chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LITTLE INFLAMMATION ON BOTH ANKLES; ANKLE LITTLE SWOLLEN; RED DOTS ON BOTH LOWER LEGS BELOW THE KNEE; This spontaneous report received from a consumer concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: knee replacement surgery 3 months ago, and concurrent conditions included: high blood pressure, high cholesterol, penicillin allergy, non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-AUG-2021, the patient experienced little inflammation on both ankles. On 27-AUG-2021, the patient experienced ankle little swollen. On 27-AUG-2021, the patient experienced red dots on both lower legs below the knee. On 30-AUG-2021, Laboratory data included: Blood test (NR: not provided) Awaiting results, CBC (NR: not provided) Awaiting results, and Platelet count (NR: not provided) Awaiting results. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red dots on both lower legs below the knee, little inflammation on both ankles, and ankle little swollen. This report was non-serious.
Pt c/o fussy, not nursing well, fever 102.4F rectal, decrease sleeping. Was seen in the office on 5/23/2006 at 4:20pm.
Left breast is hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date 20Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST PAIN (non-serious), outcome "unknown", described as "Left breast is hurting ".  Additional information: The patient wanted to know if lymph nodes in the breast is one of the side effects of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right coronary artery aneurysm and  thrombosis, ST elevation myocardial infarction
TOOK ALL FOUR DOSES OF VIVOTIF BUT DID NOT REFRIGERATE IT; A spontaneous case report was received from a caregiver on 20-May-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201905-000394 (PVX2019-1250; younger daughter) and PVX201905-000395 (PVX2019-1251, elder daughter) were created and cross-linked in the database.  This case describes a 16-year-old adolescent female consumer who "took all four doses of Vivotif but did not refrigerate it". The consumer was receiving oral Vivotif (one capsules every other day; lot no: 3003253) for typhoid prophylaxis.  Case report: The consumer took all the four doses of Vivotif but forgot to refrigerate it. The doses were taken on 12-May-2019, 14-May-2019, 16-May-2019, and 18-May-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took all four doses of Vivotif but did not refrigerate it" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took all four doses of Vivotif but did not refrigerate it" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000394:
This spontaneous report as received from a nurse refers to a 2 year old male patient. On 18-AUG-2014 the patient received a dose of GARDASIL (lot# not reported), dose 0.5 ml, intramuscularly. Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Hives, swelling, redness, and tenderness around site. Tx ice, Benadryl. 11/09/2001 called PCP office for further information- chart does not indicate hives- only 10 cm patch of redness, swelling , and tenderness. Left humeral area.
Pt reported not feeling well and can not breath well and looks pale Pt's caregiver reported that pt has history of MS and has similar reaction with blood-draw and pt does not have history of allergy to any medications. Pt's O2 Sat was 86% room air and pt was placed on O2 4L via nasal cannula and O2 sat: 100% room air. BP; 60/32, HR: 44, R: 18. 911 was called and patient transported to  Caregiver took patient's belonging. 911 called, patient taken to ED. Cancelled 2nd dose, scheduled Johnson & Johnson appointment.
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at the injection site for a couple of days) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Pain at the injection site for a couple of days). At the time of the report, INJECTION SITE PAIN (Pain at the injection site for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-044628 (Patient Link).
Patient c/o tongue feeling like it was swelling and throat started to close. She was also developing a rash on her chest. She was given 0.3mL Epi and 25mg Benadryl 5 minutes later. She felt better and did not want to go to hospital. She was observed for 30 minutes and reported at that time that her tongue was starting to feel "not right" again, and she agreed to go to hospital for further evaluation
Approximately 1 week after receiving the Janssen vaccine, pt developed fever, headache, lethargy, and confusion. He was admitted to hospital from April 1-5 with initial concern for bacterial meningitis however his workup was negative.
Agitation, Headache, Myalgia, Fever & Tachycardia Narrative:  approx. 21 hours after receiving vaccination patient started to feel flushed, skin of neck and face red, fever of 101.4, tachycardia, regular rate of 120-140 over two hours, states she feels like there is a lump in her throat. States she does not feel good and she does feel anxious which is abnormal for her. The headache started earlier in the day. She has taken 2 Tylenol.
administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that she inadvertently administered an expired dose of Bexsero to a patient, which led to expired vaccine used. At the time of reporting, the patient had not been re-dosed. The reporter consented to follow up. The healthcare professional gave permission for follow-up.
Information has been received from a pharmacist concerning a 70 year old female with no pertinent medical history and no history of drug reactions or allergies who on 02-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck). On 03-JUN-2008 the patient reported itching, a little round pink area and a "little lump" at the injection site. On 04-JUN-2008 the
the night after vaccine, patient had severe ocular migraine not relieved by his migraine meds, went to the local ED where he was dx with a R frontal SAH, transferred to medical center.  No intervention done, SAH resolved spontaneously.  Evolving Lancunar infarct seen on medical center serial imaging (CT/CTA brain).    At the time of incident, patient was not taking meds for HTN .
PATIENT FELT VERY TIRED ON THE SAME DAY SHE GOT THE VACCINE AND ON THE SECOND DAY SHE DEVELOPED A SPOTTED RED RASH AROUND THE INJECTION SITE, GETTING BETTER.
Red & warm sharp edge involving mainly his right arm with a painful elbow (Right). Treatment AUGMENTIN, BENADRYL.
A pregnancy test was given prior to administration of the Rubella vaccination. After 3 minutes, the test was negative and the vaccine was administered. Later when the MA was ready to dump the urine, she noted a faint positive. Test rerun x2 with both having faint positives. Pt was sent for Ncg testing-result 48. Was counseled by WHNP.
immune compromised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune compromised".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Hepatitis B vaccine in left deltoid muscle and then Hep A vaccine in right deltoid muscle.  He appeared to be fine and walked to the waiting room to sit after the vaccines.  A few minutes after he sat, Administrative employee, noticed he was not looking well.  She asked him if he would like a juice drink and he said yes.  She got him one and took it to him, but he would not respond and was slumping in the chair.  She got behind him and held him up and called for help.  RN came to help, as did another RN.  He was assisted to the floor where he had some mild seizure activity.  He was responsive for a few seconds, then became unresponsive again. BP was 78/56.  Oxygen was placed at 10 l/min. via non-rebreather. Pulse was weak and thready, color gray, resp.24 but shallow.  As he appeared to not be coming around, an ambulance was called at 11:25. BP 82/64; at 11:27 BP 86/60. Oxygen upped to 15 l/min. by RN.  Ambulance personnel and Fire Dept. personnel on scene at 11:28. An IV was placed and an EKG ran. The client became responsive with the EMS team.  He was taken by ambulance to the hospital.
We left the clinic and within 1-2 hours had 103-104 temp and is still having extremely high fever and chills today.
A painful bleeding rash all over my body with severe pruritis. Also migraine and loss of consciousness for up to 24 hours. No history of this previously. Also severe exacerbation of anxiety and mood disturbance, previously stable.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Information regarding the patient's pertinent medical history was not provided. The patient was vaccinated with a dose of ZOSTAVAX (lot number not specified) on 14-DEC-2012. Route was not reported. No other co-suspects were reported. No concomitant medications were reported. After receiving ZOSTAVAX the patient experienced pain, swelling, itching and soreness around injection site. No treatment was provided for the events. The patient sought medical attention; she spoke to the pharmacist. The outcome of the events was not reported. The reporter did not provide a causality assessment. Additional information is not expected.
experienced body aches, skin sensation to touch, nasal drainage, injection site tenderness, eyes watering, headache, vomiting x6 over period of 10 hrs. Spent all day March 18 in bed due to vomiting , and above symptons. Continued with low grade nausea and HA on March  19. Felt fine on March 20.     Treated self with Tylenol and restarted routine meds March 19 PM. Unable to take any meds on March 18 due to vomiting.  Did not require seeing healthcare.
I am breaking out a rash; This is a spontaneous report from a contactable consumer (Patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EN6198) via an unspecified route of administration, administered in the right arm on 04Mar2021 (at the age of 70-years-old) as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medications were reported as, patient was on just one medication (not specified, Other Products: Yes). Patient took the first dose of vaccine about 3 or 4 weeks ago (at the time of report) and she was breaking out a rash on an unspecified date in 2021 after vaccination. Patient haven't seen a doctor for it but was going to. Patient would like to know that can she take the second shot. The patient underwent lab tests and procedures which included blood test with unknown results 2 days ago (at the time of report) on an unspecified date in 2021. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
3 weeks after first varicella vaccine; the child developed 102 degrees axillary and about 100 macular-papular vesicles on arms, chest, back, legs diaper area and in the mouth. No known contact with chicken pox or shingles cases.
A physician reported the occurrence of mononucleosis in a 17 year old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were unknown.  In March 2003, the subject received his first injection of Engerix-B.  Two weeks later, in mid-March, the subject presented to the physician's office with lymphadenopathy.  A monospot test was positive for mononucleosis.  As of 04/04/03, the outcome of the mononucleosis was unknown.
Couple boils on his back/ neck; Old incision site puffed up; Needle marks flared up (turned red) from 2 years ago; This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Couple boils on his back/ neck), SWELLING (Old incision site puffed up) and ERYTHEMA (Needle marks flared up (turned red) from 2 years ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced SWELLING (Old incision site puffed up) and ERYTHEMA (Needle marks flared up (turned red) from 2 years ago). On 23-Apr-2021, the patient experienced FURUNCLE (Couple boils on his back/ neck). At the time of the report, FURUNCLE (Couple boils on his back/ neck) was resolving and SWELLING (Old incision site puffed up) and ERYTHEMA (Needle marks flared up (turned red) from 2 years ago) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment medication was provided   Reporter did not allow further contact
Pt got vaccines on 2.25.13 that night pt developed a fever. The next day pt developed hives and now has a croupy cough.
P/receiving a dose of Td, pt devel a fever & a sore, edematous (edema 2+) arm from the shoulder to the elbow, w/massive redness;
Wed 930pm  tingling nerve endings head to toe, migraine headache with aura, fever 100.3 Thu 530am SEVERE body aches, chills, migraine, sweats. 630am fever 101.3 body aches,HA/fever& chills all day.  Max fever 102. Friday fatigued, all day until HA starts again at 2pm, along with 101 fever by 5pm...carries on with chills and Migraine aura thru evening until 1245am.  Max fever 102 again.
This spontaneous report was received from a certified medical assistant refers to unspecified number of patients of unknown demographics. On an unknown date the patients may have been vaccinated with ZOSTAVAX (lot#, expiration date and route not reported) which reached a high temperature of 28 Celsius (C). No adverse effects have been reported. This is one of the several reports from the same source. Additional information has been requested.
Phone contact from pt's mom at 16:45 on 9/15/00. She verbalized that pt received Hep-B at 10:30 on 9/14/00 and around 20:30 that night, she said pt called her at work complaining of dizziness, nausea and fatigue. She advised her to go to bed and rest. She said the pt said she fell asleep around midnight. Mom said pt only complained of fatigue the next day and denies any further problems.
Almost immediately, child reported itchy/scratchy throat. Within 10 minutes he was coughing and had red eyes that were itchy. Within 30 minutes the child's skin color was bright red from head to toe, he experienced extreme itching all over his body, his skin temperature was hot, his eyes were swollen, and he complained of having trouble breathing. Two teaspoons of BENADRYL was given 1 hour after the injection. 1 1/2 hours after the injection the symptoms began to subside. 9 hours after the injection the child complained of a severe headache and had a low-grade fever (100.7).
Soreness of arm, severe leg pain, leg swelling No treatment Resolved in 24 hours
Local Varicella at VARIAX shot site 1 - 1/2" closed up vesicles on red base.
None . Vaccine expired 10/25/2022. given 02/17/2023
Fever, chills, headaches, muscle aches, body aches, nausea, diarrhea, vomiting,  fatigue, racing heartbeat up 118 according to fitbit peaking at 12:30 am 2/1/2021.
patient got the flu really bad; Initial information received on 23-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/ non-health care professional via media.  This case involved a patient of unknown age who got the flu really bad (influenza), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (20 years ago), patient got the flu really bad (influenza), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
sleep disturbance - unable to fall asleep, waking frequently - worse in the week after vaccination, gradually improving
Patient was given this only after 2 weeks from receiving the Varicella immunization. Should have waited 28 days.
About noon today (18 hours after dose), massive headache, fever, injection site soreness - as well as joint pain.  Took Tylenol for this, seemed to help.  Then approximately 9:00pm (26 hours from dose), developed dizziness and confusion, as well as shortness of breath
Throat swelling, raspy voice Narrative: Transported by EMS to local hospital for further evaluation.
04/18/2022 vaccination. 07/08/2022 I had sinus discomfort from sinus and asthma but felt I was coughing a lot more. I was a lot more fatigue. Productive cough, uncontrollable. 07/09/2022 antigen COVID-19 positive. Physician put me on PAXLOVID. I am still have a small amount of fatigue and I am still coughing.
cough; fatigue; irregular menstrual cycle; callers cycle is late by 10-12 days.; This is a spontaneous report from a contactable consumer or other non health care professional. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for Covid-19 immunisation. On an unspecified date, the patient had experienced cough, fatigue irregular menstrual cycle and caller cycle is late by 10-12 days. It was reported that she received both doses of vaccine. Patient states that she took a few pregnancy test and they were negative. She would like to know if any of these side effects have been reported. The patient underwent lab tests and procedures which included pregnancy test: negative. The outcome of the events was unknown.   Information about lot/batch number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.  It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows. The age at vaccination was not reported. The reporter described that within a few hours of receiving the 1st dose of the SHINGRIX vaccine she developed pain at the injection site. The pain lasted for 2 to 3 days and then resolved. The reporter gave permission for her physician to be contacted. For tolerance after 2nd dose of SHINGRIX, refer case US2019018249.
Intermittent chest pain ~5 hours after injection, lasting overnight and throughout following morning. Chest pain became severe ~ 27 hours after initial injection, requiring visit to ED.
My symptoms started  around 1pm with extreme tiredness.  as the afternoon progressed I developed a headache, body aches, joint pain and general fatigue
Information has been received from a licensed practical nurse concerning a 58 year old female who on Jan 06 2005 was vaccinated with a 2.5cc dose of pneumococcal 23v polysaccharide vaccine instead of a 0.5cc dose. No other information was given regarding the present status of the patient. No product quality complaint was involved. Additional information has been requested.
No SOB,Red at neck area, did not sleep, 2 hours crying x 3 days, no sleep 2 days. No fever, no nausea, no diarrhea. Swelling at face noticed by mother night after vaccine given. Seen by PMD never. 5th day after vaccines still red, no crying, not fussy, and sleeping less than normal, increased fussiness.
w/in 15 minutes of each Moderna dose patient's asthma severely flared. After first dose her symptoms resolved w/out additional treatment within 3-4 days. However, after second dose her SOD, DOE, cough, chest tightness have been lingering and difficult to resolve for nearly 1-1.5 weeks.  She ended up needing prednisone taper, increased nebulized medictaions.