chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reports she noticed sporadic itching on left arm 4 days post vaccine admin. Today she has 5 small papules (2 2mm wide) confluent on left deltoid. No swelling, redness or pustules noted. Given Benadryl and hydrocortisone cream. Will call if needed.
A spontaneous report has been received from a Health Professional concerning an 08-years-old male patient. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving FLUMIST QUADRIVALENT started on 22-OCT-2014. The reporter stated that the had a very child and was able to administer half the dose in one nostril which started on 22-OCT-2014. The outcome of the event of administer half the dose in one nostril was unknown. The reporter considered the event administer half the dose in one nostril as non-serious.
BELL'S PALSY (PARTIAL PARALYSIS OF RT BOTTOM LIP, AND RIGHT EYE LID AND EYE BROW. VISIT AT EMERGENCY ROOM SHOWED NO SIGNS OF STROKE WITH CT SCAN, AND ALL BLOOD, EKG, ANOTHER EXAMS WERE NORMAL.  TREATED WITH STEROID INJECTION AND 6 DAYS COURSE OF ORAL GRADUATED PREDNISONE.
12 hours after taking the Janssen COVID19 vaccine I woke to cold chills, fever, and no appetite.  48 hours later the fever finally broke.  It's been three weeks and my stomach still feels like a knot and my appetite is minimal.  I have lost 5lbs so far.
The patient presenting with worsening stroke symptoms and now new-onset slurred speech, can not rule out an extension of his stroke or new stroke. The patient does report he has been doing a lot of therapy but I don't think that would cause such a dramatic decrease in strength, worsening coordination, or cause his new onset of slurred speech that was present today. The patient requires a higher level of care and additional imaging and testing for further evaluation and treatment. Will send the patient to Hospital.  send to ED for eval   Out to  Hospital. on 2/23 and returned on 2/25 with diagnosis of  worsening CVA ... Patient also with previous diagnosis of CVA
Severe Localized reaction, Hive like rash from left groin to left knee, slight swelling of upper leg present and warm to the touch.
She got the vaccine, a little after 11:00 she got up from the table was pulling for air and had wheezing that was loud.  She got some hot tea, and the wheezing got progressively worse.  By 11:30 she called back to her doctors office because she didn't want to go to the hospital.  She told her to go to the hospital instead of trying to drive anywhere by the way she sounded.  She suggested her using a nebulizer and told her to try it at home since she had some.  She did that treatment and was not any better, was kind of worse.  She went to the hospital and said that she was having spasms where the larynx was.  They started her on IV, gave her Ativan through the IV and then she was somewhat better.  They also gave her a prescription for more solution as hers was out dated.  She suffered through the night and went to her doctor yesterday and was out on Prednisone.
Chills/rigors starting about 16 hours post-vaccine (second dose), lasting intermittently for 24 hours, improved with a Tylenol.  Sore arm starting about 2 hours post-vaccine, lasting about 24 hours, improved with Tylenol.
Patient presents to orthopedic clinic after several months of shoulder pain beginning soon after immunization. Pain occurs with movement, not at rest, and patient is not able to put on clothing normally. Six weeks after immunization patient fell and had a pulling injury to affected shoulder. Pain is worse with abduction and internal rotation.  Diagnosed with rotator cuff impingement vaccine-related shoulder injury with secondary bursitis and referred to physical therapy.
Itchy Rash (red and raised bumps) on neck and face that has not resolved.  Over the counter Benadryl taken
Patient states pain in arm started about 12 hrs after she got the shot. On day 3 after shot pt states the pain increased and she had difficulty moving her arm. Day 4 she took Aleve for the pain. Day 5 she presented to clinic to see provider. She was prescribed a Medrol dose pack. Spoke with pt on Day 6 and she states the pain is much improved, but still has decreased range of motion.
Swelling, redness of right arm, forearm, elbow, down to wrist area. Started on late evening of 11/16/2016, symptoms get worse over 2 days. Patient started antibiotic treatment on morning of 11/19/2016 Cephalexin 1000mg twice daily and doxycycline Hyclate 100mg twice daily. Patient has improved in the afternoon.
left eye increased intraocular pain; pressure; it felt as if I had been punched directly in my eye and was suffering from a black eye; pain in moving/touching eye; pain in moving/touching eye; it felt as if I had been punched directly in my eye and was suffering from a black eye; blurred vision changes to left eye; left eye increased intraocular pain; pressure; pain in moving/touching eye; headaches located directly behind left eye; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 14:30 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "discectomy for herniated disk lumbar region; i have lasting sciatic nerve problems" (unspecified if ongoing); "i have lasting sciatic nerve" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; TIZANIDINE. The following information was reported: INTRAOCULAR PRESSURE INCREASED (non-serious), EYE PAIN (non-serious) all with onset 23Oct2021 09:00, outcome "recovering" and all described as "left eye increased intraocular pain; pressure"; EYE CONTUSION (non-serious), OCULAR DISCOMFORT (non-serious) all with onset 23Oct2021 09:00, outcome "recovering" and all described as "it felt as if I had been punched directly in my eye and was suffering from a black eye"; EYE MOVEMENT DISORDER (non-serious), OCULAR DISCOMFORT (non-serious), EYE PAIN (non-serious) all with onset 23Oct2021 09:00, outcome "recovering" and all described as "pain in moving/touching eye"; VISION BLURRED (non-serious) with onset 23Oct2021 09:00, outcome "recovering", described as "blurred vision changes to left eye"; HEADACHE (non-serious) with onset 23Oct2021 09:00, outcome "recovering", described as "headaches located directly behind left eye". Therapeutic measures were not taken as a result of intraocular pressure increased, eye contusion, eye movement disorder, ocular discomfort, ocular discomfort, vision blurred, eye pain, eye pain, headache. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme fatigue, somnolence, muscle/body aches, brain fog, joint aches
This case was reported by a other health professional via call center representative and described the occurrence of rash in a 60-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 2nd March 2018, the patient received the 1st dose of SHINGRIX. On 3rd March 2018, 1 days after receiving SHINGRIX, the patient experienced rash, fever and joint pain. The patient was treated with ZYRTEC. On an unknown date, the outcome of the rash, fever and joint pain were unknown. It was unknown if the reporter considered the rash, fever and joint pain to be related to SHINGRIX. Additional information was received as follows: The patient was seen in the office on 6th March 2018, and prescribed with ZYRTEC. The patient's status was unknown at the time of reporting. No further information was reported regarding the event. The batch number reported for SHINGRIX (9XC38), did not exist and was updated to 9XC39, as per sales database.
On September 8, 2008, client received Td and MMR.  Screening question regarding possibility of pregnancy was answered no by client.  Prior to administration of vaccine, client was asked if there was any chance she was pregnant, client answered, no.  Was explained she should not be pregnant and receive the vaccine nor should she become pregnant for 4 weeks after receiving the vaccine.  Client stated agreement to information, and was also provided with MMR and Td VIS statements prior to vaccinating.  Client returned to HD for another appointment on Sept. 17, 2008.  During that visit, she stated to the nurse she thought she was pregnant.  Further inguiry found that clients LMP was 8/9/2008, she states her menses is the following month and two days past previous LMP date. Client states she believes her next menses should have started on 9/6/2008 and she believes she is 11 days past that due date.  States uses condoms, but did not use a condom one time.  Pregnancy test performed with positive results.  Referred client to OB Department with written information regarding receipt of MMR and instructions for client to discuss this with OB physician.
extreme pain on left sideof neck; pain extended to ear; pain on occasion moved to lower jaw; tenderness in theneck; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6205) via an unspecified route of administration in the left arm on 11Mar2021at 12:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included hashimoto thyroid. Concomitant medications included Levothyroxine sodium (UNITHROID) from an unknown date for unknown indication which was received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER6201) via an unspecified route of administration in the left arm on 18Feb2021 at 16:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. The patient had a history of allergy to eggs and corn. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient was not diagnosed with COVID-19 prior to vaccination. On 25Mar2021 at 08:30, the patient had experienced extreme pain on left side of her neck, at the base of her skull and was not relieved with ibuprofen. The pain extended to her ear and on occasion moved to her lower jaw. The following day, the pain was only at the base of her skull but on both left and right. By the 3rd day, the pain had moved to the right side primarily and on the 4th day to the right side only, radiating to the right ear, but later in the day back to left centre of her neck. For the entire 4 days, she struggled to use the muscles in her neck at times. At other times she felt she was straining the muscles. Stretching helped, when she could isolate the muscle. At times she found relief with ice or heat, at other times ice or heat caused more distress. she still had tenderness in the neck, but the pain had dissipated. Adverse events resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient received ibuprofen and treatment from a chiropractor for the reported events. The clinical outcome of the events extreme pain on left side of neck, pain extended to ear, pain on occasion moved to lower jaw and tenderness in the neck was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Initial unsolicited report received from a non-healthcare professional on 21 November 2015. This case involves a 13-year-old female patient who was vaccinated with a dose of MENOMUNE and first dose of HPV vaccine (batch number, dose in series, route and site of administration were not reported for both vaccines) on unspecified date in 2007. Patient previously received 2 doses of MMR and 2 doses of varicella and a dose of Hepatitis B vaccines and patient denied any other reactions to vaccine in the past. It was reported that patient would like to start Hepatitis A vaccine prior to her trip and prefers to take oral typhoid. Concomitant medications were not reported. On unspecified date in 2007, on same day shortly after receiving vaccination, the patient developed Bell's palsy. Lab data and corrective treatments were not reported. Outcome of event was not reported. It was reported that its never determined for certain that Bell's palsy was a result of the vaccines but she had no subsequent HPV vaccines. Upon internal review, the case was considered to be serious due to important medical events: Bells' Palsy. List of documents held by sender: none.
2 MINUTES AFTER VACCINE. PATIENT BECAME PALE AND FAINTED. NO INJURIES OCCURED AND PATIENT LEFT 15 MINUTES LATER AFTER OBSERVATION.
My appointment was scheduled for my second vaccine shot at 10:00 am on 4/13/21. The shot was administered at 10:05 am in my right arm. I waited at the site (High School gymnasium) for 15 minutes as instructed. No side effects occurred. At 10:00 pm on 4/13/21, I began to experience chills and fever. I took two Tylenol caplets and went to bed. I woke up at approximately 4:00 am with fever, chills , body aches, pain in my right arm where I was injected and headache that continued for the entire day 4/14/21. I took two Tylenol caplets at that time and went back to bed. I stayed in bed the entire day and took two Tylenol caplets at 12:00 pm and again at 8:00 pm. When I woke up the next morning 4/15/21, all of my symptoms were better. I was just really tired and sleepy. Today 4/16/21, I am much better, just a little tired.
I tested positive for COVID 13Jul2022; I tested positive for COVID 13Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 20Apr2021 as dose 2, single (Lot number: EN0170), in left arm and on 01Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hashimotos disease" (unspecified if ongoing), notes: Other medical history: hashimotos disease; "depression" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; MIRENA; CETIRIZINE. Past drug history included: Prednisone, reaction(s): "Known allergies", notes: Known allergies: prednisone. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "not recovered" and all described as "I tested positive for COVID 13Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: I tested positive for COVID 13Jul2022; (18Jul2022) Negative, notes: I tested negative on 18Jul2022 and 19Jul2022; (19Jul2022) Negative, notes: I tested negative on 18Jul2022 and 19Jul2022; (23Jul2022) Positive, notes: Today (23Jul2022), I woke up with a sore throat and tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had received other medication in 2 weeks. She had received Paxlovid treatment for COVID on 13Jul2022 and stop on 18Jul2022. She had Paxlovid rebound. She tested positive for COVID 13Jul2022, and took a full course of the medication. She tested negative on 18Jul2022 and 19Jul2022. Today (23Jul2022), she woke up with a sore throat and teste positive again.  No follow-up attempts are possible. No further information is expected.
Pt called next day on 7/28, reporting red swollen arm as well as the skin being hot. specifically, the swelling was occuring closer to the elbow and towards the bicep. pt was advised to apply ice to area, and to go to md or urgent care if pt is concerned. unable to determine what kind of reaction the pt was having upon inspection. immunization was given by rph on 7/27
I have looked it up I see what gland it is, it is my salivary gland, the saliva gland and it is the same one and it keeps popping up/its my salivary gland it swells up; it is painful; this things hurts/ taking pain killers like crazy; makes my face swells up on that side; kind of like an infection; makes my heart beats; it makes it very hard for me even sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 38-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EW0158), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic pain" (unspecified if ongoing); "Herniated disc" (unspecified if ongoing), notes: gets injections in the spine that deals with the pain. Concomitant medication(s) included: TRAMADOL; ADVIL [IBUPROFEN]; GABAPENTIN. Vaccination history included: Bnt162b2 (Dose 1, Lot Number: EW0151), for COVID-19 immunization, reaction(s): "it is painful; this things hurts", "swollen salivary gland; keeps coming back; already had this side effect pop up three more times after that"; Bnt162b2 (Dose 1, Lot Number: EW0151), for Covid-19 immunization, reaction(s): "makes my heart beats", "kind of like an infection", "makes my face swells up on that side". The following information was reported: SALIVARY GLAND ENLARGEMENT (non-serious), outcome "unknown", described as "I have looked it up I see what gland it is, it is my salivary gland, the saliva gland and it is the same one and it keeps popping up/its my salivary gland it swells up"; PAIN (non-serious), outcome "unknown", described as "it is painful; this things hurts/ taking pain killers like crazy"; SWELLING FACE (non-serious), outcome "unknown", described as "makes my face swells up on that side"; INFECTION (non-serious), outcome "unknown", described as "kind of like an infection"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "makes my heart beats"; INSOMNIA (non-serious), outcome "unknown", described as "it makes it very hard for me even sleep". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of salivary gland enlargement, pain, swelling face, infection, heart rate increased, insomnia. Additional information: Patient was also taking an unspecified penicillin. The patient reported side effects that keep coming after getting all shots. Patient thinks it was some kind of infection and took some antibiotics and some pain killers just to try to keep away the pain and swelling (facial and salivary glands).
This spontaneous report was received from a nurse and refers to a 22-year-old female patient. No information regarding the patient's medical history and concurrent conditions was provided. On 26-JAN-2018, the patient was vaccinated with a dose of PROQUAD injection via subcutaneous route in the right arm, lot # N019251 with expiration date on 20-DEC-2018 instead of M-M-R II injection. Concomitantly, the patient received a dose of VARIVAX. Other concomitant therapies included SYNTHROID. On 26-JAN-2018, the patient experienced an unspecified localized injection site reaction. The patient recovered from the event on an unknown date in 2018. The relatedness between the event and PROQUAD was not reported.
patient received vaccine at 1136, first dose of Pfizer. After dose administered developed scratchy throat, blurred vision, dizziness, headache, left arm pain and jaw pain. Brought to urgent care for further evaluation, seen by healthcare provider. Patient discharged home in stable condition.
Developed Vitiligo and Halo Nevi.  Didn't notice right away and didn't associate the timing of events until I started looking at pictures of myself to see when this began (2021).  Have been going to a dermatologist.  Was not in my record in 2020, but I did mention the development of white spots in my Aug 2021 annual appointment.   Depigmented patches distributed on the left ventral distal forearm, superior lumbar spine, and periumbilical skin
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  No treatment medications were provided.  It was reported that patient had no symptoms or quality issues.   This case was linked to MOD-2021-392935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2021: Follow up received, Reporter address and Dose information updated.
1 (+) Edema of (R) leg after receiving PEDIARIX on 9/23/16, feels slightly warm. Treatment was to give TYLENOL BID x 3 days and recheck on 10/1/16 if no better. Give vaccines separately at next scheduled time. Unable to reach 9/28/16, 9/29/16.
Severe reaction; Very high fever; Tired; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event, fever and tiredness. On an unknown date, the outcome of the adverse event, fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the adverse event, fever and tiredness to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist reported that the reporter's friend had a severe reaction, very high fever and tired. The patient got the second dose. The reporter did not consent to follow-up. The pharmacist reported this was a side note, did not wish to provide patient information.  No vaccine lot number and expiry date available.  It was unknown where the patient received the vaccine. This case has been linked with US2019178174, reported by the same reporter.
Patient given PEDIARIX combination vaccine and also given Hepatitis B and Polio vaccine's(these are components of PEDIARIX). No reaction reported/observed.
Pfizer vaccine 0.3ml given without diluting the vaccine vial with diluent.
Within 30 minutes of receiving initial dose of Moderna vaccine, patient complained of "scratchy throat" and "fuzzy tongue".  examined patient, noted red patches on tongue.  Negative for edema and shortness of breath.  Provider administered 50mg of diphenhydramine via intramuscular injection. Patient cleared to leave.  Follow up via telephone 1400 - symptoms have resolved, however she complained of soreness at the injection site. Discussed with Doctor - to be expected.  Advised patient to call if anything changes, or if she starts feeling worse.
Patient admitted to hospital with severe sepsis secondary to COVID-19 associated pneumonia.He was started on IV antibiotics,IV steroids and remdesivir.His condition gradually improved.He is weaned down to 3 L oxygen by nasal cannula and has been stable at this level.He will be discharged home today.
Fevers up to 105.0 reported by parent. Also had otitis media infection prior, then after vaccine.