chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The whole entire leg from top of the thigh to his foot was swollen, he wore a pair of sweat pants the day after the injection and we had a hard time taking the sweats off of him his leg was so huge. He refused to walk on his leg, only wanted to be held. On 01/08/2015 I did call the Hospital nurse hotline to talk to somebody, his leg was so swollen I didn't know if he needed to be taken to the Emergency Room or not. She said to take him back to the Drs the next day to report the reaction. I did take him back to the office on 01/09/2015 to report the swelling. They said there was nothing to do about it, just give it time and it would go away on its own. It eventually did go away but took 7-10 days for it to completely go away. Also he started doing this thing where he would just stare off into space but he wouldn't hear me, look at me, talk back to me. I would snap my fingers in front of him, try to get his attention and nothing, no response from him. It would last for 30 seconds to a minute and I couldn't get him to snap out of it and come back to me. Then he would start blinking and see me again, after doing more research I know now that what he was having is seizures (staring) due to the 4th dose of the DTaP vaccine. It seemed like he started to regress after this, his fine motor skills were not as keen and his speech was delayed. It seemed like his mind froze for a year or more. As a baby/infant he was taking in so much new information and was learning so quickly and then stopped taking in new information or took it in very slowly. Now going from 3 years old to 4 years old we are working with an occupational therapist and speech therapist and he is VERY slowly starting to write, hold a spoon/fork and we are just now starting to talk more. My intuition and heart know that it was the DTaP vaccine that did this. I'm his mother, even if I can't provide scientific evidence, I just know with my heart, this changed my child.
About 7 minutes after vaccine began having tingling to tongue and lips; Scratchy throat sensation; Glare/ blurry vision.  No shortness of breath or airway compromise Gave ice pack and cold water
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2012, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, 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. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX. On 12th April 2018, the patient received SHINGRIX. On 12th April 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On 13th April 2018, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the injected limb mobility decreased was unknown. The reporter considered the pain in arm and injection limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The pain was really bad for the patient about 5 days and was getting better but still there at the time of reporting. One day after receiving SHINGRIX, the patient was unable to use the arm. The patient had consulted the pharmacist for more information.
Fever; chest discomfort; dizzyness; headache   Seen a physician due to chest discomfort and was released.
fever blister; fever blister in the genital area; neuropathy; numbness; tingling; pain; burning sensation in her both feet; This case was reported by a physician via call center representative and described the occurrence of neuropathy in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th June 2019 and experienced no side effects.).   On 4th September 2019, the patient received the 2nd dose of Shingrix. On 4th September 2019, less than a day after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant), numbness, tingling, pain and burning sensation. On an unknown date, the patient experienced fever blister and genital herpes. On an unknown date, the outcome of the neuropathy, numbness, tingling, pain and burning sensation were unknown and the outcome of the fever blister and genital herpes were recovered/resolved.   It was unknown if the reporter considered the neuropathy, numbness, tingling, pain, burning sensation, fever blister and genital herpes to be related to Shingrix.  Additional information was provided as follows: The patient experienced numbness, tingling, pain and a burning sensation in her both feet that started that evening. The patient later was referred to a neurologist who did a conduction study and diagnosed her with neuropathy. Less than a year, after receiving vaccine, the patient also experienced a fever blister in the genital area and oral area that had resolved. The reporter consented to follow up.
Extreme wild ringing in ear, overwhelming and making me a little bit off balance; messed my mind up to make me forget; didn't hear; nervous with the ringing; Extreme wild ringing in ear, overwhelming and making me a little bit off balance; messed my mind up to make me forget; didn't hear; nervous with the ringing; Extreme wild ringing in ear, overwhelming and making me a little bit off balance; messed my mind up to make me forget; didn't hear; nervous with the ringing; Extreme wild ringing in ear, overwhelming and making me a little bit off balance; messed my mind up to make me forget; didn't hear; nervous with the ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: EN6200) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine headache" (unspecified if ongoing), notes: 40 years ago; "thyroid" (unspecified if ongoing); "headache" (unspecified if ongoing). Concomitant medication(s) included: IMITREX taken for migraine, headache; SYNTHROID taken for thyroid disorder. The following information was reported: TINNITUS (non-serious), BALANCE DISORDER (non-serious), MEMORY IMPAIRMENT (non-serious), NERVOUSNESS (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "Extreme wild ringing in ear, overwhelming and making me a little bit off balance; messed my mind up to make me forget; didn't hear; nervous with the ringing". Therapeutic measures were not taken as a result of tinnitus, balance disorder, memory impairment, nervousness.  Additional information: The patient reported that she wanted to tell about the side effects. She wanted to report side effects: a wild ringing in her ear with the day she had it done yesterday (23Mar2021) the vaccine and she had an extreme wild ringing in ear. She had a very little bit tinnitus and then now this morning, it's overwhelming. This, the ringing in her ear was overwhelming and it was also making her a little bit off, when she walks she was little bit off balance. Vaccine expiration date: 32321 (Further not clarified the date. Hence, not captured in the tab). When asked for due date for second shot, consumer, stated, this was first shot, she had an appointment for 13Apr. When asked for any treatment for the problem (event), patient stated, no just Imitrex and Fioricet (not clarified) for Migraine. The patient asked if she was supposed to go for the second shot because it was after 3 weeks.  No follow-up attempts are possible. No further information is expected.
No adverse effect reported; received an expired dose of VAQTA; Information has been received from a nurse referring to a 17 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided.  On 07-JUN-2019 the patient received  expired hepatitis a vaccine, inactivated (VAQTA) (1 dosage form, lot # R007388, expiration date 27-MAY-2019; strength and route were unknown) for prophylaxis (expired product administered). No adverse effect was reported.
Fever of 100.6, chills and body aches, and severe stomach pain-similar to pain you would feel from gallbladder problems
At time of 12 month visit (04/09/02), Varivax was not available due to manufacturer shortage. Parent schedule Varivax on 5/6/02. Only 27 days spaced between MMR and Varivax (should be given with same time or 1 month apart). Blood test proved patient did not have seroconvert. Varicella Zoster. ABA IgM, IgG negative.
Olfactory nerve blocked. It was not like a stopped up nose, it was like my nose didn't exist. Lasted about an hour. I had to completely breathe out of my mouth.
tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) Positive. Clinical course: She was already fully vaccinated with second booster however she was tested positive last year. Mentioned she already consulted a healthcare provider and was advised to get another booster shot. Second booster for 05Oct. She was fully vaccinated and boosted but she also had COVID on 05Jan.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (dot of liquid on top of band-aid was seen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCHARGE (dot of liquid on top of band-aid was seen). At the time of the report, VACCINATION SITE DISCHARGE (dot of liquid on top of band-aid was seen) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment information was provided.
blacking out; seeing gray splotches; nauseous; light headed; I barely made it back to bed; This is a spontaneous report received from a contactable consumer (reporting on herself). A 67-years-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP6955 and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 09Mar2021 10:15 as single dose for COVID-19 immunization. Medical history included hypertension, blood cholesterol increased, obesity , goitre , sciatica , arthritis, fibromyalgia, all from an unknown date and un-known if ongoing. Concomitant medication(s) included meloxicam (MELOXICAM); gabapentin (GABAPENTIN); levothyroxine (LEVOTHYROXINE); atorvastatin (ATORVASTATIN) all taken for an unspecified indication, start and stop date were not reported. The patient previously took ibuprofen, sulfa and synthroid and experienced drug hypersensitivity, First dose of BNT162B2 on 16Feb2021 09:15 for covid-19 immunisation The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that patient was up at 5:30 am and started seeing gray splotches and then she got nauseous and started blacking out. It happened again about 10 minutes later and she barely made it back to bed be-fore the whole thing stopped. When she woke up later she was still a little light headed. The out-come of the events was recovered on an unspecified date.
vision became blurry; 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 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19May2021 (Lot number: EZ0178) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "autoimmune anticardioid lipid" (ongoing). Concomitant medication(s) included: WARFARIN taken for thrombosis. Vaccination history included: Bnt162b2 (Dose: 1, lot number:EW167), when the patient was 57 years old, for Covid-19 Immunization. The following information was reported: VISION BLURRED (non-serious) with onset 19May2021, outcome "not recovered", described as "vision became blurry".  Additional information: Caller is a consumer, asking if her reaction after the vaccine is normal and what she should do about it. Caller reports that about 10 minutes after getting her second dose of the vaccine today her vision started to become blurry. She reports having to take her glasses off to evaluate her vision and she sat for another 5 minutes after which she reports being asked if she wanted an ambulance, she reports declining and was then told to go home and lay down for a few hours to see if she feels better. Caller reports that her vision is still blurry as if she had just cried and her eyes were foggy from the tears. Caller reports that her distance vision is more affected the close-up vision. Caller asking if this is normal and what she should do stating that she doesn't have an HCP. Transmitting for AE data capture. Caller reports that she already spoke with someone prior to being transferred over to address her question, no reference number for that encounter. Caller reports that she doesn't have an HCP. Confirmed Pfizer COVID-19 vaccine. Spoke from attached documentation. Referred to HCP (Health department /Pharm) for evaluation, discussion and guidance. Offered to send documentation via email, caller declined. Caller reports that she already spoke to someone about her reaction before being transferred over, no reference number for that encounter. Caller does not have an HCP. Survey offered. Caller states she got the second dose of the Pfizer COVID-19 vaccine today, 19May2021, and while she was waiting for her 15 min, her vision became blurry, states they kept her there, caller states it is not going away, not sure what to do, have not heard of this before, wants information about this symptom. Caller asks if we can tell her how to treat it. Caller states her arm really blew up after the first dose, states there was a firm bump at the injection site. The caller was provided with (Privacy) phone number of (withheld), option 3, and business hours prior to transfer to (Privacy) queue, hold times are longer than normal. Caller encouraged to reach out to her healthcare provider for any medical advice.  No follow-up attempts are possible. No further information is expected.
Client fainted and hit her head. Alert, oriented after fall. Transported to hospital via ambulance for further evaluation. Mother with client. AOX4 after fall.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 69 year old patient. Weight: not provided. Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Initial report received on 15 December 2009 from a consumer who is a health care professional. A 50 year old female patient with seasonal allergies and a prior history of "local red, hot, swollen" with prior seasonal influenza and tetanus vaccinations complained of pain in her arm immediately after she received Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP020AA) intramuscular in the left deltoid in November 2009 on an unspecified day. The patient also complained of pain at and around the site. The patient did not note any redness or swelling, but did have decreased mobility and limited range of motion. The patient denied numbness and tingling. The patient also received a seasonal influenza vaccine (manufacturer and lot number not provided) within four weeks of receiving the Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative vaccine. The date was no specified. At the time of the report, which was closed to 4 weeks after the time of onset, the patient's symptoms persisted. Follow-up information was received on 11 January 2010 from the patient who reported that each symptom had started on the same date she received Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative. The vaccine administrator was unable to provide the patient with the exact date of the H1N1 vaccination. The patient indicated that as of 06 January 2010, her symptoms still persisted. At the time of the report, the patient reported continued limited range of motion and pain. No further details were provided. Based on follow-up information, this case was upgraded from non-serious to serious. List of Documents held by Sender: none. The patient has another event which is captured in case number 2009-05565.
L arm site of injection of #2 shot given had warm reddened area that mom states became larger about the size of a quarter. Went to see Dr. on Friday and stated was larger by then. Dr. treated her with DURICEF 500 bid for 10 days. Mother states the swelling has resolved today.
Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotten a CT contrast, where my whole body began to feel warm, also a metallic taste in my throat. A few hours later I had a horrible headache, with tightness in my chest and palpitations. My muscles and joints ached, my hands became swollen and I was unable to remove my ring. These symptoms continued for 24 hours. I also experienced shortness of breath.I almost took myself to ER. They eventually went away and I feel fine now
ADMINISTRATION OF VACCINE STORED OUTSIDE RECOMMENDED CONDITIONS (FOR 5 HOURS AT ROOM TEMPERATURE); This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: 09-APR-2022) dose was not reported, administered on 16-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-DEC-2021, the patient experienced administration of vaccine stored outside recommended conditions (for 5 hours at room temperature). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine stored outside recommended conditions (for 5 hours at room temperature) was not reported. This report was non-serious.
Information has been received from a physician concerning a 42 month old male who on 30Mar02 was vaccinated with a dose of varicella virus vaccine live. Reported to physician on 14Apr04 and the physician noted that this was mild case of generalized varicella (also described as chicken pox breakthrough). Subsequently, the pt was recovering. The reporter also mentioned a female pt who was vaccinated with varicella virus vaccine live (WAES0404USa02517) and experienced a similar reaction. Additional information has been requested.
PT CAME TO THE PHARMACY TO LET US KNOW THAT SHE GOT ADVERSE DRUG REACTION FROM PNEUMOCOCCAL VACCINE AS PER ADVISE BY HER DOCTOR. SHE ALREADY CONSULTED HER DR. HER DR ADVISED HER THAT THE SYMPTOMS WILL SUBSIDE IN A FEW DAYS. PATIENT WAS COMPLAINING STIFFNESS FROM ELBOW TO NECK OR RIGHT ARM WITH RASH AND SWELLING ON THE INJECTION SITE. PT WAS ALSO EXPERIENCING BACK ACHE AND FATIGUE. UPON REPORTING TO US ON NOVEMBER 1 PT SYMPTOMS IS ALREADY SUBSIDING. PT ALREADY CONSULTED HER DOCTOR.
Redness, warmth, swelling, discomfort L triceps to elbow; ibuprofen and cool compress to treat
(L) arm redness and swelling underneath injection site. Advised to take CLARITIN during day and BENADRYL at nights along with hydrocortisone for itchiness per Dr.
Patient states " my arm was sore the night of 11/01/2017, which was day I got shot." Patient states " Thursday 11/02/2017 around 9 am, I noticed soreness was getting worse." " On Thursday night, 11/02/2017, I noticed swelling, redness, and lots of tenderness to touch of my left arm." Patient came to Health Department today, 11/03/2017, site of vaccine noted to be red, edematous, warm to touch, and patient stated " It is very sore to touch." Patient advised to go to PCP or urgent care for further treatment.