chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been sick for about 2 weeks with the the side effect; I still don''t feel quite like myself; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I have been sick for about 2 weeks with the the side effect"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I still don''t feel quite like myself". The events "i have been sick for about 2 weeks with the the side effect" and "i still don''t feel quite like myself" were evaluated at the physician office visit.  Additional Information: The patient had vaccine (clarified as Pfizer COVID vaccine) on October 6. The answer that the patient got from his/her doctor was that his/her just have to come in and be monitored.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had unbearable indigestion and heartburn and belching/ excessive burping; The evening of the shot, started having bad indigestion and heartburn; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration on 11Apr2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD) and coronary artery disease (CAD). The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPRIN), lansoprazole (LANSOPRAZOL) and sambucus nigra (ELDERBERRY); all taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 11Apr2021 at 20:00, the evening of the shot, the patient started having bad indigestion and heartburn. The following day, on 12Apr2021, it worsened and persisted and was really quite awful and the patient had unbearable indigestion heart burn and belching. The symptoms finally dissipated about 48 hours later. The patient had no nausea, it was strictly heartburn and indigestion excessive burping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event the evening of the shot, started having bad indigestion and heartburn was recovered on an unknown date in Apr2021. The clinical outcome of the event unbearable indigestion and heartburn and belching/excessive burping was recovered on 12Apr2021.
Received vaccine on 1/29/10 in left deltoid. Arm became sore on 1/30/10 in the afternoon. Reports left deltoid & left forearm throbs mainly at nigh. States is left-handed & types all day. Reports difficulty in moving arm at night and takes 1-2 hrs in the morning to move arm good & get relief. Intermittent feeling of numbness in lt forearm. Fingers tingle at times. No temperature after vaccine. No redness or swelling.
Heat generation; Red rash "down her injection arm" (Left); Tenderness at the injection site; Right arm  now has a similar rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat generation), RASH ERYTHEMATOUS (Red rash "down her injection arm" (Left)), RASH (Right arm  now has a similar rash) and VACCINATION SITE PAIN (Tenderness at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced RASH (Right arm  now has a similar rash). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Heat generation), RASH ERYTHEMATOUS (Red rash "down her injection arm" (Left)) and VACCINATION SITE PAIN (Tenderness at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Heat generation), RASH ERYTHEMATOUS (Red rash "down her injection arm" (Left)), RASH (Right arm  now has a similar rash) and VACCINATION SITE PAIN (Tenderness at the injection site) had not resolved.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a 62 female consumer with no known allergies and a history of shingles who in November 2007, was vaccinated with 0.65mL of zoster vaccine live (Oka/Merck). Concomitant therapy included AGGRENOX, NEURONTIN, hydroxyzine hydrochloride, CRESTOR and ALTACE. Subsequently, in "late November 2007" on approximately 26-NOV-2007, the patient developed shingles after receiving the vaccine. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Minor soreness/minor pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (minor soreness/minor pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN HCL, LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), FOSINOPRIL, ROSUVASTATIN, TROSPIUM CHLORIDE, SERTRALINE, ANASTROZOLE, AMLODIPINE, MAGNESIUM, ZINC, COLECALCIFEROL (D3), VITAMIN B12 [VITAMIN B12 NOS] and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.    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 VACCINATION SITE PAIN (minor soreness/minor pain). On 24-Jan-2021, VACCINATION SITE PAIN (minor soreness/minor pain) had resolved.        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.   No Treatment information was reported.   This case was linked to MOD-2021-381883, MOD-2021-382532 (Patient Link).
She has congestion, cough, and sneezing. I took her to the doctor, but they did not prescribe medication. I did not give her over the counter medication either. This was a very mild cold case. She still has a cough but is much better now.
patient had 2 varicella vaccines in past and presented today with chicken pox after exposure at school
1st day soreness and tingling of fingers. Second day soreness progressed and increased as each day passed. By the 9th day arm is so painful to do daily activities and is worse at night when trying to sleep. Pain consists of pressure, aches, pain, soreness, and now some stiffness. Today is the 11th day and I can barely use my arm without extreme pain. Range of motor is compromised.
Fast breathing; lightheaded, dizzy; Disorientation.; Pains in upper and lower torso; Unable to work; This is a spontaneous report from a contactable consumer. This 72-year-old female consumer reported that:  A 72-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6207 and Expiry date was not reported), dose 2 via an unspecified route of administration arm left on 19Mar2021 11:45 AM (age at vaccination was 72-year-old) as DOSE 2, single dose for covid-19 immunisation. Medical history included diabetes mellitus and known allergies like red fire ants, caterpillars from an unknown date and unknown if ongoing. The patient received other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient received other vaccine in four weeks was BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6198 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm left on 26Feb2021 as DOSE 1, single dose for covid-19 immunisation. After administration of second dose, on 19Mar2021 12:15 PM patient experienced fast breathing, dizzy, lightheaded, disorientation, Pains in upper and lower torso and she was in 2day of pains, unable to work. No treatment received for the events. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Client reports that 2 weeks after the second dose she had difficulty speaking and her voice sounded differenet. She was told by friends that she sounded different, also.  She also has chronic fatigue, which worsened. She met with her NP who said she may have had a stroke, per the client. She was given a prescription for a speech therapy and a swallowing eval. She also said that she has difficulty swallowing sometimes, and feels as if her throat is closing up, but then it resolves. Client was instructed, by this nurse, to go to the hospital for this symptoms. She said she can manage it and always "comes out of it." Client was instructed to make sure she calls 911, if she has this symptom again.
After COVID shots hands broke out; Eczema; Allergies; Dose 1, 04-Jan-2021 and Dose 2, 28-Jan-2021/ Dose 2, 28-Jan-2021 and booster 28-Feb-2021; This spontaneous case was reported by a consumer and describes the occurrence of RASH (After COVID shots hands broke out), ECZEMA (Eczema), HYPERSENSITIVITY (Allergies) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1, 04-Jan-2021 and Dose 2, 28-Jan-2021/ Dose 2, 28-Jan-2021 and booster 28-Feb-2021) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic).   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RASH (After COVID shots hands broke out), ECZEMA (Eczema), HYPERSENSITIVITY (Allergies) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1, 04-Jan-2021 and Dose 2, 28-Jan-2021/ Dose 2, 28-Jan-2021 and booster 28-Feb-2021). The patient was treated with DUPILUMAB (DUPIXENT) at an unspecified dose and frequency. At the time of the report, RASH (After COVID shots hands broke out), ECZEMA (Eczema) and HYPERSENSITIVITY (Allergies) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1, 04-Jan-2021 and Dose 2, 28-Jan-2021/ Dose 2, 28-Jan-2021 and booster 28-Feb-2021) outcome was unknown.            Concomitant medication list was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for Humira with respect to events, eczema, rash and allergy was not provided.   This case was linked to MOD-2022-645270 (Patient Link).
after receiving 3rd covid vaccine, I started feeling fatigue, no energy, then started  having atrial fibrillation symptoms around March 1st, symptoms started getting more frequent and worsening symptoms, ended up having pacemaker placement on 7/28/2022 and started on 2 new medications for atrial fibrillation
Pain in the upper left arm, day of injection. Called pharmacy and instructed to apply cold compress. Still hurt so went to Dr. office 10/31/14 and received pain medication.
The pt received shots on 12/31/01. The parent noted small areas on neck at his chest. He was taken to a physician and he was unsure of the cause of the rash. Treatment: prescribed axmocylline. Rash became more prominent.
I developed an autoimmune disease. I began to get really stiff and sore in the morning on my shoulder. At first I thought I pulled a muscle, About two to three days I got a hip pain and it felt like I ran a marathon. It was like a muscle spring. It was very strange because it was my two shoulders and my two hips. I went to my general practitioner. They gave me a divided dose of Perezone.  It went away , but it came back. I'm a nurse and I thought I need a Rheumatologist. I scheduled an appointment and they told me that I had an auto immune disease. PMR. They started me on Predesol, and I'm still dealing with it.
An MA reported that a 7 month old infant received Acel-Imune, Prevnar and Hep-B vaccines on 5/24/00 and within 24 to 48 hours, post vax, the infant developed an injection site reaction characterized by a red, warm, hard welt at the site of the Acel-Imune administration. This is 1 of 6 pts from this facility who experienced this event following receipt of 3 different lots of Acel-Imune.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. The patient's past medical history included bee sting hypersensitivity (history of delayed allergic response to bee stings). On 31st July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, headache, chills, induration and erythema of extremities. On an unknown date, the outcome of the extensive swelling of vaccinated limb, headache, chills, induration and erythema of extremities were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache, chills, induration and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient experienced swollen arm about the size of a softball, hard and red and about halfway down the arm between shoulder and elbow.
Pt. is taking HUMIRA & received ZOSTAVAX, 2 days after receiving vac. pt began experiencing itching, tingling & redness at inj. site on left arm. She contacted her Dr who prescribed VALTREX 1gm PO qd. Took VALTREX 10-31-12 thru 11-14-12. Her itching & tingling resolved after a few days of VALTREX. Pt experienced post-herpetic pain thru approximately 11-29-12. It resolved without treatment.
This patient is a male age 12.  Recommendations are that only patients 16 years and older receive pfizer boosters.
1 day after getting 4 mo shots - pt had multiple observed gen. tonic-clonic seizures. Admitted to hospital - negative work up for cause of sz.
Bilateral shoulder pain lasting 3 weeks. Slight relief with NSAIDS. Will continue to monitor and do PT if not resolved.
Patient received 0.5ml PNEUMOVAX 23 in left deltoid. Patient experienced tendinitis, bursitis, capsulitis.
During 15 minutes waiting after covid vaccination, the patient's mom came to me and said her daughter felt dizzy. When I came out, she was on the floor.  I asked her few questions. She was fully awake, no shortness of breath, her blood pressure was normal.  She said she felt dizziness only.  I told her that we already called 911.  When they came, she refused to go to ER.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date, the unspecified number of patients were vaccinated with improperly stored ROTATEQ (lot#, dose and frequency were not provided) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patient as of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ oral liquid, orally, lot # K011948, expiration date 07-JUN-2016 (dose was not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
approx 10hr p/vax rt arm became swollen down to the elbow;the swelling remained & pt had redness & itching the next day;
Pt was in training at Coast Guard 4/16-7/25/03. Exposed to vaccinia while wrestling with another trainee recently vaccinated for smallpox. Seen in ER on 7/26 with lesions on beard, chin and neck. Rx with antibiotics and no improvement. Specimens to ODH-presumptive vaccinia. Lesions scabbed, no increased temperature, as of 7/30.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with improperly stored M-M-R II (lot #, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
On 12/8/99, the pt developed shingles. The following day, the pt was treated with acyclovir. On 12/12/99, the pt recovered. It was noted that the pt did not have any illnesses or pre-existing medical conditions at the time of vaccination.
This case was received by a physician via call center representative and described the occurrence of vomiting in a 4-month-old female patient who received ROTARIX (batch number A41CB549A, expiry date 12th February 2017). On an unknown date, the patient received the 2nd dose of ROTARIX oral. On an unknown date, less than a day after receiving ROTARIX, the patient experienced vomiting and underdose. On an unknown date, the outcome of the vomiting and underdose were unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: This case was not previously reported to anyone. The patient vomited (regurgitated) her 2nd dose of ROTARIX, which led to an underdose.
Resident tested positive for COVID on 01/06/2021. Resident received out patient monoclonal antibody treatment on 01/10/2021
Pt developed numbness in right side of face approximately two hours after recieving the vaccine.  Pt woke up the next day with the same symptom.  No weakness or drooping, no swelling in tongue, lips or throat.  No itching or shortness of breath.    No treatment indicated
pt recv vax 9OCT98 10AM;noticed sore throat & throat swelling 4PM;took DPH but sx returned 1130PM;went to ER also had some diff swallowing;no diff breathing, no hx of similar problems;treated w/DPH, dexameth,  pepcid;
Supraclavicular lymph node is swollen and hard; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Supraclavicular lymph node is swollen and hard) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced LYMPHADENOPATHY (Supraclavicular lymph node is swollen and hard). At the time of the report, LYMPHADENOPATHY (Supraclavicular lymph node is swollen and hard) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with unspecified improperly stored dose of GARDASIL 9 which had a lot# of L044475, and expiration date of 12-MAY-2017 (concentration, dose, route and anatomical place of vaccination were not provided). Which were exposed to a temperature of 32.7 for 31 hours. There were no previous excursion and a data logger was involved. Information regarding concomitant therapies was not reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Pt developed a fever of ~ 101.3 (farenheit) yesterday, & today, 10/16/18, developed a fever of ~ 102.6 (farenheit). Friend mentioned that pt is currently @  Hospital ER & pt is currently experiencing n/v, "terrible headache", & tachycardia;  Admitted to Medical ICU.
expired Ipol was given to a patient, no AE; Initial and additional information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of an unknown demographics who received 0.5 ml dose of expired vaccine IPV (VERO) [IPOL] (lot number and Expiry date unknown) on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  At a time of reporting, no adverse event was reported.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Leg had knot size of gumball with low grade temperature from Monday till Wednesday.  When know increased to size of baseball.  Mother states "is decreasing" in size by small amount.