chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health authority concerning a 36 year old male who on 11/10/2005 was vaccinated intramuscularly in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot #648713/1336N, batch #hv24420). Concomitant suspect therapy given intramuscularly in the same arm included a dose of influenza virus split virion 3v vaccine inactivated (Enzira) (batch #02701). That same day the patient experienced a severe systemic reaction. The patient felt unwell (fatigue) and feverish with a very painful, red, and swollen arm. He also had a headache. The symptoms persisted for five days. At the time of report the patient was recovering. It was noted that the patient had previously received an influenza vaccination without any adverse effects. No further information is available. Other business partner numbers include E200600625 and ADROIT IE002280. The reporter felt that fever, fatigue, pain in arm, swollen arm and headache were other important medical events. (OMIC)
Tachycardia felt "cold" all over and "tingly" . hr 120 Narrative: EMS called and evaluated patient
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-AUG-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # H012351, expiry date 21-JUN-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
The vaccine administered was stored outside of temperature range for 96 hours, with a maximum temperature reaching 51.8F. Normal range is 36-46F. The manufacturer reported that Heplisav-B is good for 8 hours with temperatures above 46F. The product is no longer usable if stored longer than 8 hours, in that higher temperature setting. No treatment is indicated. Per CDC recommendations, the employee will need to be re-vaccinated and may do so immediately, no need to wait. The employee was notified of the event and the need to revaccinate; appointment was made.
This spontaneous report as received from a health care worker refers to a 1 year old male patient. The concurrent condition, medical history and concomitant medication was not reported. On 17-JUL-2015, the patient was inadvertently vaccinated with PROQUAD (Merck) and VARIVAX (Merck) (dose, route and dose details unavailable) (inappropriate schedule of vaccine administration). No adverse event was reported. Additional information has been requested.
Extreme dizziness, nausea, vomiting the following morning after shot and worsened as day progressed.  Went to Hospital Emergency Department to be seen (02/04/2021).  Was prescribed meclizine 25 mg and ondansetron 4 mg.  Was told that this was a reaction that they (hospital and doctor  had seen with recent vaccine patients.
Muscle fasciculation in left arm; This case was reported by a physician via call center representative and described the occurrence of fasciculation in a 71-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   Concurrent medical conditions included animal bite (rabid bat). Concomitant products included Rabies NVS (RabAvert).   On 3rd May 2020, the patient received the 2nd dose of RabAvert. On an unknown date, less than a week after receiving RabAvert, the patient experienced fasciculation. On an unknown date, the outcome of the fasciculation was unknown.   It was unknown if the reporter considered the fasciculation to be related to RabAvert.  Additional details were reported as follows: The patient just completed 2 doses on day 0 and day 3 after post-exposure to rabid bat on 30th April 2020 and 3rd May 2020.  The patient experienced muscle fasciculation in left arm.  Exposure could have been a week before starting treatment. The reporter did not give consent to follow up.
Patient returned ~15 minutes after her third dose and reported feeling a little dizzy with "heavy legs". She said this started immediately post vaccination. She was advised to sit for observation/monitoring, however she refused. She insisted her husband to take her home. She did call when she returned home to report she made it safely and she checked her BP, which was 118/68. She said this is normal for her. She also stated that she has a history of tinnitus and vertigo. She said she would continue to rest with her legs propped up.
Developed fever up to 99, severe aching in all joints, headache, chills, loss of taste, injection site in arm sore.  Felt fine evening of 2/2/21 (date of injection) and awoke 0500 2/03/21 with symptoms listed here. Fever broke about midnight of 2/3/21 and only mild headache and feeling of fatigue next 2 days and then all symptoms completely disappeared.
Severe body aches, fever, weakness in hands and legs, fatigue, headache, pain in right leg, right arm, neck and lower back. Difficulty holding objects or walking.
Needle was not  tighten on hub of vaccine; Small amount of vaccine went in; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (Needle was not  tighten on hub of vaccine) and UNDERDOSE (Small amount of vaccine went in) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (Needle was not  tighten on hub of vaccine) and UNDERDOSE (Small amount of vaccine went in). At the time of the report, DEVICE CONNECTION ISSUE (Needle was not  tighten on hub of vaccine) and UNDERDOSE (Small amount of vaccine went in) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided
itchy feet, hands, eyes, voice became hoarse within 15 minutes of shot; took Benadryl immediately (as I do for food allergies); cleared up symptom of voice, but not itchiness; took 3 Benadryl spaced out over 1.5 hours, under care of nurses/EMT at site, but hadn't cleared up symptoms, so nurses directed me, with my accompanying friends, to an ER, where physician gave me Pepcid (rather than a steroid which he said would compromise the effect of the vaccination) and told me to take Benadryl every 8 hours for next 3 days
Extreme fatigue from 1620 on 1/6 gone when arose at 730 on 1/7 Fever starting at approximately 1900.  Fever broke in the early am approximately 0300 awoke and noted wetness as if had been sweating No fever when arose
got the shingles shot and got shingles\ Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the Shingles shot and got shingles. The patient stated they would not give the shot if you had the shingles, which was 130.00 after insurance, they had two new shots, the shot or shots already had, did not work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dose, route and site of administration were not reported) and M-M-R II, lot # L027434, expiry date 22-JUL-2017 (dose, route and site of administration were not reported) which was also improperly stored. There were no adverse effects reported. Administered vaccines experienced following temperature excursions: on 14-MAY-2016 6 degrees Fahrenheit (F) for 1.5 hours and on 20-MAY-2016 5.9 degrees F for 5.5 hours. The freezer returned to proper range in between all excursions. Data logger was involved. This is one of several cases received from the same source. Additional information has been requested.
Frustrated; next day her palm was big as her arms; Date of 2st Shot: Consumer Stated, "2 August, 2021; arm is hot and red and itchy around where the shot was; arm is hot and red and itchy around where the shot was; arm is hot and red and itchy around where the shot was; This is a spontaneous report from a contactable consumer (Patient).   A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, in left arm on 02Aug2021 (at the age of 59-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history was not reported. The concomitant medication of the patient included levothyroxine sodium (SYNTHROID). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown) via unspecified route of administration, on 17Apr2021 as a dose 1, single for COVID-19 immunization. On 02Aug2021 the patient experienced arm was hot and red and itchy around where the shot was and bigger than it was on Monday night. Three days ago, the patient had redness. Patient was frustrated. Patient reported that her palm was big as her arms, and she was very swollen and patient stills feels it warm to the touch. Patient was informed about Pfizer Medical Information Department. Patient stated that she will call her doctor because she had already talked to three people, and it was not getting patient anywhere. So, patient was okay to not going to call anybody else. Patient had lab test 2 twice 2 weeks ago. Patient stated that she was pretty healthy. The patient received the treatment of Advil 200 mg. Outcome of all the reported events was unknown.  Information about Lot/Batch has been requested.
Patient was suppose to be receiving a meningococcal conjugate vaccine and received a Haemophilus b Conjugate Vaccine in error.
Skin red from head to toe. Itching, weakness. Tachycardia - edema. Treatment. IV NS. BENADRYL 50mg IM. 25mg IV. o2 SOLUMEDROL 50mg IVP.
Left Shoulder injury; Ear issue; Tenderness in the side of neck; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Left Shoulder injury), EAR DISORDER (Ear issue) and NECK PAIN (Tenderness in the side of neck) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Ulcerative colitis and Ankylosing spondylitis.    There was no reported medical history.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced EAR DISORDER (Ear issue) and NECK PAIN (Tenderness in the side of neck). On an unknown date, the patient experienced LIMB INJURY (Left Shoulder injury). At the time of the report, LIMB INJURY (Left Shoulder injury), EAR DISORDER (Ear issue) and NECK PAIN (Tenderness in the side of neck) outcome was unknown.            Concomitant medications were not reported.  It was unknown if patient was enrolled in COVID-19 vaccine Trial. Treatment medications were not reported.   Reporter did not allow further contact
7 days after injection,on 01/28,  an inflamed looking, slightly raised rash area developed with itching right on the injection site. By the next day a much larger area developed below that at about 3x3 in.   Now, on 02/04/2021, the area has in leased in size to about 4x3 and is still itchy.  The initial site enlarged also. It is not a big problem but I thought I?d report it.  I?ve read it should disappear within about 7 days.  I?m past 7 days now.
Her arm is getting sore now; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm is getting sore now) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her arm is getting sore now). At the time of the report, PAIN IN EXTREMITY (Her arm is getting sore now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication not provided. Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: NNI
Patient C/O of facial numbness and dry mouth. At 1330, patient's vital signs were BP 146/97; T 36.9; P 96 b/m; Oxygen saturation 100%; R 18.   The patient was evaluated by responding  physicians. At 1420, the patient denied difficult breathing or worsening symptoms, and ambulated out of the observation area with steady gait.
Ringing the in my ears; PAIN ALL OVER THE BODY; Temperature of 101-degrees F; Muscles aches; SORE ON VACCINATION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 08-MAR-2021 16:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sore on vaccination site. On 09-MAR-2021, the subject experienced ringing the in my ears. On 09-MAR-2021, the subject experienced pain all over the body. On 09-MAR-2021, the subject experienced temperature of 101-degrees f. On 09-MAR-2021, the subject experienced muscles aches. Laboratory data included: Body temperature (NR: not provided) 101 F. On 10-MAR-2021 07:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from temperature of 101-degrees f, and the outcome of sore on vaccination site, muscles aches, pain all over the body and ringing the in my ears was not reported. This report was non-serious.
Also received a influenza seasonal quadrivent high dose 65+ vaccination intramuscular injection in right arm same day 2/6/2023.  36 hours after receiving both vaccinations patient is barely able to stand on his feet, he has numbness in both legs. He needs assistance to stand up and can not remain standing without assistance.  Can not get his legs to move forward to walk across the room.  He has been having urinary and fecal incontinence since these symptoms began.  He has no balance when he is standing.  He has been having these symptoms for 2 days and I am trying to get him to go hospital.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced breakthrough varicella. Ten days post onset the pt recovered.
Injection site bruising; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE BRUISING (Injection site bruising) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Colitis ulcerative.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE BRUISING (Injection site bruising). At the time of the report, INJECTION SITE BRUISING (Injection site bruising) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication history was not provided.  Treatment information was unknown.
approx. 15 minutes after Flulaval administration, pt. began to vomit (three times in small amounts). no other signs/symptoms after vaccination. between time of vaccine admin. and adverse event, the pt. reported not eating breakfast and complained of stomach discomfort and decided to have a snack at the flu shot clinic.
Patient experienced swelling of bottom lip first.  This was followed by labored breathing.  An Epi-Pen (branded generic form) was administered in addition to two diphenhydramine 25mg tablets.  Patient was given a bottle of water.  Over the course of approximately 7 minutes she consumed about one-half of the bottle.  Paramedics were called.  Prior to their arrival at 9:47 AM, the patient experienced additional swelling of lips, this time the top, and labored breathing.  Another Epi-Pen was administered.  Patient reported some elevated heart rate and mild headache, probably as a result of the epinephrine administration.  She was transported to hospital at 9:49 AM.
Received Tdap and flu vaccine in Left arm on 2-16-16. 2 days later had swelling on arm and pain in arm when rotating arm backward from shoulder. Today at office visit requesting 2nd Td. Nurse palpated skin colored swelling approx. egg size midway upper left arm. Also pt has pain when moving arm backward. Symptoms reported as unchanged x 1 month. Nurse did not give 2nd Td. Spoke with Dr by phone and referred to see is established PCP.
tested positive for COVID virus; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, COVAX US Support. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration), via an unspecified route of administration on 02Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received her 1st dose of COVID-19 vaccine on 02Mar2021, but last 12Mar2021, she tested positive for COVID virus. She was scheduled to receive her 2nd dose on 23Mar2021, but she wanted to know if she could get it or if she needs to reschedule it since she has COVID virus. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Information has been received from a nurse via Pfizer (Mrf. control# 2016575911) for pneumococcal 13v conj vaccine (CRM197)(PREVNAR 13), referring to a 69 year old patient of unknown gender. The patient's concurrent conditions, concomitant therapy and medical history were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced a large red area, more that the local usual reaction. The reporter asked if the patient could be vaccinated with pneumococcal PREVNAR 13. The patient had not received PREVNAR 13 at the reporting time. The outcome of the event was unknown. Causality was not provided. Additional information has been requested.
1 week, 7 days after receiving the vaccine I noticed a red hard bump that was itchy on my left arm near the injection site. I googled and saw a lot of reports about ?covid arm?
received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe). At the time of the report, PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Severe itching in head advanced to face, neck, arms and legs. Treated with OTC Benadryl with little relief
Hearing loud ringing in both ears (tinnitus); This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at 1st dose, single on 25Feb2021 at 13:00 (Lot Number: EN6203, unknown expiration) and at 2nd dose, single on 18Mar2021 at 16:00 (Batch/Lot number was not reported), both via unspecified routes of administration in left arm at the age of 50 years old for COVID-19 immunization. Medical history included fibromyalgia. The patient has unspecified concomitant medication. On 25Feb2021 at 17:00 (about 4 hours after receiving the first dose), the patient started hearing loud ringing in both ears (tinnitus). The event resulted in doctor or other healthcare professional office/clinic visit. The patient was trying hearing aids, but it did not help so far. The ringing is still extremely loud 3 months later. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient had not yet recovered from the event. The event was assessed as serious (disabling/incapacitating).   Information on the lot/batch number has been requested.
local rxn w/redness & swelling 3-4" diameter;did have some vaccine 10yrs ago, could have been rhesus monkey vaccine
Severe joint pain for 24 hours.  Passed out in the morning after the vaccine.
Raised red hardened bump over injection site. Hot to touch. Very itchy. Fifty cent peice size. 5mm on wheal.
Right Foot Pain - sudden onset/similar to gout pain, however affecting the entire foot region and not the large toe.