chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report concerning a patient of unknown gender and age was received from a registered nurse. Concurrent conditions and medical history were not reported. On 25-MAY-2016, the patient was vaccinated with VARIVAX lot # K006131, expiration date: 29-APR-2016 (strength, dose, route and frequency were not provided). There were no concomitant medications and adverse events reported. No product quality complain was involved. Additional information has been requested.
Patient was feeling dizzy, lightheaded and head was feeling numb. He felt very tingly
Myalgia, Fever, diaphoresis and chills and fatigue Narrative:
Patient came for  her 2nd dose of the COVID Vaccine. Our POC, asked her if it was for Pfizer and the patient stated yes it was her 2nd dose of Pfizer she was needed. She filled out the paperwork for the 2nd dose of Pfizer. I asked her if it was Pfizer before I went and got the vaccine and she told me yes. I went and got the vaccine and came back with it and filled out my section of the paper work and gave her the shot in the left deltoid. I continued to talk to her about the Pfizer vaccine and went to fill out her covid card and she looked over at her boyfriend and he spoke up and said no we got the Moderna because he was wanting his shot also. I went and got the other nurse and she spoke to the patient and her boyfriend and the patient wasn't upset. She apologized and said it was her fault for saying she got the Pfizer because that's what she thought they got. But the way they were acting was just odd, the boyfriend was speaking for the patent and I told him he could come back on Friday to get his 2nd moderna shot since that's what they originally got and he said he called the day before, on  9/7/2021 and spoke to a woman and asked if they could come to get their shot today and if it mattered what they got as their first shot for what they would get for their second shot and he said she told him no it did not matter but he could not remember her name. They left after we explained to them I would fill out an accident report because she got the wrong 2nd dose after she stated she got Pfizer but actually got moderna.
Pt reports that @ approx 11:15 AM, she developed numbness and tingling in lips, then at approx 12:15 PM, developed a headache and nausea.  Pt took Benadryl 25 mg po at 1:15 PM.  Denied swelling of lips, SOB and difficulty swallowing.  Instructed pt to take another 25 mg of Benadryl if needed (but do not drive)(pt weighs 160 lbs).  Pt owns an EpiPen- can use if needed.
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
No adverse reactions were noted or reported since the dose was administered on  2/13/2023.
negative side effects to the booster vaccine.; constant pain; joints, muscles, and skin have become achy; can't walk half a mile; m It feels like where you got hit by a truck / constantly feeling like that; joints, muscles, and skin have become achy; joints, muscles, and skin have become achy / whole body is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (negative side effects to the booster vaccine.), PAIN (constant pain), PAIN OF SKIN (joints, muscles, and skin have become achy), GAIT DISTURBANCE (can't walk half a mile) and FEELING ABNORMAL (m It feels like where you got hit by a truck / constantly feeling like that) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 040B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced PAIN (constant pain), PAIN OF SKIN (joints, muscles, and skin have become achy), GAIT DISTURBANCE (can't walk half a mile), ARTHRALGIA (joints, muscles, and skin have become achy) and MYALGIA (joints, muscles, and skin have become achy / whole body is sore). 08-Dec-2021, the patient experienced FEELING ABNORMAL (m It feels like where you got hit by a truck / constantly feeling like that). On an unknown date, the patient experienced VACCINATION COMPLICATION (negative side effects to the booster vaccine.). At the time of the report, VACCINATION COMPLICATION (negative side effects to the booster vaccine.), ARTHRALGIA (joints, muscles, and skin have become achy) and MYALGIA (joints, muscles, and skin have become achy / whole body is sore) outcome was unknown and PAIN (constant pain), PAIN OF SKIN (joints, muscles, and skin have become achy), GAIT DISTURBANCE (can't walk half a mile) and FEELING ABNORMAL (m It feels like where you got hit by a truck / constantly feeling like that) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.   This case was linked to MOD-2022-467381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2022: Significant follow-up : Reporter added, Patient Details added, Events added, Email added, Primary reporters address added, Drug start date and Batch lot number added
Patient received vaccine at approximately 11:00 am. Patient returned to pharmacy at app. 4:00 pm complaining of arm swelling. Arm was swollen, non tender, and felt hard. Patient did not reported pain.
Pt was inadvertently given 0.5 ML dose instead of 0.3 ML dose
This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of M-M-R II (lot # K0248285, expiration date 02-DEC-2016) (lot# K021152, expiration date 02-NOV-2016), (route, dose and dose number were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
CLIENT RECEIVED PEDIATRIC PFIZER FORMULATION OF 0.2ML AT 12YO; VACCINE IS APPROVED FOR 5-11YO. CLIENT SHOULD'VE RECEIVED PFIZER GRAY CAP FORMULATION OF 0.3ML DUE TO AGE.
redness at the injection site; inflammation at injection site on her left arm; received the 1st dose of Shingrix subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 29RD5, expiry date 16th April 2022) and (batch number 3EC24, expiry date 10th May 2022) for prophylaxis.   On 26th November 2019, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, the dose was an unknown dose. On 26th November 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site erythema and injection site inflammation. The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site erythema, injection site inflammation and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema and injection site inflammation to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The patient experienced redness and inflammation at the injection site on her left arm. The reporter consented to follow up. The batch number was updated from  3EG24 to 3EC24 as per sales data sheet.
Breakthrough case admission after 5 vaccines Moderna 4/15/21 no lot #;  Moderna 5/13/21 LOt# 034C21A; Moderna 12/10/21 Lot# 013F21A;  Pfizer 7/5/22 Lot# 2639369208;  Unknown 12/22/22 LOt# FR2583  Guessing that this is Pfizer
Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose
Diarrhea around 7:30 PM, then at 1:00 AM vomiting, followed by 2 other days of diarrhea. So far, diarrhea continues.
Patient verbally confirmed twice that she was to receive Pfizer.  I checked her card and made sure the dates of 1st and 2nd shot made her eligible for a 3rd dose.  I overlooked the fact that it was Moderna on her card.  I gave the vaccine and turned to fill out the card.  That is when I noticed that the first two shots were another mRNA (Moderna).  I told the patient that I gave her Pfizer and she was supposed to stay in the Moderna dose series. Patient was not alarmed at all.   She said she was actually glad she received Pfizer.  I apologized and of course will double check going forward.  I check them every time.  I am not sure what made my attention draw away from checking the series.   Patient is not harmed or upset.
Case previously recorded as MA2009-6274. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Agency reference no. NA09-008851.
After the 2nd dose, her condition (OCD) flared in a way that she has never experienced in her life/It (OCD) flares up; All of her skin become so sensitive to everything.; If she grabs some water, or if any part of her body touches anything, she'd get anxious; After the 2nd dose, her condition (OCD) flared in a way that she has never experienced in her life.; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (After the 2nd dose, her condition (OCD) flared in a way that she has never experienced in her life/It (OCD) flares up), HYPERAESTHESIA (All of her skin become so sensitive to everything.), ANXIETY (If she grabs some water, or if any part of her body touches anything, she'd get anxious) and OBSESSIVE-COMPULSIVE DISORDER (After the 2nd dose, her condition (OCD) flared in a way that she has never experienced in her life.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A/012B21A and 091D21A) for COVID-19 vaccination.     The patient's past medical history included Brain injury (she had previous brain injury and it would be very hard for her to read). Concurrent medical conditions included Obsessive-compulsive disorder (germaphobia totally livable for the past 30+ years and was manageable and undercontrol) and Serotonin deficiency.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, 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 experienced CONDITION AGGRAVATED (After the 2nd dose, her condition (OCD) flared in a way that she has never experienced in her life/It (OCD) flares up), HYPERAESTHESIA (All of her skin become so sensitive to everything.), ANXIETY (If she grabs some water, or if any part of her body touches anything, she'd get anxious) and OBSESSIVE-COMPULSIVE DISORDER (After the 2nd dose, her condition (OCD) flared in a way that she has never experienced in her life.). At the time of the report, CONDITION AGGRAVATED (After the 2nd dose, her condition (OCD) flared in a way that she has never experienced in her life/It (OCD) flares up), HYPERAESTHESIA (All of her skin become so sensitive to everything.), ANXIETY (If she grabs some water, or if any part of her body touches anything, she'd get anxious) and OBSESSIVE-COMPULSIVE DISORDER (After the 2nd dose, her condition (OCD) flared in a way that she has never experienced in her life.) outcome was unknown.            Patient took lot of medications and declined providing the medication list.  Treatment information was not provided.  Patient stated that the condition (OCD) manifested to something that never experienced before in life. The condition stayed leveled, and it was not getting any worse or any better.   Additional information reported include that the patient did not have any psychological medication as a treatment.   This case was linked to MOD-2021-294541 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Patient history and narrative were updated
Booster dose of 0.25 ml given to a 17 year old who is ineligible to receive Moderna. No adverse effects within 15 minutes.
10 minutes following vaccination, pt reported feeling "heart racing" and hot flashes. Pt was moved to cot to lay down and was offered fluids.  at 1pm, client reported improved symptoms but continued fatigue.
Immediately patient became nauseous w/ diminished appetite, later that evening had sleep paralysis and fever. Went to ER.
Report 2001016916-1 describes a lump at the injection site of a 2 month old male who received an injection of Infanrix. There was no relevant medical history, concurrent illness, or concurrent medication. The infant had no adverse experiences following prior immunizations. On 06/01/2001, the infant received an injection of Infanrix; number of previous Infanrix injections was not reported. Unspecified concomitant vaccines were administered at "opposite sites." The infant's mother reported that he developed a lump with warmth at the Infanrix injection since later that day. The physician prescribed Tylenol 80mg every four hours for pain relief. The outcome of the lump and warmth was not provided. This is one of three infants from this facility who developed an injection site reaction following receipt of Infanrix lot DTPA992A2.
No additional AE reported; The pharmacist reported the patient did not come back until 05AUG2021 to receive her second dose; her first MMR II vaccine in September of 2019; This spontaneous report has been received from a pharmacist, referring to a 37 years old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  The patient received her first measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine for prophylaxis in September of 2019 (Product administered to patient of inappropriate age). The pharmacist reported the patient did not come back until 05-AUG-2021 to receive her second dose measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (inappropriate schedule of product administration). No additional AE reported. The dose, strength, route, lot number and expiration date for suspect product was not reported.
I was diagnosed with LADA latent autoimmune diabetes in adults; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF2593) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The did not have any known allergies. There were no concomitant medications or other medications in two weeks. Vaccination history included: BNT162b2 (Dose 1, Lot number: EH9899, Location of injection: Left arm, Vaccine administration time: 19:30 pm), administration date: 16Dec2020, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: EL1284, Location of injection: Left arm, Vaccine administration time: 19:00 pm), administration date: 07Jan2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: LATENT AUTOIMMUNE DIABETES IN ADULTS (disability) with onset 06Jan2022 at 09:00, outcome "not recovered", described as "I was diagnosed with LADA latent autoimmune diabetes in adults". The event "i was diagnosed with lada latent autoimmune diabetes in adults" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of latent autoimmune diabetes in adults which included metformin, glipizide, humalog, lantus. On 24Mar2022, the patient was diagnosed with LADA latent autoimmune diabetes in adults. There was disability or permanent damage. The facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. 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 had been tested for COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the event latent autoimmune diabetes in adults  and the suspect BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a registered nurse concerning a 46 year old female who on 17-Jan-2005 was vaccinated with a dose of rubella virus vaccine live. Less than one week later, the patient experienced a rash. 100.5 F temperature and joint pain. Unspecified medical attention was sought. The patient is recovering form the rash and fever, however the patient's joint pain persisted. No product quality complaint was involved. Additional information has been requested.
Soreness in upper right arm,  beginning around 7 pm day of shot,  injection site; soreness lessened next day, none after couple of days
6 days after initial vaccine, left arm started to harden at site of vaccination. The same day a lump appeared at the injection site and continued to stay hard and protrude for three days after it first started to appear. The following day the lump turned into a rash that began to grow around the injection site. It was hot, itchy, and painful. The following day I started to develop a rash on my hands and feet that was extremely painful and itchy. It felt like acid or burning when the rash began to appear. Heat and water seemed to make it worse and nothing helped it calm down. It came in waves and felt like needles and burning. It felt like my skin was bubbling. I felt them before they could physically appear. Then the following day after that my joints in my hands (fingers and wrists), my ankles feet and toes were also insufferable. My bones felt like glass, I couldn?t move at a certain point and was in agony because of the pain. Then the following day my joints that were in so much pain began to swell. I went to three different doctors for treatment, the last one was the one who correctly diagnosed me with serum sickness. With proper medication over the next 48 hours I began to feel relief  and my symptoms began to slowly subside over the following 72 hours. I was prescribed prednisone, Zyrtec, and Pepcid.  I am still recovering.
8/30/02 informed by reporter by mother of patient states patient started with redness and swelling right thigh. Started that evening. Patient afebrile, no complaints of discomfort other than to site at intervals. Patient alert, cheerful.
Racing  Heart Rate (160 BPM) at night... Arm Pain... Nausea.... Stomach Cramps
Patient developed a hive like reaction at the injection site. It was approx. 4-5 cm red, raised area. Patient was advised to use cool compresses, Zyrtec, Benadryl prn.
Pt received vax 6/20/12. She presented at the pharmacy on 6/21/12 with rash, induration, & swelling. She was counseled on vaccination reaction & encouraged to see physician if she was concerned. Patient presented diagnosis of "infection" on 6/22/12 with cephalexin rx. Pt's rash had spread over 24 hours,but arm was less swollen.
Noticed hives on hands and forearms that progressed to head, neck, chest, arms and legs and became severely itchy over the next five days. Treating with two Benadryl tablets every four hours.
Large painful red rash on upper left arm several inches below Shingrix injection site, covering bicep and extending down to inner elbow.  Rash painful to touch.  Could not sleep on that side.  Lasted 5-6 days. (This was in addition to soreness and swelling at injection site.)
Arm immediately stung and blew up. Constant pain, arm would twitch, fingers would go numb. Very painful to sleep
Within 2 hours of the vaccine mom called to report "unusual" symptoms - her eyes rolled back and to the right, her head dropped and this lasted for 5-10 minutes. This all occurred while nursing. She fell asleep afterwards. There were multiple episodes and she was sent to ER, then hospital. She diagnosed w/infantile spasms by EEG.