chrisvoncsefalvay/vaers-outcomes huggingface dataset:
back pain; This is a spontaneous report received from a contactable consumer via company representative. A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number and expiry date not reported) via unspecified route of administration, on unknown date, at dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced back pain. The outcome of the events 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
Approximately 1 hour after receiving vaccinations patient experienced dry cough, whole body itchiness, left sided facial rash and itchiness, lacrimation
Patient's CDC vaccination card read: 3/3/21, 3/31/21 and 3/17/21. Was discovered that 3/17/21 was written in error and should have been 3/17/22. Patient received an additional dose on 3/31/22 before the error was noted.
Dizziness, numbness/tingling in both arms and hands for 1 week after injection, severe changes in vision (blurriness/sensitivity to light) for 1 week after injection, extreme muscle weakness for about 5 days after injection to the point of visible shaking when trying to stand/walk up stairs at home. Severe fatigue/sedation to the extent of not being able to stay awake to feed self for 4-5 days after injection, pain in L ribs/flank for about 1 week after injection.
(L) upper arm red, swollen, immobile painful. Temperature 102 deg F.
Ten minutes after receiving the vaccination the patient stood up and experienced syncope.   She lie flat on the ground until EMT arrived and was assessed.  She was monitored for approximately 30 minutes.  She was not transported to the hospital.
Twelve Moderna vaccines were given in office today. Only 11 were drawn up this morning and the 12th dose was, most likely, a left over dose from yesterday. After incident was discovered, Moderna manufacturer was contacted per CDC recommendation. (Case #: MOD21-060693). Someone in Quality was also notified.   Patient received this communication: The Moderna Vaccine you received may have been outside of the 6 hour thaw recommendation. We contacted the Moderna manufacturer and CDC. At this time, there are no recommendations for revaccination. You will still receive your 2nd dose as previously scheduled. Titers will be available at no cost in 2-3 months after your second vaccine.
vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HUMIRA for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of HUMIRA (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE 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 concomitant medications are provided. treatment to the events not reported.
Vaccine: Monday, October 4th  Tuesday and Wednesday: all day in bed, weak,  disoriented. Slept on and off all day both days Thursday began to recuperate Friday: almost fainting in the evening. Unable to climb stairs. Saturday: Very weak. Could not attend my grandson's wedding party
Pt states "foot pain" started 3/30/21. He went to get it checked on 4-1-21, and was diagnosed with a "blood clot".   Started on Eliquis for 6 months.  A second dr's appt is scheduled in 3 months.  The blood clot is in the L leg.
Patient stated they noticed a red and warm area below the injection site to inside of elbow. When they arrived at the pharmacy on 10/04/22, they said that morning it was warm to the touch but was no longer warm as the day went on.  They did not report fever or any other systemic symptoms after receieving vaccine. Followed up with patient on 10/08/22 and they stated the reaction has cleared completely
Woke up from nap today. Fatigue, headache, back of neck hurting, muscle aches all over
Patient became unconscious momentarily and started to have breathing difficulty and would not answer when tried to conversate. This happened immediately after giving the MMR shot. TWINRIX shot was given about 2 or 3 minutes prior to this shot.
I was 6 weeks pregnant at the time of my flu shot. I had went to my OB that day and everything with the pregnancy was fine. 12 hours after my flu shot I had a miscarriage. I have had two previous healthy pregnancies with no history of miscarriage. The estimated due date was June 14th.
Within a week developed large cold sore (shingles) on forehead and outer lower eye lid (both left side of face) Both calves, ankles,feet swelled up massively which lasted about 8/9 days. Tired headache lymph nodes in neck, groin, armpit and behind knees
Swollen lymph node in underarm of injected arm. About the size of a nickel, mildly painful when I moved and causing slight numbness down my arm. The pain upon moving/numbness went away after a couple days. Swollen lymph still present as of today, mild and periodic throbbing  pain still persists.
Developed itchy rash and eye swelling a few hours after - TDAP vaccine given: taken to ER and required BENADRYL. No fever positive urticaria on deltoid muscle noted at site where vaccine given on Flu visit.
Rash on right forearm; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on the left arm on 17Jun2021 at 15:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. It was reported that the patient received other medications within 2 weeks of vaccination but the medication was not specified. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported allergies which was unspecified. Prior to the vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 21Jun2021 the patient experienced rash on the right forearm. The patient did not receive any treatment for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event rash was recovering at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Arm pain; Very itchy; red spot for a week of the size of a cuarter and increased to a sober dollar; swollen and size of a baseball; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), VACCINATION SITE PRURITUS (Very itchy), VACCINATION SITE ERYTHEMA (red spot for a week of the size of a cuarter and increased to a sober dollar) and VACCINATION SITE SWELLING (swollen and size of a baseball) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ATROPA BELLADONNA EXTRACT, HYOSCYAMUS NIGER DRY EXTRACT, PHENOBARBITAL (HYOPHEN [ATROPA BELLADONNA EXTRACT;HYOSCYAMUS NIGER DRY EXTRACT;PHENOBARBITAL]) and VITAMINS NOS for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), VACCINATION SITE PRURITUS (Very itchy), VACCINATION SITE ERYTHEMA (red spot for a week of the size of a cuarter and increased to a sober dollar) and VACCINATION SITE SWELLING (swollen and size of a baseball). On 28-Jan-2021, PAIN IN EXTREMITY (Arm pain) had resolved. On 01-Feb-2021, VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE SWELLING (swollen and size of a baseball) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red spot for a week of the size of a cuarter and increased to a sober dollar) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: No New information added On 22-Jun-2021: All event outcomes now recovered.
Woke up with soreness in left arm.  Red circular rash around 5 cm and swelling around 6 AM at injection site.   Rash starated itching during day.  Arm is still sore and rash still present at 8:30 PM this evening.  Applied some Triamcinolone Cream tonight.
Patient had received a dose of Janssen COVID vaccine in March 2021.  Patient stated in clinic today that he had not received COVID vaccine in the past.  He noted an incorrect birth date on his consent form.  When registration entered him into the system, they did not realize that he had received a dose of Janssen COVID vaccine in March 2021, and he was vaccinated with a dose of Pfizer COVID vaccine.  Registration subsequently realized that patient had received the March dose of Janssen vaccine
Hives/rashes, between 2-4 inches in diameter, all over body fro m shoulder, legs, back, stomach.  Very itchy.; Hives/rashes, between 2-4 inches in diameter, all over body fro m shoulder, legs, back, stomach.  Very itchy.; Hives/rashes, between 2-4 inches in diameter, all over body fro m shoulder, legs, back, stomach.  Very itchy.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 14:00 (Lot number: FK5618) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL.  The following information was reported: PRURITUS (non-serious), URTICARIA (non-serious), RASH (non-serious) all with onset 22Nov2021 15:30, outcome "unknown" and all described as "Hives/rashes, between 2-4 inches in diameter, all over body from shoulder, legs, back, stomach. Very itchy.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The 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. Since the vaccination, the patient has been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
pt recv vax; devel rash on neck,face,chest and behind ears one week following vax;
8 weeks after 2nd dose, woke up to severe Vertigo. (Went for physical therapy) Also, the day prior to Vertigo I started my men?s teal cycle. Extremely heavy with clots lasting 11 days so far without let up.
Information has been received from a registered nurse concerning a 69 year old white male. The patient said he did not have any prior adverse reactions. On 04-OCT-2007 the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #657143/0380U) intramuscularly in the left deltoid at 10:00 am. Concomitant therapy included influenza virus vaccine (unspecified) (Lot #AFLLA040AA) (GlaxoSmithKline) intramuscularly in the left deltoid at 10:00 am. One week after the injection, on approximately 11-OCT-2007, the patient reported that he developed redness and pain in the left upper arm, which lasted one week and did not require any other interventions. The patient has recovered. No further information is expected.
Pt experienced a local reaction in right arm with erythema and localized heat on upper arm surrounding vaccine site.
It took 4 shots for her to body to respond/make antibodies; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 68-year-old female patient who received HAB (Hepatitis A and Hepatitis B vaccine) for prophylaxis.   Co-suspect products included HAB (Hepatitis A and Hepatitis B vaccine) for prophylaxis, HAB (Hepatitis A and Hepatitis B vaccine) for prophylaxis and HAB (Hepatitis A and Hepatitis B vaccine) for prophylaxis.   The patient's past medical history included shingles and chickenpox. Concurrent medical conditions included hiv positive and immunodeficiency.   On an unknown date, the patient received the 1st dose of Hepatitis A and Hepatitis B vaccine, the 2nd dose of Hepatitis A and Hepatitis B vaccine, the 3rd dose of Hepatitis A and Hepatitis B vaccine and the 4th dose of Hepatitis A and Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis A and Hepatitis B vaccine, Hepatitis A and Hepatitis B vaccine, Hepatitis A and Hepatitis B vaccine and Hepatitis A and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The reporter stated that she receved  hepatitis A and hepatitis B series a long time ago and she was immuno-compromised, which led therapy non-responder. The reporter did not remember the brand name of the shot(s). The patient stated that she had to receive a series of 4 shot in order for her to produce antibodies. The reporter indicated that normally it was a shorter series ( 3 shot series) but for her it took 4 shots for her to body to respond/make antibodies because she was and is immuno-compromised. The reporter consented to follow up. This case was 1 of 4 linked cases.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021013457:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014254:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014253:Same reporter. US-GLAXOSMITHKLINE-US2021013450:Same reporter.
Large, local reaction left leg 12cmx10cm erythema, swelling. No fever and no systemic symptoms.
Patient started tearing  about 3 minutes after received the vaccine. Her face and lips turned really pale and fainted on pharmacist's arms for 30 seconds. She wore up but still pretty confused. WE gave her water. She stayed in pharmacy with her mom for about 40 minutes and went home.
This medically confirmed spontaneous report (initial receipt: 16-Oct-2015) concerns a female pregnant patient. On an unknown date, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016). On an unknown date, the pregnant patient received the excursioned vaccine. The vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported. Additional information received from HCP on 26-Feb-2016: The patient had two previous pregnancies and did not have a stillbirth, miscarriage, a birth defect or congenital anomaly in any of the previous pregnancies. On 09-Sep-2015, the patient received the excursioned AFLURIA (batch number U55406) 0.5 ml via the intramuscular route of administration. The estimated date of delivery was 07-Jul-2015. There was no evident of a defect/adverse finding from a prenatal test, and no adverse pregnancy outcome/miscarriage.
This infant has large red, swollen area with blister around the site of injection on the left thigh.
Approximately 30 minutes after the injection clients voice became raspy.  She reported 1-2 seconds of blurred vision, that resolved.  No breathing difficulty or wheezing, no dizziness.  B/P 128/88 Pulse 59.  No other complaints from client. No swelling or redness at injection site.  Waited X 60 minutes, no changes.  Instructed client to closely monitor and seek emergency care if needed.
tiredness, headache, muscle pain, chills, joint pain, fever, injection site pain, general feeling unwell
She got her vaccine, had pain at the injection site, rash around the injection site that formed a blister.  She had the worst case of flu that she had ever had and hit her all of a sudden.  Had the tiredness, headache, chills, fever, nausea, fatigue.  She also had mouth burning and distorted taste, which is still not quite back, and ringing in the ears.  She had fallen asleep and woken up as if something had hit her in the chest, and her heart was beating fast, and took her BP it was 210/170.  It stayed up over 200 for 4 days.  Friday she let it go and waited until Monday to call her cardiologist office and it was still over 212.  He increased her medications and increased them again.  She still does not feel 100%, but better than before.  He told her not to get the 2nd vaccine due to her reaction.   Her blood pressure is considerably better, but is not back to where it was before the vaccine. She is still having the fatigue and tiredness, but is better than it was.  Still feels a little nauseous, still has the distorted taste in her mouth, things don't taste right to her.  She is still having a little bit of ringing in the ears.
After receiving the shot (PNEUMOVAX), pt said that her shoulder joint/upper deltoid area became very hard to the touch. She could not move her arm up & down the next day. As a result, she could not drive to see her PCP. Pt saw a nurse practitioner and was told that it may be tendonitis. On the 4th day, she had another appt. with nurse practitioner. The TENS units helped her a lot to relieve the pain.
Pt. was supposed to receive the Pfizer Bivalent Booster ages 5yrs-11yrs instead of a 3rd primary dose. Pt. did not report signs or symptoms of distress or adverse reactions. Mother of child notified of incident.
Patient complained of swollen tongue, no shortness of breath, no chest tightness. Paramedics arrived on scene and gave a Benadryl shot. Patient will be sent out to a nearby hospital because symptoms are not relieved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FK5443) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chron's Disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: Tested positive again - 5 days after testing negative; (03Aug2022) Positive, notes: Tested positive again - 5 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19  Clinical course: Patient did not take other medication in 2 weeks. Anti-viral treatment details, product Covid 19 treatment start date was reported as 23Jul2022 and treatment stop date was 27Jul2022. Adverse event reported that Tested positive again 5 days after testing negative. Device timestamp: 03Aug2022.   No follow-up attempts are possible. No further information is expected.
Fever 102.8 day 1 and bone pain and headache and weak and tired Fever 100.1 day 2 and tired headache
Burning pain at injection site and down arm with greatest pain at top of elbow joint. It gets worse with exertion.
Swelling (6cm) and erythema (5.5 cm) at Right upper anterior thigh. Itching with or without contact.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022).    No concomitant medications were provided by the reporter.  Patient received half dose.  On 04-Jun-2022, the vials were initially stored in the refrigerator.  Vial had not undergone any temperature excursions.  No treatment medications were provided by the reporter.
New onset dizziness with hypotension, tachycardia, and vomiting blood. Sent to ER - told he went into cardiac arrest and died.
pt devel fever, myalgia & h/a 7hr post vax w/flu vax;reported as feeling better 3OCt96;
Fever of 102-103 on 8/30/07. mon states child had foul bm's & fine rash in groin area on 9/3/07. continued with fever 9/5/05.  afebrile at this time but woke with fine rash over entire body and along the hairline.  Pediatrician feels that the DX is roseola.
first Shingrix vaccine dose on 4/17/18, got another on 5/21/22; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 17th April 2018).   On 21st May 2022, the patient received the 2nd dose of Shingrix. On 21st May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-MAY-2022 Reporter's Comments: This case was received by web form. The reporter stated that the patient just got another dose of Shingrix with them. The reporter wants to know that they need to get another dose since the first and second were so far apart or had they now completed the series. No further details provided on web form. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose later than recommended interval, which led to lengthening of vaccination schedule.