chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I still have a knot on my left arm; Low grade fever; chills; felt like I had the flu; chest pains; migraine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25May2021 10:00 (Lot number: Unknown) at the age of 57 years as dose 1, single and administered in arm left, administration date 19Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing), notes: Other Medical History: Migraines; "Obesity" (unspecified if ongoing), notes: Other Medical History: Obesity; "Hypertension" (unspecified if ongoing), notes: Other Medical History: Hypertension; "Thyroid Problems" (unspecified if ongoing), notes: Other Medical History: Thyroid Problems; "Obstructive Sleep Apnea" (unspecified if ongoing), notes: Other Medical History: Obstructive Sleep Apnea; "IBS" (unspecified if ongoing), notes: Other Medical History: IBS; "Penicillin" (unspecified if ongoing), notes: Known allergy: Penicillin. Concomitant medication(s) included: METFORMIN; DOXYCYCLINE; IMITREX. Past drug history included: Tramadol, reaction(s): "Drug allergy", notes: Known allergy: Tramadol; Morphine, reaction(s): "Drug allergy", notes: Known allergy: Morphine; Cipro, reaction(s): "Drug allergy", notes: Known allergy: Cipro; Robaxin, reaction(s): "Drug allergy", notes: Known allergy: Robaxin; Norco, reaction(s): "Drug allergy", notes: Known allergy: Norco. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 25May2021 10:00, outcome "not recovered", described as "I still have a knot on my left arm"; PYREXIA (non-serious) with onset 25May2021 10:00, outcome "not recovered", described as "Low grade fever"; CHILLS (non-serious) with onset 25May2021 10:00, outcome "not recovered", described as "chills"; INFLUENZA LIKE ILLNESS (non-serious) with onset 25May2021 10:00, outcome "not recovered", described as "felt like I had the flu"; CHEST PAIN (non-serious) with onset 25May2021 10:00, outcome "not recovered", described as "chest pains"; MIGRAINE (non-serious) with onset 25May2021 10:00, outcome "not recovered", described as "migraine". Therapeutic measures were not taken as a result of peripheral swelling, pyrexia, chills, influenza like illness, chest pain, migraine.  Additional information: No other vaccine in four weeks, Other medications in two weeks: Metformin, Hydroxide, Doxycycline, Imitrex. Adverse event: Low grade fever, chills, felt like she had the flu, worse part was the chest pains and migraine and still after having the second shot she had a knot on her left arm. She had the first shot on 25May2021 and the second shot on 19Jun2021. No covid prior vaccination and no covid tested post vaccination.  This follow-up is 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.
I received my shot at approximately 11:45am.  Later that afternoon I started getting a soar throat and was starting to feel tired.  I went to bed around 9:00pm and woke up around 11:30 with a very soar throat with sinus drainage (I drank water through the night to wet  mouth and throat) Got out of bed around 7:00am.  I had lots of sinus drainage, very soar throat, head ache,  a little pressure in my ears.   I started taking Tylenol.  Slept off and on that Sunday and by the after noon I started coughing .  I've had hot and cold chills during this time but when I took my temp I had no fever. Monday Morning I called my doctor, he called in a script for prednisone.
Mother stated pt received immunizations on 2/06/07 and the next day, pts arms started swelling, had redness and warm to touch.  This occurred in both arms.  Mother took pt to urgent care on Friday and was told by doctor at urgent care that pt had allergic reaction to both alternate warm and cold packs.
Information has been received on 23-MAR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 17-SEP-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2017, the patient was treated by a physician for the onset of a severe rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
PATIENT FAINTED AND COMPLAINED OF SLIGHT HEADACHE AFTER SHE CAME TO. PATIENT WAS ONLY PASSED OUT FOR APPROXIMATELY 30 SECONDS OR LESS.
Patient felt lightheaded, nauseated, hot and sweaty and appeared pale.  She states she has a history of fainting with blood draws and vaccines.  VS improved over 25 mins, patient left via own car.
arm was sore, although not particularly really really sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "she had arm soreness"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "she had arm soreness"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "she had arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore, although not particularly really really sore".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Paitents mother c/o rednes, swelling & heat on left thigh where the vaccine were given on 08/15/14. Child also c/o itching and pain.  Complaints started at bedtime.
Received 2 doses of Johnson and Johnson Vaccine  on  4/9/21.   Patient held in observation for about 1 hour, did not display any reaction at time of departure from clinic.
WOUND ON THE LEG; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry UNKNOWN) dose was not reported, one total administered on 28-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date after receiving vaccine, the patient experienced wound on the leg, and was hospitalized (date unspecified) for 2-3 days. It was not diagnosed as a Cellulitis 4-5 weeks later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wound on the leg was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210708265- COVID-19 VACCINE AD26.COV2.S-WOUND ON THE LEG. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Moderna vaccine administered beyond published expiration date. Per Moderna, no revaccination required, vaccine was considered viable and contained enough activity to protect against Covid-19.
Redness and swelling around the site of injection with pain. Given Childrens Tylenol and Benadryl with little relief.
Patient experienced Myocarditis-like symptoms beginning 05/20/2021, 3 days after Dose 2 vaccination.  See Continuation Page for Item 18 information details. Additional information for Item 18:   Day 1 (5/18) Patient had typical dose 2 reactions of low fever (100-101 degF), headache, soreness at injection site, mild dizziness.  Day 2 (5/19) he felt much better.  On Day 3 (20 May 2021 9:00AM) Patient experienced notable chest pain (level 5-6 on scale of 10) lasting about 30 minutes.  Pain then decreased to level 1-2 for the next several hours.  Patient said this felt exactly like the pain he experienced when he had Myocarditis in Nov 2017, only less severe.  (The 2017 event required 4 days of hospitalization and temporarily left patient with heart failure in one ventricle (Ejection Fraction <40%) although EJ returned to normal after a few months).  patient was seeing his Primary Care Physician on another matter later this same morning (5/20) and mentioned the pain.  PCP listened to his heart and did not note any irregularities. Patient had no additional pain episodes for the next 3 days so we did not worry.  But daily chest pain episodes resumed 5/24, 1 to 3 times a day,  mostly level 1-2, sometimes level 3, typically lasting 30 min to 2 hrs, through 6/3.  From 6/4 and on episodes have been less frequent.   On 5/25 patient contacted his 2017 Cardiologist who ordered a Troponin-I lab.  Labs were done 5/26 and were normal so we were advised to monitor but go to the ER if severe chest pain occurred.  Patient has an office visit scheduled with his Cardiologist July 2.  As of 6/12 (date of report) episodes tend to occur after moderate physical activity but clear after rest.  This pattern is similar to what patient experienced during the first 3 months following his 2017 illness.  Accordingly patient has reduced his physical activity, using chest pain episodes as an indicator of too much activity.  The 2017 illness appeared to be completely resolved after April 2018 with normal ECG, Echo, EJ and no further reports of chest pain even with normal activity levels.  May 20, 2021 was the first time this type of chest pain reoccurred.
Friday: Received vaccine at 9am. Began feeling like cheeks were warm/flushed by early afternoon. By 5-6pm was lethargic and  had chills, but no fever. Chills continued through the night and were better but not gone by morning. Saturday: Awakened with headache. Headache and fatigue improved throughout the day. Sunday: headache was mostly gone, but still feeling low-energy and light headed after a period of activity. Monday: Felt much better in the morning, but tried standing at my desk after lunch and felt moments of light-headedness, and felt low-energy. Tried to weight train at 6pm and broke out in sweat with minimal exertion. Tuesday - I still don't feel quite right - energy level is still less than normal, with occasional moments of light headedness.
Suspected blood clot.  Day one: hard welt developed under the ball of the left foot behind the small toe.  Welt was approx. kidney bean sized and noticeable on placing weight on the foot while walking.  Day two: bruising (purple color) developed on the outside and top of the left foot behind the small toe.  Day three: welt starts to soften and subside.  Bruising lasted about a week and gradually faded. There was no other apparent cause of the injury--no unusual shoes or socks, no acute trauma, no insect bite, and no unusual physical activity.
Fever - Temperature of 100.1F; Muscle Pain; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever - Temperature of 100.1F), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Fever - Temperature of 100.1F), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever - Temperature of 100.1F), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pyrexia: 100.1 Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
84-year-old with history of Parkinson's disease who is by her self and today fell.  Reportedly hit her head.  CT scan the emergency room was unremarkable.  In the emergency room patient was quite weak and found to have a fever.  Urinalysis was significant for urinary tract infection.  Urine was markedly abnormal by visual appearance.  Patient was found to be positive for COVID-19.
Swelling of my arm and hand; Swelling of my arm and hand; This is a spontaneous report from a contactable nurse, the patient.  A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EL0140), via an unspecified route of administration, on 30Dec2020 at 04:30 PM (at the age of 58-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the right arm. Medical history included Allergy induced asthma. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included montelukast sodium (SINGULAIR) (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), estradiol (ESTROGEN) (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Sulfa (MANUFACTURER UNKNOWN) and Keflex (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 31Dec2020, the patient reported "Swelling of my arm and hand." The patient did not receive any treatment for the events. The clinical outcome of the events swelling of my arm and hand was recovering/resolving.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Left arm pain radiating to should and scapula. Unable to lift arm above head without having pain. Tingling in finger tips that come and go. My body doesn't feel the same after my second dose of the vaccine.
16 year old was accidentally given the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was accidentally given the Moderna vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was accidentally given the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was accidentally given the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided. Treatment medication not provided.   Reporter did not allow further contact
Patient reports a swollen red shoulder (not just injection site, but part of the upper arm as well as collarbone area) that is tender to the touch.
Fifteen minutes after injection patient started to complain of lightheadedness and tingling in the throat area.  Vital signs taken:  1150 - BP 87/75, P 90, O2 sat 98% respiration regular.  1155 - repositioned BP cuff - BP 126/94, P98, O2 98% respiration regular.  Continued tingling in throat. Associate given water to drink. 1205 - BP 125/94, P 79, O2 97%, respirations 20. Continues to feel lightheaded and now states stomach feels weird 1215 - 50mg Benadryl given by mouth 1222 - Associate still feeling lightheaded. Offered to be evaluated in emergency department, associate refused. Vital signs BP 125/89, O2 97%, P 82, R 20. Associate taken by w/c to be taken home by brother. Alert and oriented to self, place and time. Provided instructions to return to the emergency department if worsen or change. Associate verbalized understanding.
Around 7pm I started having chills, weakness and a temp of 101. I took a Tylenol and by the morning I felt better but still some weakness.
received an expired dose of PENTACEL on 06Nov2023 with no adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA352579.  This case involves a 15-month-old male patient who had received an expired dose of diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(VERO)/ HIB(PRP/T) vaccine [Pentacel (Vero)] on 06nov2023 with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Nov-2023, the patient received 0.5 mL expired dose of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine, suspension for injection (Frequency: once; Strength: standard) (lot: UJ804AA; expiry date: 07-Oct-2023) via intramuscular route in the right thigh for Immunization with no adverse event (expired product administered) (same day latency). Treatment: unknown  No additional information available at the time of the report.  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 the 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.
Swollen ankles; High Blood Pressure; Peeling Tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE EXFOLIATION (Peeling Tongue), JOINT SWELLING (Swollen ankles) and BLOOD PRESSURE INCREASED (High Blood Pressure) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced TONGUE EXFOLIATION (Peeling Tongue). On 23-Apr-2021, the patient experienced JOINT SWELLING (Swollen ankles) and BLOOD PRESSURE INCREASED (High Blood Pressure). At the time of the report, TONGUE EXFOLIATION (Peeling Tongue), JOINT SWELLING (Swollen ankles) and BLOOD PRESSURE INCREASED (High Blood Pressure) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medication information were Diuretic, Cetirizine provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: pt is fine. declined further follow up
This is a spontaneous report from a contactable physician. This physician reports similar events of 2 different children. This is the second of 2 reports. This physician reports about a 3-year-old girl received PREVNAR 13, dose and indication unknown, on 05Nov2010; the dose at the onset of events was unknown. Relevant medical history, concomitant medications, and medication history are unknown. It is unknown if the patient had received any other vaccines at the same time or within the previous 4 weeks. After receiving PREVNAR 13, the patient experienced pain and a rash above the injection site. There is no relevant laboratory data, diagnosis, or action taken. As of 10Nov2010, it is unknown if the patient continued on PREVNAR 13. The outcome of the events was unknown.
Patient stated about 5 minutes after vaccination during monitoring period that her arm felt warm, but was localized to left side with no other adverse effects. I monitored patient and checked back with her after 2 more minutes and she stated the warmth had gone, but she felt itchy on both sides of her arms. I confirmed that the reaction was localized to arms and no other areas or symptoms. She reported no  swelling, trouble breathing, chest heaviness, or spreading of itchy/heat. Patient was with young daughter and did not have anyone I could contact to assist for pickup so she declined Benadryl and I monitored her for 1 hour from vaccine while checking on her status approximately every 5 minutes. I confirmed that the symptoms did not progress over time and told her to take cetirizine, loratadine, or fexofenadine which she confirmed she would. I called her at 2:33PM to check on how she was doing and she stated she did take Benadryl once she was home and had nowhere else to go - she stated she was doing "ok" and the symptoms had not progressed or worsened and no new symptoms to report.
3/23/21-Afternoon/evening after vaccine, patient started with left arm local redness   3/24/21-Left arm local redness that moved down arm, left arm pain.  Left arm(entire arm) "achy pain" described  3/25/21-Fever of 101 and chills, arm pain, swelling and redness spreading to breast area towards back.  Lymph nodes around breast and axillary swollen and sore.   3/26/21-Fever and chills subsided.  All other symptoms persist currently.
High fever, chills, migraine, nausea, large red swollen area on arm where shot was administered, itching arm; no appetite as of today, Aug 18th
swelling in the injection site; 2 large areas with rash and 1 smaller area with rash; area with a bruise; herpetic looking blisters; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 47XJ3, expiry date 29th April 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 24th August 2020, refer case US2020219722).   On 3rd November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd November 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, rash, contusion and rash herpetiform. On an unknown date, the outcome of the injection site swelling, rash, contusion and rash herpetiform were unknown.   It was unknown if the reporter considered the injection site swelling, rash, contusion and rash herpetiform to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix in the right deltoid. The patient experienced swelling in the injection site, 2 large areas with rash and 1 smaller area with rash, area with a bruise and herpetic looking blisters. The pharmacist said that he believed the symptoms started on the afternoon of 3rd November 2020.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020219722:same patient (1st dose)