chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tubersol was given in error instead of Adacel/ no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00378506) and transmitted to Sanofi on 02-Dec-2020 .    This case involves a 63 year old female patient who received a TUBERCULIN TEST (TUBERSOL) (lot number C5736AA, expiry date 22-Aug-2022, Multidose vial, standard) via intramuscular route in left deltoid for tuberculin test instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) on 02-Dec-2020 (Wrong product administered).    The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   No other vaccine was administered concomitantly.  This was an actual medication error case due to Wrong product administered (latency same day).   Case details- Reporter stated that she had a vial of Adacel and mutidose vial of Tubersol and she accidentally drew up the Tubersol as 0.5mL and injected it into the patient (also reported as TUBERSOL was mistakenly administered  instead of flu shot). Reporter realized the error after the Tubersol was administered. Reporter asked if there could be any effects of overdose and intramuscular (IM) injection of the Tubersol. Reporter was unable to locate any information on this other than not to inject IM  At the time of reporting, no adverse event was reported.   Patient was administered another dose of Tubersol 0.1mL intradermal and a dose of Adacel 0.5mL IM.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Pt devel a red, raised rash over trunk & arms 9 days p/receiving flu vax;
Severe pain in left arm. Muscle pain. Extremely tired and weak. Severe headaches. Shivering. Hot flashes. Upset stomach. Piercing ear pain. 24 hours of severe pain. Then pain subsided.
On 9/20/2018 around 10pm I began experiencing severe aches and pains, overall weakness and a sore throat. I decided to go to bed as I did not feel well. When I woke up the next morning (9/21/18 around 7 am) I experienced severe dry mouth, confusion and dizziness as well as severe body pains, increased urination, a stiff neck/back and broke out into a sweat all over my body. Dizziness and confusion subsided around noon on 9/21/18 but am still experiencing extreme joint pain and drowsiness.
pt devel a lump @ inj site immed; 8 days later area became painful; 9 days later became hot, red, rash, more painful; pt would not move arm; seen @ hosp ER;
This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An 8-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose number unknown (orange cap; booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Nov2022, 1 week after the suspect product(s) administration, outcome "unknown", described as "A little itchy."; URTICARIA (non-serious) with onset Nov2022, 1 week after the suspect product(s) administration, outcome "unknown", described as "every day he is waking up with hives on his neck and torso primarily/some facial involvement"; RASH (non-serious) with onset Nov2022, 1 week after the suspect product(s) administration, outcome "unknown", described as "the rash did get one week after taking the Product". Therapeutic measures were taken as a result of urticaria, pruritus, rash.  Additional reporter: The physician has a patient who is 8 years old. She is calling in regard to the Pfizer COVID-19 Vaccine pediatric dose, 5 to 11 years of age. On 14Nov2022, the patient had the vaccine. This week for the last 5 days, every day he is waking up with hives on his neck and torso primarily. None on his extremities. Today there is some facial involvement. Everyday he gets this and every day it goes away; next day same thing, he gets it, and it goes away. This cycle continues to repeat himself. The patient was given Zyrtec, antihistamine, and she stated that he is responding to it, but hard to say. The patient also experienced a little itchy. The physician mentioned that it is more just a concern as to why this is happening and wondering if there could be an association with the vaccine. Physician confirms the symptoms didn't start immediately, but 1 week after getting the product. The rash did get one week after taking the product. The physician would like to know if there is any information on how long it will last. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
"pretty big" right arm swelling; flu-like symptoms the day after vaccination; vesicle formation on his one big toe; Herpes Whitlow; This is a spontaneous report from a contactable HCP reported for self. This 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant mediations was not provided. The patient experienced reported "pretty big" right arm swelling, and flu-like symptoms the day after vaccination (10Jan2021), both of which have resolved. He is asking about the incidence of what he described as "Herpes Whitlow" vesicle formation on his one big toe. The patient stated that it could be from beginning to run after a couple week hiatus. The patient stated he had been running which he hadn't been doing for a week or two. He has reviewed the literature and can find nothing. The outcome of events swelling in the right arm, and flu-like symptoms was resolved. The outcome of other events was unknown.   Information on the Lot/batch number has been requested.
ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 3/31/2023 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
Pt says there are 3 red dots on her arm, it is red, sore, and slightly warm to the touch
Patient stated after she waited 30 minutes her face swelled along with her eyes. She went to the physician and was given benadryl and prednisone tablets. Advised patient she should not receive the 2nd dose of Pfizer in the series and if she is requiring a 2nd dose she should investigate receiving Janssen.
6 hours after shot, severe headache and chills.  10 hours after shot vomiting every 1/2 hour for over two hours. 12 hours after shot went to ER . could not hold down fluids. was given IV and anti-nausha medicine. headache lasted two days.
Burning sensation in the chest. Three episodes in 36 hours after vaccine. Also experiencing congestion and cold symptoms since receiving the 2nd vaccine.
developed abd pain days after 2nd dose of Pfizer vaccine, came in 3 wk later for PEA arrest with dead gut secondary to extensive bud chiari syndrome w thrombosis of the portal vein, splenic vein, and superior mesenteric vein. Admitted to ICU/OR for ischemic small bowel removal.
Extreme fatigue (slept 29 of 30 hours);  all over body pain, major headache, intense shivering, horrible stomach pain and constant nauseousness.  Shot was given at 4:36pm; arm muscle soreness instantaneously.  Fatigue hit hard at 11pm same day. No idea what happened on day 2 as I was going through all the above symptoms and had mental fog.
Headaches, numbness in temples and head. Pressure on sides of head.  Pain in back of head and pressure in eyes.  These things made it impossible to sleep more than 3 or 4 hours each night.
Presented with  left neck, chest and upper extremity weakness, pain and burning that started on 5/1.  Stroke protocol followed and alteplase given 5/2. By morning of 5/3 all symptoms had resolved.
I Started to get a headache during my shift ( 6am to 14:30) . At home I became real tired and headache increased. Around 18: 00 I was so exhausted that I laid down, I got up about 45 minutes later, laid back down around 19: 30. I started to shiver and my temperature shot up ( 103.1). I was shivering so bad that my whole body was shaking. I took ibuprofen and acetaminophen to relief symptoms. Next day symptoms lasted pretty much all day. When I woke up my hands and fingers where swollen. With my first vaccination I only had a headache but second shot pretty much had the same symptoms than my booster. I did not call my physician.
heart failure; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 62-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions by healthcare provider in a clinic. On an unspecified date, the patient experienced heart failure. On an unspecified date, the patient was treated by a physician for heart failure. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event of heart failure was considered to be medically significant.
She had her 2nd shot on Thursday, April 22, 2021and 830 Saturday, April 24 2021 she was found on her floor unconscious by a neighbor who had not seen her since Friday morning (April 23). She has had several tests while in the hospital (she was admitted April 24, 2021) and cannot walk or remember what happened, yet all of her tests show no abnormalities.
Received expired vaccine/Punctured Vial was used beyond 12 hour expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine/Punctured Vial was used beyond 12 hour expiration) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine/Punctured Vial was used beyond 12 hour expiration). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine/Punctured Vial was used beyond 12 hour expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Total amount of time vial was exposed to room temperature range 46° to 77° F a little over 24 hours. Concomitant medications were not provided. Treatment information was not provided.
PATIENT RECEIVED VACCINE AND BECAME NAUSEOUS/DIZZY ALMOST IMMEDIATELY.  PATIENT VOMITED AND FELT BETTER.
not sure if last nights episode was an A Fib event; Woke up with a bout of tachycardia; This case was reported by a consumer and described the occurrence of atrial fibrillation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included paroxysmal atrial fibrillation (the patient not had any A Fib symptoms since an ablation was performed last summer).   On 15th December 2020, the patient received the 1st dose of Shingrix. In December 2020, 8 hrs after receiving Shingrix, the patient experienced atrial fibrillation (serious criteria GSK medically significant) and tachycardia. On an unknown date, the outcome of the atrial fibrillation and tachycardia were recovered/resolved.   The reporter considered the atrial fibrillation and tachycardia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient had paroxysmal A-Fib for which he/she was being treated. The patient received 1st dose of Shingrix and 8 hours after vaccination, the patient woke up at around midnight with a bout of tachycardia and it subsided after about 10 to 15 minutes. The patient was not sure if last night's episode was an A Fib event or just Tachycardia and was trying to confirm that with his/her cardiologist. The patient wanted to know should he/she still get the 2nd shot as required in 2 months. The patient does believe that the event was related to the vaccine.
8-8-2007 Mother noticed red "pimple" looking spots on left side of waist and 2 spots on lower back
No adverse effect; Four month old baby was administered a dose of GARDASIL 9; This spontaneous report was received from a healthcare professional referring to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), (1 dosage form, intramuscular) (strength, anatomical location and lot number with expiration date were not reported) for prophylaxis. On 27-SEP-2019, a four month old baby was administered with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product administered to patient of inappropriate age) and  the patient had no adverse event. The outcome of product administered to patient of inappropriate age and no adverse event was unknown.
Broke out in hives 5 days after first vaccine. Given steroid pack for treatment, symptoms subsided 6 days later. Have also had chest flutters and tightness in chest. Numerous random joint pain throughout the body since injection
PCV vaccine given 5-5-08.  Fever started that night per Mom and went up to 104.8 on 5-7-08 (ER visit to hospital).  Motrin and Tylenol given.
Severe adverse effects from the Pfizer Covid 19 first dose lasting from 10/15/21-10/24/21, including: Heart palpitations, shortness of breath, fever, soreness, weakness, and swollen gums.
About 3 pm on the 21st my arm started to ache, when Ibwoke up on Friday morning my entire arm was sore, the pain persisted all day and Friday evening the pain went into my entire arm to my hand and also to my chest and upper left back and neck.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  The vaccine was administered after 2 days of first puncture.  The Moderna vaccine was used as though it had preservative, just like flu multi-dose vials.
she got COVID between the first and second vaccine doses; she got COVID between the first and second vaccine doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: ER8733) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "she got COVID between the first and second vaccine doses".
Day 1-2: Hot flashes without fever; pain throughout nerves on left side (injection side), as well as numbness and tingling; neck pain; fatigue; inflamed joints.  Day 5-8: Bad fatigue (too tired to get out of bed or hold a pen to write); extreme pain in left side of neck and shoulder causing extreme pain in a nerve strip along base of the neck, up the skull, down the face and stopping at the nose-ear level; extreme headache on entire left side of head; Advil makes it tolerable after about an hour, then it comes back; entire left side still feels icy and hot, as well as numb and tingling; brain fog
Woke up in the morning, GI upset, diarrhea, woke up throwing up and it continued about a week. I went to Urgent Care in Payson -IV fluids and nausea medicine - Zofran- and that seemed to help. The IV fluids and I got better. Am fine now.
Developed acute gout in right foot, which presented as progressively severe pain in joint of my big toe. Diagnosed by doctor at urgent care. Indication was that gout occasionally occurs after vaccines due to effect on immune system. It was treated with prescribed prednisone for 10 days.
Had to wake patient up for school. Refused lunch at 12Pm, At 1:00PM Fever 101.4 Gave Motrin and put patient to bed.
Patient c/o abdominal pain, nausea and being pale 2 hours after influenza vaccine.
VIAL 1  was diluted with sterile diluent and injected into patient. VIAL 2 was not administered.
This spontaneous report was received from a physician referring to a 81-year-old male patient. The patient's pertinent medical history included unspecified type of cancer. The patient was allergic to penicillin. On an unspecified date in 2011 the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# and expiration date were not reported). On 23-AUG-2016, the patient developed shingles. The patient sought medical attention in the physician's office. No lab diagnostics studies were performed. The patient received unspecified treatment for the event. The outcome of the event was unknown. The causality between the event and ZOSTAVAX was not reported. This is one of two cases received from the same reporter. Additional information has been requested.
Less than a week after receiving my second dose of Phizer, I started having a sharp pain in the center of my chest (heart), felt like palpitations. It would happen a couple times a day. This continued for a little less than a week, maybe 5 days. Since then, no symptoms.
No adverse effect; Medical assistant called to report that on 2/20/2020 patient received a dose of improperly stored VAQTA.; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 20-FEB-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) 1 dose, lot # S025993, expiry date 17-OCT-2020 for prophylaxis (strength, vaccination site, route of administration unspecified). The temperature excursion was reported as below 36 degrees Fahrenheit (34 F) for a time frame of 27 minutes. Digital data logger was involved. There was no previous temperature excursion. No further adverse effects were reported. Product quality complaint (PQC) was not involved.
sore arm; dizzy; headache; muscle ache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIZZINESS (dizzy), HEADACHE (headache) and MYALGIA (muscle ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (sore arm), DIZZINESS (dizzy), HEADACHE (headache) and MYALGIA (muscle ache). At the time of the report, PAIN IN EXTREMITY (sore arm), DIZZINESS (dizzy), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
2:00 A.M. 2/18/2021 I awoke with muscle pain in left arm and left side of body.  I arose to use the bathroom and when standing at the sink experienced the room beginning to spin and darken.  I steadied myself at the sink; the dizziness passed; I returned to bed after taking two Tylenol tablets to relieve the pain.  My husband, who also received the Covid Moderna vaccine yesterday 2/17/2021 at 10:55 a.m. , was also awakened at 2:00 a.m. 2/18/20121 with the same muscle pains.   6:30 a.m. 2/18/2021 we were both feeling much better and able to carry on usual life activities (such as they are...)  [note 1: I walked 3 miles yesterday afternoon after receiving the vaccine and feeling perfectly fine.] [note 2: we both are enormously grateful for the vaccine!]