar bone area on the left side.  tender to the touch.  Saw Family Care on 3/23. She said it was a swollen lymph node. Also a swollen lymph node on neck, left side.
Arm pain and weakness for 10 (ten) days.  600 and 800 mg doses of ibuprofen
Pt recvd vax & w/in 24 hrs had onset of inc apnea & required supplemental 02 & stimulation;
Pt felt nauseated after administration. After resting 15 minutes, drinking some water, and eating a piece of candy, adverse event subsided.
had all the symptoms of covid noting he lost his sense of taste and smell; had all the symptoms of covid noting he lost his sense of taste and smell; symptoms of covid; This is a spontaneous report received from the Pfizer Sponsor Program. A contactable consumer reported for a 37-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date as 1st dose single for covid-19 immunisation  .  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient received the first dose of the Pfizer covid 19 vaccine and eight days later had all the symptoms of covid noting he lost his sense of taste and smell on an unspecified date with outcome of unknown.  Patient was not tested for Covid but caller knows the patient has Covid.   Information on the lot/batch number has been requested.  The events Smell loss, Taste loss, and COVID-19 occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.
Pt recvd 1st dose of Engerix-B vax & exp stiffness in neck rt side 4-5 days post vax; Pain in lt upper arm 4 days post vax lasting 2 days & fatigue; 10APR91 pt still having problems w/neck & is still fatigued;
pt recv vax & devel an inj site rxn characterized by redness & swelling;also exp myalgia & arthralgia w/immobilization of shoulder;tx w/topical corticosteroid cream & advil;
APPETITE LOST; LETHARGIC; DIDN'T DRINK; This spontaneous report received from a health care professional 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 not reported, batch number: Unknown) 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 subject experienced appetite lost, lethargic, and didn't drink. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from appetite lost, lethargic, and didn't drink. This report was non-serious. This case, from the same reporter is linked to 20210642553.
The pt complained of fever, diarrhea, and vomiting for 2-3 days after the second injection (first injection not verified).
pt exp nausea & fatigue following vax w/MMR; pt recovered; No further details were provided;
Patient reported 1-26-21 that he has maintianed a hard knot at the sight of shingrix vaccine  five 11-10-2020   had never reported any adverse effect up to this date
IMM INJECTION SITE, LEFT DELTOID WITH SWELLING, REDNESS AND PAIN. ADVISED WARM COMPRESSION PACKS, IBUPROFEN/TYLENOL, BENADRYL CREAM/ORAL.
Case number PHEH2013US022999 is an initial spontaneous report received from a nurse on 31 OCT 2013. This report refers to a 25-yera-old female patient. On 30 OCT 2013, she was vaccinated with FLUVIRIN 2013/2014 (batch number 13461P, expiry date: May 2014) subcutaneously. On 31 OCT 2014, she developed burning, redness and swelling at the injection site and received Benadryl 25 mg orally. Outcome of the events was unknown. No seriousness and causality was reported for the events.    After an internal review on 15 NOV 2013, it was identified that labeling of the event "FLUVIRIN received subcutaneously" was erroneously assesed as listed. Hence significant was done and labeling was changed to unlisted.
patient came to the pharmacy on 11/24/21  to report bruising and mild pain at the site of injection. The first Janssen injection was given on 11/9/21.
Migraine; Nausea; Vomiting; Fever; Swollen and painful lymph node in armpit of same arm of injection; Swollen and painful lymph node in armpit of same arm of injection; Tenderness at injection site; Tired; Off label use; A third (booster) dose of BNT162b2 was administered subsequent to the Initial 2 dose regimen of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Sep2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified prescription oral birth control from an unknown date and unknown if ongoing and influenza vaccine (MANUFACTURER UNKNOWN) on 15Sep2021 for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 27Jan2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 17Feb2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy The patient received influenza vaccine within four weeks prior to the COVID-19 vaccine. On 01Oct2021, the patient experienced migraine, nausea and vomiting, fever, swollen and painful lymph node in armpit of same arm of injection, tenderness at injection site and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, nausea and vomiting, fever, swollen and painful lymph node in armpit of same arm of injection, tenderness at injection site and tired was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash on face, leg, back, spread throughout their body/Rash arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on face, leg, back, spread throughout their body/Rash arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (Allergic to formaldehyde). Concomitant products included VITAMINS NOS, VITAMIN E NOS and RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, 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 RASH (Rash on face, leg, back, spread throughout their body/Rash arm). The patient was treated with PREDNISONE (oral) for Rash, at a dose of twice steroid pills. At the time of the report, RASH (Rash on face, leg, back, spread throughout their body/Rash arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Skin test: positive (Positive) Positive- allergic to formaldehyde.      After the second dose of the Moderna COVID-19 vaccine the broke out with a rash that has spreaded from their face to their leg, arm, and back. Patient has been following up with the Dermatologist. Dermatologist had prescribed 3 different steroid ointment and twice steroid pills called Prednisone. The Prednisone had help calm down the rash. Couple months ago, the rash on the face had cleared up but the rash on the hand, leg, and arm has progressed. Dermatologist also suggested to stop taking concomitant medicine to see if the rash goes away. Patient stated that even stopping their concomitant medicine did not help.   This case was linked to MOD-2021-390034 (Patient Link).
Her 18 y/o son who received the 2nd dose of GARDASIL 9 one month later; This spontaneous report was received from a nurse referring to her son, a 18 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      Approximately in September 2020, the patient received the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strenght, dose, route of administration, anatomical location, lot # and expiration date were unknown). Then, one month later, probably in October 2020 (as the patient's mother was not certain), 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) for prophylaxis (strenght, dose, route of administration, anatomical location, lot # and expiration date were unknown).
Day of injection i got pain i my neck on the left side.  I took a vicoden 325 mg. The next morning, i won't up feeling really cold, when i usually wake up sweating . Really bad pain in my arm, fatigue, pain in my neck, bad migraine, eyes hurt and nausea.  I took 2x vicodens 325mg when i woke up.
Patient reports injection site and surrounding muscle tissue remains sore and makes range of motion uncomfortable even though it has been four months since vaccine administration.
The pt received injection at 10:30 on 11/19/01 in the left deltoid. By 14:30, the pt complained of symptoms of extreme pain and inability to lift arm. On 11/26/01, the pt is able to move arm and has no pain. Physician thinks vaccination caused acute bursitis.