chrisvoncsefalvay/vaers-outcomes huggingface dataset:
till today burning, and tingling sensation, down arm underneath arm pit and starting today like a numbing tingling feeling up the left side of my neck, spreading at the site out through the arm; started swollen and red at injection site/Left (injection arm) swelling; started swollen and red at injection site/Left (injection arm) swelling, really red; fever; till today burning, and tingling sensation, down arm underneath arm pit and starting today like a numbing tingling feeling up the left side of my neck, spreading at the site out through the arm; till today burning, and tingling sensation, down arm underneath arm pit and starting today like a numbing tingling feeling up the left side of my neck, spreading at the site out through the arm; This is a spontaneous report from a non-contactable consumer (patient). A female patient of age 51 (units: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, in left arm on 22Mar2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she had a side effect, don't know if it was normal. Patient received the Pfizer covid vaccine on Monday (22Mar2021). On Tuesday (23Mar2021), the patient experienced fever. On Wednesday (24Mar2021), the patient experienced left (injection arm) swelling, really red. started swollen and red at injection site, but slowly throughout till today (25Mar2021) burning, and tingling sensation, down arm underneath arm pit and starting today (25Mar2021) like a numbing tingling feeling up the left side of her neck, spreading at the site out through the arm. It did it two days after. Patient stated that it seemed like it was getting, not worse as far as tingling or redness, it was just spreading, still red, tinging burning sensation, like when stood next to a fireplace or heater, warm on that side, it was like a warmness tingling. The patient wanted to know if there is anything that she can take to help it, or it would go away. The outcome of the events pyrexia, vaccination site swelling and hypoaesthesia was unknown and rest of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache, Myalgia, Fever, neck pain, chills, lightheaded Narrative: Reports that she had chills, severe body aches, fever, neck pain, fatigue, headache, and lightheadedness
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 27-SEP-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N018273 with expiration date 17-JUN-2019 (dose, route and anatomical location were not reported). The vaccine was exposed at temperature of 1 C (Celsius) during 10 hours. There was previous temperature excursion and no digital data logger was filled. No adverse effects reported.
Felt spot of 2-3 inches around on left abdomen like sunburn 6-8 hours after vaccination. The spot had increased in size to about 8 inches in diameter after 3 days. It is tender to touching. Also, felt tightness in her chest.
Information has been received from a certified medical assistant concerning a pediatric patient who on an unspecified date was inadvertently vaccinated with a dose of PEDIARIX during the same visit. No symptoms reported. Follow-up information has been received from vaccine adverse experience report refers to a 6 months old female patient with birth weight 8lbs 1ozs. On 26-JUN-2012 the patient was 19lbs 4ozs. The patient was vaccinated with RECOMBIVAX HB on 26-JUN-2012. On the same day, the patient was vaccinated with PEDIARIX (Intramuscular, lot # 1481AA), PREVNAR 13 (Intramuscular, lot # 917243 and Expiration Date was unspecified), ACTHIB (Intramuscular, lot # UH412AA and Expiration Date was unspecified) and ROTATEQ (oral, lot # 671576/1240AA and Expiration Date 29-MAY-2013 00:00). Additional information is not expected.
maladministration of Infanrix to a 12 year old patient; Infanrix was administered instead of Tdap; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On 16-AUG-2023, the patient received Infanrix. On 16-AUG-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: maladministration of Infanrix to a 12 year old patient) and wrong vaccine administered (Verbatim: Infanrix was administered instead of Tdap).  The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-AUG-2023 The healthcare professional (HCP) was not sure, but she thoughts Infanrix was administered to 12-year-old patient instead of Tdap, which led to inappropriate age at vaccine administration and wrong vaccine administered. The HCP asked if the patient had to be re-vaccinated. The reporter consented to follow up.
Acute embolism & thrombosis right femoral vein; Antiphospholipid; hair loss; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 02:15 (Batch/Lot Number: EL5318) as single dose, for covid-19 immunisation at hospital when 64 years old. Medical history included SI joint, BP and migraines. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ); metoprolol succinate (TOPROL); levothyroxine sodium (SYNTHROID); esomeprazole sodium (NEXIUM); potassium chloride (POTASSIUM CHLORIDE) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 13:00 the patient experienced acute embolism & thrombosis right femoral vein, antiphospholipid and hair loss. All the events were serious as life-threatening and hospitalization. The patient was hospitalized for the events for 3 days. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-1 test negative: negative on 29Mar2021 (Nasal Swab). Therapeutic measures were taken as a result of the events and included Warfarin and Lovonox. The outcome of the events was recovered with sequelae in 2021. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number: EL9266) in left arm on 18Feb2021 at 14:00.
About 10 hours after the jab, I developed a worsening headache, chills, a weird sensation on my skin all over - almost like fire, joint pain, shakiness, fever of 100.2
nausea for 5 days after the vaccine,   breakout rash  1/2 days after vaccine on head and body and arms itching/ for a day and Benadryl 50 mg  a day itchiness resided
Suspected vaccination failure; Still got shingles; Suffering the pain even after 17 months of the blisters disappeared; Suffering the pain even after 17 months of the blisters disappeared; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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), shingles, pain and blister. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and blister to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the son or daughter of the patient. The age at vaccination as not reported. The reporter stated that, his or her mother had the Shingles vaccine, still got shingles and was suffering from the pain even after 17 months of the blisters was disappeared.  The reporter said that, it was very heart breaking that there was nothing for the pain. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
discomfort in my back; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (discomfort in my back) and MYALGIA (muscle pain) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (discomfort in my back) and MYALGIA (muscle pain). At the time of the report, MUSCULOSKELETAL DISCOMFORT (discomfort in my back) and MYALGIA (muscle pain) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
This spontaneous report was received from a pharmacy student refers to a male patient of unknown age. No pertinent medical history of the patient was reported. Approximately on an unknown date in 2009 (reported as 5 years ago) the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route of administration, lot number and expiry date were not reported). No concomitant medications were reported. It was reported that the patient was diagnosed with pneumonia twice (unknown dates) since he received PNEUMOVAX 23. It was unspecified if any treatment was given for the event. It was unspecified whether the patient had sought any medical attention. There was no product quality complaint involved. The outcome of pneumonia was unknown. The causality of the event was not provided. Additional information is not expected.
After waiting 30 minutes, patient complained her left shoulder and neck were hurting. felt like when you sleep wrong., stiff, sore. Waited another 10 minutes with no change in symptoms. Denied numbness. Patient stated she would go home and call her PCP.  Spouse was driving her home.
Initial unsolicited report received from a nurse on 21 Oct 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number, expiry date, dose and site were not reported) via intramuscular route on 2015 (unspecified date). Patient medical history revealed that he had seizure disorder. Illness at time of vaccination and concomitant medication was not reported. On 2015 (unspecified date), post vaccination; the patient had experienced seizure (shortly). Lab data was reported as none. Corrective treatment was not reported. On an unspecified date, the patient was recovered from the event. Upon internal review, the company decided to consider the event serious because of important medical event seizure. List of documents held by sender: none; Sender's Comments: This case is very poorly documented. The final diagnosis is not reported. The time to onset is compatible with a role of the vaccine. Reportedly patient had a medical history of seizure disorder. An alternative etiology cannot be ruled out. Further information on investigation results (EEG, MRI) ruling out alternative causes of seizure, patient's birth history, immune status at the time of vaccination, would be helpful to fully assess the case. Based on available information, the role of vaccine cannot be assessed.
Upon self exam, discovered an oval nodule about 1" long and 1/2" wide resting on the area of my right collarbone.  It was not there yesterday.  There isn't any pain when touching it unless I do so repeatedly and that is only a soreness.  I had a liposarcoma removed from my right thigh in 2013 so I'll need to report it to my oncologist and PCP.
Client called Health Department to report symptoms of pain, swelling, area warm to touch, difficulty raising Right Deltoid one week after receiving TDAP vaccine. Client did not take any medication to relieve pain or discomfort. Denied fever.
Injection site reaction. A nsg reported that a child received Prevnar on 4/10/01, she developed an injection site reaction characterized by a large hard, reddened area. She was treated with cold compresses. She recovered. Additional information received from the physician on 5/22/01 indicated that no other vaccines were given within 4 weeks of Prevnar administration.
Fever onset on Friday 9/22/17, highest recording of 101.1. Rash onset Sunday 9/24/17. Mild case of mostly macular/papular lesions along the back hair line and clavicle down to mid sternum. Per mom, "rash is disappearing, as of 9/26/17 only a few lesions left. No scabbing, and not itchy." Patient attends Daycare, where there was a confirmed case of chicken pox from 9/19/17.
3-4 days after injection arm pain in deltoid diffuse lasted 5 months, still intermittent mild discomfort.
This spontaneous case was reported by a pharmacist and describes the occurrence of HEPATITIS B IMMUNISATION (received Hepatitis B vaccine 6 days before almost getting the Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: HEPATITIS B VACCINE.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEPATITIS B IMMUNISATION (received Hepatitis B vaccine 6 days before almost getting the Moderna COVID-19 vaccine). At the time of the report, HEPATITIS B IMMUNISATION (received Hepatitis B vaccine 6 days before almost getting the Moderna COVID-19 vaccine) outcome was unknown.        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.   Concomitant medications were not provided. Treatment information was not reported.
Nausea and chills 3 days after injection (2/15). Resolved after several hours. Rash, hardness, and mild itching at site of injection, beginning approximately 1 week after injection (2/19).
NOT an Adverse Event.  Administration Error only.  12YO patient given the Pfizer COVID-19 formula for 5-11YO.
Two days of fever 100 degrees, decrease appetite-oral intake 6oz/feed (prev. 8oz/feed), red blanching, papule rash began on torso then generalized. WBC 6,000, H/H 12.1/34.5. No N/V/D.
At the DT injection site, the pt experienced swelling and enlargement (size of a pancake) on 3/24/01. On 3/29/01 the erythema and tenderness had decreased.
Information has been received from a consumer concerning her sister, a 63 year old female who in May 2007, was vaccinated with ZOSTAVAX (Merck) (route and site not reported).  In March 2008, the patient acquired a bad case of shingles and developed post herpetic neuralgia.  The patient had required multiple doctor visits and taken NEURONTIN for her pain.  At the time of reporting, the symptoms of "post herpetic neuralgia" was still ongoing but was getting better, but the outcome of shingles was unknown.  Additional information has been requested.
This is an administration error, not an adverse event.  The patient is only 17 years old but is a college students and her age was missed when scheduling and administering the Moderna vaccine, which is only approved for ages 18 and over.  She will turn 18 in approximately 6 weeks. She qualified for the vaccine by having 2 medical conditions, Type 2 diabetes mellitus and BMI >30 (her BMI is 39).
No adverse effects; an unspecified 16 year old "vaccine naive" patient was administered a dose of PROQUAD; This spontaneous report was received from a pharmacist refers to a 16 year old patient of unknown gender. The patient's concurrent condition, concomitant medication and medical history were unknown. On an unknown date in May 2019 (reported as "earlier this week"), the "vaccine naïve" patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), (strength, frequency, route of administration, lot # and expiry date unspecified) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported (no adverse event). The outcome of the events was unknown. No product quality complaint was involved.
About a minute or two, I was sitting down  and felt a tingling feeling was all over my body and head. I got up and has a buzzing sensation all over my body. I walked over the the nurse station and told them I was having a reaction, nurse took my vitals my HR was 165 and my BP 170/120.  They took me upstairs to observations and eventually my BP came down a bit. Later that evening it was 160/105. I though I was having chest discomfort. I went to the Emergency Room. They did an EKG which was normal, so they sent me home.  It took my BP another 12 hours to be within a normal reading.  Within 24-36 hours things came back to normal I had recovered.
blood sugar has been elevated over 300; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 13:15 (Lot number: ER727) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure", start date: 2019 (ongoing), notes: diagnosed about 1.5 years ago; "Diabetes Type II", start date: 2019 (ongoing), notes: diagnosed two years ago; "migraine" (unspecified if ongoing), notes: every 28 days she takes a shot. Concomitant medication(s) included: CHLORTHALIDONE taken for blood pressure abnormal, start date: 2021 (ongoing); LANTUS taken for type 2 diabetes mellitus (ongoing); LISINOPRIL taken for blood pressure abnormal, start date: 2019 (ongoing). The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 24Mar2021 16:00, outcome "not recovered", described as "blood sugar has been elevated over 300". The event "blood sugar has been elevated over 300" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: In Mar2021, prior to the vaccine the blood sugar was between 101 and 115. Ever since the patient received the vaccine the patient's blood sugar has been elevated over 300. She talked to an on call doctor who said since she only had two results over 300 in a 12 hours period and he said not to come in, it was reported that the patient had another. She had one or two results since 24Mar2021 that have been within normal range. It was reported that the event was ongoing.  No follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), on or about late 2016, from her local pharmacy, for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster.  On an unspecified date, shortly after receiving the ZOSTAVAX, the patient developed a painful rash on her arm and torso. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from the shingles. The onset of the event is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
PNEUMOVAX <"Severe pain in arm, like he had surgery with no pain meds." Extreme difficulty in moving arm. Referred to primary care.
A mother reported that her son received Orimune, Tripedia and MMR vaccines on 7/21/95 at the age of 30 months. He also received Tetanus in 1994 at approximately 18 months of age. the mother reported that after her son's final series of vaccinations at the age of 18 months he developed autism. On either 7/24/95 or 7/26/95 he developed a fever of approximately 105. Since that time, his mother watched him lose language skills and interest in interacting with other children. He was reportedly officially diagnosed with autism at 3 years old. Autism is considered "medically important".  Follow-up states that the pt also developed gastrointestinal problems. Information received on follow-up also indicated that the event resulted in permanent disability. The pt also received tetanus toxoid adsorbed purogenated (IM) in 1994 apt approx. 18 months of age. Aditional information has been requested.
no additional AE; expired dose of MMR II was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) 1 dose, lot # S013536, expiry date: 02-MAY-2021 (formulation, strength, frequency, route of administration were not provided) for prophylaxis. No additional adverse events were reported.
pt states rt arm felt heavy painful/felt achy all over; clammy all noc; sore throat & h/a; states had recv Hep B vax 14JUL & had fever;