chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles, which lead to hospitalization. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Patient came into the pharmacy and was asked about his 2nd covid vaccine, he state that he had a reaction after the first shot.  he said that he suffers from barometric sinus eye when he flies.  he had a reaction similar to that his upper eyelid swelled and was red and itchy this lasted for about 8 hours before it resolved. he was advised to contact his md before he received the second dose. he said he was between mds but would check with his new md. he was called a couple of weeks later but he had still not been evaluated by his new md he was waiting on an appointment
Approx. 1 day, post vax, child presented with red, raised rash confluently distributed over entire body with pruritus, lasted appox. 1-1 1/2 weeks.
redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site; a circular bubble in the middle, the area was 15 cm in diameter at the injection site; itching at the injection site, the area was 15 cm in diameter at the injection site; redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site; Initial and additional information received on 27-May-2021 regarding an unsolicited valid non-serious case received from a physician (Contact specialty Pediatrics) via Medical Information  (Reference number- 00618803).  This case involves a five year old female patient who experienced redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site (inflammation), circular bubble in the middle, the area was 15 cm in diameter at the injection site (blister), itching at the injection site, the area was 15 cm in diameter at the injection site (pruritus) and redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site (vaccination site reaction), while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included POLIO VACCINE for prophylactic vaccination on 25-May-2021 at the same visit.  On 25-May-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5765BA and expiry date: 28-Aug-2022) (Injection) via an unknown route in the left thigh for prophylactic vaccination.  On 25-MAY-2021, the patient developed a non-serious redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site (inflammation), circular bubble in the middle, the area was 15 cm in diameter at the injection site (blister), itching at the injection site, the area was 15 cm in diameter at the injection site (pruritus) and redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site (vaccination site reaction), on same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was also reported description: Health Care Professional called to report DAPTACEL has been causing chemical reaction in four patients. The caller stated that she has had four patients that developed the same injection site reaction after a vaccination with Daptacel and Doctors nurse called back stating they would like a replacement. Three of the patient received the same lot number for sure, the caller was not sure about the fourth patient. She will send pictures of the reaction areas of all of these patients. Product used, Still using product: No  No laboratories details reported.  The patient was treated with BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] and cool compresses for all the events.  On an unknown date, the patient recovered from all the events after five days.
she got COVID-19 the first two weeks of Janaury of this year; she got COVID-19 the first two weeks of Janaury of this year; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "she got COVID-19 the first two weeks of Janaury of this year". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive.  Clinical course: caller wants to know if it is to soon for her to receive the second booster dose of the vaccine if she already received two doses of the Pfizer´s COVID-19 vaccine and she got COVID-19 the first two weeks of January of this year.  During the call patient mentioned that she was unable to review in a web page if her vaccination schedule was complete, she stated that the website did not work properly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer and described the occurrence of sore arm in a patient who received Influenza vaccine. The patient's past medical history included blood sugar increased (she lost 55 pounds to get her blood sugar down to normal 4 years ago). Concurrent medical conditions included seasonal allergy, osteoarthritis, blood pressure high and gastroesophageal reflux disease. On an unknown date, the patient received influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sore arm and got the flu. Rechallenge with Influenza vaccine as positive. On an unknown date, the outcome of the sore arm and got the flu were unknown. It was unknown if the reporter considered the sore arm and got the flu to be related to Influenza vaccine. See case US2014GSK002983 for reaction after next vaccinations.
Pt contacted rph on duty on 6/30/16 stating she experienced swelling and pain at the injection site starting day she received vaccine and it has persisted thus far, states she has iced with no relief, she is concerned about infection, she was counseled to seek evaluation by physician for concerns of infection and advised this is a typical site reaction to vaccination.
Patient given 2nd CoVid 19 Pfizer vaccine. An hour later developed itching and swelling of eyes and "weird sensation in throat"
Headache; sore arm; muscle aches; fatigue; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FG3527, Expiration Date: 28Feb2022) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; CHILLS (non-serious), outcome "unknown", described as "chills".
Patient RTC complaining of facial flushing ten minutes after administration of Hep B. Patient presents with mild facial flush but no rash, no hives, no respiratory distress. Given one Claritin 10mg. Patient requested and was given ice pack for face, and reclined on exam table.   Patient states facial warmth has "almost gone away." Still no respiratory distress, no hives and no rash. Patient checked out by PAC. Patient discharged home with instructions to call 911 if symptoms return. Patient understands and agrees with plan.
Flu symptoms 2 weeks after vaccination for 3 days; bed rested; right breast was tender; right breast was hot to touch; joint hurt; body ache in other area; severe cold sore; something behind her eye and it was sensitive to light and sore while blinking; something behind her eye and it was sensitive to light and sore while blinking; fatigue; Lower back pain; sore arm; redness; Swelling; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (redness), SWELLING (Swelling), LETHARGY (lethargic) and PHOTOPHOBIA (something behind her eye and it was sensitive to light and sore while blinking) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN, LEVOTHYROXINE SODIUM (SYNTHROID), CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) and ESTROGEN NOS for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ERYTHEMA (redness), SWELLING (Swelling) and LETHARGY (lethargic). On 29-Jan-2021, the patient experienced PHOTOPHOBIA (something behind her eye and it was sensitive to light and sore while blinking), EYE PAIN (something behind her eye and it was sensitive to light and sore while blinking), FATIGUE (fatigue) and BACK PAIN (Lower back pain). On 30-Jan-2021, the patient experienced PAIN (body ache in other area) and ORAL HERPES (severe cold sore). On 31-Jan-2021, the patient experienced ARTHRALGIA (joint hurt). On 02-Feb-2021, the patient experienced BREAST TENDERNESS (right breast was tender) and BREAST DISCOMFORT (right breast was hot to touch). On 03-Feb-2021, the patient experienced ASTHENIA (bed rested). On an unknown date, the patient experienced INFLUENZA (Flu symptoms 2 weeks after vaccination for 3 days). On 18-Jan-2021, PAIN IN EXTREMITY (sore arm), ERYTHEMA (redness), SWELLING (Swelling) and LETHARGY (lethargic) had resolved. At the time of the report, PHOTOPHOBIA (something behind her eye and it was sensitive to light and sore while blinking), EYE PAIN (something behind her eye and it was sensitive to light and sore while blinking), FATIGUE (fatigue), BACK PAIN (Lower back pain), PAIN (body ache in other area), ORAL HERPES (severe cold sore), ARTHRALGIA (joint hurt), BREAST TENDERNESS (right breast was tender), BREAST DISCOMFORT (right breast was hot to touch), ASTHENIA (bed rested) and INFLUENZA (Flu symptoms 2 weeks after vaccination for 3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Myalgia, Arthralgia, Employee reported that she had pain at injection site, joint pains, muscle or body aches and fatigue or tiredness Narrative:
Allergic reaction in mouth, severe canker sores on tongue and roof of mouth developed a few days after the first shot and continued after the second shot, getting worse
Chills, Fever, Fatigue, Nausea, Migraine, No Appetite, Shakey
low temperature, chills/rigors, nausea, vomiting, myalgias, severe abdominal pain, anorexia.  started within 12 hours of vaccination, much worse by 24 hours.  Seen in E.D. received IV fluids and NSAIDS with improvement.
Patient walked into pharmacy today (9/22/22) and reported possible adverse events from high dose flu shot from 9/12/22. Patient reported having tightness in feet and hands where her feet and hands would clench. She also reported having travelling pain sensation going from shoulder and arm to neck, and same sensation from knees to ankles. This made it difficult to walk for about 24 hours after. These symptoms resolved in about 24 hours on their own. Patient did not seek any medical attention.
Hallucinations, Myalgia, Arthralgia, chills, pain injection site, fatigue Narrative:  Other Relevant History:
Baby became very fussy and crying like in pain. Right leg was swollen and red down to his knee. I put a cold wet towel on it and gave him 1.25ml of Tylenol. This seemed to help and the swelling went down around 12:00 am.
expired ipol was given to a child with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via health professional on 14-Oct-2022. number: 01322355.  This case involves a 7-year-old male patient to whom expired IPV (VERO) [IPOL] was given to a child with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) for Prophylactic vaccination; Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination; and Influenza Vaccine (Flu) for Prophylactic vaccination.  On 13-Oct-2022, the patient was administered expired dose of suspect IPOL at dose 0.5 ml once (lot: T1E872M, expiry date: 10-Oct-2022) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) at same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
persistent cough; malaise; pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (persistent cough), MALAISE (malaise), PAIN (pain) and PYREXIA (fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced COUGH (persistent cough), MALAISE (malaise), PAIN (pain) and PYREXIA (fever). On 23-Apr-2021, MALAISE (malaise), PAIN (pain) and PYREXIA (fever) had resolved. At the time of the report, COUGH (persistent cough) outcome was unknown. Not Provided          Action taken with response to the events were not applicable.
tested positive for the COVID ten days ago; tested positive for the COVID ten days ago; This is a spontaneous report from a contactable consumer. A patent of unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; solution for injection; Lot Number: Unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for the COVID ten days ago. It was reported that the reporter (an x-ray technician) called to report a patient who received the first dose of the Pfizer Biontech COVID19 (Comirnaty) vaccine and tested positive for COVID ten days ago. The patient received a "COVID infusion" or the convalescent plasma. The reporter wanted to know if there was a time period the patient needed to follow before the patient got the second dose of the vaccine. The clinical outcome of the event tested positive for the COVID ten days ago was unknown.   The lot number for the vaccine BNT162b2 was not provided and will be requested during follow up.
Mother reports started running fever 3 to 4 days after shots, then broken out with red "dots" and then several days later had blisters all over body. Took to physician on 6/30/03.
Thurs eve felt warm-2:00 pm T 102, T on Fri 104.5 Friday eve T 103, Sat am /w eyes swollen took to MD Sat @ 12noon. Returned to Dr on Tues 12Feb/w 100 T & cough, RX Amoxicillin, Advil, MD feels rxn due to DTP,recommends DT for future use.
Headache; Injection site pain; tiredness; chills; joint pain; Nausea; feeling unwell; This is a spontaneous report from a contactable consumer(patient) reported that. A 66-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 09:00 (Batch/Lot Number: Pfizer Eng201) as DOSE 1 SINGLE for covid-19 immunization(Age at vaccination 66 years). The patient Medical history included compression fracture L1 vertebrae from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 22Feb2021, the patient experienced headache, injection site pain, tiredness, chills, joint pain, Nausea and feeling unwell. No treatment was reported. The event outcome was not recovered.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm and as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type1" (unspecified if ongoing), notes: Diabetes type1; "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 07Jan2023 to 07Jan2023, Lot number: GF1750).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Numbness in arm that started to go away. Numbness in face started and continued since 4 pm on 1/17/2022 (3 days after vaccine administered). All numbness occurred 3 days after vaccination.
Student had varicella vaccine as required by med school program. Redness, swelling, warmth, itching at site of injection that increased over a few days. Arthus rxn vs. infection? Pt. seen by provider who prescribed CIPRO and instructed pt to RTC with any additional symptoms or worsening of symptoms.
Mother phoned on 12/13/00 to ask questions on reactions. Child became dizzy and pale, post vax (approx. 10 minutes) and had watched his twin brother get his injection. She felt he got sick from that. Later, he said he felt the fast heartbeat, weakness and dizziness which lasted for approx. 1/2 hour.
I woke up today with rashes and itchiness like mosquito bites on my elbows. I thought it was bed bugs so took a shower and washed bedding. Throughout the day the rashes kept showing up on other parts of my body with an unbearable itching. They showed on my knees then hips , thighs, neck,  now on my ears and around my mouth. I just took a Claritin 24 hours. But it?s still unbearable.
Pt had mild arm pain 1-2 days after the injection. Then it healed. On day #7 had a 3x5 inch hive develop only at the injection site. Has been using claritin daily with some improvement
Case came in with parent for 1 year shots:hepatitis A,MMR,and varicella.Nurse thought she had dose of MMR ll but it was MMR and varicella (Proquad).Proquad dose given sub-q in right thigh.Varivax dose also given in left thigh by sub q route.
Hot flashes; chills; This is a spontaneous report received from a non-contactable Nurse.   A 26-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231 and Expiration date was unspecified) on 30Dec2020 14:00 as single dose, (at 26  years of age), intramuscular left arm for COVID-19 immunisation. Medical history included allergic to shellfish.  Concomitant medication was none.  The Patient is not pregnant.  The patient did not have Covid prior to vaccination.  The patient was not tested post vaccination for Covid.  No other vaccine was taken within four weeks. The patient did not have treatment.  The patient experienced Hot flashes and chills 24hrs after receiving vaccine (31Dec2020 16:00). Outcome of event Hot flashes was recovered and chills  was recovered.   No follow-up attempts are possible. No further information expected.
This case was reported by a healthcare professional and described the occurrence of antigenemia in an infant subject of unspecified gender who was vaccinated with Pediarix for prophylaxis. On an unspecified date the subject received unspecified dose of Pediarix (unknown). At an unspecified time after vaccination with Pediarix, the subject experienced antienemia. Relevant test results included a positive hepatitis b surface antigen two days after Pediarix was given. At the time of reporting the outcome of the event was worse.
Chills, body aches,? fever, extreme fatigue. Pt was not seen in clinic for symptoms. Spoke with RN and MD via telephone