chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old female patient who developed a red, somewhat papular rash with fine bumps and sandpaper feel.  At 4 months of age, the patient received a dose on 26-Apr-2007.  Relevant medical history was not provided.  Product was administered on 26-Apr-2007.  Additional suspect medication included TRIPACEL, Polio Vaccine "Pasteur", ROTATEQ and RECOMBIVAX-HB.  Concomitant medications were not reported.  The patient developed a red, somewhat papular rash with fine bumps and sandpaper feel on 27-Apr-2007.  The rash was on her lower abdomen down to the left upper thigh.  No additional information was available at the time of this report.
Initial solicited report received on 12DEC2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. This is a 27 year old male who received immunization with ACAM2000 on 27SEP2017. The patient had no prior cardiac or other relevant medical history. No concomitant medications or vaccines were reported. On 08OCT2017 (12 days after smallpox vaccine) the patient had an abnormal electrocardiogram and troponin I (5.69ng/mL) and a normal echocardiogram. On 17OCT2017, he was diagnosed with myocarditis, unspecified. At the time of the report the outcome was unknown. Follow-up information received on 19DEC2017. Diagnostic test results were provided. On 08OCT2017 electrocardiogram results included normal sinus rhythm with RSR or QR pattern in V1 suggestive of right ventricular conduction delay (borderline) with QT/QTc-352/405 ms (notes written: PR depressions and STE consistent with myocarditis); nine days later the electrocardiogram was abnormal with sinus bradycardia and nonspecific t-wave abnormality with QT/QTc=420/408ms; echocardiogram impression was normal but with small pericardial effusion without signs of tamponade. Adjudication Committee consensus received on 09JAN2018: A consensus was determined by this study protocol adjudication committee:  Based on the information received the subject experienced suspected myocarditis; the information was insufficient to adjudicate for pericarditis; the information did not meet the case definition for subclinical myopericarditis. As a result of the adjudication committee consensus review - there were no changes to the reported events in this case.
7 days after vaccine, a 2" circular area developed at injection site. The site was itchy, red,  and slightly tender to the touch.
On 02/04/2022 I went into store pharmacy to get my 2nd Moderna Shot. They sat me down and gave me my injection. I went home and went about my business as the day went on my arm started hurting. The days after that it never stopped hurting and it became pretty painful. After about 5 months it got to the point where I couldn't use my arm on my left side without it being extremely painful. Months preceding that I had talked to a doctor and gone to a chiropractor. The doctor has given me Naproxen - Flexerile and a muscle relaxing pill to get rest at night. It helps me sleep but it doesn't help the condition.
Syncope, BP 104/61 (pulse 100), O2 sat 100%. Given water and rested 45 minutes. Final BP 129/86.
pt is under age 18, she received the johnson and johnson vaccine in error.   pt did c/o fever and body aches later that pm  that was relieved with Tylenol.  we have talked to mom since and she is feeling better, fever has resolved. no sob, no chest pain, no other symptoms.  symptoms pt displayed is common with all covid vaccines.
Patient reported swelling at site of injection, along with tenderness, heat, and redness beginning day of receiving injection. Noted symptoms progressed the next 2 days after, with red discoloration at site and knot at injection site. Patient was to try to take anti-inflammatories and diphenhydramine to attempt to reduce symptoms. Patient stated he has not experienced systemic adverse effects and will continue to monitor site and seek medical attention if symptoms do not improve.
At 7:00 pm the same day I received the booster I began to feel numbness, tingling, and weakness in my left arm, the one I received the shot in. I was unable to pick up objects in my left hand. At 7:30 pm, I lost my ability to swallow food with weakness in my tongue, throat, jaw and mouth. I could not even swallow saliva. I now have difficulty swallowing all the time and produce less than half the saliva that I remember. The condition has not improved as of 11 December. I've choked on food more than a dozen times now in the past week. I have more episodes of syncope now as well. At 9:00 pm, I developed fatigue and a headache that lasted five days. I develop a fever at 10:30 on the same night that continued for 24 hours
3 days after vaccine she got  numbness and tingling in feet & legs.  Attempted to walk she felt like she was going to fall.  She could not feel the floor under her feet as she was walking. She sat down for a couple of minutes and then started to walk again it was alittle better.  The symptoms occurred repeat daily for 1 week or 2.  Now when she sits daily her left foot becomes numb and tingles.  When she stands up it goes away.    No treatment.
itching; redness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itching), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling). At the time of the report, INJECTION SITE PRURITUS (itching), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Heavy Nosebleed with blood clots - Nosebleed lasted 25 minutes -started in right side nose.
Army medic did not dilute the vial of pfizer and patient received a full vial of pfizer vaccine undiluted
Client called 5/26/04 to report adverse reaction after flu shot given 11/05/2003. She stated she broke out in a rash that on right arm spreading to most of body. Treated with steroid then antihistamines. When she tries to wean off medications (antihistamines), rash reappears: has never had it completely resolved.
Total body aches and burning; stomach burning; headache and fever of 100. Awake all night following the shot. No treatment. Symptoms waned at the end of the day after the shot.
I received my second dose of Pfizer, per the mandate, after previously having had an allergic reaction myself (hives, numbness/tingling of lips and mouth) 3/8/2021. I was seen by an allergist who recommended that after allergy testing, I pre-medicate for 3 days prior to and 3 days after vaccination and that I receive it at a hospital where I can be closely monitored for a subsequent reaction. I had my vaccine at 2:55 and stayed in observation for 1 hour. After returning home, I breastfed my son at 6 pm and within a half hour he started to break out in hives. They started on his legs and then spread to his trunk and arms. I called the on- call nurse at our pediatrician who said to give Benadryl. 5 mls of liquid Benadryl was given per the on call doctor, and then we took him to a pediatric urgent care.
This is a spontaneous report from a Pfizer-sponsored program, (Call Center for HCPs), received from a contactable nurse. A patient of unspecified age and gender receive PREVNAR 13, and PNEUMOVAX 23; both via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient had an allergic reaction on an unspecified date. The reporter wanted to know if the patient had an allergic reaction to PNEUMOVAX 23 or the PREVNAR 13. The outcome of the event was unknown. Information on the batch number has been requested.
Pain and tenderness at injection sight almost imediately.  Muscle pain within first hour. Dizziness, weakness, loss of consciousness, nausea, and vomiting approximately 10 hours after injection.
patient was administered expired VAQTA; This spontaneous report was received from a medical assistant, referring to a 2 year old male patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.   On 24-AUG-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular (indication, formulation, strength, anatomical site of vaccination was not reported; lot number S019435, expiration date reported as 23-AUG-2020, which was verified to be valid). No additional information were provided.     combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S019435; 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
Patient called the pharmacy on 1/25/19 to report to the staff pharmacist that she has had persistent arm pain after her Flu shot on 10/25/18. The pharmacy manager called the patient back later that day at 2:30pm to get more information and again on 1/29/19 at 1:54pm. The patient returned the call on 2/1/19. She stated that she has had pain in her left arm and sometimes throbbing pain when she turns her arm certain ways. She stated that she was referred by her PCP to PT and had her first appt on 1/28/19 with Rehab Center. The pharmacy mgr called Dr. office on 2/1/19 to find out when the patient reported the arm pain. Per staff the office notes do not specifically mention arm pain related to a vaccine. The patient was seen on 1/14/19 and was referred to PT. Patient stated at that PCP visit that she likes to work out in the pool at the gym three times a week.
Dull achy pain to the right side of abdomen; pain radiated to back; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Dull achy pain to the right side of abdomen) and BACK PAIN (pain radiated to back) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 002P021A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, APIXABAN (ELIQUIS), LEVOTHYROXINE and DOFETILIDE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ABDOMINAL PAIN (Dull achy pain to the right side of abdomen) and BACK PAIN (pain radiated to back). The patient was treated with PARACETAMOL (ACETAMINOPHEN EXTRA STRENGTH) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Dull achy pain to the right side of abdomen) and BACK PAIN (pain radiated to back) outcome was unknown. Not Provided          Treatment medication includes: Extra Strength Tylenol. Action taken with mRNA-1273 in response to the event was not applicable.
Patient states she was receiving her COVID vaccination today, 12/23/20, in the left arm. About 5 minutes after the vaccine was administered, patient felt left arm pain that radiated into the left shoulder. About 10 minutes after the arm/shoulder pain began, she had left anterior chest tightness. She had her blood pressure taken, which was 109/104. She states the 104 diastolic is high for her.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Systemic: Tachycardia-Mild
temp 22APR92 that evening & slept all noc until 4AM awoke vomiting; diarrhea started 6AM mom states had 2 very large diarrhea stools & vomited about 6 times Thursday; vomited once today; also has pruritic rash covering abdomen & chest;
Patient reported she could not raise her arm because it was painful.  Also reports the arm was warm to the touch, she was having diarrhea, and the pain stretched down her side near her ribs.  She took Ibuprofen 800 mg, but that did not help.  Patient went to urgent care for further treatment although she did not disclose further treatment.
Subarachnoid hemorrhage with f/u angio normal no risk factors, no trretment
tongue feels as if it is swollen; tongue feels as if it is sprained; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue feels as if it is swollen) and PARAESTHESIA ORAL (tongue feels as if it is sprained) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (tongue feels as if it is swollen) and PARAESTHESIA ORAL (tongue feels as if it is sprained). At the time of the report, SWOLLEN TONGUE (tongue feels as if it is swollen) and PARAESTHESIA ORAL (tongue feels as if it is sprained) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Pt states no reaction immediately after administration. She was sleeping that night, and then around 3 am she woke up with severe muscle aches. She said that she was too weak and in pain to get up out of bed. She laid awake in bed until about 6 am and then was able to get up and take some acetaminophen. As of today (2 days post vaccine) she still has pain in her arm but generalized muscle aches have subsided.
Fever; Aches; Exhaustion; Headache; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on 29Mar2021 at 00:00 (at the age of 63-years-old), as a single dose for Covid-19 immunisation. Medical history included high blood pressure and COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medication included paroxetine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), propanol (MANUFACTURER UNKNOWN) and losartan hydrochlorothiazide (MANUFACTURER UNKNOWN); all taken for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 08Mar2021 at 00:00 (at the age of 63-years-old), as a single dose for Covid-19 immunisation. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 20:00, the patient experienced fever, aches, exhaustion, headache and vomiting for four days. The patient received acetaminophen (MANUFACTURER UNKNOWN) and antacids (MANUFACTURER UNKNOWN) as a treatment drugs for the fever, aches, exhaustion, headache and vomiting. The clinical outcome of fever, aches, exhaustion, headache and vomiting was not resolved at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained.
pain in the muscle; flu like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 5th October 2021 03:00, the patient received the 2nd dose of Shingrix. On 6th October 2021, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On 7th October 2021, the patient experienced muscle pain. On an unknown date, the outcome of the influenza-like symptoms and muscle pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt like flu like symptoms and had a real bad pain in the muscle area. The follow-up would not possible as no contact details were available.
No additional AE reported.; VAQTA was administered on 16 NOV 2021 after experiencing a temperautre excursion; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 16-NOV-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, lot # T031202, expiration date 14-JUN-2022 (route of administration was not reported) for prophylaxis. The vaccine was stored in temperature of 1 degree Celsius for 40 minutes. There was no previous temperature excursion. It was not reported if the Digital Data Logger was involved. No additional adverse event was reported.  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA006603:
Menvo was not mixed  with the liquid conjugate component . Was mixed with sterile water diluent .
10 people who are having/had the same side effects as his; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (10 people who are having/had the same side effects as his) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (10 people who are having/had the same side effects as his). At the time of the report, VACCINATION COMPLICATION (10 people who are having/had the same side effects as his) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient who had previously called to report his side effects, stated that he knew up to 10 people who are having/had the same side effects as his. Patient was not specific with the people he knows who are having side effects.  No treatment information was provided.
Tinnitus; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Sulfa drug), Drug allergy, Galactose intolerance, Fructose intolerance and Gluten intolerance. Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for Hormone therapy, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for Supplementation therapy.   On 27-Feb-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced TINNITUS (Tinnitus). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Tinnitus, at a dose of 1 UNK. At the time of the report, TINNITUS (Tinnitus) had not resolved.            Patient reported a gradual worsening of the tinnitus until could hear it while talking. Patient stated that doctors exam showed no external ear problems and normal blood pressure. Concomitant medications include lutein and acidophilous.  The patient had galactose, fructose, gluten allergy.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up was received to include reporter's contact information. On 10-Aug-2021: Significant F/UP: Onset date, doctors visit for Dose-2 event,concomitant medications addded
pt recvd 3 doses of Engerix-B & did not seroconvert 8 wks p/last dose;
Joint pain throughout body followed by spasm in my lumbar region. This is the first spasm I've had since I got the spinal cord stimulator implanted over a year ago.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 27-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).
This spontaneous report as received from a patient's cousin refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were unknown). On an unknown date, the patient developed shingles inside her body similar to his wife after receiving ZOSTAVAX and after researching online he found that a multitude of people experienced similar things (called did not want to provide contact information for the cousin and the information he found online). The outcome of shingles inside her body was unknown. Relatedness between shingles and ZOSTAVAX was not reported. This case is linked to MAARS#1403USA008896 and MAARS#1403USA009550 (same reporter link). Additional information is not expected.
Swelling in arm, hands, fingers 1-2 days after she received shot lasted about 1 week.