chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Congestive heart failure; Other related health complications; Bell's Palsy; Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to 76-year-old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. In September 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (also reported as shingles vaccine) for prophylaxis (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided) at a pharmacy (he was 73-year-old when he received the vaccine). On an unknown date, as result of said administration, the patient suffered congestive heart failure, including any and all of its sequelae. Then, in or about January 2015, as a result of his receipt of zoster vaccine live (ZOSTAVAX), he suffered shingles. Then, in or about February 2015, as a result of his receipt of zoster vaccine live (ZOSTAVAX), he suffered Bell's Palsy, including any and all of its sequelae. On an unknown date, he also experienced other related health conditions (ill-defined disorder). As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. In addition, the patient required and would continue to require healthcare and services. He had incurred and would continue to incur medical and related expenses. Besides, he had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient reported direct medical losses and costs included physician care, monitoring, and treatment. He had incurred and would continue to incur mental and physical pain and suffering. The outcome of cardiac failure congestive, facial paralysis, herpes zoster and ill-defined disorder was reported as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Cardiac failure congestive, facial paralysis, herpes zoster and ill-defined disorder were considered disabling events by the reporter.  Upon internal review, facial paralysis and cardiac failure congestive were considered medically significant events.
Left arm sore at injection site/pain on left arm/pain in left arm were vaccine was injected; 14 year old son was given the Moderna covid19 vaccine an that it was the wrong vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE. Past adverse reactions to the above products included Hand pain with INFLUENZA VACCINE. Concurrent medical conditions included Allergy to nuts, Crab, Pollen, Cat, Dog, and Improvement after treatment since April 2018. Concomitant products included VITAMIN D from 2019 to an unknown date, VITAMIN C from 2019 to an unknown date and MULTIVITAMIN for an unknown indication.    On 29-Oct-2021 at 3:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE. On 29-Oct-2021 at 8:00 PM, the patient experienced VACCINATION SITE PAIN. On 29-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE had resolved. On 01-Nov-2021, VACCINATION SITE PAIN had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter stated that patient was inadvertently given his first dose of the Moderna vaccine on 29 OCT 2021 instead of Pfizer's. Patient had treated his left arm pain with pack of ice. Treatment information was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes on 01-Nov-2021 the Follow up received contain significant information. Added reporter details, patient Date Of Birth, suspect product details, and events. On 04-Nov-2021 the Follow up received was non significant. On 04-Nov-2021 the Follow up received contain significant information, updated patient demographics, medical history, vaccination time, concomitant drugs, and event details.
I experienced severe hives on my arms, legs, feet, back and neck. I also was experiencing some swelling in my fingers and feet. My hives were very warm to the touch and looked like a sunburn. I noticed the hives the day after I rec'd my injection. I rec'd my injection on 10/18/2005 at approximately 2:20pm. I noticed the hives 10/19/2005 at approximately 10:30am. They contined until I was able to get an appointment on 10/20/2005 at 2:30pm. I had been taking my Atarax for the itching with some sign of itching relief, but not the hives disappearing. Once in the Dr. office I was given a shot of Benadryl and sent on my way. I have noticed the hives and itching are back after taking 2 doses of Atarax today 10/21/2005. Its bothersome.
DROWSINESS; SLEPT THE WHOLE DAY; FELT SLOW; COULD NOT REALLY MOVE; JOINT ACHES IN LEGS; TIREDNESS; HEADACHES; MUSCLE ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (2 beers a week), and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, administered on 10-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 11-JAN-2022, the patient experienced drowsiness, slept the whole day, felt slow, could not really move, joint aches in legs, tiredness, headaches, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint aches in legs, and muscle aches on 12-JAN-2022, was recovering from tiredness, and drowsiness, had not recovered from headaches, and the outcome of could not really move, slept the whole day and felt slow was not reported. This report was non-serious.
Night sweats, woke up 4 times; Sore arm; Tightness in chest; Fever; Headache; Pain under armpit; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2022, the patient received the 2nd dose of Shingrix. On 24th January 2022, less than a day after receiving Shingrix, the patient experienced pain in arm, chest tightness, fever, headache and axillary pain. On 26th January 2022, the patient experienced night sweat. On an unknown date, the outcome of the pain in arm, chest tightness, fever and headache were recovered/resolved and the outcome of the axillary pain and night sweat were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chest tightness, fever, headache, axillary pain and night sweat to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The reporter stated that she experienced a sore arm, tightness in the chest, fever, headache, and pain under the armpit which started on that day.  All symptoms had resolved except for the pain under the armpit which was still present. The reporter also stated that she started to experience night sweats last night on 26th January 2022 and woke up 4 times during the night.  The night sweats had not resolved. The reporter did not consent to follow-up.
Slight swelling of tongue within a few minutes of injection. Symptom subsided within next 10 minutes
Pfizer Dose 1 4/6/21 (ER8734) Pfizer Dose 2 4/30/21 (ER8736) Pfizer Dose 3 11/22/21 (FH8028) COVID Positive 2/20/22  2/20/22: A 56-year-old gentleman with history of end- stage liver cirrhosis, presented to the emergency room with history of confusion that started yesterday as per family member. Family member also reports that the patient was bleeding in the gums.  He was recently seen at the Hospital and Clinic and discharged from the emergency department.  He normally follows there for his end-stage liver cirrhosis with jaundice.  He has relapsed with drinking alcohol and is no longer on the transplant list as per family member.  Currently, patient is a poor historian. He is obtunded.  The patient and family do not want to be transferred to the hospital for further care. Transferred 2/20/22
throat "tight" - no skin rash;  no swelling of tongue;  no difficulty swallowing / talking.  TX: removal of mask, fresh air & bottle of water to drink per request - drank 1/3 of bottle initially without difficulty and reported improvement of SX immediately.  Remained in observation lot entire wait time & further issues.     Allergy PCN;  DM.
Information has been received from a healthcare worker (also a certified medical assistant) referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. The patient was administered a dose of MMR II on 30-SEP-2013 and a dose of another live vaccine (Oka/Merck) VARIVAX (dose and route were unspecified), on 03-OCT-2013. No adverse events were reported. Additional information has been requested.
Red streak down back of arm at injection site.  Tenderness.  Approx 3 days after injection, I developed a jittery, trembling feeling in both arms (similar to when you overexercise)  No physical signs of trembling are evident, just the feeling.  This has continued with no increase or decrease in the symptom.
brought to ED for confusion, placed on 4L O2, started on decadron 6mg daily
Patient was in for a 5 year old well child check. Nurse was supposed to give Infanrix(Dtap), IPV, varicella, MMR. The nurse ended up giving Pediarix (Dtap, IPV, Hep B), IPV, varicella, and MMR.
diarrhea; sick of the stomach; headache; pain in hte "Cheekbutts"; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VACCINATION SITE PAIN (sore arm), ABDOMINAL DISCOMFORT (sick of the stomach), HEADACHE (headache) and MYALGIA (pain in hte "Cheekbutts") in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 20-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (sick of the stomach), HEADACHE (headache) and MYALGIA (pain in hte "Cheekbutts"). At the time of the report, DIARRHOEA (diarrhea), VACCINATION SITE PAIN (sore arm), ABDOMINAL DISCOMFORT (sick of the stomach), HEADACHE (headache) and MYALGIA (pain in hte "Cheekbutts") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX. Concurrent medical conditions included blood pressure high, cough and difficulty breathing. Concomitant products included fluticasone propionate, ADVAIR DISKUS, Calcium, FLONASE, SINGULAIR, Celapram, fish oil, lisinopril, MVI, TOPROL XL, verapamil and NORVASC. On 25th April 2018, the patient received SHINGRIX. In April 2018, 1 day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, tiredness, headache, fever, chills and upset stomach. On 25th April 2018, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the swelling arm and erythema of extremities were not recovered/not resolved and the outcome of the tiredness, headache, fever, chills and upset stomach were unknown. The reporter considered the pain in arm, swelling arm, erythema of extremities, tiredness, headache, fever, chills and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX shot on Wednesday. The patient experienced soreness immediately that day.  The next morning, the patient's husband saw her arm was redness and swelling. The patient received the shot on the back side of her arm up toward her shoulder blade. The patient stated that her arm was increased about 2 by 2 to 3 by 4 areas, but it was not as sore. The patient also stated that the day after later in the evening experienced upset stomach, fever, chills, headache and tiredness. The patient began taking lisinopril the day before the vaccination and that day had trouble breathing and cough. The patient took it for about 2 days then contacted the physician's office, who instructed her to stop the Lisinopril. The patient denied the cough and breathing trouble being related to her SHINGRIX and she had the same issue with two other blood pressure medications verapamil and NORVASC. She was being started on another medication but had not picked it up yet. She was encouraged to notify her physician about the experience she had with the SHINGRIX, since she had not already.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HLAB27 related autoimmune arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report as received from a healthcare worker via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HIB (lot #, expiration date, dose not reported). No concomitant medications were reported. The reporter stated that the patient had only received the first two doses in the RECOMBIBVAX HB series, and those two doses were given abut a year apart at an unspecified facility. No adverse effects reported. Additional information has ben requested.
12.5cm X 9.5cm reddened area, mildly tender, no swelling noted. Pt. c/o "fever" X 2 days.
Sensation of swelling in legs, knees, elbows and hands. Mild pain in quads, sweating, sensation of dyspnea. Treated 2 weeks prior for hives due to ibuprofen (took BENADRYL). Multiple sensitivities, told she had "hereditary angioedema type 2 protein", unconfirmed record. No rxn at injection site. Started on PREDNISONE 3/20. Unremarkable exam.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. 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.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 23rd July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 1 days after receiving SHINGRIX, the patient experienced headache, appetite absent and fever. On an unknown date, the outcome of the headache, appetite absent and fever were recovering/resolving. It was unknown if the reporter considered the headache, appetite absent and fever to be related to SHINGRIX. Additional details were reported as follows: This case was linked with case US2018133440, reported by the same reporter for the same patient.
Patient was ordered a COVID vaccine on 5/3 which was prepared by the pharmacy. Patient later refused administration and it seems that the dose was placed back in the unit's refrigerator. The vaccine was ordered again on 5/4 when patient agreed to take it. The patient was given the dose prepared the day before instead of the one prepared the same day. Upon contacting the manufacturer, new information was made available regarding the vaccine's stability. Physical stability is maintained for up to 24 hours, but clinical immunogenicity is not tested.
tired; nausea; headache; Upper arm rash; pain; itching; Puckering of skin; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th November 2019, 2 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced tiredness, nausea and headache. In November 2019, the patient experienced rash zosteriform, pain in arm, itchy upper limbs and skin wrinkling. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the tiredness, nausea and headache were resolved with sequelae and the outcome of the rash zosteriform, pain in arm and itchy upper limbs were recovering/resolving and the outcome of the skin wrinkling was unknown.   It was unknown if the reporter considered the tiredness, nausea, headache, rash zosteriform, pain in arm, itchy upper limbs and skin wrinkling to be related to Shingrix.  Additional details were received as follows: The patient received the 1st dose of vaccine and was very tired and had slight nausea and headaches. The symptoms lasted a couple days before resolving.  The patient also noticed horrendous rash on most of her upper arm. The patient arm was painful so she  could not touch it and it itched. The patient thought the rash looks like shingles. The patient sent a picture to her physician and he prescribed valacyclovir, but she did not actually go to the physician's office. The patient stated that rash has improved, it was lighter and a little smaller and the pain was leaving her arm.  The patient noticed some puckering of the skin on her arm. The patient consented to follow up. This case has been linked to US2019205795 and US2019GSK206553 reported by the same reporter.
10:30pm uncontrollable shivering and shaking and teeth chattering, racing thoughts and mild-moderate delirium, 11:30pm pounding and racing heart (my normal resting HR is 55bpm, and Hr was 120-130bpm) which continued the entire night into the morning, 12:30 hot and cold flashes, neck pain and stiffness and jaw pain, pain/discomfort in lungs when taking deep breath, 1:00am took 1000mg acetaminophen, insomnia the entire night as well until 4am. These symptoms continued into the following day 4/25/21 on and off until 9pm (along with expected symptoms like muscle aches and joint aches) and the pain in lungs with a deep breath continued consistently until 9pm 4/25/21. As of 4/26/21 all symptoms have resolved.
(L) arm raised welt with heat and flushing down (L) arm halfway. Was given Depomedrol 80 mg IM.
Pt. states she had nausea & fever 102 degrees that night, also a headache. She reports diarrhea the following day, with 99 degrees T.
9 days after she received her first dose of the Moderna vaccine, she developed tenderness, swelling and redness at the injection site. After the injection itself, she had only minimal symptoms for 2days. She did not have a fever. No further testing was done, and no specific treatment was prescribed.
quite dizzy and loopy; she was quite pale; feeling to being high or drunk; feeling to being high or drunk; almost fell over the coffee table; notes a warm sensation; slept for many hours; This is a spontaneous report from a contactable consumer (patient).   A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 02Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.   On 02Feb2021, after receiving her first dose of Pfizer-Biontech Covid19 vaccine last Tuesday patient experienced a severe reaction. She waited in her car for 15 minutes after administration, then notes a warm sensation when she started driving away, states she drove home on autopilot not sure how she made it home. Upon arriving at home, she noted she was quite dizzy and loopy, almost fell over the coffee table, her husband told her she was quite pale, and she equates the feeling to being high or drunk. She stated that she went to bed, slept for many hours, and when she woke up, she felt a lot better and asked is this a severe reaction and what should she do about the second dose. The clinical outcome of all the events was resolving.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.         Question: Caller is a consumer reporting AE's after receiving her first dose of Pfizer-Biontech Covid19 vaccine last Tuesday, 02Feb2021. She believes she had a severe reaction. She waited in her car for 15 minutes after administration, then notes a warm sensation when she started driving away, states she drove home "on autopilot" -not sure how she made it home.  Upon arriving at home she noted she was quite dizzy and "loopy", almost fell over the coffee table, her husband told her she was quite pale, and she equates the feeling to being high or drunk.  She state she went to bed, slept for many hours, and when she woke up she felt a lot better.  Is this a severe reaction? What should she do about the second dose?   Call Details:  Callback to (phone number withheld); (name withheld) 43 y/o  Had the Pfizer first dose last Tuesday 02Feb2021 at a college in (place name withheld) Questions about the second dose-  Severe Reaction? Waited in the car 15 minutes -  warm sensation and then as I started driving away, I was on autopilot and felt stoned-ish- not right - dizzy/loopy almost fell over the coffee table. slept it off and had my husband check on me-  when I woke up I felt better  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.