chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient immunized with Smallpox vaccination on 9 July 04 on left arm and returned on 24 Jul 04 stating that he had developed a pustule on his right 3rd finger (DIP).
Upper respiratory symptoms, cough, asthma exacerbation roughly 5 days after 1st and 2nd dose of vaccine given.
Shingles; rash on their back; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date 1st July 2021) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 13th April 2019, 1 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.   Additional details were provided as follows: The medical assistant on the line reported that the patient developed a rash on their back and was unsure if it was just a rash.  On 15th April 2019, the reporter followed up on the morning with the doctor and are being treated for shingles. They were seen on 23rd April 2019 and are still being treated for shingles.
2nd Vaccination for Covid 19 given 2/25/2021 Noted weakness in her legs, when stood up. In April she Noted her gait was OFF She however had No pain, so waited until she can get in to drive on July 29th, he diagnosed right foot drop. She could no Longer dorsiflex her Right Foot. The orthopedist Referred to Neurologist who saw her Sept 21, 2021 and referred her to Physical Therapy and for EMG-NCS which are pending until 12/15/2021, The physical therapy ended after week 6 and she was told it did not help her Foot Drop and thus Further therapy was suspended. Her walking is worsening, she has fallen twice. Now has chronic Knee Right pain compensating for the Foot Drop. She was told by me today to also setup Foot/Ankle Specialist or ortho specialist to get a Foot Brace.
She completed 2nd COVID vaccine and reported left arm swelling and redness, occurred one day after administration and  lasted one week.
Caught COVID, felt like I had a cold coming on,  antigen tested immediately and it came back positive.  Felt flu-like for 3 days, then just feels like a cold.  Mild congestion, runny nose, no fever after day 2
Pain; Weak; Excruciating hip pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), ASTHENIA (Weak) and ARTHRALGIA (Excruciating hip pain) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), ASTHENIA (Weak) and ARTHRALGIA (Excruciating hip pain). At the time of the report, PAIN (Pain), ASTHENIA (Weak) and ARTHRALGIA (Excruciating hip pain) outcome was unknown.            No concomitant medicines reported. No treatment medicines reported
Ache in upper arm when raised above shoulder level. This started a week after flu shot. No other symptoms. Continues to date.
Right arm swelled the night of immunization administration.  On 2/18/2004, patient had a "charlie-horse" in right leg.  Pain seemed to move up into right groin area.  Child unable to bear weight.  CBC, dif, Blood culture done.  Xray showed effusion of right hip and child sent to Hospital for possible septic arthritis.  Patient ultimately diagnosed with synovitis of right hip.  I saw her back on 2/26/04 with some improvement.  I had her use ibuprofen and saw her back today (3/5/04) and she continues to improve.  She only has some mild discomfort of her right hip with internal rotation.  I will see her back in 2 weeks for another recheck
No treatment.  Just waited for it to subside. Metallic taste in mouth. Lasted that day only.  Normal amount of pain in arm at injection site on the evening of injection.  Next day also moved into top of shoulder. Still sore on 3/11/21 but much better.
Information has been received from a registered nurse concerning an 8 year old male with no medical history who on 06-APR-2000 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. There was no illness at the time of vaccination. On 24-SEP-2007 the patient developed rash for 2 days and was diagnosed in the office on 26-SEP-2007 with approximately 100 lesions. No diagnostic laboratory tests were undertaken. On 02-OCT-2007 the patient recovered. No further information is expected.
50 X 65mm red localized reaction to L deltoid, 48 hours after DTAP #5 administered.
This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 27-FEB-2017, the patient was vaccinated with GARDASIL 9 (dose, route of administration were not reported) lot number L001312 that had expired 24-FEB-2017, for prophylaxis. No adverse effects were reported. Additional information has been requested.
Patient returned to vaccination site within an hour after receiving their 2nd dose vaccination. Pt reported rash on chest that feels hot and tingly.  Denied pain sob/aphagia.  Pt was evaluated by EMS and released. Advised to call 911 or seek medical attention if problem worsens.
Headache, fever (101.7), nausea, lethargy for several hours on day after vaccine was administered. Fever broke during the night. Energy level was still low second day after, slight headache that morning.
Had an episode where had cold sweats, turned purple around lips/mouth, was "unresponsive" for 30 to 40 seconds. Mom had been nursing, then was going to put her down in crib and noted she was unresponsive, immediately put her feet in cold water and she woke up. I did not evaluate the patient afterwards and in fact, did not see her until 2 months later at her next check up. This episode seemed consistent with HHE (hypotonic hyporesponsive episode) associated with DTAP vaccine.
The second day in the evening my arm was sore. and you took Excedrin to relieve the pain lasted about 24 hours and gradually started started to go away and get less and less over the next few days.  At that time there was no redness. Last night the 01/24/2021 it is itchy, pink and warm to the touch. This morning it is still that way.   *Called the physician this morning and is waiting for a call back
Patient had episode of convulsions and loss of consciousness immediately following injection (within one minute). Convulsions witnessed by medical assistant after administering. Patient moved to patient bed; diaphoretic, pallor, BP 70/45, bradycardic mid 40s,o2 98-100% RA. Elevated legs, pushed fluids. BP recheck 90s/50s, recheck again low 100s/70s (15 minutes after the event), pulse returned to high60s-mid70s after interventions. Patient transferred to Hospital via EMS to rule out seizure due to witnessed convulsions. Patient c/o weakness and fatigue. No loss of bowel/bladder.
both sides of neck muscles achy radiated down both arms; nausea's (vomited only 1x); nausea's (vomited only 1x),; rash across the top upper part of back; at 8:00pm got chills extremely bad had a hard time getting warm,1:00am finally got warm; at 8:00pm got chills extremely bad had a hard time getting warm,1:00am finally got warm; dizzy again like 1st time; major headache; This is a spontaneous report from a contactable consumer (patient) reported herself. A 62-year-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158) via an unspecified route, administered in left arm on 09Apr2021 at 13:30 (age at vaccination 62 years) as dose 2, single for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included chronic neck pain due to auto accident in 1997 and had allergies to penicillin. She received other medications within 2 weeks of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613) via an unspecified route, administered in left arm on 19Mar2021 at 13:30 (age at vaccination 62 years) as dose 1, single for COVID-19 immunization and experienced dizzy after 5 min of injection. On 09Apr2021 16:00, patient experienced dizzy again like 1st time, major headache, at 20:00 got chills extremely bad had a hard time getting warm, at 1:00 finally got warm. Next day both sides of neck muscles achy radiated down both arms, very nausea's (vomited only 1x). Then chills started again at 17:00 lasted till midnight. And lastly she developed a rash across the top upper part of back. Seriousness of the events was reported as non-serious. Prior vaccination she was not diagnosed with COVID-19 and since the vaccination she has not been tested for COVID-19. Adverse events did not result in physician office visit or emergency room visit. No treatment for the adverse events. The outcome of all events was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of more than - 15 but less than -10 degrees Celsius for 3 hours 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001482:
Vaccine #1 12/19/2020. No immediate reaction. 12/20/2020 started to get burning around Left eye. 12/21/2020 started to get swelling and puffiness around both eyes, also started with cough and back pain. Feels like symptoms improving. Taking Benadryl.
Patient missed 2nd dose, beyond 42 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose, beyond 42 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose, beyond 42 days.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose, beyond 42 days.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Passed out for a few minutes; Nausea; 24 hours of fever; A spontaneous report was received from a consumer concerning a male patient of unspecified age, who received Moderna's COVID-19 Vaccine (mRNA-1273).  The patient's medical history included immunodeficiency, cancer and gall bladder removal (not specified). Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unspecified date.   On an unspecified date, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection.  The patient had fever for twenty-four hours. On 26 Feb 2021, while on outing with patient's friend's patient had 2 beers. Later patient reported nausea and passed out for few minutes. However, patient drove back to home. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The event, fever was considered recovered/resolved on an unspecified date, and the events passing out and nausea were considered recovered/resolved on 26 Feb 2021.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Vaccine was given to the wrong patient, no treatment was necessary, and there was no adverse reactions noted in the patient.
I went to ER with complaints of stiffness in legs on Mar 21 2016, blood work was drawn and medicine was prescribed saying probably over worked muscle. 2nd trip to ER on Mar 27th with even more stiffness so more blood work and more meds. Mar 30 2016 went to another ER with severe stiffness, after blood work I was given 1 bag IV for Rhabdomyolysis. Apr 1 2016 went back first ER with no relief from stiffness and walking was a task as well as driving, took my results for the Rhabo and tests were done there, it had doubled so I was admitted the next day for 3 days to do nonstop IV. The test was done daily and it was going down but the stiffness was even worse and severe spasms had started
Patient had Varivax vaccine in 1996 and had chicken pox disease in 2004.
No additional adverse event; the pediatric patient was inadvertently administered an adult dose of VAQTA; the pediatric patient was inadvertently administered an adult dose of VAQTA; This spontaneous report was received from a medical assistant referring to a pediatric patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 13-APR-2020, the patient was inadvertently administered an adult dose of hepatitis a vaccine, inactivated (VAQTA) (lot# S025258 with expiration date 05-NOV-2020, route was not reported) for prophylaxis (incorrect dosage administered and product administered to patient of inappropriate age). The hepatitis a vaccine, inactivated (VAQTA) was administered with hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)). No additional adverse event was reported. For hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)), the lot number was reported as S025258 and the serial number was not available.   combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025258; expirationdate: 05-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
irregular bowel movements; I puked a few times; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BOWEL MOVEMENT IRREGULARITY (non-serious), outcome "unknown", described as "irregular bowel movements"; VOMITING (non-serious), outcome "unknown", described as "I puked a few times".  Additional information: Stated he puked a couple of times after he received the vaccine and would like to know does that relinquish the effect of the vaccine or is the vaccine discarded throughout his body regurgitated or is it intact since it is in the blood stream. Caller declined to make a report stating he was wondering if it was still in his system or regurgitated. Caller declined to provide name of contact number. Suspect Product: Pfizer, the general vaccine base, states the card says Pfizer BioNTech Covid 19 vaccine. Caller declined to make a report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt is claiming her arm has been hurting ever since her shot two weeks ago and it is staring to go numb.
Developed light fever and headache aroung 800 pm.  Following morning, could not get up .  grandson had to come over and pick me up and place me in chair.  Extreme muscle weakness in both legs.  Could not use legs until next day.  Still extremely weak in both legs.
1/25/2021 Patient presents today stating that she had her 1st COVID vaccine in her L arm and states she had no reaction other than soreness in the L arm for a day. However, 10 days later on 1/21/21 she developed a red, hot, itchy, oval shaped lump on her L upper arm that was squishy and felt fluid filled. She states it really wasn't painful, but a little tender to the touch. She otherwise felt fine. She states that she has put OTC hydrocortisone on it for the itching and she always takes 2 benadryl at night to help her sleep. She states that the redness and lump have gone down since 1/21/21, but now the area of redness is larger and extending down the L upper arm, but it is less red. There is still mild itching and mild tenderness to palpation. The patient denies any rash elsewhere and denies any fever. She states she did recently start taking myrbetriq for her bladder, but she stopped this a couple of days ago just in case it was causing the symptoms. She has no prior history of allergic reactions to vaccines other than having a sore arm. She does have an anaphylactic reaction to shrimp.
Lightheaded, dizzy, weak, headache -10:00am Left work by noon. Feeling same
ON DECEMBER 7TH 2021 AT 5AM IN THE MORNING, PATIENT'S FACE STARTED SWELLING ALONG WITH REDNESS. PT DID NOT EXPERIENCE ITCHING OR DIFFICULT BREATHING.
A non-serious spontaneous report of expired FLUMIST was given was received from a health professional concerning an adolescent male patient. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 12-Dec-2010. On 16-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 03-Mar-2011 and incorporated into case: no late occurring adverse events.
This case is linked to case number 2013-06987 (same reporter after ActHIB). Initial misuse report received from a healthcare professional on 21 May 2013. A nurse administered an expired ActHIB powder (batch number: UF566AA) with diluent (batch number: UH636AC) to a child. No adverse event was reported. List of documents held by sender: none.
The day before my COVID-19 test I started feeling cold symptoms, I felt really cold and my taste was different, my knee also hurt. I took a home COVID-19 test and it came back positive. Then I confirmed it by going to Urgent Care. Decided to have the infusion that Tuesday 07/05/2022. Started to feel a little better before the Infusion. Then after the Infusion I felt worse. Have been taking medicine on my own, but still having congestion with coughing a lot.
Excessive nasal drainage resulting in sore throat; Excessive nasal drainage resulting in soar throat; This creates an intermittent cough; These symptoms are in addition to muscle aches and headaches.; These symptoms are in addition to muscle aches and headaches.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 15:45 (Lot number: 301458A) at the age of 69 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "Diabetes (Type2)" (unspecified if ongoing), notes: Other medical history: Diabetes (Type2), High blood pressure; "High blood pressure" (unspecified if ongoing), notes: Other medical history: Diabetes (Type2), High blood pressure. Concomitant medication(s) included: METFORMIN; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9266, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Administration date: 19Feb2021), administration date: 19Feb2021, when the patient was 69 years old, for Covid-19 Immunization; Pfizer (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Administration date: 29Jan2021), administration date: 29Jan2021, when the patient was 69 years old. The following information was reported: RHINORRHOEA (non-serious) with onset 03Oct2021 15:00, outcome "not recovered", described as "Excessive nasal drainage resulting in sore throat"; OROPHARYNGEAL PAIN (non-serious) with onset 03Oct2021 15:00, outcome "not recovered", described as "Excessive nasal drainage resulting in soar throat"; COUGH (non-serious) with onset 03Oct2021 15:00, outcome "not recovered", described as "This creates an intermittent cough"; MYALGIA (non-serious), HEADACHE (non-serious) all with onset 03Oct2021 15:00, outcome "not recovered" and all described as "These symptoms are in addition to muscle aches and headaches.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rhinorrhoea, oropharyngeal pain, cough, myalgia, headache. Additional information : Patient did not receive any other vacancies four week prior to vaccination. Patient receive treatment for AE. (Ibuprofen and OTC flu type medication). patient not covid positive prior to vaccination, Post vaccination on 05Oct2021 patient undergo Nasal Swab test and result is negative.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2015US026836 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 61-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and concomitant therapies were not reported. On an unknown date in 2016, the patient was vaccinated with a dose of PREVNAR 13. On an unspecified day in 2017 and again on 11-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 (for both: strength, dose, frequency, route of administration, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported.