chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs were reported; patient was inadvertently administered 2 doses of VARlVAX within a 4 day time period.; low VARIVAX titer results; This spontaneous report refers to a female patient of unknown age. There was no information about her concurrent conditions, concomitant therapies or medical history provided. On 26-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported)for prophylaxis. During the visit on 26-MAR-2021, a titer was drawn and the result was low for varicella virus vaccine live (oka/merck)(VARIVAX). On 30-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) again. The outcome of antibody test negative was not reported.  The causality between the event and the varicella virus vaccine live (oka/merck)(VARIVAX) was not provided.
Are still sore from shot, hard time raising arm and buckling seat belt. He felt shot going in at time.
Itching/burning sensation for 10 days and a large rash, about 4 inches in diameter and continues to get larger
Pain, redness, swelling, hardness 7cm x 5 1/2 cm warm to touch, Tylenol or Motrin - ice pack 15 every hour x 2-3 days - if worse return to office or ER.
Patient woke up about 8 AM and was unresponsive. His arms and his legs were not moving and his eyes were rolling back. Patient's father then rushed him to the hospital where they were visiting. Where the doctors wanted to initially fly patient to Hospital two hours away. He was kept overnight. The doctors later determined patient had a febroid seizure.
Hospitalized for retropharyngeal abscess post surgical extraction of molar elsewhere.  Asymptomatic for other symptoms 10 days post positive COVID test.
Advised by the local authority that Pfizer Covid Vaccine adminstered was stable based on manufacturer but was not stored in accordance of approved guidelines. Patient's are not recommended to be revaccinated  217 patients were effected
painful; hard spot belowthe elbow; warm rash from elbow to wrist; warm rash from elbow to wrist; swelling increased a bit; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm rash from elbow to wrist), SWELLING (swelling increased a bit), PAIN (painful), VACCINATION SITE INDURATION (hard spot belowthe elbow) and RASH (warm rash from elbow to wrist) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol and Hypertension. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), CLONIDINE and AMLODIPINE for an unknown indication. On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced FEELING HOT (warm rash from elbow to wrist), SWELLING (swelling increased a bit) and RASH (warm rash from elbow to wrist). On an unknown date, the patient experienced PAIN (painful) and VACCINATION SITE INDURATION (hard spot belowthe elbow). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) for Adverse event, at a dose of 1 dosage form twice a day. At the time of the report, FEELING HOT (warm rash from elbow to wrist), PAIN (painful) and RASH (warm rash from elbow to wrist) outcome was unknown and SWELLING (swelling increased a bit) and VACCINATION SITE INDURATION (hard spot belowthe elbow) had not resolved. This case was linked to MOD-2021-385971 (Patient Link).
Case number PHEH2015US019364, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 16 year old patient (gender unspecified). Past medical history and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 02 Aug 2015 and the vaccine administered was stored in (34.0 degrees Fahrenheit, and 50.2 degree Fahrenheit 48-120 hours). No adverse event was reported following this maladministration (incorrect storage of drug). Follow-up information received on 25 November 2015: Previously administered products included MENVEO which was well tolerated. Concomitant products included GARDASIL received intramuscularly on 2nd August 2015. The patient's vaccination status was current. On 2nd August 2015, the male patient received the 2nd dose of MENVEO (intramuscular) .5 ml on left deltoid. The patient's details (height and weight) were provided.
Patient presented with weakness in left side, particularly in the hand and leg. She was also unsteady when getting out of bed. The only new exposure was the COVID vaccine received on 4/9/21. Husband notes no change in speech or facial symmetry. The patient was diagnosed with TIA and was treated with aspirin, plavix, atorvastatin. Patient was stable and symptom free and was discharged from the hospital.
45min p/vax were given pt started crying & shivering, then seemed to have shaking chills & turned blue gasping respiration; this lasted approx 10 & 15 min taken to ER & was basically asymptomatic;
pt recv vax 2OCT95 & 26JAN97 pt devel pox p/exposure to varicella @ school; It was reported that by 31JAN97 pt had over 300 pox;7FEB97 pt recovered;
Vaccine shot taken on 1/29/21 in the morning.  Normal vaccine shot soreness for 2 days.  2/6/21 at 7:00 itching and redness at injection site.  White spot at injection.  Swelling and itching increased throughout the following day.  Treated with cold compress and Cortisone ointment.  No change. Spoke with my physician on 2/8/21 at 1:00 P.M.  She suggested Benedryl (sp?) ointment for the itching and said to contact her if there were any further symptoms.  The rash and itching are still with me today 2/9/21.  I am hoping that from what little information is available that the rash and itching should start to abate within the next day or 2.
Patient reported that she felt dizzy following administration of the vaccine.  Seven minutes after getting the vaccine she reported feeling dizzy and asked for some water. The patient did state that she ate 15 minutes prior and has a history of vertigo. At 11:22, 8 minutes after drinking water and juice, she stated that she felt better. Blood pressure was taken at 11:15  (122/72) and again at 11:26 (120/72). Patient left after her last blood pressure check. Stated that she felt good and denied vertigo/dizziness.
Covid vaccine given one day past use by date, (73 days) in the refrigerator.  No symptoms, physician notified parent and discussed options.  Will not revaccinate at this time.
Approximately 24 hrs. after immunizations, patient had febrile seizure. Seen in ER but no treatment necessary.
No adverse event; as the second dose they received the Bivalent; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (as the second dose they received the Bivalent), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Sep-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (as the second dose they received the Bivalent) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (as the second dose they received the Bivalent), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (as the second dose they received the Bivalent) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered).    Concomitant product use was not provided by the reporter.   The patient got Moderna monovalent as first dose on 06-Aug-2022 and on 12-Sep-2022, a floater pharmacist confused the patient's Moderna dose with a Moderna Bivalent dose in error.   The patient thus received the Bivalent as second dose.  Treatment information was not provided.
other random pains; Headache; Chills; Tinnitus; Injection site pain vaccination; Unable to sleep on left side with both vaccines for one night.; Left arm pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 11:30 (Lot number: FF8841) at the age of 60 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Known allergies: sulfa, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL1283), administration date: 21Jan2021, when the patient was 60 years old, for COVID-19 IMMUNIZATION, reaction(s): "Chills", "Tinnitus", "ble to sleep on left side", "Left arm pain", "other random pains with injections"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EH9889), administration date: 31Dec2020, when the patient was 60 years old, for COVID-19 IMMUNIZATION, reaction(s): "Injection site pain". The following information was reported: PAIN (non-serious), outcome "unknown", described as "other random pains"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "recovered", described as "Chills"; TINNITUS (non-serious), outcome "not recovered", described as "Tinnitus"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain vaccination"; INSOMNIA (non-serious), outcome "unknown", described as "Unable to sleep on left side with both vaccines for one night."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Left arm pain". Therapeutic measures were taken as a result of headache.  Additional information: It was reported that patient headache was approx. 5 out of 10 scale at worst, started within 5 mins of injection. For headache patient was given Tylenol 650 mg as a treatment. Chills sporadically during HS, Resolved without intervention. No Covid prior vaccination and not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101343017 same reporter/patient/product, different dose/event.;US-PFIZER INC-202101343018 same reporter/patient/product, different dose/event.
Patient was given ADACEL instead of DAPTACEL. Patient was monitored for one month. There were no reaction to the injection. Patient had no high temperature or any other reaction.
Sore L-arm around 9pm? a few hours after vaccine. Urticaria everywhere around 10pm. Fever/chills/headache/body aches during the night, plus dizziness, L-vision aura and  L-ear clogged in the morning. L-vision aura and L-ear congestion subsided later the day, but fever/headache persisted. Took Tylenol at night to relieve fever/headache. Heavy sweat/urticaria for the night. Today is 3rd day - urticaria persists, and dizzy/weakness throughout the day :( L-sore arm persists.
Patient was diagnosed with cellulitis after getting her flu shot - she had pain, itching, redness, and swelling at the site of the injection that was 4 cm wide. Patient was treated with doxycyline hyclate 100 mg.
Her routine labs showed platelet count 550,000. This persisted into summer and resolved by Nov 2021.
Initial case was received from a healthcare professional on 12 March 2014. A patient of unknown demographics whose medical history and concomitant medications were not reported had received the ACTHIB component that was reconstituted by the sterile water and not the DTaP/IPV component of PENTACEL vaccine (batch number, dose, route and anatomical site of administration not reported) on an unknown date. List of documents held by sender: None.
Pt. became weak immediately after receiving vaccine.  Husband assisted pt. to passenger side of vehicle and stated she is "ok".  Husband and pt. refused emergency svcs. Pt. became weak and lethargic after receiving Pfizer vaccine.  Pt. and husband refused emergency services. Pt was observed and left site saying she is ok.
Patient got first dose of the Moderna vaccine and second dose of the Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient got first dose of the Moderna vaccine and second dose of the Pfizer vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Blood pressure high, Acid reflux (esophageal) and MS. Concomitant products included COLECALCIFEROL (VITAMIN D3) and ASCORBIC ACID (VIT C) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient got first dose of the Moderna vaccine and second dose of the Pfizer vaccine). On 17-Mar-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient got first dose of the Moderna vaccine and second dose of the Pfizer vaccine) had resolved.            Concomitant medications taken by the patient also included unspecified high blood pressure medication and acid reflux medication.  No treatment medications were reported.
Severe swelling of lymph nodes in the right armpit, the size of a golf ball/tennis ball.  Later that day the right armpit and side began to swell and fill with fluid.  I experienced a sac of fluid and pain for just over 8 days after the shot. The area was hot to the touch and sensitive. The swelling was visibly noticeable and protruded a few inches from the body.
Around March 3rd: -painful sores on tongue (gargled with salt water-no help) -Ear Blocks up/Painful March 8: -Wake up with painful rash across entire left side of face (did not know what was) -slept 1 1/2 days -went to Urgent Care 3/11/2021 -Diaignosed with shingles accompanied by Bells Palsy (left side of face) -Urgent Care refered to eye doctor for exposed left eye-appointment 3/12/2021 -Follow-up eye apponiments 3/19 and 3/26 -Referered to Neuro-Ophthalmology appointment set for 3/31/2021
itchy & gen rash starting @ inj site & over 72hr to most of body;saw MD & used oral DPH w/complete resolution by 5 days p/inj;
pt recvd vax on 27JUL; 28JUL stated had 3" red, raised, hard, warm reaction @ site of inject & fever to 101; induration, erythema; lump better 29JUL;
Acute appendicitis. Urgent care for diagnosis. Appendectomy 3/14, 7:45 pm.
Tingling headaches, tremors on left side of body (including face, shoulder, arm, leg, foot).  Loss of sensation and muscle weakness on left side of body.  Vertigo.
Patient experienced severe vomiting and fatigue 24 hours after receiving vaccine.  This occurred throughout 48 hours after and patient was found d/c on 03/20/2021.
Left shoulder hurted every single day, each time I reached for something, it had pain on the joint of my shoulder that lasted from 10-30 seconds. It had never hurted before until the Covid-19 shot.
pt recv vax; 11:30 start crying inconsolably; inc T;pt had T thru noc;
Patient lost consciousness after receiving Gardasil injection, and fell backward and hit his head.  Smelling salts were used to revive the patient, and he regained consciousness.  EMS was called and the patient was monitored.  EMS stated they would be taking the patient to Hospital.
After pneumococcal vaccine, left arm administration (IM injection): left arm soreness, painful to touch in evening after administration similar to past injections. Next morning: Severe pain, inability to raise arm laterally past 90 degrees, severe pain to touch, required ibuprofen to control pain > 48 hours after administration. Malaise, fatigue, localized muscle pain. No fevers. Rash noted >48 hours after administration approx 3 inch x 2 inch in area of injection site. At 72 hours mild pain and rash continue.  Reported because of length of pain / rash, no life-threatening side effects.
Information has been received from a physician concerning a 10 year old female with no related medical history and drug allergy who was vaccinated her first dose of VARIVAX vaccine (Oka) (lot # was not available) on 30-JUN-1998. On 13-MAY-2008 the patient was subcutaneously vaccinated her second dose of VARIVAX vaccine (Oka) (Lot # 660335/0097X). Subsequently the patient developed redness and pain of the vaccine site. On 14-MAY-2008 the patient was seen by the physician and was diagnosed as cellulitis. The patient started on KEFLEX and didn't improve. On 16-MAY-2008 BACTRIM was added. The symptoms lasted for 7-10 days and subsequently the patient recovered from cellulitis. No further information is available
/Per store needed to report due to conflict in stability of product. Pfizer stated product was okay until 10/19/2022
Moderna vaccine was administered outside of the clinic - reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------- ACUTE NON ST ELEVATION MI 5/1/2023 ACUTE NON ST ELEVATION MI
Tingling all over throat, face, arms legs, swollen throat, redness all over neck and chest
At first just nausea. Then I woke up in the middle of the night with shivers and could not get warm enough. Terrible headache. I kept dreaming that I had boils on my arms. Woke up and the shivers are gone but the headache remains. Of course I have a sore arm too. The first dose only gave me a sore arm.
This spontaneous report as received from a other health professional refers to a female patient of unknown age. The patient was vaccinated with dose 1 GARDASIL in APR-2012 in the office and received the second dose of series on 28-JAN-2013. No adverse effects were reported. It was not reported if the patient had sought medical attention. Additional information has been requested.
Soreness; Tingling sensation; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. An adolescent patient of unspecified gender started to receive meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had a tingling sensation and soreness just after the vaccine was administered. The outcome of the events was unknown.   No follow-up attempts are needed. Information about Lot/Batch Number cannot be obtained.
I received the vaccination while 16 weeks pregnant (due date 9/8/2021). On 4/5/2021, I began getting an itchy red bumpy rash around the vaccination site on my right arm. The area is swollen and approximately 3-inches in circumference. Today, 4/9/2021, the area is still swollen and itchy, but not as intense as earlier in the week.
A pediatric vaccine was given to a adult. No reaction occurred after the vaccine. Correct vaccine given due to needing coverage to go out of the country.
My son started to throw around 3pm on 9/2/22. He vomiting ended  by the time we went to bed around 9p and woke up the next morning, 9/3/222 with diarrhea that lasted till 9/6. A rash started the morning of 9/4 on the outside of his thighs and buttox.  It was a blotchy red rash that looked like large patches of dry skin. We gave him benadryl for the rash 9/4-9/6/22. Monday when he woke up the rash moved to several areas of his body including his arms, torso, legs, hands and feet and then after his nap Monday afternoon his rash turned into hives, his face was very swollen & hands and feet and he had a fever 102.5. I callled his doctors office after hours and they highly suggested I take him to the ER. The Emergency Room I took him to ran a series of blood tests to rule things out. They gave him tylenol for his fever and sent us home around 10:30pm 9/5/2022. I tried to get him seen the next day, 9/6/2022 by his primary care physician or another provider in the office that administeredd the vaccine and they had no availailble opened appointments. They then set me up with a virtual appointment Telemedicine with another doctor at 3pm. Suggested I take patient back to the Emergency Room and ask for Steroids as his hives did not improve and kept coming back.  He fever adn hives returned once again so  At 7pm on 9/6/2022 Patient father took him to the Urgent Care and they gave him a dose of a steroid and called in a presciption for Prednisolone, 15MG/5ML SOLN. On the bottle it reads give 5 ML by mouth once daily for 4 days. After they came home from the Urgent Care I gave him more benadryl and around 2am, 9/7/2022 Patient woke me up asking me for a drink and he was covered in sweat. This is when I feel the fever finally left his body and when he woke up at 8am his skin was clear from all hives and the swelling on his face had dramatically reduced only leaving red marks under his eyes. The swelling from his hands and feet had gone down and he seemed like the child he was before I  brought  him in to get this vaccine.
I had a miscarriage at 6 weeks pregnant. I have had 0 miscarriages in the past. I have 2 healthy children.
Information regarding PREVNAR was received from a healthcare professional regarding a patient who received PREVNAR that had been frozen on an unspecified date. On an unspecified date, the patient received a dose of PREVNAR that had been frozen (medication error). No adverse events were reported. No additional information was available at the time of the report.
Within 1 hour of the shot (3/4 @ 13:00) I had significant dizziness and felt my heart flutter frequently. Personal heart monitor showed arrhythmia. The following day (3/5) I had significant muscle aches causing me to miss work. On 3/6 the pain had subsided. By 3/7 I had facial weakness to the point of difficulties eating around 11 am, and difficulties talking. At 20:00 I realized when I smiled half of my face did not move. I proceeded to the Emergency Room where I was diagnosed with Bells Palsy.
patient lightheaded, dizzy, winded, fatigue, chest pressure, diaphoresis, sense of fogginess in his thinking.
THROAT BURNING; CITRUS TASTE; This spontaneous report received from a patient concerned a 72 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: spinal stenosis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported.   On an unspecified date, the patient experienced throat burning, and citrus taste.(dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the throat burning and citrus taste was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211143069 (Dose number in series 2).