chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rt lower back, muscle spasms 24hr p/vax progressed to lt side unable to move;tried Ibuprofen w/o much relief;dental complication Erythromycin since 26JAN;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Tinnitus-Medium
Information has been received from a physician concerning a 16 year old female who was vaccinated IM (date not provided) with a first dose of Gardasil (lot # not specified).  It was reported that the patient experienced some swelling after the first dose however it was not as severe as after the 2nd dose.  The patient received her 2nd IM dose (date not provided) of Gardasil (lot # not specified) and immediately after "got a little knot/swelling at the injection site" and a couple days later the upper arm and under the arm area was swollen.  The patient sought unspecified medical attention.  Additional information has been requested.
Pt was given dose one of the pfizer vaccine. Pt is 14 years old. Pt's mother signed the consent form. Pt and mother were notified of the mistake. The mother assumed responsibility. Pt mother stated she just "came and assumed everyone could get the vaccine". Pt appeared older than 16 years of age given the pt height and weight. The birth date written, was overlooked. When error was noticed, staff went to the observation area where the pt was already waiting their alloted observation time. Pt and mother were held for an additional 20 minuets on top of their already 30 min wait. No severe reactions/ anaphylactic  Pt's vitals were 88P 20 Resp 97.5 Temp and the site was clean. Pt and mother were both instructed to go to the ED and or family physician if any serious reactions occur.  Pt's mother verbalized she would and it is not necessary at this time. Pt felt normal and left the site.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298676, 2018SA298677, 2018SA298675, 2018SA298672 (same reporter). This case involves a 58-yeart-old female patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history was not provided. No other vaccines were administered on that day. On 25-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AA via intramuscular route in the left arm. It was a case of actual medication error due to inappropriate age at vaccine administration, Overdose accidental and Product name confusion. It was reported that they had two different kinds of flu vaccine which caused the confusion. Patient had questions regarding having ulcerative colitis. The patient did not experience any 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 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.
Red, swollen, hot, hard center, itchy, painful to touch. Started as a quarter size patch and each day increased in size to about 3 inch by 5 inch patch as of today (day 4).   Used cold compress several times daily.
In the spring, i developed unexplainable runs of Supraventricular tachycardia with rates up to the 220s as evidenced by a 24 hour holder monitor. I had increasing episodes of feeling lightheaded and went to the ER 6/16/2021.
Sore arm; Hot and sweaty; Hot and sweaty; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot and sweaty), HYPERHIDROSIS (Hot and sweaty) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot and sweaty), HYPERHIDROSIS (Hot and sweaty) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot and sweaty), HYPERHIDROSIS (Hot and sweaty) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Information has been received from a healthcare professional concerning a patient of unknown age and gender. The concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose with VARIVAX (Merck) (lot # L028276, Expiration Date 28-JUL-2017 or reported as L019994, Expiration Date 02-DEC-2016, strength, dose and route were not provided) with M-M-R II (lot #, strength, dose and route were not provided). The VARIVAX (Merck) was improperly stored at 24.6 F for 60 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects reported. The M-M-R II did not undergo any excursion. This is one of two reports from the same source. Additional information has been requested.
IgG test that was zero; This is a spontaneous report from a non-contactable physician via a Pfizer-sponsored program. A patient of unspecified age and gender received the second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date) with unknown age of vaccination via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date) with unknown age of vaccination via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The reporter mentioned that one of the doctors that she knows had an IgG test that was zero on an unspecified date after getting the second dose of the covid vaccine. The physician was asking how does that doctor that had the IgG test of zero know they are protected. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Not feeling well; Not feeling this way until receiving the shot; Weakness; Coughing; Does not have appetite; No taste (loss of taste); No smell (loss of smell); Stool is black/Black stool; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), FEELING ABNORMAL (Not feeling this way until receiving the shot), ASTHENIA (Weakness), COUGH (Coughing) and DECREASED APPETITE (Does not have appetite) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well), FEELING ABNORMAL (Not feeling this way until receiving the shot), ASTHENIA (Weakness), COUGH (Coughing), DECREASED APPETITE (Does not have appetite), AGEUSIA (No taste (loss of taste)), ANOSMIA (No smell (loss of smell)) and FAECES DISCOLOURED (Stool is black/Black stool). At the time of the report, MALAISE (Not feeling well), FEELING ABNORMAL (Not feeling this way until receiving the shot), ASTHENIA (Weakness), COUGH (Coughing), DECREASED APPETITE (Does not have appetite), AGEUSIA (No taste (loss of taste)), ANOSMIA (No smell (loss of smell)) and FAECES DISCOLOURED (Stool is black/Black stool) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on pacemaker prior to receiving the first dose of Moderna vaccine.  Second dose of the patient was scheduled on 04-Sep-2021.
pt recvd vax 16AUG93 & 20AUG93 930AM lump devel @ inject site; pt taken to MD & lump examined 1" x 1 1/2 " x 1/4"
Dose #1- 2 days after receiving my first covid 19 vaccine I had 2 days of scant/light vaginal bleeding and lower back pain. Very abnormal because I have the Nexplanon implanted in my arm and may have 2-3 periods per year. Normally the periods I do have are heavier and last 3-5days.  One week later I had about 3 days of left ovarian pain. Dose # 2- One day (which is today) after receiving my second vaccine I started with scant/ light vaginal bleeding and lower back pain. No ovarian pain yet.
04/01/21: Period was heavier than normal with clots larger than quarters. Lasted longer than previous periods. 04/19/21: Developed idopathic non-pruitic rash all over torso that lasted 3 weeks. Periods every month remained longer and heavier, bright red with large clots, worsening each month. 07/06/21: Developed tendinitis in left elbow with no injury preceding 07/22/21: Second idopathic rash to wrists, arms, knees, this one was pruitic with accompanied right eye swelling.  Lasted 3 days. 07/22/21: Period now so heavy I was bleeding through a super plus tampon every 2 hours. 09/13/21: Menstrual bleeding started and did not stop for 38 days.  This time with two 5 day stretches in the middle that I passed numerous blood clots the size of kiwis.   Stopped bleeding on 10/20/21 10/30/21: Started menstrual bleeding again, this time until 11/07/21 days with large clots.   11/16/21: Started menstrual bleeding again, bright red.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "tired". Additional information: Caller stated he was a Pfizer colleague, and that when anyone told him an adverse event or potential adverse event he had reported it, stated he did this a handful of times because someone had told him something in conversation or passing, states he got a letter in the mail asking for additional information for a report, states he was unsure which reported event the letters are referring to, stated he got 2 of these letters, stated they do not state what the events were regarding. Reporter stated he thought maybe these letters are in reference to his most recently filed report on 22Aug2021. He further stated he was talking to a friend he plays video games with online, states he does not know him in real life, states the friend stated he and his wife got the Pfizer Covid vaccine and they had a sore arm after and they were tired, but the friend stated he was glad they got the vaccines. Caller stated he does not know any further information. 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-202101206829 same reporter/drug/event, different patient.
Pt states she first noticed redness, itching 2 days ago, on her right upper arm where she had PREVNAR shot on 3/4/14. The area is itchy. No fever, chills, or sweats. She has had increased migraines 1/day since having the PREVNAR vaccine.
Bad stomach pain; I had extreme abdominal pain for hours and diarrhea; I had extreme abdominal pain for hours and diarrhea; This is a spontaneous report from a non-contactable other Health Professional (patient).  A 19-years-old female patient (not pregnant) started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176), via an unspecified route of administration at left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient historical vaccine included the first dose of BNT162B2 (lot number: EL1284) at left arm on 22Dec2020. The patient had extreme abdominal pain for hours and diarrhea. She ended up in the emergency room and nothing was found wrong with her ultrasound, bloodwork, or urine sample. She never had stomach issues so the doctor thinks this was a result of the second dose of the vaccine. She have had experienced such bad stomach pain. The adverse event (AE) start date was 13Jan2021. AE resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events included intravenous fluid and pain relievers and zofran. The patient recovered from events in Jan2021. Since the vaccination the patient hadn't been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
CHILD WITH POST IMMUNIZATION TEMPERATURE OF 103F ON 12SEP03@0824; PATIENT SEEN AT THE clinic AND  DIAGNOSED WITH VIRUS. CHILD GIVEN SUPPOSITORIES FOR FEVER.  PATIENT EATING AND URINATING Q4 HOURS, CLINIC WILL SEE PATIENT AS WALK IN APPOINTMENT BEFORE 1100 HOURS. FATHER CONTACTED BY THE ON CALL NURSE , TO MAKE FOLLOW UP APPOINTMENT. CHILD TREATMENT WITH ANTIBIOTIC; AMOXICILLIN AND TYLENOL; PARENT TOLD NOT TO LET THE CHILD HAVE PETUSSIS VACCINE
Pt. c/o bilateral peri-orbital swelling and lower lip swelling. Lungs clear to ascultation. No rashes, urticaria at site of injection. Benadryl 50 mg. by mouth adm. Ice packs to eye lids bilaterally.
30-45 min after vaccines given child felt light-headed, sat down on front steps.When I was notified child was in back seat of cab and back to normal condition for child
Immediately following both shots, my throat started to tighten, but never got to a point where I could not breath.; now have to pee every hour; I developed mild vertigo; I have pressure in the front of my head above my eyes and headaches daily; I am now always tired; I have not been able to think straight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 10:00 (Lot number: ER8732) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROAT TIGHTNESS (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "Immediately following both shots, my throat started to tighten, but never got to a point where I could not breath."; POLLAKIURIA (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "now have to pee every hour"; VERTIGO (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "I developed mild vertigo"; HEADACHE (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "I have pressure in the front of my head above my eyes and headaches daily"; FATIGUE (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "I am now always tired"; FEELING ABNORMAL (disability) with onset 25Mar2021 09:00, outcome "not recovered", described as "I have not been able to think straight". The events "immediately following both shots, my throat started to tighten, but never got to a point where i could not breath.", "now have to pee every hour", "i developed mild vertigo", "i have pressure in the front of my head above my eyes and headaches daily", "i am now always tired" and "i have not been able to think straight" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; covid-19: negative. Therapeutic measures were taken as a result of throat tightness, pollakiuria, vertigo, headache, fatigue, feeling abnormal.  Clinical course: All of these symptoms developed immediately after the first shot and got worse when I got the second. I was a healthy person before the vaccines which is why I am filing this report. Happy to assist in providing any tests to try to resolve these issues. patient did not have COVID prior to vaccination. the patient tested COVID after vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101803748 similar report from same reporter
This case was reported by a pharmacist via call center representative and described the occurrence of eye swelling in a 62-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9335Y, expiry date 30th June 2017). On 17th November 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 17th November 2016, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced eye swelling and sticky eye. on 18th November 2016, the patient experienced squint. On an unknown date, the outcome of the eye swelling, sticky eye and squint were unchanged. The reporter considered the eye swelling, sticky eye and squint to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. At 12 hours, the patient received a dose of FLUARIX QUADRIVALENT in her left deltoid. Later in the evening after receiving the flu shot, the patient reported that her left eye began to have gunk in it and was swollen. On the day of reporting (Friday), when she woke up, her both eyes had gunk in them and they were swollen. On the same day, she had squint eyes. The reporter's call was transferred to medical information.
strained muscle; shingles hurts/pain/in pain; little bumps; little bumps that look like heat rash; little bumps that look like heat rash and discolored.; can't sleep; received the second dose of Shingrix in the summer 2018 / last Thursday, 9/3/2020 he was diagnosed with shingles/ Suspected vacination failure; shingles/shingles again; This case was reported by a consumer via call center representative and described the occurrence of suspected  vaccination failure in a 66-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 shingles (experienced shingles in 2013, for 5 to 6 months with nerve pain) and nerve pain. Previously administered products included Zostavax.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In August 2020, unknown after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced muscle strain, pain, swelling, heat rash, skin discoloration and sleeplessness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, muscle strain, pain, swelling, heat rash, skin discoloration and sleeplessness were recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the muscle strain, pain, swelling, heat rash, skin discoloration and sleeplessness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that he received the second dose of Shingrix in the summer 2018, in left arm.  He thought that he had a strained muscle on his side from playing golf so he saw his physician on 3rd September 2020.  The patient was diagnosed with shingles which started 8 days ago on his right side. He reported that the shingles hurts a lot with a few little bumps that look like heat rash and were discolored. The patient could not sleep at night and the area affected was from his right side going from his sternum under his right breast along his side and spine and back. He claimed that it was around his torso. In 2013, patient had a horrible case of shingles for 5 to 6 months with nerve pain on his left side. The patient reported that he did get the Zostavax vaccine after his shingles experience in 2013. This shingles experienced was not as bad as his first case of shingles. He believed that he received the Shingrix in his left arm and his condition was improving a little from last week and his pain has lessened 20 percent at the time of reporting. The patient stated that he was just frustrated. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Early April wife noticed major changes (face dropping) doctor said reoccurrence after surgery is rare; Facial weakness and spasms; Facial weakness and spasms; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Early April wife noticed major changes (face dropping) doctor said reoccurrence after surgery is rare) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Facial weakness, Facial spasm and Surgery (To eliminate left side facial weakness and spasms.) in 2015. Concomitant products included TIABENDAZOLE (STATIN [TIABENDAZOLE]), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), VITAMIN B12 [VITAMIN B12 NOS] and BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Early April wife noticed major changes (face dropping) doctor said reoccurrence after surgery is rare) (seriousness criterion medically significant), FACIAL PARESIS (Facial weakness and spasms) and FACIAL SPASM (Facial weakness and spasms). At the time of the report, FACIAL PARALYSIS (Early April wife noticed major changes (face dropping) doctor said reoccurrence after surgery is rare), FACIAL PARESIS (Facial weakness and spasms) and FACIAL SPASM (Facial weakness and spasms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information included blood pressure medication (not specified).  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested