chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; COLD SORES; LIP SWELLING WITHOUT BREATHING INVOLVEMENT MORE PRONOUNCED ON THE BOTTOM LIP; LIP ULCER; This spontaneous report received from a pharmacist concerned a 37 year old male patient. Initial information was processed along with the additional information received on 10-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 DM (diabetes mellitus) without longterm use of insulin (The reporter stated controlled with A1c 6% on 16-FEB-2022, down from 8% on 21-DEC-2021), and autistic disorder of childhood onset, and other pre-existing medical conditions included: The reporter stated that patient had no known drug allergies. On 15-DEC-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, 01 total, administered to right arm for prophylactic vaccination. The patient age at time of vaccination was 37 years old. Concomitant medications included dextromethorphan hydrobromide/quinidine sulfate, famotidine, hyoscyamine, lorazepam, metformin, omeprazole, ondansetron, propranolol, and risperidone. On 21-DEC-2021, Laboratory data included: HbA1C (Haemoglobin A1C)(NR: not provided) 8 %. On 16-FEB-2022, Laboratory data included: HbA1C (Haemoglobin A1C) (NR: not provided) 6 %. On an unspecified date, the patient had suspected covid- 19 infection and suspected clinical vaccination failure. On 27-APR-2022, the patient was treated for covid-19 with non-company suspect drug Paxlovid (oral route of administration, batch number and expiry were not reported) dose and frequency were not reported.  On 01-MAY-2022, on 3 day of medication the patient started lip swelling without breathing involvement, more pronounced on the bottom lip. 01-MAY-2022, the patient had lip ulcer.  On an unspecified date, the patient experienced cold sores and improving by using Lysine and (LLT) Abreva on day 4 post non-company suspect drug (Paxlovid) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lip swelling without breathing involvement more pronounced on the bottom lip, lip ulcer, and cold sores, and the outcome of suspected clinical vaccination failure and suspected covid 19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000230266.; Sender's Comments: V0-20220516356- Covid-19 vaccine ad26.cov2.s - Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient came in today 9/21/7 at 9:10 am complained of itching and swelling at the injection site, no pain, no symptoms of difficulty breathing. I advised patient to apply ice pack to the site to help reduce swelling, take benadryl for the itching, and advil for the inflammation. Also, advised patient to see the doctor if the swelling increases.
Received vaccine around 0700 this morning.  Started itching around 1300, rash appeared on both hands around 1500.  Arms also itch but no current sign of rash.   Has taken benadryl.  Talked to employee health and was directed to go to ED if rash spreads.
I first started to feel weak and achy around 6 pm. Around 7 pm the body aches started to intensify especially in my lower back and thighs. I started to get chills and had a temperature of 102.8. The next morning I woke up with a low fever of 100 and was very tired and had a headache the rest of the day. My arm at the site of the injection was mildly sore for 3-4 days after the vaccine
Sinus Allergies; Itchy eye; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGIC SINUSITIS (Sinus Allergies), EYE PRURITUS (Itchy eye) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 ALLERGIC SINUSITIS (Sinus Allergies), EYE PRURITUS (Itchy eye) and HEADACHE (Headache). At the time of the report, ALLERGIC SINUSITIS (Sinus Allergies), EYE PRURITUS (Itchy eye) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product use was reported. No treatment details were provided.
9:50 am patient states she does not feel right, feels funny, leaning over in chair,  denies SOB no CP c/o of heart racing, NKA RN and RN summoned to help.  Patient laid down on floor. BP 192/103 P-112 PO 100%.  Eyes noted to be pink, denies itchiness. RN called 911, advised not to give Benadryl.  9:55am BP 178/99 P-119 PO 100% patient continue to feel heart racing but no SOB, chest or throat tightness.  10am BP 177/100 P-114 PO 100% continues to be A&O x3 no resp. distress 10:03 EMS arrived and took her to the ER. Patient states her 15 min observation time was up at 10:05am. RN
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 02-FEB-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L030587, expiration date 10-FEB-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Extensive leg swelling reported by mom at next visit. Described the (L) thigh as red, swollen in comparison to other leg, hard, and warm to the touch. Symptoms started within hours after the vaccine and lasted for approx 3 days.
Flu like symptons, achy, fever 101. At 3am temp 104 took 800 Motrin fever come down to 101.6. Fever broke Sunday 10/21 feem much better today lymph node under left arm tender.
pt began having difficulty swallowing p/30min;pt was treated @ urgent care ct w/IV med;pt adm to hosp;physical exam revealed erythematous rash on upper chest;diffuse rash in face & neck;edema of face, lips & neck & swelling of rt deltoid;
ABOUT 5 MINUTES POST SHOT CLIENT C/O NOT FEELING WELL AND NEEDING TO LAY DOWN, LIGHT HEADED AND LEGS ARE WEAK. ABLE TO GET TO TREATMENT ROOM AND ON THE EXAM TABLE - THEN SHE C/O BEING/FEELING HOT AND DIAPHORETIC. APPLIED ICE PACK AND START TAKING VS Q 5 MINS - PEAKED AT 130/90 FOR BP AND 90/MIN FOR PULSE. 20 MINS POST SQ SHOT OF EPINEPHRINE  0.3mL BY CLINICIAN A.BODIFORD FNP - THE CLIENT FELT BETTER AND VS BACK TO NORMAL OF 112/70 FOR BP AND 68PULSE. CLINICIAN DISCUSS WITH HER SUP WHAT TO DO NEXT SINCE THE CLIENT IS STABLE AND THEY DECIDED SINCE SHE IS STABLE SHE CAN BE RELEASED TO HOME WITH HER BOYFRIEND THAT ACCOPANIED HER. AND ADVICED IF ANY RETURNED OF THE S/S OF ALLERGY GO TO ER AT NO DELAY AND ADVICE OF NO IZs AT THIS TIME.
Woke up next morning with neck on skin dry, scale-like, wrinkly appearance.  Applied aquaphor, skin on neck started to peel off. Not red or painful  underneath.  Two mornings later, skin around lips, nose and eyelids started to being look the same, applied aquaphor.  Trouble opening mouth and eyes all the way.
Patient received immunizations on Monday 5-19-14. Late that evening the area became red, swollen and itchy. He also developed a fever of 102. The patient was seen in the office on 5-22-14 and was feeling better and afebrile. Returned to office 5/23/14 to have redness on arm assessed.
leg cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (leg cramps) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Spinal disorder and Gastrointestinal disorder (Patient has medical condition where the pressure on his intestine causes the cramps.).    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 MUSCLE SPASMS (leg cramps). At the time of the report, MUSCLE SPASMS (leg cramps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # L045713 with expiry date 14-JAN-2017, lot # L009445 with expiry date 01-JUN-2017, lot # M022556 with expiry date 26-MAY-2016 (dose, route of administration and anatomical locations were not specified). Administered doses of VAQTA underwent temperature excursion of 31 Fahrenheit degrees for 189 hours (7 days and 21 hours, 2 cycles). There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Severe muscle & body aches, chills, headache, sweating, nausea.  Contacted physician via portal to advise.
These are the dates of my illness. Approximately on September 15 or 16th I went to pharmacy for a regular flu vaccination and my first shot of the Singles vaccination. September 23 I woke up with weak legs, after I had been doing heavy yard work and tired myself out. September 24 in the evening, I had to be helped up by my daughter and son in law, and she said at that time I should go to the doctor. I said I would go in the morning. September 25, I had to scoot down the stairs to get to the living room, made it to the couch with my cane. But when I tried to get back up from the couch I fell and could not get up again. I called the ambulance. They brought me to Hospital. I was
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Product: COVID 19 Treatment; Positive, notes: Rebound with new positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient also tested positive for covid on 1-2-22.  Sounds as though her discharge on 01/08/2022 the patient initially did well.  In follow-up by telephone the patient was weak as of the 11th.  Not able to get up and out of the better chair without assistance.  Oxygen needs had remained stable as he was discharged on 2 L nasal cannula.  Sounds as though there were attempts made at home health as well as therapy.  Today in dialysis patient stated he was having falls at home.  Noted bruising on his left shoulder.  Also mention of confusion.  Following this was sent to the emergency department for further evaluation.  Noted to again be somewhat confused though interestingly aware of his confusion from time to time. Labs showed no hypercarbia on ABG, elevated CRP of 13 up from 2.0 on the 8th.  LFTs unremarkable.  Daily lytes with mildly elevated potassium.  Procalcitonin noted to be elevated at 1.73.  Lactate mildly elevated at 2.1.  INR slightly subtherapeutic at 1.9.  No leukocytosis.  Hemoglobin stable.  Head CT obtained due to altered mental status and without acute findings.  Chest x-ray obtained and showing likely pneumonia with discrete infiltrate.  thought to have secondary bacterial pneumonia.  Started on Zosyn and vancomycin for possible Hcap.  Admitted for further cares
March 6:  Severe body aches and chills, 101.1 fever, extreme tiredness  March 7:  Body aches and chills, 100.2 fever, extreme tiredness  March 7:   99.3 fever,  tiredness for first half of day
patient received an expired dose of menactra, with no adverse event; Initial information received on 04-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced patient received an expired dose of menactra, with no adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hpv Vaccine (Hpv Vaccine) for Immunisation.  On 03-May-2022, the patient received a  dose (dose: 0.5ml )of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine (lot U6921AB)  via intramuscular route in the left deltoid for Immunisation.  On 03-May-2022 the patient developed a non-serious patient received an expired dose of menactra, with no adverse event (expired product administered) following the administration of Meningococcal A-C-Y-W135 (D Conj) Vaccine.  Action taken with: not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received an expired dose of menactra, with no adverse event).  Outcome: Unknown for the event patient received an expired dose of menactra, with no adverse event.  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.
w/in 1wi of vax pt devel itchy, watery eyes, postnatal drip & a low grade fever;7APR97 pt called MD c/o arthralgia;pt advised to take APAP but the arthralgia persisted on 14APR97;
After 3 vaccines in 4 wks - child of 42 lbs, very healthy, (swims, skates - hockey etc) stopped eating & drinking & complained of abdominal pain - starting Nov 15 for 4 days - complete loss of appetite, weakness, tired, pain.
Headache; Vertigo; nausea; Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th May 2019, 1 days after receiving Shingrix, the patient experienced headache, vertigo and nausea. In May 2019, the patient experienced diarrhea. On 7th May 2019, the outcome of the diarrhea was recovered/resolved. On an unknown date, the outcome of the headache and vertigo were not recovered/not resolved and the outcome of the nausea was unknown.   It was unknown if the reporter considered the diarrhea, headache, vertigo and nausea to be related to Shingrix.  Additional details were reported as follows: After receiving Shingrix vaccine in right arm the day before reporting, twelve hours after the patient complains of diarrhea last night.  The morning of reporting, caller complains of nausea, a terrible headache, and vertigo. The reporter consented to follow up.
HAS NOT EATEN; COULD NOT KEEP ANYTHING DOWN; SYMPTOMS LIKE THE FLU/ HEADACHE/ BODY ACHES/ GOT SICK/ FEELS AN ACHY, FLUISH FEELING; SPARKS RUNNING THROUGH JOINTS, HANDS, LOWER LEGS, FEET, TOES, WRISTS, FINGERS/LITTLE SHOCKS/NERVE SHOCKS; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was not reported and height was 64 inches. The patient's past medical history included: bilateral total knee replacement, and concurrent conditions included: alcohol consumer, non smoker, and allergy to pain medicine, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient sometimes take vitamins. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-AUG-2021, the patient experienced symptoms like the flu/ headache/ body aches/ got sick/ feels an achy, fluish feeling. On 24-AUG-2021, the patient experienced sparks running through joints, hands, lower legs, feet, toes, wrists, fingers/little shocks/nerve shocks. On 25-AUG-2021, the patient experienced has not eaten. On 25-AUG-2021, the patient experienced could not keep anything down. The action taken with covid-19 vaccine was not applicable. The outcome of the symptoms like the flu/ headache/ body aches/ got sick/ feels an achy, fluish feeling, sparks running through joints, hands, lower legs, feet, toes, wrists, fingers/little shocks/nerve shocks, could not keep anything down and has not eaten was not reported. This report was non-serious.
Pt recvd 3rd dose hep B vax 08JUN90 & exp negative (anti HBS) 26JUL90 w/ addt'l doses given 03AUG90 & 05SEP90 w/ positive (anti HBS) 01NOV90.
Heavy spotting the next morning, 14 days into cycle (not sexually active). Spotting dissipated by the next day.
Since the day after the first injection I have had ongoing facial nerve pain on the left side, nerve pain on my left pudendal nerve, SI joint nerve pain down through the left lower extremity. This pain has been ongoing for over 1 year now.
This is a spontaneous report from a contactable physician, reporting for her daughter. This 17 year-old female patient of an unspecified race and ethnicity received a single dose of TRUMENBA intramuscular in the left upper arm on 12Oct2016 for immunisation.  The patient medical history and concomitant medications were not reported. On an unspecified date in Oct2016 the patient developed a large (approximately 10 cm) rash on upper arm, rash was not itchy but it was red and warm, and she had severe pain that limited arm movement. The patient received ADVIL as treatment but pain only partially responded to it. The patient was recovering.
C/O not feeling well 30 minutes to an hour after vaccination.  Mom says client's face was very bright red and that she was also c/o nausea.  No fever, No shortness of breath.  The next morning when she got up, mom said client's face looked like she had been in a bad car accident, both eyes were swollen shut, nose was swollen as were her lips.  Still, no shortness of breath, so mom contacted her MD and was seen at her MD's office by the ARNP.  Dx of allergic reaction to HPV vaccine.  Treatment included cold / hot packs to face.  Per mom, client got better as the day went on.
p/vax pt devel run dow, overly tired, general achiness;11/23 woke up to pain @ area of  anthrax inj w/redness, firmness & swelling & cont general feeling poorly;
Patient states she had bad flu like symptoms after the vaccine and on Saturday 5/12 her arm was swollen and red. It so bad she came into the pharmacy and showed us her arm, we instructed her to go to the doctor. She went to the urgent care and was told her had cellulitis. She has to be on Cephalexin for 7 days.
Sore upper arm mild; Major fatigue; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 02Apr2021 at 14:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), hypothyroidism, hypertension, hypertension intracranial, major depression and anxiety. The patient was allergic to pollen, soap and laundry detergent. Concomitant medications included acetazolamide (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), drospirenone, ethinylestradiol betadex clathrate (YAZ), lisinopril (MANUFACTURER UNKNOWN) and potassium chloride (MANUFACTURER UNKNOWN). 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 04Apr2021, the patient experienced sore in upper arm, mild and major fatigue two days later after the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether the patient did receive any treatment for the events. The clinical outcome of the events sore upper arm, mild and major fatigue were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a consumer via interactive digital media and described the occurrence of nerve root irritation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of radiculopathy (1st dose received on unknown date, for tolerance refer case US2021AMR163721). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced nerve root irritation. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the nerve root irritation was not recovered/not resolved. It was unknown if the reporter considered the nerve root irritation to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the 2nd dose of Shingles shot on left side and after the vaccination the patient stated that it irritated the nerve in the shoulder and neck on the side where he/she got the shot. The reporter stated that since his/her 2nd dose it's been 6 weeks and patient was under his/her doctor care to tried to get it resolved, hoping soon.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR163721:same reporter.
Starting same evening as vaccination, chills, fevers, body aches, lethargy, dizziness. This continued for almost 4 days, and then 2 more days with headache that was one-sided. It took me almost a week to feel better. I was unable to function normally, had to stay home most of the time and felt like I had a flu. I am a healthy person and hardly ever get sick.
On 11-4-16 it was discovered last year's FLUZONE QUADRIVALENT was administered. The expiration date on the vaccine was 30Jun16. No known reaction. Vaccine manufacturer was called.