chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unilateral painful rash; Herpes zoster; Itchy; Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2016US164467).  This spontaneous report has been received from a healthcare professional, referring to a 4 years old female patient. The patient's history condition and concomitant medication were not provided.  On 18-NOV-2008, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) and influenza virus vaccine (unspecified), both for immunisation. The dose for both vaccines was 1 dosage form. The route, strength, lot number and expiration date for both vaccines were unknown.  On 16-APR-2016 (the patient vaccinated in 2008 and was 4 years old in 2016, which was an inconsistency), the patient experienced unilateral painful rash, herpes zoster and itchy. The outcome of the events was reported as recovered. The causality assessment between varicella virus vaccine live (oka/merck) (manufacturer unknown) and the events was unknown. The causality assessment between influenza virus vaccine (unspecified) and the events was reported as suspected.  The agency considered the events to be serious for the following reason: medically significant.
Inmate received first COVID-19 Moderna injection on 1-21-2021 lot number 013L20A. CDC paperwork was completed and first injection was denied. The nurse educated the inmate on the injection. No adverse outcomes occurred.
Sore throat; Head ache; Muscle ache; Fever; Tiredness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 03Apr2021 at 09:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and high blood pressure. The patient had no known allergies to medications, food or other products. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) and nifedipine (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 15:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 15:00, the patient experienced head ache, muscle ache, fever, tiredness and sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of head ache, muscle ache, fever, tiredness and sore throat were recovering.   No follow-up attempts are needed. No further information is expected.
Arm pain,; Armpit pain; This is a spontaneous report from a non-contactable consumer. An unspecified aged non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Jul2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 22Jul2021, the patient experienced arm pain and armpit pain after administration. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of event arm pain and armpit pain was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was brought to clinic by staff at facility she resides in for influenza vaccination.  She was administered the vaccine, it was determined a short time later that she had already had same vaccine 9-4-20 at another facility.  Contact was made with the vaccine manufacturer, who had no specific recommendations or guidance as no studies have been conducted on extra dose by this company.  Contact was made with CDC who offered that  extra dose in same season of Flulaval has not been found to be harmful.  Event was reported to contact person at facility where patient resides, who reports that she will contact resident's guardian and physician.
Chills, advised to take ADVIL and checked with pt next day - feels tired, but fine now.
Pain in the leg couldn't put the pants on and broken out in patches all over by 12/23/18.
Pt recvd vax 1DEC92 & on the same evening exp severe vomiting; pt was hospitalized; No further details were provided;
This solicited report was received from a 60 year old female patient, as part of a market research, referring to herself. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On an unknown date, the patient stated that "the vaccines caused the disease". The outcome of general symptoms was unknown at the time of reporting. The patient considered general symptom to be related to PNEUMOVAX 23. Additional information is not expected, because the reporter contact details were not provided.
This spontaneous report as received from a reporter (details unspecified) refers to a 13 year old female patient with no medical history. On 08-JAN-2013, the patient was vaccinated with a first dose (1 dose) of GARDASIL, intramuscular. No concomitant medications were taken. On 08-JAN-2013, the patient who saw her menstrual cycle was complaining about abdominal pain and headache the same day after receiving the dose one of GARDASIL. No laboratory test was performed. The event menstrual cycle, abdominal pain and headache disappeared without treatment on 11-JAN-2013 (reported as after 3 days). The outcome of unexpected therapeutic was unknown. Additional information is not expected.
hot and cold; Achy feeling/ achy mostly in his legs and left arm hurts; fever; sweats; Awoke after 13 hours of sleep; This case was reported by a consumer via call center representative and described the occurrence of fever in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 3rd March 2020, refer case US2020AMR090729).   On 26th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). In May 2020, less than a week after receiving Shingrix, the patient experienced tiredness. On 26th May 2020, the patient experienced fever, sweating and pain in extremity. On 27th May 2020, the patient experienced feeling hot and cold. On an unknown date, the outcome of the fever and pain in extremity were unknown and the outcome of the sweating and feeling hot and cold were not recovered/not resolved and the outcome of the tiredness was recovering/resolving.   It was unknown if the reporter considered the fever, sweating, feeling hot and cold, pain in extremity and tiredness to be related to Shingrix.  Additional information was provided as follows: The patient claimed that he had two nights of fever, an achy feeling and sweats that started on the evening of  the day of vaccination. On 27th May 2020, 1 day after receiving vaccine, the patient went to bed at 8:00 PM and awoke after 13 hours of sleep and called out of work today. The patient was hot and cold at the time of reporting and achy mostly in his legs and his left arm hurts. The reporter consented to follow up.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 5-year-old female subject who was vaccinated with (KINRIX, GlaxoSmithKline). Previous and/or concurrent vaccination included (HAVRIX, GlaxoSmithKline, unknown) given on 9 April 2009; tuberculin PPD (Sanofi Pasteur MSD, unknown) given on 9 April 2009 and VARIVAX (non-gsk, Merck, unknown) given on 9 April 2009. There were no concurrent medications. On 9 April 2009 at 16:00 the subject received unspecified dose of KINRIX (.5 ml unknown, left thigh). this vaccine was reported as the 5th dose of the vaccination series. On 9 April 2009, less than one day after vaccination with KINRIX, the subject experienced injection site redness and injection site pruritis. The reporter indicated that the redness and itching were just confined to the injection site. The subject was treated with BENADRYL and ice was applied to the injection site. Medical attention was required at the doctor's office. At the time of reporting the events were unresolved.
Change in skin texture to face and neck. Skin texture change originally was around the mouth and on the chin but has since spread up to both sides of the nose and into the T-zone. The texture  extends down onto the neck and jaw line. No current itching or redness. I reached out to the pharmacy where I received my first Moderna COVID19 vaccination and was advised to take antihistamines for the next 3-4 days and if sx's did not resolve after that, to go to the doctor's. Today (09/2/21) is the first day of antihistamines with little to no change in sx's.
Rash/hives over most of the body, sore arm by lymph nodes.  Pt was started on a course of prednisone for 10 days for the rash/hives.
Warm to the touch; Real hard; It itches real bad; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE INDURATION (Real hard), VACCINATION SITE PRURITUS (It itches real bad) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE INDURATION (Real hard), VACCINATION SITE PRURITUS (It itches real bad) and VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE INDURATION (Real hard), VACCINATION SITE PRURITUS (It itches real bad) and VACCINATION SITE ERYTHEMA (Redness around the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment included cortisone cream.
Information has been received form a physician's assistant concerning a 15 month old male who in the "end of November 2006", was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). At the "end of December 2006", four weeks after receiving the vaccine, the patient developed chickenpox; over 100 lesions. The patient had a doctor's visit on 26, Dec 2006. The lesions cleared up within ten days. The patient was considered recovered at the time of the report. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/4/2007. Information has been received from a physician's assistant concerning a 15 month old male, with no pre-existing allergies, birth defects, medical conditions or illness at the time of vaccination. On 20-NOV-2006, the patient was vaccinated subcutaneously into the thigh, with his first dose, 0.5ml, of PROQUAD (Oka/Merck upgrade process) (Lot # 655000/0829F). On 26-DEC-2006, four weeks after receiving the vaccine, the patient developed an generalized itchy, vesicular rash, with greater than 200 lesions over his entire body, determined to be chickenpox. The patient had a doctor's visit on 26-DEC-2006. The lesions cleared up within ten days. The patient recovered on 05-JAN-2007. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. No specimen collected. No further information is expected.
Initial spontaneous case received from a physician on 08 June 2010. A 7-month old female patient received her first doses of ACTHIB, PREVNAR (Wyeth) and hepatitis B vaccine (manufacturer not reported) on 07 June 2010; lot numbers were not reported. The patient had a history of "strange, unexplained pneumonia up to 3 months of age", and so vaccine administration had been delayed. Per the reporter, no explanation had been found for the pneumonia, and the child had seemed normal since 3 months. She received the vaccines in the afternoon of 07 June 2010, and that evening developed a temperature of 104 degrees and a rash. The following morning, the rash had spread to her entire body, and she had developed facial swelling. She was seen by her physician on 08 June 2010 and at that time was noted to have a whole body rash, facial swelling, a temperature of 102 degrees, and 3 watery stools. The physician was planning to coordinate with an allergist for possible skin testing due to a presumed allergy, and planned to give shots separately in 2 months. No additional information was reported. Of note, no serious criteria were reported by the physician. However, this case was considered serious by the company according to internal guidelines. Documents held by sender: None.
Caller stated that she had a reaction to the Shingles vaccine she stated she noticed immediately that her was extremely sore and red at the injections site. She stated she can't lay on her right arm and can only move it very slowly. If she moves it a certain way it hurts. She started to become nausea, feverish and very tired. Called dr and waiting on the nurse to call her back.
Questionable serum sickness. Urticaria, arthralgia, arthritis, joint swelling, fever
Myalgia, Rash, UrticariaPruritus, injection sire reaction Narrative:  Patient received Moderna vaccine (2nd dose) on 02/0424/2021 and began experiencing symptoms of hives and injection site redness/swelling/pain/itching 5-6 days after receiving vaccine. Patient reports presented to PCP and urgent care due to symptoms. Reports was prescribed dexamethasone (unknown dose/frequency/duration) and was taking OTC Benadryl for symptom relief. Patient reports had not fully recovered as of date of this report (03/29/21).
A little pain in the arm the next day (after dose 1); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little pain in the arm the next day (after dose 1)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Hypertension, Urinary infection (Chronic), Cardiac disorder NOS (something for the heart) and Blood cholesterol abnormal.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (A little pain in the arm the next day (after dose 1)). At the time of the report, PAIN IN EXTREMITY (A little pain in the arm the next day (after dose 1)) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product includes unspecified drugs for depression, cholesterol, high blood pressure, something for the heart and chronic urine infection. No treatment medications were reported.   This case was linked to MOD-2021-378180 (Patient Link).
over 1 week of migraine unresponsive to medication; nausea; vomiting; severe stiff neck with pain; severe stiff neck with pain; feels like someone poured acid in my body and set it on fire; feels like someone poured acid in my body and set it on fire; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 11:00 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fact V Leiden heterogeneous type" (unspecified if ongoing), notes: Fact V Leiden heterogeneous type; "Migraine" (unspecified if ongoing), notes: history of migraine. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Allergy", notes: Known allergies: Codeine. Vaccination history included: Bnt162b2 (dose administration time= 05:30 PM, dose number= 1,, dose vaccine location= Left arm, Adverse event start date and time: 03Sep2021 18:00 PM), administration date: 03Sep2021, when the patient was 45 years old, for COVID-19 Immunization, reaction(s): "vomiting", "Insomnia", "Nausea", "Headache", "Dizziness". The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "over 1 week of migraine unresponsive to medication"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "vomiting"; NECK PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 2021, outcome "not recovered" and all described as "severe stiff neck with pain"; FEELING ABNORMAL (non-serious), FEELING HOT (non-serious) all with onset 2021, outcome "not recovered" and all described as "feels like someone poured acid in my body and set it on fire". Therapeutic measures were taken as a result of migraine. It was unknown if therapeutic measures were taken as a result of nausea, vomiting, neck pain, musculoskeletal stiffness, feeling abnormal, feeling hot.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. There was no treatment AE. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Reported Event: First shot--vomiting, nausea, headache, dizziness and insomnia lasted 10 nights.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning an elderly male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2010, at approximately 78 years of age, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Essentially the nurse gave me more than one does because the first shot didn?t inject properly and I think she hit a nerve in my arm. Then I received a full shot. I felt very tired the rest of the day. I took a nap after work and woke up with a bad headache, body aches, severe pain in my left arm where I received the injection, my heart was racing, I was wheezy and having trouble catching my breath, and had no appetite. I was in so much pain I was starting to cry and took two Tylenol?s then tried to calm down and go back to sleep.
Had reaction in November to tetanus vaccine.  Had flu vaccine with no reaction.  Then had this vaccine, no reaction initially, came home, feeling fine but an hour later had flushing in her left ear, just creeping over to her eye and the side of her face.  This lasted for about 15 minutes and left the feeling of something not quite right around her eye.  Nothing compared to her reaction in November from a tetanus booster.  Still has the feeling but not an adverse reaction.  Then at 10:00 PM all of a sudden her face went really hot, and presumed she had a fever, started feeling badly.  Started walking around the house, took Tylenol.  That feeling lasted for about 30 minutes and resolved.  Went to bed and did not feel anything but a funny feeling.  All symptoms have subsided except for a weird feeling around her eye.
Info recv from a man concerning a female who was vax w/2 doses varicella virus vax live. Lab eval revealed a lack of response. Pt had no hx of chickenpox.
pt recvd measles vax on 16SEP91 & on 22SEP91 pt devel a red pin-sized rash on upper extremities & torso; rash was noted to be non-pruritic & heat sensitive; 12DEC91 exp fever, malaise; MD felt pt had a hypersensitivity reaction to the vax;
MD from hosp called & reported that pt was in ER; mom stated that driving home from clinic pt was gasping & wheezing for about 30min; MD said that pt was alright pt cried for @ least 15 mins p/immun; 15-20 mins p/inject mom was feeding;
Developed few vesicular lesions Rt. upper arm at site of the varicella vaccine - onset about 10 days after vaccine given. Cleared in a few days. No Rx.
Infant found in crib not breathing and cyanotic, parent began CPR and call 911. Child placed on life support and later declared brain dead. Taken off life support and pronounced dead. Child treated with various medication for infection , blood pressure.  7/20/07 Received Autopsy Report which reveals COD as unexplained sudden death; ischemic brain injury & diffuse cerebral edema; coagulopathy; metabolic acidosis; & stool positive for rotavirus (possible false (+) secondary to vax 5 days prior.  Patient had undergone organ retrieval & autopsy was limited to lungs, uterus, ovaries, trachea, esophagus, distal colon & brain.
The patient reported pain/stiffness in his arm the morning after the flu shot was given. He said he could not lift his arm. A doctor (unnamed) told him at the Orthopedic that they could not see any damage on XRAY, but gave him a steroid shot in the shoulder.
Menstrual cycle changes, started having my menstrual cycles twice a month, or every 2 weeks
Severe pain in left arm.  Felt like arm had been wrenched from shoulder socket.  Pain radiated down arm from shoulder to wrist.  Could not lift arm more than halfway to the front or side for 3 days.  Took 6 days for all pain to dissipate.