chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ankles and feet are swollen; Ankles and feet are swollen; I woke up and could barely walk; calfes were sore; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Sep2021 at 09:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation.  The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Sep2021 at 09:00 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. On 10Nov2021 at 07:00, the patient's ankles and feet were swollen like he was a 300-pounds man whereas the patient weight was 150 pounds. The patient did not know what was going on but when he woke up, he could barely walk because his calves were sore like he was lifting weights as well. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 10Nov2021, the patient underwent COVID-19 antigen test via nasal swab and the result was negative. The clinical outcome of the events ankles and feet are swollen, could barely walk because his calves were sore was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
At 1009 Pt received 2nd moderna vaccine. 10 minutes post had tingling on lips. Spread to right eye and side of face briefly.  Pt brought to observation area. Vital signs monitored. Pt has stated had reactions to vaccines previously and experiences high anxiety with clinic visits. Within 10 minutes eye and right side face tingling subsided. Still had lip tingling. Talked to pt regarding Benadryl. Pt refused at this time. Monitored for 30 minutes. No worsening effects. Discussed talking to doctor to let him know. Instructed that if condition worsens to go to ED and also take benadryl if needed. Sent home on own accord per pt wishes.
transverse myelitis that started in his left leg and moved to his right; 36 year old male patient received a FLUZONE HIGH DOSE; 36 year old male patient received a FLUZONE HIGH DOSE; Initial information received on 01-Jul-2020 regarding an unsolicited valid serious case from a nurse.  This case involves a 36 year old male patient who experienced transverse myelitis that started in his left leg and moved to his right (myelitis transverse), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment, vaccination and family history were not provided.  In November 2018, the patient received a 0.5 ml dose (once) of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UI995AB and expiry date: 01-Apr-2019) via an unknown route in the left deltoid for prophylactic vaccination.  The patient did not receive any other vaccines or medications at that visit.   In January or February of 2019 the patient experienced what they thought were shingles but on 23-May-2029, the patient was hospitalized for serious transverse myelitis that started in his left leg and moved to his right (myelitis transverse) (few months latency) following vaccination. This event was also assessed as medically significant.   It was a case of actual medication error due to Product administered to patient of inappropriate age and overdose.  Details of laboratory data not reported.   Final diagnosis were myelitis transverse.  It was not reported if the patient received a corrective treatment.  At the time of report, outcome of events was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: This case concerns a 36 year old male patient who presented with myelitis transverse after vaccination with FLUZONE HIGH DOSE. The time to onset is compatible. However, patient's medical condition at time of vaccination, lab data ruling other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Dizziness, nausea, eyes stinging, increased pain in arm, eyes burning, dry mouth, felt like going to "pass out".
My 11 year old brought it home from school. Four days later my  husband and I were sick. I was fine when I tested for COVID on the 7th and had a positive result. I am still feeling a little bit - on the 8th, I felt extremely tired and dizzy. That Saturday - low grade temperature 99.8 and a little bit of chills and coughing and sore throat and lots of snot and congestion. The highest the fever got was 100.8 or .9 for three days. The chills were awful. Sore throat and ear aches and extreme congestion in my  head that went down to my chest. My oxygen stayed above 96 - never dropped real low. My blood pressure was always fine. I didn't need my rescue inhaler until later on. I didn't feel a whole lot of chest tightness until when I started feeling a bit better. It felt like a bad case of flu. As I got better for 16th and 17th. I taught online the entire week that I was sick - I was seriously sick and fever broke Tuesday morning early finally. I started feeling better The following Saturday, the 18th, I started feeling bad again - my head started feeling bad again.  Doctor didn't put me on anything until  I felt sick again and then he put me on Prednisone  (one course - that I finished yesterday)- it had gone into a sinus infection. I get those - because my sinuses rest on my upper jaw bone. They are real lift. I had one side lifted because I had to get a tube replacement (in the past.) I am just now getting over the congestion today but I'm still coughing. I had to do my rescue inhaler finally the past couple of days. I went back to work in person on Monday. My 10th day out of the building was 17th - my last isolation day. I have to talk loud and through a mask at work - so I'm using a lot of oxygen doing that and that might contribute me to using my inhaler now - have only needed it use it only  once a day. I am recovering slowly. Note:  I had a sinus infection - prior to this but about three months after the vaccination. But I didn't get bronchitis with it.
passed the 35-day marker for second dose; arm did not feel right; shoulder having bursitis and it became acute; arm felt like when "you hit your funny bone"; an itch on his shoulder; became red; had scratch marks; worse ache/worse pain; from his shoulder to neck and across his shoulder blade down his whole arm and shoulder; from his shoulder to neck and across his shoulder blade down his whole arm and shoulder; tinnitus; felt pressure; tinnitus sounded louder/tinnitus more persisten/the sound itself was affected; his shoulder did not feel right; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (passed the 35-day marker for second dose), ARTHRALGIA (his shoulder did not feel right), PAIN IN EXTREMITY (arm did not feel right), BURSITIS (shoulder having bursitis and it became acute) and PARAESTHESIA (arm felt like when "you hit your funny bone") in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tinnitus since an unknown date.    On 10-Mar-2021, 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 DOSE OMISSION ISSUE (passed the 35-day marker for second dose), ARTHRALGIA (his shoulder did not feel right), PAIN IN EXTREMITY (arm did not feel right), BURSITIS (shoulder having bursitis and it became acute), PARAESTHESIA (arm felt like when "you hit your funny bone"), PRURITUS (an itch on his shoulder), ERYTHEMA (became red), SCRATCH (had scratch marks), PAIN (worse ache/worse pain), NECK PAIN (from his shoulder to neck and across his shoulder blade down his whole arm and shoulder), PAIN (from his shoulder to neck and across his shoulder blade down his whole arm and shoulder), TINNITUS (tinnitus), FEELING ABNORMAL (felt pressure) and TINNITUS (tinnitus sounded louder/tinnitus more persisten/the sound itself was affected). At the time of the report, PRODUCT DOSE OMISSION ISSUE (passed the 35-day marker for second dose), ARTHRALGIA (his shoulder did not feel right), PAIN IN EXTREMITY (arm did not feel right), BURSITIS (shoulder having bursitis and it became acute), PARAESTHESIA (arm felt like when "you hit your funny bone"), PRURITUS (an itch on his shoulder), ERYTHEMA (became red), SCRATCH (had scratch marks), PAIN (worse ache/worse pain), NECK PAIN (from his shoulder to neck and across his shoulder blade down his whole arm and shoulder), PAIN (from his shoulder to neck and across his shoulder blade down his whole arm and shoulder), TINNITUS (tinnitus), FEELING ABNORMAL (felt pressure) and TINNITUS (tinnitus sounded louder/tinnitus more persisten/the sound itself was affected) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment drugs were not provided,  Concomitant medicines were not included,  Action taken with mRNA-1273 in response to the event was unknown
Patient reported having a fever of 103, shaking, swollen tongue for 2 days after receiving the vaccine. She reported symptoms lasted for one week. (Said it took her a week to feel good again.)
Injection site swollen; Injection site red; knuckles and wrist and became very sore; painful; traveling down her arm into her phalanges between knuckles; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-SEP-2023, the patient received the 1st dose of Shingrix (left arm). In SEP-2023, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: painful) and radiating pain (Verbatim: traveling down her arm into her phalanges between knuckles). On an unknown date, the patient experienced injection site swelling (Verbatim: Injection site swollen), injection site erythema (Verbatim: Injection site red) and wrist pain (Verbatim: knuckles and wrist and became very sore). The outcome of the injection site swelling and injection site erythema were unknown and the outcome of the injection site pain, radiating pain and wrist pain were resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, radiating pain and wrist pain to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site erythema, injection site pain, radiating pain and wrist pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-NOV-2023 The consumer was the reporter stated that had her 1st Shingrix vaccination.    The reporter stated the injection site was swollen, red and painful.   Reported that 3 days after receiving the Shingrix vaccine the injection site pain began traveling down her arm into her phalanges between knuckles and wrist and became very sore.   The pain resolved about one month later. The consumer declined to provide any demographics or any information for her physician. The reporter did not consent to follow-up.
Patient felt light headed; sat on table and then passed out for approx. 30 seconds to one minute.  She was given ice packs to place on her neck and head. Also ammonia inhalant was used to help arouse patient. She gradually sat up and vital signs were checked. Vital signs were normal and patient was able to stand and rest until she had her friend pick her up. She was told if feeling light headed again to go to ED.
On 04/26/22 woke up and had a dry sore throat took at home COVID-19 test which was negative, went to school, little soreness and cough, by 5pm on 04/26/22 I had a non-productive dry cough. On 04/27/22 I took another test due to worsening cough and tested positive, taking Vicks Day Quill to suppress the cough spoke w/doctor and he stated no anti-virials. Worsening cough and body aches on 04/28/22. Morning of 04/29/22 felt better went up to talk to my wife, felt dizzy sat down started turning blue and eyes rolling in the back of my head, she called ambulance, they took me to hospital and they gave me 2 bags of fluids and release me. Called my doctor on 04/30/22 he prescribed Paxlovid, feel a little better have fatigue and metallic taste in my mouth. Will finish Paxlovid on this Thursday (05/05/22).
Dizziness for hours; vomiting; sleepiness; This is a spontaneous report from a contactable healthcare professional.  A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm on 30Dec2020 16:00 at single dose for COVID-19 immunisation.  The patient had no medical history.  There were no concomitant medications.  The patient known allergies: amoxicillin. The patient experienced dizziness for hours, vomiting, sleepiness on 31Dec2020 22:00. The patient received no treatment.  The outcome of the events was recovering.   Information on the lot number has been requested.
Left arm has been twitching and weak since second shot. Continues to shake and ache. Has caused neck pain and weakness in fingers and strength.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 2-year-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 24-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
HCW was given pfizer first dose on 12/17/20.  HCW thought she will have to re-start the series all over because she waited too long to get 2nd dose of pfizer so she opted for the Janssen vaccine. She did not inform vaccinator that she had already received a covid-19 vaccine. HCW denies any side affects or adverse reactions at this time.
Pt. rev'd 3 vaccines on left arm (DTAP, IPV, VARICELLA) 7/28/09.  Mom reported one day later adverse reaction.  Nurse practitioner examined and notes large area of erythema w/ central vesicles & smaller area of deeper erythema.  Subsequent visit 7/31/09 notes improvement.  Pt prescribed SULFATRIM 40 mg - 200 mg / 5 ml, 1/2 tsp BID.
3/20/22 (12-24 hours after shot): extreme fever and fatigue - unable to stand for any length of time 4/6/22 (18 days after shot): temporary blindness (ca. 2 minutes), blood pressure at 90/42, sent to ER for suspected Sudden Cardiac Arrest
On 2/10/21, intense itching started, on 2/11/21 redness developed in area. Intense itching stopped on 2/11/21 in PM but minor itching continued through 2/14/21
Moderna COVID-19 Vaccine EUA Patient stated her left arm was initially sore and subsided. Seven days later her left arm became extremely itchy, firm and hot. Her left arm became red and subsequently went to an urgent care where she received a course of cephalexin for a possible infection. It has been approximately 36 hours since taking cephalexin, and the patient reports that her reaction is began to clear.
I got a horrible headache, body aches so bad I could barely get out of bed to go to the bathroom, chills, nausea and bad back pain for 18 hours.  I have had trouble sleeping ever since I got the booster.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-APR-2016, the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # K009874, expiration date: 19-MAR-2016; dose and route were not provided). No adverse effects were reported. Additional information has been requested.
Patient received flu shot at 1:30 pm 10/8/16 and shortly after fainted, regained consciousness within 15 seconds, lay on ground recovering for a couple minutes, sat up against wall on ground and fainted again within minutes, regained consciousness quickly again, remained laying on ground conscious until EMS arrived. Stood up and remained fine after.
65 year old woman received Fluzone High-Dose vaccine today, then realized that she had already received Fluzone Quadrivalent this past september, no adverse event; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 65 years old female patient who was vaccinated with a 0.5 ml first dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ308AA and expiration date 30-Jun-2020) via an intramuscular route in the left arm on 27-Nov-2019. Also patient was vaccinated with a dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on an unknown date of this September.  Medical history not reported and no other vaccines were received by patient   It was an actual medication error case due to extra dose administered.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient states that he felt "floaty" after receiving the vaccine today. It began within about 5 minutes. No chest pain. No shortness of breath. NO numbness or weakness.         He does note he tends to be emotional and has been quite emotional about the vaccine. He has been under a lot of stress for the last ten years.     Vital Signs  HR 69 /min, 39 /min, BP 181/124, 195/126, Ht 59, RR 18, Oxygen sat % 95, 96, Oxygen Liter(s)    Patient had EKG which showed bradycardia and flipped T waves inferiorly. He was sent to the ER where his blood pressure remained high. Pulse remained low initially but gradually improved. Cardiac work up was normal and patient was discharged to home.
Hives on right arm from shoulder til right above elbow, on upper back, baseline of hair, and one on lower right cheek.
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX 0.5 ml, once, lot # N017399, expiration date 07-JUN-2019, for prophylaxis (strength, route and frequency were not reported) reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 15 Fahrenheit degrees (°F) to 46 °F (33.8°F) during 7 hours 15 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-:
Information has been received from a pharmacist referring to a 37 year old male patient who was allergic to penicillin (PCN). The patient was a physician himself. He was not allergic to eggs to latex. The patient had never had serious reactions after receiving a vaccine and was not sick at the time of vaccination. In the past 4 weeks, the patient did not receive any vaccinations. He had no long-term health problem, blood disorder, seizure, brain or nerve problem, immune problem and did not take steroids, anti-cancer drugs or X-ray treatments. During the past year the patient dd not receive transfusion of blood or blood product, or immune (gamma) globulin. The patient had had shingles twice previously in his lifetime. In the noon of 08-AUG-2015 the patient was vaccinated with 0.65ml dose of ZOSTAVAX (lot # L006381, expiration date 25-MAY-2016), subcutaneously (SQ) in the right deltoid (RD). After vaccination, the patient aware of potential reactions. On 09-AUG-2015, the patient had local injection site erythema and whelp. His both legs and opposite arm had wheals max of 10. The patient also experienced itchy. There was nothing on the trunk and the body. The patient treated with ZYRTEC for itch. The outcome of the events was unknown. Causality assessment was not reported. Additional information has been requested.
Moderate episode of vertigo.  Tele med PA who recommended therapeutic exercise, which worked.  Slight episode still occur.  Exercise still relieves the issue.
Case number PHEH2015US019684, is a combined initial and follow-up spontaneous report from a nurse received on 10 Oct 2015 and on 02 Oct 2015. This report refers to a 54 year old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.