chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Received expired bivalent booster beyond 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired bivalent booster beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired bivalent booster beyond 12 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired bivalent booster beyond 12 hours after first puncture) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired bivalent booster beyond 12 hours after first puncture).    Concomitant medication was not provided.  It was reported that the vial was  initially stored in refrigerator on 03-Nov-2022 at about 3:30PM and doses administered to patients on 04-Nov-2022 at unknown time and 05-Nov-2022 at 3PM. The pharmacist reported that it was Unsure, there were doses given from the same lot number on 03-Nov-2022, but she is not sure if it was from the same vial. She does not have the time of puncture.  The vial did not undergo any temperature excursions.  The vial was not exposed to room temperature. It was stored in the refrigerator after puncture.It was exposed to refrigerator temperature for about 24 hours, if the first puncture was 04-NOV-2022.  Treatment information was not provided.  The case contains information of patient 2 out of 2 patients.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose six months before the date of reporting, refer case US2018216881). In November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, dizziness and blood pressure decreased. In November 2018, the outcome of the influenza-like symptoms and dizziness were recovered/resolved. On an unknown date, the outcome of the blood pressure decreased was unknown. It was unknown if the reporter considered the influenza-like symptoms, dizziness and blood pressure decreased to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. Two weeks before the date of reporting, the patient received 2nd dose of SHINGRIX and experienced flu-like symptoms which lasted 48 hours, dizziness and blood pressure decreased.
Patient describe he has sweats in his chest a couple of hours after getting the influenza vaccine. His BP was 138/82 and temperature was 98.1f degrees. We monitor symptoms and was asked to come back to use the cold compress. He elected to go home after 30 minutes.
Saturday evening, August 14, developed low grade fever and severe arm pain where shot was given, severe fatigue.  Sunday, August 15, low grade fever-- 100 degrees F all day, treated with Tylenol.  Severe head pain in center of head-- worse than migraine pain.  Severe fatigue, nausea, body aches all over body, chills.  This all lasted for about 24 hours.  By Monday, 8/16, symptoms mostly gone except for arm pain.
Patient admitted to hospital a few weeks after his second Moderna vaccine with an acute febrile illness of unclear etiology. Patient was felt to be septic due an atypical infection with an elevated procalcitonin level. All tests for infectious etiology were negative. He responded to ceftriaxone and doxycycline and was feeling better at transitional care management follow-up on 5/21/21.
sl temp,  drowsiness, limp, not alert, very disoriented, no appetite, paleness, upset stomach;
lost control of her bladder; Chills; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (lost control of her bladder), CHILLS (Chills) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 002A21A) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN, CALCIUM, COLECALCIFEROL (CALTRATE D [CALCIUM;COLECALCIFEROL]) and DENOSUMAB for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced CHILLS (Chills) and HEADACHE (headache). On 24-Feb-2021, the patient experienced URINARY INCONTINENCE (lost control of her bladder). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at a dose of 1 dosage form. On 23-Feb-2021, CHILLS (Chills) and HEADACHE (headache) had resolved. On 25-Feb-2021, URINARY INCONTINENCE (lost control of her bladder) had resolved.            sore arm was reported in  the event which was experienced after 1st dose vaccine event reported unknown.   This case was linked to MOD-2021-048104 (Patient Link).
Patient developed sore throat and stuffy nose, states that websites say that these symptoms are not common in one location, but are common in another location.
Rapid onset confusion (lasting less than 5 minutes). Followed an hour later by silent (absent) seizure  lasting @ 3 minutes. mental disorientation (@30 minutes)Jaundiced coloration of skin. Lips absent of color. (@20 minutes) 911 emergency services dispatched to patient's home. Patient transported to ER via ambulance Extreme fatigue (continuing ). Headaches for several days following day of event and continuing.
I had flu-like symptoms; a fever for approximately ten days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, I had minimal symptoms), administration date: 2021, for COVID-19 Immunization, reaction(s): "only the arm where I got the shot was sore". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "I had flu-like symptoms"; PYREXIA (non-serious), outcome "recovered", described as "a fever for approximately ten days". The events "i had flu-like symptoms" and "a fever for approximately ten days" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Patient had received two shots of the Pfizer COVID vaccine. After receiving the first shot, he had minimal symptoms--only the arm where he got the shot was sore. After receiving the second shot, he had flu-like symptoms and a fever for approximately ten days. He went to his personal physician and received negative results for a flu test and COVID test.   The follow-up was being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Raised bumpy rash began about 2 hours after vaccination over left triceps about the size of a pop can by the next day.  Burning and itching for 1 week.  Area stayed large about 7-10 days.  Used hydrocortisone and calamine to treat symptoms.  Still has a little residual bumpiness and irritation. Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.
On 4/28/2022, I was found to be in Acute Renal Failure.  I was admitted to Hospital for a week.  I am still in renal failure but my numbers are slowly improving.
Felt ache in arm, fever, chills.  Went to bed, no medication.  Drank water.  Body felt like there was a heavy weight on me.  Slept thru the night with extra blankets for chill.
Sore Throat; 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 OROPHARYNGEAL PAIN (Sore Throat) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore Throat). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat) 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 provided.   Reporter did not allow further contact
mild headache & fatigue same night of vaccine through early afternoon next day, and then approx 35 hours after shot had nausea, chills, mild headache middle of night through morning
Muscle spasms / severe spasming 10-15 times a day, slowly got better; twitching in right forearm within hours of 2nd dose.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 7534, Location of injection: Arm Left), administration date: 26Mar2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 16Apr2021, outcome "recovering", described as "Muscle spasms / severe spasming 10-15 times a day, slowly got better"; MUSCLE TWITCHING (non-serious) with onset 16Apr2021, outcome "recovering", described as "twitching in right forearm within hours of 2nd dose.". Therapeutic measures were not taken as a result of muscle spasms, muscle twitching.  Additional information: It was reported that patient had not received any other vaccine in four weeks. It was reported that Muscle spasms/twitching in right forearm within hours of 2nd dose. Started severe spasming 10-15 times a day, slowly got better. Spasming was less severe but t multiple times a day for several months. Now mild and several times a week. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had local reaction - redness and swelling after Hepatitis A administered in (R) deltoid. Applied ice and administered BENADRYL 25 mg. Swelling/redness noted immediately after immunization was given.
Severe eye pain requiring prednisolone eye drops, per patient could have resulted in vision loss. One eye only.
L arm soreness; muscle ache at site of injection; itchy like hives; itchy and red L arm at site of injection; Red; L arm, site of injection with a bruise; L arm, site of injection swollen; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (L arm, site of injection with a bruise), URTICARIA (itchy like hives), INJECTION SITE PRURITUS (itchy and red L arm at site of injection), MYALGIA (L arm soreness) and INJECTION SITE PAIN (muscle ache at site of injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included VITAMINS NOS and THYROID for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CONTUSION (L arm, site of injection with a bruise) and INJECTION SITE SWELLING (L arm, site of injection swollen). On 11-Mar-2021, the patient experienced INJECTION SITE PRURITUS (itchy and red L arm at site of injection) and INJECTION SITE ERYTHEMA (Red). On 12-Mar-2021, the patient experienced URTICARIA (itchy like hives). On an unknown date, the patient experienced MYALGIA (L arm soreness) and INJECTION SITE PAIN (muscle ache at site of injection). At the time of the report, CONTUSION (L arm, site of injection with a bruise), URTICARIA (itchy like hives), INJECTION SITE PRURITUS (itchy and red L arm at site of injection), MYALGIA (L arm soreness), INJECTION SITE PAIN (muscle ache at site of injection), INJECTION SITE SWELLING (L arm, site of injection swollen) and INJECTION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.
Patient was waiting the required 15 minutes under observation. She then felt a tightness in her chest and stated she felt itchy. 50mg of diphenhydramine was administered by mouth to alleviate the patients allergic symptoms. Symptoms started to dissipate after the medication was administered and we had the patient wait in the observation area until  9:45am (about an hour since the vaccine was administered). At the time, the patient stated she felt okay and asked to go home.
Agitation and insomnia for a few hours  Confusion when I woke up  Injection site tenderness  Weakness for 3 days
This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 18-APR-2018, the patient was inadvertently vaccinated with one expired dose of VARIVAX injection, (lot # M017290) (expiry date: 07-APR-2018) for prophylaxis (dose not reported) (expired vaccine used). No adverse effects reported. No product quality complaint (PQC) was involved.
Severe shortness of breath, chest pain and pressure. Pounding heartbeat. Occasional sharp pain
Pt had COVID-19 Moderna vaccine administered. approx 9 days later developed itching and bright red rash that was warm to touch at site of injection (right deltoid). No systemic symptoms. Pt was seen in office 11 days after administration (1/21/21). Pt was treated with antihistamines and an antibiotic (Bactrim).  To follow up if no improvement in 48 hours.
Pt was treated in the ER for Serum Sickness Reaction. She presented with swelling and pain of ankles and rash over body  11/7/08 Reviewed ER medical records of 6/20/2008. FINAL DX: Serum sickness secondary to menactra Records reveal patient experienced HA, generalized maculopapular rash, painful ankle swelling w/erythema & limping x 4 days, chest pain on palpation x 1 day w/cervical lymphadenopathy & sleep disturbed due to pain. Tx w/meds.  D/C to home w/PCP f/u.
Brief (< 4-5 seconds) loss of consciousness, decreased BP/pale skin/decreased heart rate
PATIENT WAS MONITORED FOR 30 MINUTES AND THERE ARE NO ADVERSE EVENTS TO REPORT.
Case number PHEH2014US019004, is an initial spontaneous report from a medical assistant received on 19 SEP 2014. This report refers to a 67-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with an expired dose of FLUVIRIN 2013/2014 (batch number: 1310301) intramuscularly on 18 SEP 2014. No adverse reaction was reported following the maladministration (expired vaccine used).
Vaccines given 04/25/06 (3rd set for 6mo old). Broke out in rash 4/27/06. Face first then trunk. Fine erythematous sandpaper rash. Pt appeared well. Was on Zithromax April 5-9 for URI.
devel varicella 7DEC96 @ home reaffirmed by mom 17FEB97;
Gave pt a ADACEL immunization on 12-3-10. On Wed. 12-8-10 pt. came in and complained of fevers, redness, swelling at injection site.
Patient received vaccine at 12 mos of age. Patient presented in office today with "chicken pox". Multiple lesions in various stages from papules, flattened macules, crusted lesions.
I received the J & J vaccine on 4/11/21 and on 12/30/21 when I had COVID-19 I got a very intense pain in my left arm where the vaccine was administered. It became tingly and like pins and needles were going down my arm, into my elbow, forearm, and up into my neck only on my left side. It was worse at night and felt like my entire arm was asleep and would not wake up. Very painful and uncomfortable. Also extreme fatigue in left arm, and a tingling cold sensation in my brachial plexus. When a dull ache moved into my left chest, I went to the ER on 1/23/22. No cause was found but the nerve pain continues. I am suspicious it could be Parsonage Turner Syndrome or another syndrome related to Guillain - Barre Syndrome.
Menactra, Varivax, and Havrix administered on 11/6/08. Pt. noted abrubt onset of blurred vision in left eye on 11/26/08. Seen by a neuro-ophthalmologist, diagnosed with optic nueritis on 12/5/08. Follow-up shows some recovery of vision, though still signifigant blurred vision.
Fall on 12/11/21, presented to ER and was found to be COVID-19 positive.  Initially on 15LPM (12/11/21) for hypoxia on admission and currently on 2LPM (12/15/21).    TX received: Remdesivir, dexamethasone, Oxygen
Right arm swelling and redness (x3 days). Patient tried ice. Arm red and hot - swollen 11 x 17 cm.
devel fine rash all over body the day p/vax;mom called LMD & told to give pt DPH;much improved in few hr;
Felt liquid going down the back of his arm and wrist; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 Immunization. The following information was reported: INJECTION SITE EXTRAVASATION (non-serious) with onset 22Apr2021, outcome "unknown", described as "Felt liquid going down the back of his arm and wrist".  Additional information: Pharmacist states that she had a patient who received the second dose of the Covid vaccine on 22Apr2021, in which the patient states he felt liquid going down the back of his arm and wrist. Caller believes the vaccine may have came through the hub, in which they were unsure of how much vaccine was lost.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Neck pain; Swollen arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck pain) and PERIPHERAL SWELLING (Swollen arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Gastric bypass. Concurrent medical conditions included Spinal stenosis.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced NECK PAIN (Neck pain) and PERIPHERAL SWELLING (Swollen arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form three times a day. On 23-Mar-2021, NECK PAIN (Neck pain) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication reported. treatment information includes steroids.   This case was linked to MOD-2021-230030 (Patient Link).
Pt recv vax on unspecified day;  post vax pt dx=optic neuritis in one eye
Information has been received from a nurse practitioner in physician's office concerning a female who was vaccinated with GARDASIL IM, no Lot number was provided. Nurse practitioner reported that a patient experienced a widely disseminated rash all over her body 4 weeks after receiving the vaccine. No further information was provided. At the time of the report the patient symptoms were resolved. The patient sought medical attention. Additional information has been requested.
Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked to case 2019SA037139 (same reporter). This case involves a 10 months old male patient who received vaccine FLUZONE lot number UI983AA, expiry date: 30-Jun-2019 via unknown route in unknown administration site on 04-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage and poor quality product administered. It was reported that temperature excursion on the following vaccines: FLUZONE QUADRIVALENT, IPOL, TDAP, ADACEL. Temperature 19-Nov-2018 32 F through 19-Nov-2018, and Dec-2018 33 F through 28-Jan-2019. 28-Jan-2019 to present 31F. FLUZONE QUAD was not viable at the time it was administered. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
I found a small lump just able left clavicle while rubbing neck. Went to doctor Monday morning 12-13-2021. Got antibiotics and went for recheck on 12-23-2021. Lump still present so Doctor ordered CT scan which I had in January 2022 and results said no masses. So presumable this is either a small cyst or just enlarled lymph node from vaccine. Doctor said don't worry unless it doubles in size.
Patient received a fourth dose of Pfizer Covid vaccine. First was 1-22-21, second was 2-12-21, third 10-15-21 fourth 11-22-21.   Patient vomited through the night per family members.  Symptoms resolved the following morning, requiring no additional medical intervention. Patient was advised to seek treatment at Indian Health Service ER for evaluation of status d/t vomiting, but declined.