chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wrong injection technique; Redness at injection site; Swelling at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 3rd May 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In May 2019, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site swelling and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix but the injection was given lower on the arm than the deltoid muscle and believed that it was given subcutaneously rather than intramuscularly, which led to intramuscular formulation administered by other route. The patient experienced injection site reactions of redness and swelling at the site. She was seen by her physician. This was considered as medication error with adverse event.
Shortly after receiving the first dose, I felt numbness in both my temples. I have never experienced this sensation before. This was a constant feeling throughout the entire day, with occasional 'waves' where the numbness felt more intense. The next day, I still felt it but it wasn't as noticeable. By night time, the numbness had descended behind the ears. The third day (today) I can still feel it every now and then but it is not nearly as strong as on the first day (barely there). I have not consulted a doctor about it because I was not feeling sick otherwise, but I have decided to report it because, with the exception of a single forum, I have not been able to find anything about a similar side effect online to reassure myself that it is normal.
Red itchy rash with multiple pale colors wheals encircling the entire chest from center of chest and few inches below. Resembled the same reaction to an environmental allergy test. Benadryl 25 mg given as well as showered in case there was another cause.
Serum Sickness (Hypersensitivity) High fever at 103, urticaria beginning in lymph area then moving to a widespread bordered dark red rash over entire body.  Regression with walking, increased falling, trouble walking and frequently seeking comfort for pain.
13-year-old male, received intramuscular Pfizer vaccination (Lot# EW0191) in right deltoid on June 9th 2021 at 10:31 AM. At approximately 10:36 AM the client went limp, pale, and complained of vision changes to his guardian. The RN at observation went over to assess the patient with other onsite staff. Patient appeared pale and was alert and oriented x 3. Extremities appeared flaccid. The patient denied difficulty breathing, lungs were clear bilaterally.  Client reported vision changes and stated "everything looks dark and blurry". Vital Signs were taken at approximately 10:37 am- Temperature was 99.1; Pulse 58; RR: 12; B/P: 104/59; O2: 99%. Second B/P was taken at 10:44 and was 111/63. Client denied eating breakfast or drinking water today. No medication was given. Denied having difficulty swallowing. Water was provided. EMS was called. EMS assessed client- B/P 98/66; Pulse 86; RR 14; O2 98% . At time of EMS assessment, the client reported feeling "normal" and denied having any signs or symptoms. After assessment, EMS reported that the client does not require an ambulance. Patients guardian, decided to opt out of ambulance transportation and opted to take the client to his health provider. The client and his guardian left at 11:01 am to be evaluated at pcp.
Patient passed out following the vaccination.  Patient fell and became slumped over and started to shake for a minute of two.  We layed them down on the floor and they started feeling better.
C/O tightness in throat at around 0840, clearing throat repeatedly, EMS called. 0843 reclining- BP 148/80, 0.5 ml of epinephrine 1:1000 administered SQ rt arm.  0845 EMS arrived, BP 160/82, sitting, hoarseness noted.  0852 transported to ER by EMS- alert, stable, still hoarse, clearing throat, states "jittery from epi".
Pt arose to get ready for work at 6:30 in the morning and didnt feel well. She went to get ready for work and went to  bathroom and became dizzy and passed out. Mom and dad came in and mom became dizzy as well and passed out. Pt, mom and dad went to ER.
Fever, NauseaVomiting, Chills, body aches, sore arm,fatigue. Narrative;
Onset of fevers to 101-102 day after vaccine admin x 4 days. Development of hives on day 4-5 after vaccines.
Herpes zoster; 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 prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 25-JUL-2013, at age 59, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Developed a red rash on my left arm the day after receiving my 2nd COVID-19 Shot.  Rash went from my injection site down my left arm and stopped above my left elbow. It started out swollen, was hot to the touch, and very sore. I called the clinic that gave me the shot and was advised to report it to my Primary Care doctor. When I called my doctor I was told that this is called "Covid Arm".  I was instructed to use an antihistamine or cream, and ice on the site. I was instructed on what to do if it got worse.  I was told that it should go away in a few days to a week.
Patient has significant swelling at injection site about 3 to 4 in round in size, warm to the touch and hard. (Normal reaction). No other symptoms. Advised to follow up with unit/PCP.
sore/arm is still sore/at the injection site; warm/hot/warm like hot/at the injection site; 2-3 inches diameter of redness/2-3 inches in diameter with it being red/at the injection site; puffed up a little/at the injection site; tinge of a headache; This is a spontaneous report from a contactable consumer. This 82-year-old female consumer(patient) reported that: An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6198), via an unspecified route of administration as dose 2, single on 19Feb2021 (at the age of 82-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on 29Jan2021 (at the age of 82-year-old) for covid-19 immunisation and experienced sore arm that last a day, then it was fine. Patient had the second dose (as reported this past Friday), and her arm was still sore, warm like hot, and was maybe 2-3 inches in diameter with it being red on unspecified date. It was also puffed a little on unspecified date. The patient was wondering how long these symptoms will last at the injection site. On unspecified date, the patient had tinge of a headache. Patient had 2 friends and after their vaccine they had nothing. Patient have been put ice on it because it's warm. She asked whether she could continue to put ice of it. At the time of the report, the outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient reports swelling, tingling and numbness in left arm. Also, a bump at admin site. Patient reported 12/16/16.
This spontaneous report has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received improperly stored vaccine for children stock (reported as VFC stock) PEDVAXHIB (reported as PEDVAX HIB) (lot# M025193, expiration date 21-MAR-2019) (dose, frequency and route were unknown) for prophylaxis. At the time of report, the storage temperature and time frame were not determined. There was previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006622: US-009507513-1612USA007532: US-009507513-1612USA007533: US-009507513-1612USA007534: US-009507513-1612USA007536: US-009507513-1612USA007537.
Information has been received from a consumer concerning "someone in her neighborhood" who was vaccinated with varicella vaccine, and died the day of the vaccine. Follow up information from a registered nurse from the consumer's MD office, reported that she had heard that a child of approximately 5 years of age had died in town after a live virus vaccine, but the child also had a viral illness with a high fever. The cause of death was not reported. It was reported that another child had adverse events following exposure to varicella virus vaccine. Additional information has been requested.
On flight to (Privacy) experienced severe headache & low oxygen levels (77-89) throughout duration of the flight.  1 brief (5-6 minutes) episode of chest pain under ribs radiating up to jaw while in (Privacy).  Experienced same symptoms on return flights with headache, extreme fatigue, lightheaded and low oxygen (69-84) throughout duration of flight and lack of coordination for a brief time  (20-30 minutes) after landing.
This is a spontaneous report based on information from the FDA's VAERS database. Regulatory authority report number (VAERS-ID 395496). A 6-month-old male patient received the second dose of PREVENAR 13 (Lot E57642) intramuscularly in the left leg, the third dose of PEDIARIX (Lot AC21B248CA) intramuscularly in the right leg, a dose of ROTATEQ (Lot 0510Z) orally, and the third dose of ACTHIB (Lot UH045AB) intramuscularly in the right leg. All vaccines were administered on 26July2010. Relevant medical history was reported as none. The patient's concomitant medications were not reported. On 04Aug2010 the patient experienced Kawasaki's disease. Relevant laboratory data included the following: leukocytosis with platelet count increasing to 922K, CRP greater than 300, and erythrocyte sedimentation rate max at 130 mm/hr. A urine analysis on an unspecified date revealed leukocytosis. Cultures of the blood, urine, and CSF on an unspecified date were negative. An echocardiogram on an unspecified date demonstrated coronary artery ectasia with a clinical picture of Kawasaki's disease. Therapeutic measures were taken as a result of the event Kawasaki's disease and included treatment with  two rounds of intravenous immunoglobulin (IVIG). The clinical outcome of the events was reported as recovered. Follow-up (11May2011): This follow-up is submitted to amend previously reported information trade name for non-Pfizer suspect vaccines.
pt was unable to walk after shot yesterday, pt began having increased sever pain to back and stomach, also c/o head and chest pain on 02/03/2022, pt mother then brought pt to ED, pt was c/o headache, pt then had a witnessed tonic clonic seizure.  pt was brought to ed bed, fluids were started, blood was drawn, ed md and pa notified. ekg was completed and shown to have left atrial enlargement.
Left arm started hurting at 3 PM.  By 6 PM it ached badly down into my fingertips.  I woke up at 3 AM that night with fever, chills, body aches.  The next morning I had a headache, no appetite, neck ache, back ache, fever/chills which remained all day.  I slept more than half the day.  The next day I still have mild headache and mild fever chills which went away gradually over the day.  Was tired that day too.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 25-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours and temperature of 6 F to 14 F for 30 minutes on 16-JUN-2018 and 01-AUG-2018, respectively. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA001261: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261.
Head cold; Stuffy nose; Thick voice; Chills; Right arm is sore but soreness is more localized; Back was sore from something else as it was achy last night; This spontaneous case was reported by a non-health professional and describes the occurrence of NASOPHARYNGITIS (Head cold), NASAL CONGESTION (Stuffy nose), DYSPHONIA (Thick voice), CHILLS (Chills) and PAIN (Right arm is sore but soreness is more localized) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced NASOPHARYNGITIS (Head cold), NASAL CONGESTION (Stuffy nose), DYSPHONIA (Thick voice), CHILLS (Chills), PAIN (Right arm is sore but soreness is more localized) and BACK PAIN (Back was sore from something else as it was achy last night). At the time of the report, NASOPHARYNGITIS (Head cold), NASAL CONGESTION (Stuffy nose), DYSPHONIA (Thick voice), CHILLS (Chills), PAIN (Right arm is sore but soreness is more localized) and BACK PAIN (Back was sore from something else as it was achy last night) outcome was unknown. Not Provided
This spontaneous report as received from a physician refers to a 17 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 04-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N000326, expiry date 14-DEC-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1709USA012770 US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
At 8/11 follow-up visit with primary care physician, patient stated felt like nerve was possibly hit when vaccine was administered. Notes shoulder pain and numbness with difficulty raising right arm after vaccination was received. Reports that entire shoulder joint and neck hurt for several weeks after immunization. Reports site bled quite a bit after administration. Notes continued symptoms since vaccination, but symptoms have improved and leveled off.
Redness, swelling with warmth and tenderness noted by mom next day after vaccines were given ? time, brought to child on the 11/13/2008. Prescribed Motrin and alternate warm and cold compress every 2 hours.
While on vacation developed sinus infection that turned into Bronchitis. Prescribed antibiotics and decongestant by local MD.  After entering change in condition during weekly VAERS check up, was contacted by CDC requesting additional information.  As of today, still having productive cough and sinus drainage.  Will be seeing MD again later today.
received her 1st dose of Moderna covid vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received her 1st dose of Moderna covid vaccine) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 06-Oct-2020 to an unknown date and CYANOCOBALAMIN (VIT B12) from 06-Jun-2016 to an unknown date for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 14-Sep-2020 and the estimated date of delivery was 20-Jun-2021. On 02-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received her 1st dose of Moderna covid vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 02-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (received her 1st dose of Moderna covid vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. Estimated date of conception was reported as 04-Oct-2020. Previous pregnancy included live full-term birth without complications on 18-Sep-2018.
Parent called and child seemed to have seizure like activity upon driving home from appointment in our office after vaccinations. Advised to go to ER for evaluation.
This medically confirmed spontaneous report (initial receipt : 10-Oct-2012) concerns a 63-year-old female patient. On 17-Sep-2012 the patient received flu shot (manufacturer, brand name and batch number were not provided). Concomitantly she also received ZOSTAVAX (batch number: 0468AA, exp: 04-Apr-2013) injection at a dose of 0.65 mL subcutaneously as vaccine. The patient had a local injection site reaction to ZOSTAVAX. She developed itchy redness in the upper left arm that persisted for 7 days. No lab diagnostic study was performed. The patient did not receive any treatment. She sought medical attention by phone call to the HCP (healthcare professional). The event outcome was recovered.
After not having a period for 6 months, I started spotting one-week post 2nd vaccine. A week following that began an extremely heavy period lasting on and off (so far) for 2 months. Will have two or three days of nothing and then go back into heavy flow.  Doctor finally prescribed Megestrol to try and stop bleeding.
Only liquid portion was administered.; Only liquid portion was administered.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) for prophylaxis.   On 10th August 2022, the patient received Menveo. On 10th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment: The health care professional reported that after vaccination of 5 patients they became aware one of them was administered only the diluent of menveo without the lyophilized part but did not know which patient was. The reporter consent to follow-up by email. This case was for 3 of 5 linked patients, reported by same reporter. Additional Supportive information: The patient received the menveo vaccine before reconstitution with only the diluent portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022168203:same reporter US-GSK-US2022168199:same reporter US-GSK-US2022168210:same reporter US-GSK-US2022168209:same reporter
Intense pain at injection site, low grade fever, chills, headache, achiness all over, fatigue,