chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spontaneous report received on 10DEC2021. A healthcare professional reported that the patient had a "reaction to the BioThrax (anthrax vaccine)" (PT: Vaccination complication). On 29MAR1999, the patient received BioThrax (lot number: FAV038) and in the same year, the patient had a reaction (not specified) to the anthrax vaccine. Outcome of the reported event was unknown. No additional information was reported. Company comment: It was reported that a patient received BioThrax and had a reaction (vaccination complication). Further information regarding the event, medical history or concomitant medication is limited. Considering the limited information, the causality of vaccination complication is assessed as possible with BioThrax (its role cannot be ruled out). On 20DEC2021, significant follow up information received from the healthcare professional. The follow up information included patient information (date of birth, name, gender, age), vaccine information, and event details. It was updated that the patient was 34-year-old female. Earlier, it was reported that the patient had reaction to Biothrax vaccine, now the specific details had been received from the reporter and it was updated that she had "severe whole arm swelling which turned purple with pruritis" (PT: Peripheral swelling, PT: Skin discolouration and PT: Pruritus). The reporter was not sure about the treatment for the events. Additionally, it was reported that the patient did not have any idea about the administration of the BioThrax vaccine but assumed that it might be intramuscular (IM), and the information provided was about the second shot of the vaccine. Outcome of reported events "severe whole arm swelling which turned purple with pruritis" was unknown. Company comment: It was reported that a patient received BioThrax and developed severe whole arm swelling which turned purple with pruritis (peripheral swelling, skin discolouration, and pruritus). Further information regarding the events, medical history or concomitant medication is limited. Considering the case information, the causality of peripheral swelling, skin discolouration, and pruritus is assessed as possible with BioThrax (its role cannot be ruled out).; Sender's Comments: It was reported that a patient received BioThrax and developed severe whole arm swelling which turned purple with pruritis (peripheral swelling, skin discolouration, and pruritus). Further information regarding the events, medical history or concomitant medication is limited. Considering the case information, the causality of peripheral swelling, skin discolouration, and pruritus is assessed as possible with BioThrax (its role cannot be ruled out).
Description: feeling general malaise over the weekend and into the following week, pain, redness at inoculation site. Decreased mental clarity noted by fellow service members. Flu-like symptoms < 96 hours Start: 09/22/2007 Confused Start: 09/27/2007 Comment: decrease in mental clarity Erythema Start: 09/25/2007 Swelling Start: 09/25/2007 Pain Start: 09/25/2007 Comment: at inoculation site. 6/26/08-records received for DOS 9/27-9/28/08-DC DX: Vaccine Reaction non specific. Presented with fever and confusion, mental acuity slower, malaise, decreased appetite and fatigue over past 1-2 days. Fever and chills.
Information has been received from a nurse, concerning her niece who approximately on 30-OCT-2008 ("two weeks ago") was vaccinated a dose of GARDASIL (lot number, route and injection site not reported).  The patient believes that she is having  cardiovascular problems since she was given GARDASIL.  It was unknown if she sought any medical attention.  At the time of report, the patient's symptom persisted.  Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 63 year old female patient. No medical history and concurrent condition were reported. On 08-FEB-2016, the patient was vaccinated with ZOSTAVAX (dose 0.65 ml, once, lot # L035285, Expiration date 15-DEC-2016) subcutaneously for shingles prevention. Concomitant medications included unspecified blood pressure medication and unspecified stomach medication. On an unknown date in February 2016 (reported as on an unspecified time after vaccination) the patient developed rash and swelling at the injection site. On 09-FEB-2016, the patient experienced vomiting. The patient sought medical attention and called pharmacist. The reporting pharmacist instructed the patient to take BENADRYL (unspecified manufacturer). The outcome of injection site rash, injection site swelling and vomiting was reported as not recovered. The reporter did not provided the causality between the events and the suspect therapy. Additional information has been requested.
Redness on right outer thigh below vaccine site of vaccines given on 10/18/2004. Treatment: cool compress and Tylenol for discomfort.
Vaccine administered 10/5/10 am. Sore throat, chills, fever 10/5/10 afternoon. Had been exposed to strep throat 10/2/10
Information has been received from an unspecified reporter, as part of a marketing research program, referring to a 42 years old female patient. On an unknown date the patient was vaccinated with a dose of pneumococcal vaccine (manufacture unknown) (strength, lot#, dosage and route unspecified). On an unknown date the patient reported that she caught a very bad case of acute bronchitis. The outcome of acute bronchitis was unknown. The causality between the event and pneumococcal vaccine (manufacture unknown) was unknown. The seriousness of the event was not assessed by the reporter. Additional information has been requested.
Severe chills, fever & severe body aches began around 12-13 hrs. after vaccine.  Sore throat & cough started around 15 hrs. after vaccine 24 hrs. later I passed out face first onto concrete.  The fall bruised me terribly but did not wake me up - I was revived by medics.  I have no memory at all of passing out.  Cough, shortness of breath & wheezing became worse for the next few days.  18 days later, I *STILL* have problems with breathing & coughing.   Note that although I had no known Covid exposures prior to receiving the vaccine I got tested for Covid  three days prior to vax, just to be 'sure' and tested twice in the days after the vax since I developed such breathing problems.
headache; nausea; This is a spontaneous report from a contactable consumer (patient) or other non HCP received via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 23Mar2021 as 1ST DOSE, SINGLE  for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache and nausea. patient queried if she could take tylenol. She also mentioned that her second dose schedule was beyond 3weeks, she was scheduled on April 22 and wanted to know this was okay. The outcome of the events were unknown.    Information on the lot/batch number has been requested.
Dizziness, Headache, Myalgia, NauseaVomiting, Loss of Apetite, Sleepy, Pain at Injection Site Narrative:
I started to salivate a uncontrollably for hours on April 14, at around 1am. Still happens now sporadically. I had nerve damage to my tongue from oral surgery so I dont know if its related. I started to develop vertigo today the 15th around 1pm. Vertigo has come and gone on waves. Have had a mild headache all day as well. In addition Ive had alot of trouble concentrating.
Numbness on  Face and Feet; Tingling on  Face and Feet; 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 HYPOAESTHESIA (Numbness on  Face and Feet) and PARAESTHESIA (Tingling on  Face and Feet) 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 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness on  Face and Feet) and PARAESTHESIA (Tingling on  Face and Feet). At the time of the report, HYPOAESTHESIA (Numbness on  Face and Feet) and PARAESTHESIA (Tingling on  Face and Feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment medication was not provided.
Extreme vertigo-numbness in face-paralized in arms and legs-nausea-sensitive to light -could not walk-brain fog MRI of brain without contrast-xray of chest - CT scan Vertigo has not gone away-nausea has not gone away Currently on antivert (meclizine)
10/13-Headache; Fever 101 deg; Rash Rt arm 10/14 Headache; Fever 102; Fatigue-went to urgent care. No treatment 10/15-Redness Rt arm-fever 98 deg-feeling much better 10/16-Rt arm swollen and painful-seen by Dr-diagnosed Cellulitis-Antibiotics given
A TB test was suppose to be administered, was injected with wrong vaccine, on my forearm, my arm swelled and was red, was hot to touch, itchy, bad headache,  The doctor told me he thinks the technician injected me with  tetnaus vaccine , but was not 100% sure.
Rash - started at injection site, then on wrists, followed my stomach/back and arms; Rash - started at injection site, then on wrists, followed my stomach/back and arms; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to any medications, food, or other products. The patient did not receive any medication within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 10:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Prior to the 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 four weeks prior to the vaccination. On 07Apr2021, the patient experienced rash that started at injection site, then on wrists, followed by stomach/back and arms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events rash that started at injection site, then on wrists, followed by stomach/back and arms was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient felt a tingling sensation on the tip of her tongue. Continued to observe her for an hour and the sensation progressed to her entire tongue. Escorted her to emergency department.
Patient states about 30 minutes after receiving the SHINGRIX vaccine he experienced left facial paralysis & problems with his kidneys which lasted a couple of days.
Patient said his left arm was sore at the site of injection not longer after getting the shot. He told the pharmacy today that it has been sore for 3 months now. No bruising or redness visibly seen on his arm today.
injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection (type was not known located on buttocks). Concomitant products included valaciclovir hydrochloride (Valaciclovir).   On 17th May 2019, the patient received the 1st dose of Shingrix. On 17th May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 24th May 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported that she experienced pain at the injection site for one week. The reporter consented to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019132862.
Pt called pharmacy on Thursday 9/19/2013 at approximately 6:15pm to complain of severe headache and nausea and denied vomiting. Pt later went to ER that night as advised by pharmacist. Pt said Flu shot gave her the flu - was later advised at ER she did not have the flu.
severe hip pain on her left joint side; cannot move her leg a lot; cannot walk; muscle pain; fever; chills; headache; abdominal pain; nausea; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (severe hip pain on her left joint side), LIMB DISCOMFORT (cannot move her leg a lot), GAIT DISTURBANCE (cannot walk), MYALGIA (muscle pain) and PYREXIA (fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (severe hip pain on her left joint side), LIMB DISCOMFORT (cannot move her leg a lot), GAIT DISTURBANCE (cannot walk), MYALGIA (muscle pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), ABDOMINAL PAIN (abdominal pain) and NAUSEA (nausea). The patient was treated with TRAMADOL for Adverse event, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) (oral) for Adverse event, at a dose of 600 milligram. At the time of the report, MUSCULOSKELETAL DISCOMFORT (severe hip pain on her left joint side), LIMB DISCOMFORT (cannot move her leg a lot), GAIT DISTURBANCE (cannot walk), MYALGIA (muscle pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), ABDOMINAL PAIN (abdominal pain) and NAUSEA (nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: 103 (High) Patient had fever of 103. On 04-Jun-2021, SARS-CoV-2 test positive: positive (Positive) Patient was sick/symptomatic for 11 days due to COVID-19. On an unknown date, Blood culture: pending Inconclusive. On an unknown date, Blood test: pending Inconclusive. On an unknown date, X-ray: pending Inconclusive.     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.   Concomitants were not provided. Patient's treatment plan included 2 Liters of IV fluids.
Fever; Injection site was red/purple; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Injection site was red/purple) 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, the patient experienced PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Injection site was red/purple). At the time of the report, PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Injection site was red/purple) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided by the reporter Treatment information was not provided   This case was linked to MOD-2021-031890, MOD-2021-032177 (Patient Link).
Elevated heart rate, headache; Elevated heart rate, headache; This is a spontaneous report from a contactable other Healthcare Professional (HCP, patient).  This 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), intramuscular, on 29Dec2020 at 12:30 PM at single dose for COVID-19 immunisation. Vaccine location was right arm.  The patient was vaccinated at hospital, age at vaccination was 58-years-old. No other vaccine was received in four weeks. Medical history was unknown. Concomitant medications included rosuvastatin calcium (CRESTOR) and lisinopril. On 29Dec2020 at 04:00 PM, the patient experienced elevated heart rate, headache. The event was reported as non-serious. Outcome was recovered on Dec2020. No treatment was received for the event.   No follow up attempts are possible. No further information is expected.
Have had it; burning sensation; it hurts pretty bad, cant take how it feels, it's painful,; warmth sensation under right breast; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced shingles, burning sensation, pain and feeling of warmth. On an unknown date, the outcome of the shingles, burning sensation, pain and feeling of warmth were not recovered/not resolved.   It was unknown if the reporter considered the shingles, burning sensation, pain and feeling of warmth to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received dose of Shingles vaccine couple of weeks ago but he/she guessed he/she had to have another one there's two shots they have to had, he/she thought it was within six months. The patient just had a burning sensation other than it was hurts, he couldn't take how it felt, it was painful other than like he/she said it was hurts pretty bad. The patient was hoping it eventually went away but like he/she said he/she was not broke out he/she just had that warm sensation and burning and it was right on the right side up under his/her right breast. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Patient did not experience adverse effect, this is a report of an error in administration of vaccine. Patient is under 18 years old received Moderna Vaccine. At the time of vaccination it was understood that in  County , anyone 16 and older could receive Moderna. Since it was pointed out by the DOH that it is not the case, our facility stopped vaccinating 16 to 18 year olds with Moderna.
Dizziness, lightheadedness, sweating, diaphoretic.  Patient is diabetic, had high BP, dizziness, loss of hearing, tunnel vision, emotional/crying.  Patient was given juice, observation done,  vital signs monitored, glucose checked, pulse ox checked.  Patient improved after interventions. Patient verbalized feeling better and was discharged to home/self care with husband @ 1:15PM.
This spontaneous report as received from a nurse via company representative refers to a 9 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 15-MAR-2016, the patient was vaccinated with incorrectly stored M-M-R II injection (recombinant human albumin) (lot #L032181, dose of 0.5 ml, subcutaneously) that was out of range for an unspecified amount of time. No adverse effects were being reported. Additional information had been requested.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated 4 times with the Pfizer product, having received vaccine on 12/30/2020, 01/20/2021, 10/13/2021, and 04/27/2022. They tested positive for COVID-19 on 07/24/2022 and died on 07/25/2022. I have no indication they were hospitalized related to the illness. Death certificate lists COVID-19 pneumonia.
14Jun positive with new symptoms; 14Jun positive with new symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EN6200), on 11Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 04Oct2021 as dose 3 (booster), single (Lot number: FF8871) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022, outcome "not recovered" and all described as "14Jun positive with new symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Positive; (08Jun2022) Negative but symptomatic; (14Jun2022) Positive with new symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Anxiety-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Mild, Additional Details: Patient experienced high levels of apprehension and anxiety pre-administration. After 15 minute observation period, pt was visibly anxious and reported a "weird" feeling on her left side, local to administration and radiating from left shoulder. Pt BP was read as 173/109 and 5 minutes later 168/95. Pharmacist advised pt leave site due to perceived anxiety/worry, measure again in an hour, and report to ER/Urgent care if BP still above 120/80. RPh will follow up with pt following day.
Sore muscle and skin near injection site. Itchy, red and swollen, about the size of palm of hand. Tried ice, and will try benadryl for antihistamine.
I received a flu shot with the Covid Moderna Booster. 24 hours later I became lethargic, had severe joint pain and a sharp piercing , jabbing pain in ,y right ear that occured about every 14-15 seconds. I began coughing with a deep horseness type dry cough. I have no fever.
Patient was given Moderna 1st dose as opposed to Pfizer, which is the current recommendation for 14 year olds.  Pt was observed for 30 minutes, parents ultimately left the clinic with the child.
Ringing in ears.  Got the vaccine on 8/6/21 and the ringing started on 8/8/21.  I am still hearing the ringing constantly in my ears and it it now 10/24/21.  The ringing has never gone away and has stayed constant since 8/8/21.
Patient's mother called office 3pm stating child crying unable to calm child.  Patient seen in office around 3:30, smiling when arrived sitting in car seat.  Examined by doctor, felt right leg- painful, no fever.