chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight icnrease in pain; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 57 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 57 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis", start date: 2018 (unspecified if ongoing). Concomitant medication(s) included: FLUARIX QUADRIVALENT; METOPROLOL SUCCINATE; B COMPLEX [VITAMIN B COMPLEX]. Past drug history included: Lisinopril, reaction(s): "Allergy: Lisinopril"; Motrin, reaction(s): "Allergies: MOTRIN"; Diltiazem, reaction(s): "Allergies: DILTIAZEM". The following information was reported: PAIN (non-serious), outcome "unknown", described as "slight icnrease in pain".  Additional information: Patients wife Withheld completed the assessment for her husband has missed 3 days of medication and has had a slight increase in pain. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Last fall / unclassified neurological illness after / first dose; Has had some other health issues in the last year; This case was reported by a physician and described the occurrence of neurological symptom in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced neurological symptom and illness. On an unknown date, the outcome of the neurological symptom and illness were unknown.   It was unknown if the reporter considered the neurological symptom and illness to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself. The age at vaccination was not reported. The patient received 1st dose of Shingrix in last fall (Fall 2020) and experienced an unclassified neurological illness. The reporter stated that he also had some other health issues in the last year.
01/02/2022: Event occurred after 2nd vaccine.   77-year-old female presents the emergency department for evaluation of abdominal pain, bloating distention nausea.  She states that her symptoms initially started on December 14.  outpatient ultrasound which showed gallstones.  She denies fevers, chills, diarrhea or change in stools.
Got vaccine 1 day past the BUD of 11/19/23. Vaccine was not expired yet. No adverse event reported
Rectal temp of 108.2 & febrile seizures, recovered back to normal in 2 days;
Couldn't move her hands or legs stopped after 10 minutes; This spontaneous case was reported by an other caregiver and describes the occurrence of HYPOKINESIA (Couldn't move her hands or legs stopped after 10 minutes) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Lung nodule and WBC increased (Past medical history reported white blood cells are elevated). Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic. Concomitant products included ARIPIPRAZOLE (ABILIFY) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HYPOKINESIA (Couldn't move her hands or legs stopped after 10 minutes). On 17-Mar-2021, HYPOKINESIA (Couldn't move her hands or legs stopped after 10 minutes) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was okay with Amoxicillin . Treatment information was not provided. Symptoms resolved after 10 minutes
WHEN FIRST INJECTION OF INFLUENZA WAS GIVEN TO  PATIENT USING NEEDLE ( 25G X 1') FROM LOT: 4155460, EXPIRATION DATE-06/08 THERE WAS A MALFUNCTION AT THE HUB OF THE SYRINGE/NEEDLE CAUSING ALL OF THE INFLUENZA FUILD SPIRT OUT. sO PATIENT HAD TO BE INJECTED A SECOND TIME & THIS WENT WITHOUT INCIDENT. PATIENTS SKIN INTREGITY WAS NORMAL AT BOTH INJECTION SITES
the patient has not reported any additional AE; PNEUMOVAX23 was inadvertently administered to a 77 year old patient on 2/13/2023 who had previously been administered PNEUMOVAX23 on 11/5/2020; patient was intended to receive Prevnar20; This spontaneous report was received from an office manager and refers to a 77-year-old male patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported.  On 05-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (dose, lot #, expiry date, route of administration and anatomical location were not provided).  On 13-FEB-2023, the patient was inadvertently vaccinated with an extra dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 mL, lot # U025499, expiration date: 07-AUG-2023,  administered for prophylaxis (route of administration and anatomical location were not provided). The patient was intended to receive Pneumococcal 20-valent Conjugate Vaccine (PREVNAR 20) (Wrong product administered).No additional adverse events reported (No adverse event).
Narrative: COVID infection following COVID vaccine series 03/05 Janssen, dose #1 12/28 COVID swab, result: detected 12/21 pt. cc: cough, chills, diarrhea, fatigue, fever, headache, myalgias, rhinorrhea, sore throat exposure: unknown
Joint and muscle pain everyday. I?m not sure it?s because of the vaccine obviously, but I?ve never experienced it before. My elbows and my right shoulder and back have been hurting so much recently.
Injection site hard, hot and swollen. Swelling progressed down entire arm unable to lift arm for 2 days. Gone after 4-5 days. Never had this type of reaction before.
5:00 AM, bad headache and fever 8:30 AM, numbness in feet 12:00 PM, numbness in legs and arms
Patient was given the Hep A vaccine, then the flu vaccine, and last the HPV vaccine (1st dose).  Within minutes of the HPV vaccine, patient stated he was dizzy.  Before he could be moved from sitting in a chair to lying on the exam table, patient fainted.  He was caught by the nurse and did not fall.  There seemed to be some mild shaking/jerking as well. He came to and was then picked up by the nurse and laid on the exam table.  He requested something to drink and was given some Sprite and a cool rag for his forehead.  Patient's skin was clammy and he was weak.  After a few minutes he was able to sit up and drink the Sprite.  He sat in the exam room for approximately 30 minutes until he felt strong enough to walk.
swollen lymph nodes in both lower armpits; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 06Mar2021 11:00 (Lot number: EN6204) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Active Auto Immune Disorder" (unspecified if ongoing); "Alopetia Areata" (unspecified if ongoing); "known allergies : Fructose Malabsorption" (unspecified if ongoing); "known allergies:many foods problematic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single at 11:00 AM, lot number: EL9266, vaccine location: Right arm), administration date: 13Feb2021, when the patient was 49 years old, for Covid-19 Immunisation.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 07Mar2021, outcome "not recovered", described as "swollen lymph nodes in both lower armpits". The event "swollen lymph nodes in both lower armpits" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: On day 2 after second shot (07Mar2021) swollen lymph nodes in both lower armpits. Mammogram clear - ultrasound shows three enlarged lymph nodes on left lower armpit and one large enlarged lymph node on right lower armpit. Uncomfortable and very visible. Can cup the swollen area on both sides in her hand. No improvement and physician had no treatment to improve condition at this time. Benign lymph node swelling. The patient was tested negative for Nasal swab test (22Mar2021). The patient was not pregnant at the time of this report. The patient did not receive any other vaccine within four weeks of COVD vaccine. The patient did not had COVID prior vaccination.   No follow-up attempts are possible. No further information is expected.
Pt received PNEUMOVAX on 9/23/17 and reported continued symptoms of irritated injection site on 9/26/17. Headache and left arm is swollen, red and hot.
Cellulitis, tenderness, swelling, increased warmth, erythema within 24 hours, Clindamycin given.
Left-arm pain, axillary pain, and inflammation shooting down to left hand  left side neck swelling, pain, shooting to the left side of the head.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 26-MAR-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Rt Deltoid swollen, red, hot,itchy and Axillary lymphadenitis.
No adverse reaction reported- immunizations not due at this time, administered in error. Patient had a Tdap 5/22/2019.
This spontaneous report as received from a LVN (licensed vocational nurse) and a health worker refers to a 4 month old male patient. The patient was vaccinated with the first dose of ROTATEQ on 23-JAN-2013, the second dose on 01-MAR-2013 and the third dose on 08-MAR-2013 (route orally, dose and lot# for all doses were not reported). No adverse event was reported. It was also reported the therapy of ROTATEQ was not discontinued. Additional information is not expected.
Body aches 2:00am for approx 24 hrs. Sore throat 2:00am for approx 24 hrs. Low grade fever 2:00am for approx 24 hrs. Motrin taken at 9:30 am Swollen under left arm approx. 12:30 am Sunday took hot shower at 8:00 am swelling down, but still a little swelling and tenderness.
Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days; Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days), PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No information about patient's vaccine history and historical conditions.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days), PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days), PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days).    No concomitant medications was reported.  Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days. No other information about the patient's was known.  No treatment medications were reported.  This case contains information for the 2nd of 2 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-714297 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714297:Patient 1 of 2 Patients
Headache, Rash, Fatigue, mild headache, and rash at the injection site that went away within 5-6 days. On 8th day (today) redness and raised area 4inX2in. Denies any fever. Able to work remotely. Narrative:
Eczema flareup after first injection; This is a spontaneous report from a contactable consumer. A female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if patient had any allergies to medications, food or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021 after the first injection the patient experienced eczema flareup. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event eczema flareup after first injection was unknown at the time of the report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Hospitalization for pneumonia due to COVID-19 on dates 1/28/2023- 2/7/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
102.1 fever; Severe joint pain in large and small joints; Tingling; Swelling right lower face; Rash; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 22Apr2021 at 16:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Apr2021 at 10:00, the patient experienced fever 102.1, severe joint pain in large and small joints, tingling and swelling right lower face and rash. On the same day, the patient underwent body temperature test and the result was 102.1 (unit unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 102.1, severe joint pain in large and small joints, tingling and swelling right lower face and rash was resolved with sequelae on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Hives on right arm on 3/14 in evening. Took benedryl and they were gone in morning. On 3/15 at 6 pm hives started appearing on right arm. Then spread to left arm and knees. Took one benedryl at 8 pm and they were gone again in morning other than some redness.
Mom stated redness and swelling began around 1500 on 5/20. She applied cool compress around 1700 applied ice pack, at 2000 applied lotion "aloe vera" and went to bed with ice pack- woke up at 0630 blister noticed, swelling and redness increased. Returned to clinic, referred to PCP- prescribed- Hydroxyzine 10 mg/5ml, Clindamycin 75mg/5ml oral solution. PCP appt @ 1620.
Shots given Friday 7/7/06. Developed hives per mom late afternoon Sat 7/8. Ate bacon 1st time on Sat. Rash started on head, mild fever, strep throat screen negative.
Pt states day after receiving vaccine, she experienced chills, fever, body aches.  Her right arm (arm where she received Shingrix vaccine) was hot, red and had a knot.
high fever; cough; ST; sneezing; HA; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 3, Booster dose; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Primary immunization complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, Primary immunization complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 06Feb2023, outcome "not recovered", described as "HA"; OROPHARYNGEAL PAIN (non-serious) with onset 06Feb2023, outcome "not recovered", described as "ST"; COUGH (non-serious) with onset 06Feb2023, outcome "not recovered"; FATIGUE (non-serious) with onset 06Feb2023, outcome "not recovered"; PYREXIA (non-serious) with onset 06Feb2023, outcome "not recovered", described as "high fever"; SNEEZING (non-serious) with onset 06Feb2023, outcome "not recovered". The events "high fever", "cough", "st", "sneezing", "ha" and "fatigue" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, cough, oropharyngeal pain, sneezing, headache, fatigue.  Additional information : Unknown exposure symptoms high fever 101.3 cough ST sneezing HA fatigue then Tested positive: 08Feb2023.If Covid prior vaccination Unknown. If Covid tested post vaccination Yes  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300062267 same patient different dose/drug/event;
Shortness of breath; chest tightness; dizziness; fatigue; joint and muscles pain; joint and muscles pain; headache; chills; injection site soreness; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 20Jan2021 09:15 at single dose for Covid-19 immunization. There was no medical history. The patient was not pregnant at time of vaccination. The patient's concomitant medication included losartan, citalopram hydrochloride (CITALOPRAM [CITALOPRAM HYDROCHLORIDE]), clonazepam, hydrocodone bitartrate, paracetamol (NORCO), carisoprodol (SOMA [CARISOPRODOL]), and hydrochlorothiazide. On 20Jan2021 09:15, the patient experienced Shortness of breath, chest tightness, dizziness, fatigue, joint and muscles pain, headache, chills, injection site soreness. The patient did not received treatment for the events. The outcome of the events was recovering. No other vaccine was given in four weeks. The patient was not tested positive post vaccination.
Patient fainted, diaphoretic, pale, lethargic following commands A & O x c. Gave fluids PO, had pt put his head between knees. HR 70s-80s. Reg rate unsuccessful getting BP reading d/t small of arm. Pt continued to pass out then had came to. 911 was called and they found vitals were stable and encouraged pt rest at home.
Experienced a warm feeling that went up along neck and across the left side of face (the same side the vaccine on).; Experienced a tingly feeling that went up along neck and across the left side of face (the same side the vaccine on); This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in left arm on 19Apr2021 at 10:15 (at the age of 39-years old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Apr2021 at 10:45, 20 minutes after receiving the vaccination, the patient experienced a warm, tingly feeling that went up along his neck and across the left side of his face (the same side the patient's the vaccine on). After an hour the patient felt 90% better and five hours later, the patient had still felt a low sense of tingly, warm feeling along his left side of the neck and face. Since the vaccination, the patient had not been tested for COVID-19.  The events did not result in doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of events. The clinical outcome of the events, warm and tingly feeling in neck and across the left side of face was recovering at the time of report.  No follow-up attempts are needed. No further information is expected.