chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a literature article regarding patient of unknown demographics. The study used a retrospective electronic database chart review of all patients 18 years of age or older at a tertiary care. This review was approved the Review Board. Subjects met inclusion criteria if they had a visit at the allergy-immunology clinic between 2002 and 2009, received an International Classification of Diseases, Ninth Revision (ICD-9) diagnosis of Chronic rhinosinusitis (CRS), and underwent evaluation for immunodeficiency by assessment of quantitative serum immunoglobulin levels and pneumococcal antibody titers pre-and post immunization with a pneumococcal polysaccharide vaccine (PPV). The treating physician made the decision to evaluate the individual patient with CRS for immunodeficiency. All subjects had normal IgG levels (>550 mg/dL). Subjects were included if they had a sinus CT scan documenting CRS and met criteria for CRS as defined by nationally recognized consensus statements. The presence of nasal polyposis was determined by rhinoscopy or surgical pathology specimens, and subjects were subsequently classified as chronic rhinosinusitis without nasal polyps (CRSsNP) or chronic rhinosinusitis with nasal polyps (CRSwNP). Atrophy was determined in all subjects via skin testing to pollens, dust mites, pets, molds, and cockroach using Hollister-Stier extracts. Asthma diagnosis and severity was determined in accordance with the 2007 National Asthma Education and Prevention Program (NAEPP) expert panel report 3 guidelines using % FEV1 values. Subjects were excluded if they had common variable immunodeficiency, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome, primary ciliary dyskinesia, cystic fibrosis, malignancy, IgA deficiency, or any acquired immunodeficiencies (eg, HIV/AIDS or secondary to medications such as chemotherapy). Evaluation of subjects' characteristics, antipneumococcal antibody titers, and serum Ig levels was performed via Analysis of variance (ANOVA) with post hoc Tukey analysis. Analogous chi-square tests were used to compare percentages for categorical variables. Data are expressed as mean with standard deviation. A P-value less than 0.05 were considered statistically significant; such results have been marked with an asterisk in the table in which they appear. Total number of patients were 239. On an unknown date, the patient was vaccinated with PPV (manufacturer unknown) (dose, anatomical location and lot number was unknown). Concomitant medications were unspecified by reporter. On an unknown date, the patient experienced specific antibody deficiency (had less than 50% of the pneumococcal serotypes greater than or equal to 1.3 mg/ml after PPV immunization). The outcome of the event was unknown. The author considered the event to be related to PPV. This is one of the several reports received from the same literature article. Additional information has been requested.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: RITUXAN in January 2021, TETANUS VACCINE and FLU VACCINE VII. Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (Levaquin, Bacitracin, Z pack), Drug allergy (Codeine) and Waldenstrom's macroglobulinemia (improvement in symptoms in blood. The patient had an information of Rituxan in Jan, 21'. she was advised to wait about 90 days before she had the first vaccine to the effectiveness of it.) since 17-Jul-2019. Concomitant products included CLINDAMYCIN from 01-Jan-2015 to 01-May-2021 for Acne, LORATADINE (CLARITINE) from 01-Jan-2015 to an unknown date for Allergy, ROSUVASTATIN from 01-Oct-2020 to an unknown date for High cholesterol.    On 17-Mar-2021 at 4:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient experienced soreness in arm for few days after 1st dose of vaccination.   This case was linked to MOD-2021-076633 (Patient Link).
Patient came into the pharmacy on Sunday 10/22/17 and reported red rash appeared at the injection site on Saturday 10/21/17. Patient was informed to put cold compress (iced) to rash for approximately 15minutes and take Benadryl for the itching, redness, and swelling. Patient also need to go to the emergency room If symptom worsen. Prescriber was informed and confirmed treatment on 10/22/17.
I tested positive for COVID-19 on 11/14/22. I had a fever, chills, body aches, loss of taste, headaches, and congestion. I was very sick for 5 days with these symptoms. Then on day 5, I lost my smell and taste, but was feeling a little better. I was still congested though. I went to the doctor on day 12 because I was still testing positive, and I still had postnasal drip. They did a rapid test, and I was negative at that time. They prescribed benzonatate, and FLONASE. They told me I could take any over-the-counter medications for allergies. On 12/6/22 I started to feel bad again. I had the same symptoms, but less severe and I lost my voice. I am still dealing with these symptoms.
POSSIBLE CELLULITIS--ROUND RED AREA 7 INCHES WITH DARKER AREA ABOUT 3 INCHES NEAR INJECTION SITE.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (dose, route, lot # and Exp unknown) on an unspecified date 4 years ago (approximately in January 2009) and would like to receive the second dose today on 18-JAN-2013. No adverse symptoms. No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Information has been received from a registered nurse concerning a female who was vaccinated with Gardasil (possible lot # 03884", 658222/0927U, 657737/0522U).  Subsequently, reported on 20-AUG-2007 as in the "past few months", the patient light headed.  Subsequently, after about ten minutes of lying down, the patient recovered from being light headed.  This is one of several reports received from the same source.  Additional information has been requested.
arms are sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arms are sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced PAIN IN EXTREMITY (arms are sore). At the time of the report, PAIN IN EXTREMITY (arms are sore) outcome was unknown.            Patient took second booster dose of Moderna COVID-19 Vaccine. No concomitant information were reported by the reporter. No treatment information were reported by the reporter.   This case was linked to MOD-2022-592045 (Patient Link).
Severe redness around injection site, down the arm to the breast area and lower left side of her body down to the leg area. Soreness of breast. Feverish sensation. Symptoms persisted up to 3 weeks after injection.
Patient was given initial series Pfizer dose for booster instead of new bivalent Pfizer dose.
This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, pain in arm, feeling unwell, fatigue and pain. In July 2018, the outcome of the influenza-like symptoms, pain in arm, feeling unwell, fatigue and pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, pain in arm, feeling unwell, fatigue and pain to be related to SHINGRIX. Additional details were provided as follows: The patient dropped by the clinic and reported that he received his 2nd dose of SHINGRIX from another location and experienced the effects as noted within 24 to 36 hours after receiving the vaccine. The patient had mild sore arm and did not feel well. The symptoms resolved within 24 to 36 hours later.
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
frequent short duration  intense headaches few times a week, bouts of dizziness lasting less than a minute every other week in addition to the original day after vaccine symptoms of flu-like aching and cramping leg, calf and feet muscles, fever of 101.3, intense pressure headache which lasted approximately 36 hours, sore arm when injection was given.
PCP called to report on child seen in ER, taken by parents on 5/2/01 with a rash on body and erythema, post vax, on 4/28/01. ER ordered Benadryl; 0.2ml Epi and Aveeno bath. Given rapid strep A screening on 5/2/01 and it was positive for group A strep, per PCP. PCP feels rash not related to vaccines.
3 hrs after receiving influenza vaccination employee developed severe itching, slight rash - no hives - BENADRYL resolved 24 hrs later.
Back , chest and neck itches that bleed when are scratched; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Back , chest and neck itches that bleed when are scratched) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 PRURITUS (Back , chest and neck itches that bleed when are scratched). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Back , chest and neck itches that bleed when are scratched) outcome was unknown.            No concomitant medications provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-107957 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Additional information received on 23-APR-2021. Patient alternate phone number, Email Address and Second dose information added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-107957:second dose case
I have had situations where my heart feels like it drops and flutters and I get goose bumps up the side of my neck and on the side of my head.  I would get light headed.  I began keeping track of blood pressure.  My meter was telling me I was having an irregular heart beat.  We went to ER on July 7th.  Dr. felt that I should stay so they could monitor my heart and see cardiologist the next day.  The nurse said my heart was "doing funky things".   Dr. stated that he felt that I would need a pace maker.
pt recvd vax 19SEP95 & exp dry throat & dizziness on 20SEP95 & recovered on 21SEP95;
Muscle pain right shoulder, right clavicle unable to move arm. No redness, no lump, no temp. Pain started 3 hours after vaccine. Progressed until unable to move arm 1 hour MD.
This case was reported by a healthcare professional and described the occurrence of facial nerve pain in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included seasonal hayfever. On 28 October 2010 at 08:12 the subject received 2nd dose of ENGERIX B (unknown, left arm). On an unspecified date in 2010, 4 or 5 days after vaccination with ENGERIX B, the subject experienced left side facial nerve pain and face pressure. The 2nd dose of ENGERIX B was administered and the subject felt the same amount of pressure, but he was still on the GABAPENTIN. Specific dates regarding when the events occurred or resolved could not be provided. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the outcome of the facial nerve pain improved and face pressure was unspecified. The subject experienced events with the 1st dose of ENGERIX B, see case A0890416A.
14 year old client was given Janssen Vaccine instead of Pfizer Vaccine. Complained of mild headache after receiving the vaccine at 3:32 pm.  T 97.3  P 66 ,  BP 117/76.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 15-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
2 months after receiving last dose, I then also got the virus and it was a severe to mild case.; 2 months after receiving last dose, I then also got the virus and it was a severe to mild case.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 05Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codine for known allergies codine, notes: known allergies codine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2022, outcome "recovered" (2022) and all described as "2 months after receiving last dose, I then also got the virus and it was a severe to mild case.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Positive, notes: Nasal Swab; (Feb2022) Negative, notes: Nasal Swab. Adverse event after both the initial and 2nd dose the following occurred 12hours from receiving vaccine shot, had tightening of upper back and neck muscles. Muscle pain was unbearable for entire body for a few hours. Sharp pain was experienced from back up the neck up to head. This lasted for 7 days. Severe headache lingered for 2 weeks. The headache experiences was abnormal. Usually patient feel pressure or pounding headaches, this however felt like a tingly nerve pain. 2 months after receiving last dose, she then also got the virus and it was a severe to mild case. Patient had not received any other vaccine in four weeks and not received other medications in two weeks. patient had not received any covid prior vaccination and received covid tested post vaccination. 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 other health professional via call center representative and described the occurrence of blindness in a 72-year-old female patient who received SHINGRIX (batch number 27KF5, expiry date 10th June 2021) for prophylaxis. On 2nd April 2019, the patient received the 2nd dose of SHINGRIX. On 6th April 2019, 4 days after receiving SHINGRIX, the patient experienced blindness (serious criteria GSK medically significant). On an unknown date, the outcome of the blindness was not recovered/not resolved. It was unknown if the reporter considered the blindness to be related to SHINGRIX. Additional details were reported as follows: The reporting healthcare professional stated that the patient had no known history of blindness or eye disease. The patient received SHINGRIX and 4 days after vaccination, the patient was completely blind. The patient has been seen by her primary care physician for this issue. The blindness was still ongoing. The reporter did not know which arm the patient received injection.
Second shot was not administered, the second dose within 36 days; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Second shot was not administered, the second dose within 36 days) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Second shot was not administered, the second dose within 36 days). At the time of the report, OFF LABEL USE (Second shot was not administered, the second dose within 36 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
weird/odd taste in mouth only after receiving vaccine. no recent known contact w/Covid infected person and no symptoms of Covid
had swollen, painful rt thigh p/vax;went to ER 2 days later;resolved w/warm soak/motrin;
Arm was sore on day of vaccines. Next morning  arm was very painful and swollen 3 inches on each side. On 9/19/2020 the swelling started to travel to elbow.
Menactra vaccine was given first, then Tdap. About 15 sec after Tdap. pt. became pale, weak, fainted. Had some jerking of arms and legs lasted 2-3 sec. Pt was unconscious for 5 sec. Responded o her name didn't remember fainting. Hadn't had anything to eat that day. Dr recheck pt for vital signs, B/P 118/62-P-76-R-16. Gave pt. lemonade and doughnut to eat. Felt better walk out of office with parent.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Nov2021 15:00 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Some food" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. The following information was reported: PAIN IN EXTREMITY (disability) with onset 03Nov2021, outcome "not recovered", described as "Her arm has been in major pain"; VACCINATION SITE PAIN (disability) with onset 03Nov2021, outcome "not recovered", described as "Her arm has been in major pain. Especially in the shot injection site"; MUSCLE TIGHTNESS (disability) with onset 03Nov2021, outcome "not recovered", described as "tension in her left side from left arm spanning all muscles in her neck and upper arms"; MYALGIA (disability) with onset 03Nov2021, outcome "not recovered", described as "extreme pain and tension in her left side from left arm spanning all muscles in her neck and upper arms"; VACCINATION SITE PRURITUS (disability), VACCINATION SITE BRUISING (disability) all with onset 03Nov2021, outcome "not recovered" and all described as "The injection site feel itchy and like an extreme bruise"; NERVE INJURY (disability) with onset 03Nov2021, outcome "not recovered", described as "slight nerve damage on her left arm and fingers"; PAIN (disability) with onset 03Nov2021, outcome "not recovered", described as "pain". Got shot in left arm 03Nov2021. She never once had Covid. Once the shot happened. Her arm has been in major pain. Especially in the shot injection site. That day and Still till today she has had extreme pain and tension in her left side from left arm spanning all muscles in her neck and upper arms. The injection site still felt itchy and like an extreme bruise and it was not going away. She has also experienced slight nerve damage on her left arm and fingers. It was not getting better and she was very scared to take her second shot and not sure when her arm, tension and the injection site will get better. She was so upset and it was affecting her badly. She was in so much pain. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Nov2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain, muscle tightness, myalgia, vaccination site pruritus, vaccination site bruising, nerve injury, pain. The lot number for bnt162b2 was not provided and will be requested during follow up.
A non-serious spontaneous report of a 53 year old patient was given H1N1 LAIV was received from a health professional concerning a 52-year old female patient. The patient's medical history was not provided. On 19-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
This spontaneous report was received from a physician, via a company representative, referring to an unknown number of infant patients between 6-11 months of age, of an unknown gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (manufacturer unknown) for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients were hospitalized for an unknown reason (adverse event). At the reporting time, the outcome of adverse event was unknown. The causality assessment was not provided. Sender's Comments: US-009507513-1905USA004181: US-009507513-1905USA004180: US-009507513-1904USA013391: US-009507513-1905USA004178: US-009507513-1905USA004182: US-009507513-1905USA004177.
I had 2 weeks of heavy menstruation (Sep 16-30) and passing big blood clots from my menstruation period.  I am pre menopausal so my period is lighter and lesser days now, so I'm shocked this suddenly happened after my 1st dose of vaccine. Other friends and many women per reading experienced the same and yet you are not mentioning this as side effect.