chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gets the flu; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves a female patient (age not reported) who got the flu (influenza), when received vaccine INFLUENZA VACCINE.  The patient's past vaccination included Influenza vaccine with reaction of flu (every time got the flu shot, patients get the flu)  The patient's medical history, past medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Very swollen injection site that turned purple. Very sore. Pain extends to back and down to pinky finger.
Rash; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 21-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   On 14th September 2019, the patient received FluLaval Tetra 2019-2020 season. In September 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The reporter stated that, the patient developed a rash after receiving vaccine. The reporter stated that, the patient had not taken any treatment. Rash has resolved. The healthcare provider did not provide the patient's initials and did not have the lot or expiry date.
epistaxis; lymph nodes inflammation in neck, underarm, groin and hands joint inflammation; lymph nodes inflammation in neck, underarm, groin and hands joint inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Hashimoto disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "allergies". Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for COVID-19 immunization. The following information was reported: EPISTAXIS (non-serious) with onset 24May2022, outcome "unknown"; LYMPHADENITIS (non-serious), ARTHRITIS (non-serious) all with onset 2022, outcome "not recovered" and all described as "lymph nodes inflammation in neck, underarm, groin and hands joint inflammation". Additional information- It was reported that patient had experienced EPISTAXIS after the  4 day administration of vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache started 12 hours after receiving vaccination followed with fever up to 102 degrees F, chills, and vomiting. Left arm tender at injection site. Feeling well on 10/20/16 AM.
received a 3rd dose of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2021, the patient received the 3rd dose of Shingrix. On 15th December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter was not able to confirm which arm the vaccine was administered into or if it was given intramuscularly. The consent to contact was not obtained from the patient since the HCP was reporting.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 at 15:00 as dose 1, single (Lot number: ER8732), in left arm, on 23Apr2021 at 14:00 as dose 2, single (Lot number: EW0172), in left arm and on 26Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 48 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 04Feb2023 at 11:00 as dose 4 (booster), single (Lot number: 049d22a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Feb2023 at 11:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 10Apr2023 to 14Apr2023.
Nausea, Dizziness, Diarrhea, Low-Grade Fever
redness on my hands; swelling on my hands more on the right one than on the left one; Rash; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old male patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; Unknown), via an unspecified route of administration in the right arm on 31Mar2021 at 10:45 ( at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021, patient experienced rash, redness and some swelling on hands, more on the right one than on the left hand. The patient did not receive any treatment for the adverse event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event rash, redness and some swelling on hands were unknown at the time of report.   Information about lot number cannot be obtained. No further information is expected.
At ~1:40 pm, daughter of client observed client itching his hands ~30 min after receiving vaccine.  EMT on site responded.  Client complained of itching in hands and localized red hives observed.  Client is currently being treated with ciprofloxacin for a UTI on 10th day of treatment.  EMT obtained VS:  BP140/90, 93% SpO2, 77 pulse.  50 mg oral solution benadryl was given at 1:50 pm.   VS ~15 minutes later:  BP 132/82, 97% SpO2m 64 pulse.  Itching subsided.  Client and daughter left site  at 2:35 pm, with daughter driving.
2 days following vaccination patient began having fever and chills. 3 days later breaking out of RASH on face and few spots on arms and legs. Patient described as painful and itchy. 3 to 4 days later fever dissipated, and appetite returned. As of today 5/25/2018 patient is feeling better and taking BENADRYL which patient says has helped.
Severe swelling, red and heat radiating off entire upper arm, turned purplish, large knot, could not move arm at all for 1 day, limited mobility for several days after also, fever, .....but #1 worst symptom was the pain. It was incredibly painful, and the swelling made my left arm 3x's bigger then my right arm. I have amazing pictures, looks like I have elephantiasis of the arm. Still have small amounts of lingering pain, feels like some limited mobility still but seems to slowly be getting better. I also had a severe headache. I iced my arm on and off for 2 days -heat coming off my arm would melt the ice packs.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 12:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Mar2021 at 12:30 as dose 1, single (Lot number: EN6204), in left arm, on 03Apr2021 at 12:30 as dose 2, single (Lot number: EP6955), in left arm, on 19Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 22Apr2022 at 14:45 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Moderately Obese BMI: 32.6" (unspecified if ongoing); "Environmental Allergies" (unspecified if ongoing); "Elevated Blood Pressure Readings at Doctor's office without diagnosis of hypertension" (unspecified if ongoing); "Vitamin D and B-12 Deficiencies" (unspecified if ongoing); "Vitamin D and B-12 Deficiencies" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cefprozil, reaction(s): "Known allergies: Cefprozil"; Augmentin, reaction(s): "Known allergies: Augmentin"; Celebrex, reaction(s): "Known allergies: Celebrex".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: 32.6. Therapeutic measures were taken as a result of vaccination failure, covid-19 and the treatment was Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness,swelling with knot, heat to site. 3-4 inch knot in diameter. Chills & fatigue.
sore arm; headache; transitory fever for about one hour; This is a spontaneous report from a contactable pharmacist. A 56-years-old male patient received second dose of bnt162b2 (BNT162B2 solution for injection, Batch/Lot number was not reported),  via an unspecified route of administration, administered in Arm Right on 27Jan2021 as single dose for covid-19 immunisation. Medical history included seasonal allergy. The patient's concomitant medications were not reported. He received his seasonal allergies SC injection 24 hours before receiving the second BNT 162 b2 injection. patient reports that he received his seasonal allergies SC injection 24 hours before receiving the second BNT 162 b2 injection on 27Jan2021 in his right deltoid muscle. Patient also reports that he took 50mg of Benadryl prior to his BNT162b2 injection. A couple hours after receiving the BNT 162b2 vaccine he experienced a transitory fever that lasted 1-2 hours and resolved. The next morning,28Jan2021, patient stated that he had a headache that lasted for a day and a half which was unresolved by sleep or ibuprofen, 400 mg taken 3-4 times in the day and 1/2 time period. On Thursday 28Jan he noticed a lump in his Right arm pit which was visible and sore. The lump resolved by after 4-5 days and he has been symptom free. On 27Jan2021, the patient experienced transitory fever for about one hour and sore arm, headache on 28Jan2021.The outcome of the events was recovered. This is a supplement to the previous report submitted 28Jan. Patient emailed (Name) with additional information pertaining to the original report, information was added. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number: 211421A expiry: UNKNOWN) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.9 F. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-OCT-2021. This report was non-serious.
No additional AE reported; A patient received a 2nd dose of PROQUAD in error before 4 years of age. Patient was supposed to receive the 2nd dose when she was 4 years old. Patient is 2 years of age now and received a 2nd dose today (11/16/2022).; This spontaneous report was received from a medical assistant regarding a 2-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) administered for prophylaxis.  On 16-NOV-2022, the patient was vaccinated in error with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, product quantity 1, lot #W024548, expiration date: 31-JAN-2024 (strength, anatomical location, and route of administration were not provided) administered for prophylaxis, before 4 years of age (Product administered to patient of inappropriate age).
Patient began to feel lightheaded and sweating a few minutes after getting shot.  Her vitals were obtained and were stable. She was placed in recumbent position and then given juice pouch, graham crackers. After 30 minute observation period she reported feeling much better. Her repeat vitals were stable, patient discharged from site.
Generalized vaccinatum, pain, redness w/streaking, itching. Symptoms started 9days post vaccination. Pt Vaccinated 13Feb03 and symptoms began 22Feb03. Benadryl for itching. Tylenol for pain. Pt medevaced  for further evaluation/treatment.
Pt received incorrect COVID vaccine, received age 12+ vaccine  Pt has had no known reactions or side effects.
ACUTE PERICARDITIS, UNSPECIFIED 12/12/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
slight shortness of breath all lasting over 1 week; Extreme chills; extreme fatigue and tiredness; whole body muscle aches; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received bnt162b2 (batch/lot number and expiration date not provided, not available/provided to reporter at the time of report completion), via an unspecified route of administration, at arm left, first dose on 23Dec2020 09:15, at single dose, for COVID-19 immunization. No relevant medical history. No known allergies to medications, food, or other products. There were no concomitant medications. The patient is not pregnant at the time of vaccination. 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 patient experienced extreme chills, extreme fatigue and tiredness, whole body muscle aches, slight shortness of breath all lasting over 1 week, all from 23Dec2020 16:15. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test (test type: Nasal Swab, test name: rapid test): negative, on both 27Dec2020 and 30Dec2020. The outcome of the events was not recovered.  Information about Batch/Lot number has been requested.
I got really high temperature with aches and pains that persisted for 3 days. It moved to my stomach and caused it to be upset. I called my doctor at that point and he advised me to carry on what I was doing and rest. After about 5 day my symptoms subsided and I was completely recovered.
This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On an unspecified date in 2010, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) at a physician's office as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date, the patient contracted a persistent strain of herpes zoster. On an unspecified date in 2012, the patient was treated at a physician's office for a persistent and severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a physician refers to one of twin boys of unknown age. The patient received his first dose of GARDASIL (dose, route and lot number not reported) in October of 2011 and his second dose in July 2012 (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. In July 2012, at an unspecified time period post second dose, boy complained of stomach pain. Boy was seen by the physician who diagnosed him with gastritis. The patient was given ZANTAC as treatment. At the time of the report the outcome of gastritis was unknown. The relatedness for gastritis was unknown for GARDASIL. This is one of several reports received from the same source (MARRS # 1207USA012762). Additional information has been requested.
Information has been received from a registered nurse concerning a 25 year old female, with no drug reaction/allergies, and with normal PAP smear, who on 10-JAN-2007 was vaccinated with the first dose of GARDASIL (lot number unknown) IM 0.5 mL, and late on 21-MAY-2007 was vaccinated with the second dose of GARDASIL (Lot number 655324/0088U) IM 0.5 mL. Concomitant therapy included unspecified birth control pills. In the morning of 18-JUL-2008, the patient was in the office and mentioned to the physician she had genital warts. The patient had a PAP smear done (results unknown). The physician treated her for condyloma and will be back to the office later on 18-JUL-2008, possibly to receive the third dose of GARDASIL. At the time of the report the patient had not recovered. The patient sought medical attention, phone office and visited office. Additional information has been requested.
17 years of age at the time of the vaccination; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age at the time of the vaccination) and FATIGUE (Tiredness) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age at the time of the vaccination) and FATIGUE (Tiredness). On 24-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age at the time of the vaccination) had resolved. At the time of the report, FATIGUE (Tiredness) 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 case was linked to US-MODERNATX, INC.-MOD-2021-132185 (E2B Linked Report). This case was linked to MOD-2021-208960 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132185:
Information has been received through the Merck pregnancy registry through an 18 year old female consumer who on 09-OCT-2007 was vaccinated with her first dose of Gardasil.  Concomitant therapy included hepatitis B virus vaccine (unspecified), varicella virus vaccine live (unspecified), meningococcal vaccine (unspecified) and tetanus toxoid.  The patient experienced mild cold symptoms for approximately 1 day following the vaccinations.  On 16-OCT-2007, the patient found out she was pregnant (LMP approximately 29-AUG-2007).  The patient sought unspecified medical attention with her physician.  The patient had a pregnancy test and unspecified blood work performed.  Additional information has been requested.
About 12 hours after receiving the vaccine I had a coldness in my chest. It feels sharp to breath and like I'm taking in a large gust of freezing cold air.