chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered below deltoid; A spontaneous report was received from a Consumer concerning herself, a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and who was administered vaccine below deltoid.  No patient's medical history was reported. No relevant concomitant medications were provided.  On 08 Mar 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in left arm for prophylaxis of COVID-19 infection.  On 08 Mar 2021, the patient was administered vaccine below deltoid.No Laboratory investigations were provided. No Treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The event administered vaccine belowdeltoid was considered resolved on 08 Mar 2021.; Reporter's Comments: This report refers to a case of Vaccine administered at inappropriate site for mRNA-1273, lot # unknown with no associated AEs.
My left thumb started twitching immediately and has continued twitching on and off (but quite continuously) since the injection.
Patient had a raised red area where the Varicella was administered. This area was sore. Patient was advised this reaction will pass if not to come back to the clinic.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Patient was administered the vaccine in his left deltoid on 8.4.08. On 8.6.08 he called to inform me that he felt "achey" and there was small spot on that are that "looks like a pimple but with no head on it". Patient he felt like he had a fever on 8.5.08 but is feeling better today (8.6.08).
Varicella - Information has been received from a registered nurse concerning a 5 year old caucasian male patient who on 24 Jan 1998 was vaccinated SC in the right arm with one dose of varicella virus vaccine live (lot #62449/1422E).  On 22 Mar 2000, two weeks after exposure to a contagious child at Mursory school.  the patient experienced breakthrough chickenpox.  It was noted that there were only 40 -50 pox with no other symptoms.  Follow up information from a reqistered nurse reported that on an unspecified date, the patient recovered.
He got Creutzfeldt-Jakob disease (CJD) and died a horrific death.
pt recv vax & fell to the floor (behind mom) got pale & unconscious, eyes rolled back & had 1 jerky movement;bladder incontinence;c/o tummy hurting;no v/d;no fever BP OK;dx sz disorder;
Raised area and sore injection site followed by feeling very sick with lower back pain of pain scale of 7 - Dr. did blood panel confirming an allergic reaction pt still in pain. Pain scale of 3 now. Swollen lymph nodes.
Sitting propped up on couch, father napping next to him. After a few minutes found slumped forward, lifeless, with blood around nose and mouth. Pt asystolic and apneic by paramedics. Transported to PICU. Pt with minimal cortical activity.
I just wasn't prepared for how much my arm was going to hurt from the vaccine.  I just wished my arm would fall off so that I didn't have to feel it...lol!!!
HEAD BURNING; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. 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. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the subject experienced head burning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of head burning was not reported. This report was non-serious. This case, from the same reporter is linked to 20210419762.
Sore arm, fever, varying between chills and hot flashes, extreme fatigue, and very severe headache. These symptoms lasted approximately 24 hours after onset. Onset was approximately 10 hours after 2nd vaccine dose. No symptoms with first vaccine dose other than sore arm at injection site.
Staff member reported reaction on left upper arm. Red raised area noted on left upper arm measuring 4cm x 5cm. Area warm and fevered in appearance. Staff member expressed she was unable to sleep on left side due to arm pain. Reported to RN. Advised staff member to go to Health Center for follow up per RN.
Patient don't speak too much; Received the second dose twice; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Received the second dose twice) and SPEECH DISORDER (Patient don't speak too much) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received the second dose twice). On an unknown date, the patient experienced SPEECH DISORDER (Patient don't speak too much). On 30-Mar-2021, EXTRA DOSE ADMINISTERED (Received the second dose twice) had resolved. At the time of the report, SPEECH DISORDER (Patient don't speak too much) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter said the patient received the second dose twice, once on the morning and again on the afternoon on 30-Mar-2021. The reporter mentioned that the they had a 24 hour caregiving service and the first caregiver brought the patient on the morning and the second caregiver on the afternoon. The reporter also mentioned the patient don't speak too much.  Reportedly, the reporter was outside of the pharmacy.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Vaccine was placed at 1101. At 1117 when parents was getting up to leave after 15 minute wait period, child started expressing that her arm hurt and started crying. Gave mother an ice pack to apply to site. After about 5 minutes, the mother took the child outside. Child was playing, running around outside with no crying. After a couple minutes, mother brought child back inside due to crying and stating arm hurt again. Child was reassess for site placement and localized reactions. No abnormal findings found. Mother was educated on giving an anti inflammatory to help with pain and to contact the child's pediatrician if in the next hour or so child is still complaining of soreness.
Patient complaint of swelling in left arm (COVID vaccine) some on date shot was given 10/30/2023. Then upon wakening on 10/31/23, patient noticed swelling in neck, face, and lips. She stated she thought it was slightly improving. Patient was instructed to take benadryl and contact her PCP. The pharmacy also reached out to the PCP (per nurse) to inform them of the reaction. Patient received Spikevax 23-24 on 10/30/23 and has received the Moderna vaccine in the past without issue
Red circle (2" in diameter) around area vaccine was given, warm to touch, hard to touch.
On day 3 following, 2nd dose of Pfizer vaccine, he had right sided calf pain. Initially thought to be recurence of strain injury, although no history of trauma or obvious trigger. Pain conitnued to worsen and had different characteristics than original strain symptoms. Continued to worsen to point wher eunable to weight bear and swollen, hot and red. Saw orthopedist who refered to vascular surgeon, and on day 13 was officially diagnosed with large DVT extending form  tibeal & peroneal, popliteal up to the femoral veins. Has no known clotting defects. Currently under evaluation with hematologist who recommended anticoagulants for remainder of his life.
Shingles on her left eye to the tip of her nose. 3-4 times a year.
Swelling, redness to L arm extending down to elbow, whole upper arm swelling, +pain.
She has not had a bowel movement; 20 hours of diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via unspecified route of administration on 01Mar2021 at 14:00 (at the age of 79 years) at a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medication were reported as none. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient called to report that her second dose is due on 25Mar2021 (24 days after the first dose) and wanted to know if this is ok to do. She stated that she had 20 hours of diarrhea yesterday (10Mar2021) and today (11Mar2021), she has not had a bowel movement. The events did not result to emergency room/ physician clinic visit. The outcome of the event 20 hours of diarrhea was recovered on 11Mar2021 while the other event was unknown.
sz are reported in pt who recvd vax; onset of sz devel 15 days p/was vaxed; hx of syncope;
pt recvd vax;dizziness,blurred vision,shortness of breath,difficulty w/ speech;irregular heart rate(50's & 130's);tachycardia;numbness in both hands;fatigue;muscle aches/pains;BP elev;exacerbation of asthma;hypersensitivity,itching;
Patient reported itching to left forearm thirty minutes after COVID 19 vaccination. No redness, hives at site. Client reports anxiety. History of psychosomatic symptoms. No treatment given; provided quiet environment.
This spontaneous report as received from a nurse practitioner refers to a 25 year old female patient. Pertinent medical history, drug reactions/allergies and concomitant medication were not reported. Reporter stated that on 01-MAY-2015, the patient may had been vaccinated with GARDASIL 9 (dose, frequency and indication were not reported), who was nursing. Reporter also stated that GARDASIL 9 had not been administered to the patient yet at the time of reporting. Patient sought medical attention due to the office visit. The outcome of event was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for COVID-19 immunization.  Medical history was none. There were no concomitant medications. The patient had soreness in the shoulder for only one day and he had bruising. No treatment received. The outcome was unknown.
6 hours post vaccine chill-freezing, 18 hours post vaccine dizzy, HA, passed out x 10", a 2nd time. Squad checked out sweating, 9x6 cm redness , tender.
Adverse reaction. HA, fever, fatigue, arthralgia, stomach upset without vomiting or diarrhea.  04/17/2007 MR received for OV for c/o fever, H/A, fatigue, arthralgia, and GI upset.  PE: WNL except for ankle pain 2' to fx. and ill-appearing. Temp. 101.2'F Assessment:  Drug reaction to Adacel vaccine.  Right ankle sprain (later dx as fx by X-ray). No other tx. sought.
pt recv vax & devel an inj site rxn characterized by redness, swelling & warmth;this is 1 of 7 employees of this facility to have an adverse exp p/vax lot# 4978167;
Dizziness, weakness, nausea, cough, HA, fever, sore throat, CBC Nl, Treated with OTC cold medications, Tessalon and Vicodin.  Symptoms persist Physician eval 3/2/10, DX allergic rhinitis, E-Tube dysfunction. Tx Loratadine, Sudafed, Nasonex. Physician eval 4/6/2010 c/o same symptoms and decreased libido, difficulty sleeping, decreased appetite, difficulty focusing, hyper sensitive to sound, reports feeling well while on spring break.  Exam normal. Labs normal 4/8/2010 trial Prilosec and Ambien.  4/20/2010 Symptoms persist although sleeping better. Dizziness, headaches, personality changes, nausea. MRI of brain normal.  5/11/2010 Bronchitis, treated with Mucinex DM and Augmentin.  Patient is international student and will follow up with physician.
Narrative:  COVID infection following COVID vaccine series 02/26 COVD vaccine dose #1 03/07 seen in ED c/o pain on swallowing x 1 week, pt declined inpatient admission, rx'd  sucralfate, maalox, fluconazole 03/10 pt reports swallowing pain resolved 03/18 COVID vaccine dose #2 07/05 seen in ED c/o difficulty swallowing, unable to eat or drink x 2 days, diarrhea; tx'd with maalox, famotidine, acetaminophen; rx'd maalox and fluconazole 11/29 seen in ED c/o rectal bleeding x 5 days, nausea, fever, weak, SOB on exertion; admitted to inpatient 12/02 pt left hospital AMA 12/06 COVID vaccine dose #3 12/14 pt c/o SOB, weakness, nausea/vomiting, productive cough and loose stools, 1 week s/p hospitalization for anemia/GI blled; COVID positive, no pneumonia 12/17 discharged from hospital
My arm has hurt starting two days after the 1st vaccine shot and continues to hurt today, May 27, 2021.  I cannot sleep on my right side because of the pain. At times it hurts too much to lift the arm.
malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included throat cancer (The patient had previously battled throat cancer) and covid-19 (patient was diagnosed with Covid within the last year). Previously administered products included monoclonal antibody treatment (The patient received monoclonal antibody treatment). Concurrent medical conditions included skin cancer (The patient was currently battling skin cancer) and immunocompromised (The patient was very immunocompromised).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Linked case(s) involving the same patient:US2022136444   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comment: The case was reported by patient's sister-in-law. The reporter reported that, patient experienced malaise after receiving a Shingrix.  The reporter did not consent to follow-up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022136444; Sender's Comments:  US-GSK-US2022136444:Same patient, 2nd dose
CHILLS; FEVER; This spontaneous report received from a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021 10:00, the subject experienced chills. On 10-MAR 2021 10:00, the subject experienced fever 101.8f. Laboratory data included: Body temperature increased (NR: not provided) 101.F F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and fever 101.8f was not reported. This report was non-serious.
Patient came returned to our facility for her 2nd dose of Moderna 7 days earlier than her scheduled appointment with us. Vaccine card was present with the 1st dose stamped for Jan 6, 2022. The vaccine was administered then the error was found after.  In order to inform the patient of the error and next steps (restarting), the patient received 2 phone calls from us including a voicemail with information to contact our facilities at her earliest convenience. Patient has not yet been reached, our facility will continue with our outreach.
Patient received the Shingrix vaccine outside of our office.  88 yo male here with pain behind his left ear that has been present for the past 8-10 days. Described as a throbbing pain with radiation down the neck. Pain with turning the pain to the right. When he turns his head quickly he hears a ringing "ting" sound in left ear. No headache or dizziness. No trouble with swallowing. No globus. No fever or chills.  No new medications and no recent travel. No tobacco abuse.  Had some pains behind his left ear. Went away with tylenol. Slowly improving. Now feels an occasional pulsation, from behind the ear to an area over the clavicle. This has gone on for about 2 weeks.   Had shingles shot 16th sept., just before sx's began. Likely an attenuated course due to previous administration of the old shingles vaccine.  He did receive his first dose of the shingrex a week before the current sx's began, but I am not aware of any reports of shingrex causing shingles.  His sx's already fading, and the 3 lesions are healing with no new ones appearing, so no treatment indicated at this time.
Loss of sense of taste.  No treatment.  Still have not gotten back my sense of taste.
pt recv vax 1JUN96 & OCT96 pt had been exposed to younger sister who had devel chicken pox following vax;2 wk later 4NOV96 pt devel a fever of 104 & 35 pox on back & legs;MD could provide no details regarding exp;
Tender lymphadenopathy in left axilla. Began 12/24 (one week after vaccine administration on 12/17).
3/15/21:  Rash and Hives on Neck in a few spots 3/20/21:  Rash and Hives - very itchy and very hot covering full front of neck and across chest; some hives on stomach; a few hives that were extremely itchy outside of nose and around mouth.
4 days after receiving Varivax and MMR broke out in a papular-vesicular rash.  One on ear, two at nape of neck and one on cheek at time of exam. +pruritis.  No fever.  Runny nose day before -resolved today.  No known Varicella exposures.
Upper left arm, in area of MCV4 vaccine, the arm is red, swollen, hot. The redness extends approx. 12 cm x 10 cm. The symptoms started several hours after the immunization was given. Patient has taken ibuprofen and BENADRYL. I have advised to continue as needed. And ice several times daily. Seek medical attention immediately if he has any difficulty breathing.
administered Pentacel  that was not reconstituted, no AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that was not reconstituted.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)); HEPATITIS B VACCINE (HEPATITIS-B); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 07-Nov-2019, the patient received a dose 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U63996AA, expiry date- 14-Oct-2020 via intramuscular route in the right thigh that was not reconstituted.  It was actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Was in sitting position; fell onto mother 3 minutes after shots. Jerking movements of both upper limbs, rigidity of body; lasted 30 seconds; then asked what happened
1st shot-Head ache and swollen neck lymph nodes started 12 hrs after injection and ended 3 days later. Tylenol/Advil for treatment  2nd shot- fever/chills/body aches started 16 hrs after injection and lasted 36 hrs after. Tylenol/Advil for treatment.  Rash on left shoulder, neck and back/chest mid trunk and above. No itch or pain. No treatment. Currently less noticeable, but still present 48 hrs later
This spontaneous report as received from a pharmacist refers to a 67 year old male patient with high blood pressure, high cholesterol, asthma, diabetes and anxiety. On 17-SEP-2013, the day after vaccination with ZOSTAVAX the patient experienced tingling in his injection arm, radiating distally toward his hand, for an unspecified period of time. The patient continued to have tingling from his shoulder to his fingers in the arm he received ZOSTAVAX on 07-OCT-2013. The sensation was waking him up when sleeping. His sense of touch was slightly decreased, but arm strength remained normal. The patient was not experiencing rash. The patient contacted the pharmacy on 22-SEP-2013 to inquire about the symptom, and stated he has notified his physician of this experience. The patient did not receive any treatment for the events. No lab diagnostic studies were performed. At the time of the report the patient has not recovered. Additional information has been requested.
Hospitalized (9.18.21);  COVID-19 positive (9.18.21);  fully vaccinated  Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 9/18/2021 Discharge Date: 9/21/2021  DETAILS OF HOSPITAL STAY: Patient is an 80-year-old woman with history of chronic stage IV coccygeal ulcer with chronic osteomyelitis, paroxysmal atrial fibrillation on Xarelto, hypertension, obstructive sleep apnea, hyperlipidemia, hypertension, depression, hypothyroidism and chronic pain who presented with 2 days of fever and generalized weakness along with cough.  She follows with Wound clinic who sees her every 6 weeks for chronic sacrococcygeal osteomyelitis and ulcer.  Due to concerns for fevers patient presented herself to the emergency department.                In the ER patient was hemodynamically stable though had a fever of 38.0 degree centigrade. CT thorax abdomen and pelvis with contrast was done which was consistent with inflammation related to chronic osteomyelitis however concerns for possible epidural abscess. MRI of sacrum showed sacral decubitus ulcer 4 cm in depth located just below the tip of the sacrum. No abscess. Acute on chronic osteomyelitis. Extensive changes of chronic osteomyelitis involving the bilateral iliac bones and sacrum. There is chronic near complete destruction of the coccyx with a few tiny bony fragments noted on comparison CT.  Wound was consulted who recommended to continue Dakin's dressing changes follow-up with Wound Clinic as scheduled before.                Due to fever, cough she was tested for COVID-19 and she was positive.  She did receive Pfizer COVID vaccine in March.  She had no indication for remdesivir or Decadron.  She declined monoclonal antibody infusion.  She did not require any oxygen. For chronic pain she will continue methadone 5 mg 2 times a day and Lyrica 150 mg 2 times a day. For all other:  She will continue her previous medication.   She was discharged home with her husband who is primary caregiver.