chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel a little arthritis pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored Programme Covax US Support. A 63-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: EN6198) via unspecified route of administration in left upper arm received on 22Feb2021 at 11:30 hours (at the age of 63-year-old) as single dose for COVID-19 immunisation. Medical history of the patient included arthritis and allergy to eggs. Concomitant medications were not reported. Patient did not receive any other products. Patient doesn't get the Flu vaccine because he has an allergy to eggs. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On unspecified date of Feb2021 (two or three days after the first vaccine), patient feels a little arthritis pain after the first vaccine. Arthritis pain has doubled, increased and skyrocketed: arthritis includes pain and swelling of hands, thumbs, right shoulder and knees. Patient states that he has been getting a needle, with medication, in his hand, for the pain, and it was not working. Patient could not tolerate the pain of his arthritis, and the needle, with medication, did not helped his pain. Patient states he does not know what medication he was injected with. Patient had physician office visit. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse concerning a 13 year old female who on 02-MAY-2007 was vaccinated with the first dose of Gardasil. Ten minutes after receiving the vaccination, the patient passed out. Subsequently, the patient recovered on 02-MAY-2007 and was noted to be fine. Additional information has been requested. 07/08/2008 Initial and follow up information has been received from a nurse concerning a 13 year old female student who on 02-MAY-2007 was vaccinated with the first dose of GARDASIL. Ten minutes after receiving the vaccination, the patient passed out. Subsequently, the patient recovered on 02-MAY-2007 and was noted to be fine. In follow up information from the doctor's office it was reported that patient felt very faint on 03-MAY-2008 (previously reported as patient passed out on 02-MAY-2008). She recovered on the same day. Additional information is not expected.
Temp running 100 to 102; headache; sore throat; body hurts; extreme fatique; chest feels congested; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the left arm on 12Apr2021 at 10:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6208) via an unspecified route of administration in the left arm on 18Mar2021 at 07:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 20:00, the patient experienced temp running 100 to 102, headache, sore throat, body hurts, extreme fatigue, chest feels congested. On 12Apr2021, the patient underwent Body temperature measurement and the result was 100 to 102 (UNSPECIFIED UNITS). The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events temp running 100 to 102, headache, sore throat, body hurts, extreme fatigue, chest feels congested was not recovered.  No follow-up attempts are needed. No further information is expected.
IMMUNE SYSTEM NOT RIGHT; BREAST SWELLING; GOT SICK; SWOLLEN ARM AT INJECTION SITE FOR MONTHS; GI (GASTROINTESTINAL) ISSUES; UNBEARABLE JOINT PAIN AS LONG AS 18 MONTHS AFTER SHOT; SWOLLEN LYMPH NODE IN ARMPIT; FATIGUE; This spontaneous report received from a patient via a company representative concerned a female 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 covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced immune system not right, breast swelling, got sick, swollen arm at injection site for months, gi (gastrointestinal) issues, unbearable joint pain as long as 18 months after shot, swollen lymph node in armpit, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen arm at injection site for months, had not recovered from immune system not right, and the outcome of got sick, unbearable joint pain as long as 18 months after shot, swollen lymph node in armpit, breast swelling, fatigue and gi (gastrointestinal) issues was not reported. This report was non-serious. This case is a duplicate of 20220911625.
Hep-A: 28-AUG-2008, 25-SEP-2015 09:46; This spontaneous report has been received from a licensed practical nurse, via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)(2303USA000170), concerning an 11-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies prior to vaccinations were not reported.  On 28-AUG-2008, the patient was vaccinated with the first dose of with hepatitis a vaccine, inactivated (manufacturer unknown) intramuscular injection for prophylaxis (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis. On 25-SEP-2015 at 09:46, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (manufacturer unknown) intramuscular injection for prophylaxis (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (inappropriate schedule of product administration).   This is one of several reports regarding the same patient.  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-2303USA000170:Original Case: 2303USA000170 US-009507513-2306USA000599:Split 2306USA000599 US-009507513-2306USA000600:Split 2306USA000600
Covid positive symptom onset 2/6/2021 and positive test 2/10/2021
suddenly felt the left side of his mouth drop; Initial information was received on 05-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non health care professional.  This case involves a 69 year-old male patient who suddenly felt the left side of his mouth drop (facial paralysis), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Vaccination(s) included Influenza vaccine for prophylactic vaccination every year but it was not sure if High Dose. Past medical history, medical treatment(s) and family history were not provided. No other vaccine was given.  Concomitant medications were not reported.   On 30-Sep-2020, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (single dose vial) (lot UJ484AB and expiry date 30-Jun-2021) via unknown route in the left arm for prophylactic vaccination.  On 01-Oct-2020, the patient suddenly felt the left side of his mouth drop (facial paralysis) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  Case Detail: The patient was driving his car and suddenly felt the left side of his mouth drop. He tried to smile and noticed that it did not look right. The patient thought that he was having a stroke so he went to the emergent room.   Relevant laboratory test results included: Computerized tomogram - On an unknown date in Oct-2020: [Bells Palsy] and Magnetic resonance imaging: [Bells Palsy]  It was not reported if the patient received any corrective treatment.  At the time of reporting, patient was recovering from the event (he started to get back the feeling on the left side of face).  It was also reported that patient supposed this was related to the flu vaccine.; Sender's Comments: This case involves a 69 year-old male patient who experienced facial paralysis one day following the vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset was compatible. Laboratory test included computerized tomogram and magnetic resonance imaging. Further information regarding condition during vaccination, previous medical and allergic history and laboratory details excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium.
The day after the second shot, he noticed his legs were not functioning normally, as they could not support his own weight. He also had hot/cold flashes and severe pain in his lower legs. He took the day off of work. He recovered the next day.
PT WAS ASKED AND GIVE "1ST DOSE PFIZER SHOT" NAD IT WAS ASKED AND MARKED ON CONSENT FORM--UPON CHECKING ON THE WEBSITE AND BILLING INS-PT HAD RECEIVED A JOHNSON AND JOHNONS DOSE ALREADY!
my ENT told me about an influx of patients who had an over reaction; thousands and thousands of patients have had vaccine injury; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (my ENT told me about an influx of patients who had an over reaction) and VACCINATION SITE INJURY (thousands and thousands of patients have had vaccine injury) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (my ENT told me about an influx of patients who had an over reaction) and VACCINATION SITE INJURY (thousands and thousands of patients have had vaccine injury). At the time of the report, VACCINATION COMPLICATION (my ENT told me about an influx of patients who had an over reaction) and VACCINATION SITE INJURY (thousands and thousands of patients have had vaccine injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Dx is Guillain-Barre seen on 2/1/10 by neurologist for 1 week of weakness. 2 weeks before 2/1/10 had H1N1 injection.
Heart flutters all day on 26Aug. Happened every couple of seconds, nothing in my routine changed.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 25-year-old (non-pregnant) female patient received second bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in arm left on 28Jan2021 at 11:00 (at the age of 25-year-old) as Dose 2, single for COVID-19 immunization. Medical history included PCOS, covid-19 (If covid prior vaccination: Yes). Known allergies: Bactrim, Pyridium. Concomitant medications included ethinylestradiol, norgestrel (CRYSELLE); metformin (METFORMIN); clonazepam (KLONOPIN); vortioxetine hydrobromide (TRINTELLIX) all taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Patient did not have other vaccine in four weeks. Patient has not tested for covid post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: EK9231) via an unspecified route of administration, administered in arm left on 07Jan2021 11:00 (at the age of 24-year-old) at dose 1, single for COVID-19 immunization. On 26Aug2021 at 08:00 the patient experienced heart flutters all day. Happened every couple of seconds, nothing in my routine changed. Patient did not receive treatment for the adverse events. Outcome of the event was resolved on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Second dose administered at approx 11:45am on 3/27/21.  I woke up at 3:30am on 3/28/28/21 with teeth chattering chills, headache and a fever of 101.6.  I took 2 Tylenol and went back to sleep.  Woke up about 8:00am on 3/28/21 with a fever of 102.6, stiff neck, chills, nausea, headache.  Continued with Tylenol throughout day.  For 3 days I had all of those symptoms plus diarrhea. I assumed this was normal but was getting concerned because I had no symptoms from the first vaccine on 3/5/21.  I never got a stiff or painful arm but I did get a rash on my arm face and neck starting on 3/31/21.  The rash continues on my neck, face and shoulder intermittently to date, more than 2 weeks later.  On 3/31/21 about 12 noon my fever had gone down to 99.0.  Every time I would get out of bed my fever would spike immediately to 101 or 102.  On 4/1/21 I called the nurse through my insurance company and she said to stop taking the Tylenol and if the fever continued to go to Urgent Care on 4/2/21, which is what I did.  They performed a rapid Covid test which was negative and my fever was normal but my blood pressure was quite high which is not normal for me.  I had nausea, headache, fatigue, sore muscles.  They really didn't tell me what to do and said my reaction to the vaccine was "normal" and they didn't know how long it would last.  It is now more than 2 weeks after the vaccine and I do not feel great.  Although the fever has gone away I still have the intermittent rash, nausea, diarrhea, stiff neck.  The soonest I could get an appointment with my Primary Care doctor is 3/27/21.  I am concerned because I have the gene mutation Prothombin 20210A (Factor 2) which is  a clotting disorder.  In 2010 I was hospitalized and almost died from a massive DVT and PE in both lungs.  I did not know until I was admitted to hospital that I had this clotting disorder.  I am also a Colo-rectal cancer survivor and had radiation and chemotherapy along with several surgeries in 2013.  I have been NED since.  Given today's news about blood clotting problems with the Janssen vaccine (although I had Pfizer) I just wanted to report my side effects since I have a blood clotting disorder.
Erythromelalgia; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: er2613) at the age of 28-years, via an unspecified route of administration in left arm on 20Mar2021 at 14:00 at single dose for COVID-19 immunization, in public health clinic. Medical history included asthma. Patient had no known allergies, was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and spironolactone. On 24Mar2021, onset of burning red feet and hands 4 days after vaccination, with patches on legs (flare up after walking, pressure such as standing, heat, and at night). Diagnosis of Erythromelalgia. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received nifedipine, sildenafil citrate (VIAGRA), multiple compound creams as treatment for the adverse event. Outcome was not recovered. Seriousness criteria was provided as disabling/incapacitating. Since the vaccination, the patient has not been tested for COVID-19.   Follow-up attempts are needed. Further information is expected.
Pain and extreme muscle weakness began in right arm and then spread to lower legs, upper legs, left arm, shoulders, hands.  All over body.  Muscles would twitch and still do.
Had a pregnancy ultrasound on august 4. Baby measured 5weeks 5days with a heartbeat and normal looking sac. Got the vaccine Sunday, august 8. Went back for another ultrasound on august 18 and the fetus had only progressed 4 days? the same amount of time between first measurement and first vaccine dose. I have had two healthy, full term pregnancies over the last 4 years with zero complications during conception and delivery.
Pain during injection, increased pain 3 days after injection and muscle/joint pain 2 weeks after.  My left arm continues to hurt, especially if I try to raise or lift anything.
Patient required hospitalization due to breakthrough infection. Patient received J&J vaccine on 03/15/21. Patient was hospitalized from 07/29/21 - 08/18/21. Below is copied from discharge summary:   HOSPITAL COURSE  o Acute Hypoxic resp failure due to Covid 19 PNA ,  Completed Decadron for 10 days 7/30 to 8/8  . Pt completed 14 days of Thereuptic AC dose .. changed   to Prophylactic dose. Pt Now on 4L O2 and spo2 95% on 4L . Home o2 arranged      o HTN cont Losartan  o AKI resolved  o DM On Metformin at Home , Now on SSI Only . A1c 7 . o R forearm discoloration sec to Bleeding , . Hb stable .  o Mild Transaminitis elevated but stable      Discharge Diagnoses: Acute Hypoxix resp failure due to Covid 19 PNA  HTN  AKI  Dm  R forearm discoloration sec to Bleeding  Transaminitis
Within a few minutes after receiving vaccine, the patient fell to the floor and had a few jerking movements. Within a few seconds he was able to speak and was alert. He was monitored for 15 minutes and left with mother.
Description: 37 y/o female developed severe right shoulder and arm pain and swelling a few hours after receiving ADACEL vaccination. Symptom: Pain Start: 10/31/2006 Comment: in the right shoulder and the right arm, a few hours after vaccination. Symptom: Swelling Start: 10/31/2006 Comment: In the right arm and right shoulder starting a few hours after vaccination. Symptom: Erythema Start: 10/31/2006 Comment: At the right shoulder injection site.
Arrhythmia; cough; Asthma; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0175, at the age of 46-year, on 13May2021 14:15 at single dose in left arm for COVID-19 immunisation. Medical history was none. The patient had no known allergies. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medication was not reported. On 20May2021, the patient experienced Arrhythmia, cough and Asthma. Lab data included Nasal Swab negative on 21May2021. All events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the events included Advil, biodesp, singulair. The outcome of all events was not resolved.
Had TDAP 01/20/2006, right deltoid, no symptoms until 48 hours after vaccine, arm became red, hot, and swollen, edema 1.5 inched wide and 1 inch long.  No systemic reaction, just local redness, wound site no visable, no drainage.  Cloth cover, ice pack to for pain and edema. Advised to call doctor for follow up.
Pain burning itching severe, pain body aches, fever, nausea & diarrhea, stuffy nose/congestion/cough. Started immediately. Skin out break on spine & across back, general malaise, weakness, dizziness. New outbreak of shingles or chickenpox on 4/7/10 being treated by Dr. with ACYCLOVIR and pain.
Internal shingles after both doses/ suspected vaccination failure; Internal shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer (stage 4 unspecified cancer).   On an unknown date, the patient received the 2nd dose of Shingrix (right arm) and the 1st dose of Shingrix (right arm). On 01-FEB-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Internal shingles after both doses/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Internal shingles). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Linked case(s) involving the same patient:  US2023AMR048483   Additional Information: GSK Receipt Date: 29-MAR-2023 The patient was self-reported this case. The patient reported that he received both doses of Shingrix vaccine in 2020 and experienced internal shingles and was still suffering with them after 8 weeks. The patient received Valacyclovir as a treatment and he was on his third regimen of Valacyclovir. The patient reported that the Valacyclovir did not seem to help. The patient had stage 4 unknown type cancer that had been just declared cancer free by his physician since he was getting internal shingles. The reporter gave permission to contact his cancer MD physician. The reporter did consent to follow up. This case was considered as suspected vaccination failure as laboratory confirmation regarding shingles were unknown at the time of reporting. This case has been linked with case US2023AMR048483 reported by same reporter for same patient; Sender's Comments:  US-GSK-US2023AMR048483:Same Report (Vaccines Case)
Experienced pain and bruising in shoulder and arm. Swollen and painful to push and touch. Has been going on for 2 weeks.
Pt received the vaccine. Waited the 15 minutes within his office visit. Pt initially tolerated the injection well. While standing at the receptionist's desk scheduling his follow up appointment, patient became lightheaded and fell. Patient never lost consciousness. Patient sustained a non-injury fall. Both nurses and provider were on hand. Patient's vitals were taken and patient moved to a room for observation. Patient had not had breakfast and was very anxious as he has mental compromise and has a difficult time handling stressors.
Herpes Zoster diagnosis in a two-dose variella vaccine recipient. Diagnosed at Health Center on 11/12/2014. Painful rash in one dermatome (left back). She has a history of eczema. Treated with unknown antiviral. Other symptoms included headache and nausea.
4-1-04 pt given DTaP right thigh. 4-2-04 right leg 12 x 10 cm redness and swelling. Was sent to urgent care, due to no doctor in our office.
Became feverish and all muscles became totally incapacitated. Unable to get up, roll over or walk. This went on for about 36 hours. Afterwards felt weak and lethargic.
Noticed pain on arm from the shot for a few days, then a rash occurred and developed to spread. Saw MD and said it is an arthus reaction she developed. No treatment.
Breakthrough case admission after 6 vaccines Pfizer 2/24/21 Lot# En6202;  Pfizer 3/17/21 Lot# En6204;  Pfizer 10/26/21 L:ot# FH8020;  Pfizer 4/29/22 Lot# FJ9943;  MOderna 5/19/2 Lot# 038A22A; Pfizer 9/21/22 Lot# GJ5342