chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and HEADACHE (Headache) 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 14-Mar-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 14-Mar-2021, the patient experienced PAIN (Achy). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, PAIN (Achy) and HEADACHE (Headache) outcome was unknown.            Concomitant and treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.
pt recv vax 13NOV97 & about 36hr p/vax pt exp unilateral hearing loss (70% left ear), slowed speech & malaise;first impressions were that pt had suffered a small stroke however MRI was reported as WNL;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 12Mar2021 at 15:30 as dose 1, single (Lot number: EN6302) at the age of 20 years, in left arm, on 02Apr2021 at 17:15 as dose 2, single (Lot number: ep6955) at the age of 20 years, in left arm and on 29Oct2021 at 11:30 as dose 3 (booster), single (Lot number: FF2590) at the age of 21 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; LEVOTHYROXINE; VITAMIN D3; FAMOTIDINE; KLONOPIN; PREDNISONE, start date: 15May2022, stop date: 19May2022; ADVAIR, start date: 14May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid to treat vaccination failure, covid-19, treatment start date: 14May2022, treatment stop date: 19May2022.
Allergic type of reaction; rash flares; pain; fever; Dose 4 bivalent dose of Pfizer and Moderna dose 3,2,1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 18:00 as dose 4 (booster), single (Lot number: G16665) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose: 01, Batch number: 0I0M20A), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose: 02, Batch number: 0I2A21A), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose: 03, Batch number: O65F21A), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Oct2022 at 18:00, outcome "unknown", described as "Dose 4 bivalent dose of Pfizer and Moderna dose 3,2,1"; DRUG HYPERSENSITIVITY (non-serious) with onset 24Oct2022, outcome "not recovered", described as "Allergic type of reaction"; PYREXIA (non-serious) with onset 24Oct2022, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 24Oct2022, outcome "not recovered"; RASH (non-serious) with onset 24Oct2022, outcome "not recovered", described as "rash flares". The events "allergic type of reaction", "rash flares", "pain" and "fever" required physician office visit. It was unknown if therapeutic measures were taken as a result of drug hypersensitivity, rash, pain, pyrexia.  Additional information: Serious, seriousness criteria-Results in death, seriousness criteria-Life threatening, seriousness criteria-Caused/prolonged hospitalization, seriousness criteria-Disabling/Incapacitating, seriousness criteria-Congenital anomaly/birth defect reported as no. No other vaccine in four weeks. Adverse event reported as Allergic type of reaction rash flares, pain, fever. If COVID prior vaccination reported as Yes. If COVID tested post vaccination reported as No. No known allergies. No other medical history. Device Date was 01Nov2022.
Patient has slight swelling and tenderness at injection site it is also itchy 3 days later.
This spontaneous report was received from a registered nurse refers to a 5 years old patient. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # L008272, expiry date 11-MAR-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
After completion of first shot, menstrual cycle became heavier than normal.  After the third shot, it became heavier beyond that.
No adverse event occurred,  the employee forgot she had taken a booster in 2022 and requested an additional covid vaccine prior to traveling.
First noticed red blotchy rash on cheeks, chin of face; chin bright red & hot; fever up to 101.2 ax; diarrhea; cranky & irritable & screaming;
I felt like I was getting a cold or flu; I felt like I was getting a cold or flu; Very tired; low energy; slight nasal and ear congestion; slight nasal and ear congestion; Slight headache Below my temple; shivered most the night; Muscle ache at injection site; Muscle ache/shoulders and knees; This is a spontaneous report from a contactable consumer (patient).A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 07Mar2021 at 17:00 (at the age of 55-year-old) as DOSE 1,SINGLE for covid-19 immunization. Medical history included hot flush and night sweats. Concomitant medications included herbal pollen nos (RELIZEN) taken for hot flush, and alendronate sodium (BONAFIDE) taken for night sweats. 07Mar2021 17:30, After about 30 min patient felt like she was getting a cold or flu. Very tired and low energy, slight nasal and ear congestion. Slight headache Below temple, shivered most the night, muscle ache at injection site and in shoulders and knees. The outcome of the event Shivering was recovered, while all other events were  recovering at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a patient of unknown age and gender referring to them self. Patient's relevant medical history, concurrent conditions and drug reactions/ allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose/frequency, lot # unspecified). No concomitant medications were reported. Patient reported that they had a bad reaction in their arm where they received the shingles shot. Patient stated that their arm swelled and it was all red around the injection area. The patient had a 4-inch long redness by 3-inch wide circle and was placed on antibiotic. They had to get injection to relieve swelling and itching. Outcome of the events were unknown. Patient stated that it was not a good experience. Causality assessment was not provided. Additional information is not expected as the reporter did not wish further contact.
A serious life-threatening report has been received from a nurse concerning a nine-year-old male experiencing an anaphylaxis reaction. No medical or drug history has been reported for the patient. The patient received both FLUMIST and VARIVAX vaccinations on 30-Oct-2007. Within five minutes of receiving the FLUMIST and VARIVAX vaccines, the patient experienced an anaphylaxis reaction described as wheezing, shortness of breath, facial edema and facial mottling. He was transported to the hospital. No additional information regarding treatment or outcome was available at the time of this report. Additional dosing of FLUMIST was not reported. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Localized reaction to IM injection of influenza vaccine - redness, swelling, discomfort lasted about 3 days.
1:45 presented himself in observation w/ c/o numbness in lt.arm.  Skin W/D, capillary refill left hand quick.  No other symptoms. Second observation.  Very talkative, laughing, telling jokes, w/ no further c/o lt.arm numbness.  Advised if reoccurs seek medical attention.
Chills; This is a spontaneous report from a non-contactable consumer. An adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), via an unspecified route of administration, on 11Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot Number: EJ1685) on 21Dec2020 for COVID-19 immunization. The most recent COVID-19 vaccine was administered in a hospital facility. On an unspecified date, the patient experienced chills. Therapeutic measures were taken as a result of the event which included ibuprofen (ADVIL). The event was considered non-serious. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Talked to mother and she said that first it was like she was wearing a red shirt. Then after the BENADRYL wore off it looked like she was red all over with some white splotches and she did have hives at that time. Today she does not have any redness. Told mother to let me know if she does develop this. Will write up a VAERS report and send it in.
5 min after shot i could taste medicine in my mouth. That lasted for 3 days. I had painful body aches headaches. Felt so tired like all the energy was drained from my body. I had severe abdominal pain and diarrhea. My energy level still has not returned to normal.  I also feel shot of breath. Before I could wear my mask with no problem but now I must remove to breathe. I had shooting pain in my abdominal area.
8/22/02: complained of burred vision for 1 week with both eyes hurting. Saw opthalmologist 8/22/02; symptoms worsened: diagnosed with retrobulbar neuritis. 8/25/02 Admitted to hospital and diagnosed with Devic's Syndrome. Inter optic neuritis and myelitis. Responded dramatically to IV steroid treatment. Remained on such for time after outpatient. Follow up to neurologist/rehab medicine. Patient to regain full mobility and balance. Symptoms: bilateral vision deterioration, inability to void, decreased sensation bilateral left extremities and weakness. Right numbness/tingling.  Followup: He was treated with IV Solu-Medrol and had partial improvement. He is now back to his baseline with no residula symptoms. He has been placed on azathioprine 50 mg, three per day and prednisone 10 mg per day. He has no current complaints. He is till in training with the Coast Gauard and receives his follow up blood tests from them. Cranial nerves normal. Motor 5/5 thoughout. Cordination:normal. Reflexes symmetric. He is doing quite well. I recommend tapering the steroids. I have written a taper for him ovr the next six months from his current dose of 10 mg per day. I recommend CBCs and liver funciton tests every three months while on the azathioprine. the question of a smallpox vaccine has arisen b/c of his affiliation with the Coast Guard. I recommend against using the smallpox vaccine because of his immune suppression on the azathioprine and steroids. He will see me in follow up in six months.
This spontaneous report was received from a nurse refers to a 18 year old patient of unknown gender. Patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 27-JUL-2016, the patient was inadvertently vaccinated with ZOSTAVAX (lot number/expiry date unknown by reporter), instead of VARIVAX. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
This is a spontaneous report from a contactable nurse. A 77-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot/Batch # L62074, Expiration Date Nov2016), intramuscular in the left deltoid on 03Jun2015 at 0.5 ml, single. Medical history and concomitant medications were not reported. The patient experienced cellulitis like symptoms in left arm and redness after the vaccine was given, both on an unspecified date with outcome of unknown. The patient had no fever so she was told TYLENOL and ice.
Back problems; This is a spontaneous report from a contactable consumer (patient's wife).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's wife and the patient both had their shot two days ago (20Jan2021) and patient had back problems and the doctor wanted him to get a cortisone shot. The reporter was asking if it can interfere with the COVID shot. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
did not report any symptoms that the patient was experiencing; a female patient in her 60's was given an expired M-M-R vaccine; This spontaneous report as received from a pharmacist refers to a female patient in her 60's. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 23-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA, lot # R030813, expiration date: 24-OCT-2020, subcutaneously into the right arm for prophylaxis.        The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA did not have any temperature excursions. The reporting pharmacist was concerned with efficacy of the expired vaccine and did not report any symptoms that the patient was experiencing.
Information has been received from a public health nurse supervisor concerning an adult male who in the 1980's was vaccinated with 3 doses of Hep B (manufacturer unknown). On unspecified date an antibody test was drawn and showed the patient did not seroconvert. So in 1997 the patient was vaccinated again with a 4th dose of Hep B (lot # not reported) (manufacturer unknown). Again the patient failed to seroconvert. The patient sought unspecified medical attention. The status of the patient was unknown. Additional information is not expected.
Pt noted tongue and throat swelling approximately 10 minutes after shot.  VS assessed, hypertension, tachycardia notes. Symptoms of swelling improved, then urticaria noted.  IM Benadryl given.  VS noted above Pt. improved and was sent home and partner. Education provided on when to seek further medical attention.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with VARIVAX (Merck). The physician reported that on an unspecified date, after received the VARIVAX (Merck), the patient experienced shingles. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
none of them actually prevent getting the disease/ hospitalized after second dose; Suspected vaccination failure/ none of them actually prevent getting the disease/ hospitalized after second dose; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that new mRNA jabs had a whole list of adverse side effects. The three people whom reporter knew where hospitalized after receiving their second dose of Shingles jabs. The reporter reported that none of them actually prevent getting the disease. The reporter also mentioned that Flu vaccine was still only 40 to 60 percent effective. This was 1 of 3 linked cases reported by same reporter for different patients. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR156120:Same reporter US-GSK-US2022AMR156127:Same reporter US-GSK-US2022AMR156128:Same reporter (Case deleted, case created in error) US-GSK-US2022AMR156129:Same reporter (Case deleted, case created in error)
patient received the first dose of expired Imovax vaccine; Initial information received on 08-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 8 years old male patient who received the first dose of 0.5 mL expired vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] lot N16402M, expiry date- 29-JUL-2019 via intramuscular route in the right arm on 07-Aug-2019 at 07:00 PM.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IMMUNOGLOBULIN HUMAN ANTI-RABIES (IMOGAM) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether the patient had any adverse event.  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 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.  Documents held by sender: none.
Narrative: Pt had multiple immunizations yesterday, has headache minimal fever chills began last night one episode loose bm no blood no cough no sob no chest pain mild light headed no sore throat no rash mild right knee pain no swelling had negative covid
Fell backwards in home flat on back. Did not trip, just fell without feeling dizzy or slipping from a standing position.
redness; 2-3 inch wide round spot on arm; rash under arm and up to her neck; big spot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), RASH MACULAR (2-3 inch wide round spot on arm), RASH (rash under arm and up to her neck) and RASH (big spot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), RASH MACULAR (2-3 inch wide round spot on arm), RASH (rash under arm and up to her neck) and RASH (big spot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of benadryl tablets and benadryl cream. At the time of the report, ERYTHEMA (redness), RASH MACULAR (2-3 inch wide round spot on arm), RASH (rash under arm and up to her neck) and RASH (big spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck and arm
Injection site has rash and swollen to silver dollar size. Apply cold compress and take BENADRYL as directed.
Paralysis on right side , leg and arm and shoulder. Quickly developed Rheumatoid Arthritis all over body, primarily in hands, shoulders and knees.
This spontaneous report was received from a nurse practitioner and refers to a 15 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies were reported. The patient had a twin sister. In an approximately November 2015 (reported as about 1 year ago), the patient was vaccinated with a dose of GARDASIL (exact dose, route of administration, lot number and expiration date were not reported). On 09-NOV-2016, the patient came to receive a second, late dose of GARDASIL 9 (exact dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved. The relatedness between the event of interchange of vaccine products and suspect vaccines was unknown. This is one of two reports received from the same reporter and considered the patient's twin sister. Additional information has been requested.
Warm and redness around injection site 6 days after administration. Hurt day after injection and now itchy. Told pt to consult physician on Friday 10-7-16 because MD out on Thursday.
Certified technician administered vaccine and leakage occurred running down the patient's arm.  Offered revaccination based on CDC guidelines and she verified with her rheumatologist that this was okay.  patient was revaccinated.
sx stated hr p/vax including sore throat, severe myalgias, fever, chills, nasal congestion;on exam was very diaphoretic, but otherwise unremarkable;sx lasted about 1wk;
I breastfed my infant son as usual following vaccination, not expecting there to be any side effects in him.  However, starting around 10:00pm, he woke every few minutes all night moaning and crying.  This has never happened before and I have nothing else to a attribute it to.
About one hour after her 2nd dose of SHRINGRIX she experienced headache, dizziness, wooziness and upset stomach. With a few hours she began to have all over body aches which then became worse and described as bone aches as well in hips, back and neck. By the following evening symptoms were subsiding, but she still has reoccurring headaches which she never had before.
3 day H.O. rash (7 days) post vaccine. Erythematous papular rash over cheeks, upper back, extremities. Blanching to pressure.