chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 3/12/02, given DTAP, IPV and Prevnar. On 3/13/02, admitted to the hospital with diffuse petechial and purpuric rash with fever of 101.2F, WBC-12.5, Platelet Count-104K over 3 hours later WBC-14.2, Platelet Count-78K. Blood and urine cultures done and prescribed ceftriaxone and vancomycin and transferred to another hospital. On 3/13/02 to 3/18/02, at the other hospital, was felt to have an atypical Henoch-Schonlein Purpura. Labs improved; sepsis ruled out. Mild glomerulonephritis per review of hospital discharge summary.
2 cm in diameter erythematous lesion on the (R) upper arm.  Site of varicella shot 24 hrs after injection.
This RN gave Pediarix (DTaP, IPV, Hep B) along with a single, separate Hep B vaccine
Patient began complaining of itching  over entire body. No hives or rash present. No breathing difficulty. Benadryl 25 mg given po per order of FNP. Observed patient for 30 minutes after oral Benadryl given. 1550-pt states itching has resolved, no hives , no rash, no difficulty breathing, skin-pink, no signs of any distress. Released to return to work at 1550 and instructed to go to the ER if symptoms return.
This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose: not reported, on Apr 7, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. Apr 2021, patient experienced lightheadedness and tiredness. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered. This case, from the same reporter, linked to 20220407545.
2 days p/vax lt thigh was red & swollen; Then about a 4 inch line of bruising appeared; no fever noted; 25MAR seen by MD felt was sterile abscess; did not recommend any tx;
Suspected accidental implantation of left ear, hands and arms bilaterally, and right thigh.  Symptoms began approximately 16 days after receiving primary smallpox vaccination.  Pt presented on day 19 (2 Feb 03), after vaccination and was afebrile, smallpox site well healed with scab in place.  Eruption on dorsal aspect of both hands mostly around the 2nd and 3rd digits.  Additional lesions noted on palms bilaterally and a few scattered raised, erythematous lesions were noted on the arms bilaterally.  Left ear was edematous and oozing amber colored discharge and the entire pinna was erythematous.  No lesions identified on face, torso, feet or scalp.  Pt was treated with benadryl for itching.  Aside for generalized itching at sites of implantation, pt denies any systemic symptoms.  Pt will be monitored for resolution of symptoms.
RPh administered FLUZONE QUAD (Pre-filled) upon patient signed consent.  At around 2:45 pm after the administration of vaccine, she immediately told RPh that she felt a tingling sensation from her arm (site of injection) through her fingertips.  Then immediately through the left side of foot.  Upon consultation with RPh about common side-effects, patient left but came back after 5-10 minutes to report that she felt "weird "and the symptoms are still present.  To monitor her symptoms, RPh advised the pt. to stay, gave her bottle of water, 1 tablet of Potassium gluconate to help relieve symptom and had pt. elevate her left leg on chair.   RPh documented the adverse event and interviewed pt. if she needs to seek medical help (call 9-11 or primary care DR).  She decided to have me call the nearest urgent care clinic and ask she can be seen by a doctor.  Rph  told pt. we need an update on her condition and we will be calling her.
Significant local swelling in upper arm of injection site, lasting several days. Still swollen when seen in follow up 10/30/2017.
Pfizer Booster injection site reaction, pain in shoulder, arm turned red injection site area and itchy. inflamed  site was warm to touch. was adv to take Benadryl, use ice and anti inflammatory meds. Noticed redness and swelling was spreading all over body. Went to doctor, and was prescribed antibiotics.
On 10/04/2021, there is a question on the immunization consent form asking if patient received any COVID vaccine before and patient put down "No" as the answer. He received Pfizer at our pharmacy as his first dose. However, patient came in on 1/24/2022 and we found out that he has another vaccine card because he received Moderna dose from Rite Aid pharmacy on 06/29/2021. Patient explained that he thought because it has been more than 28 days since he received Moderna vaccine, he needs to restart the series. Therefore, he did not mention about him receiving Moderna vaccine when he came for the Pfizer vaccine appointment. Patient did not experience any adverse reaction. Patient mix-matched the first two doses.
swelling & soreness in arm, lasting 3 or 4 days dizziness, h/a, nausea, tiredness;APAP was used for relief of sx;still has nausea & tiredness;
Client contacted office, via telephone, 4 days after receiving vaccines, reporting his right arm is swollen, red, warm to the touch and pain to his elbow.  Client states the redness to his whole upper right arm started the day after receiving the vaccines, moved to his lower right arm by the third day post vaccines, and unable to move his elbow by the fourth day post vaccine. Client states he placed ice on his arm and it was effective on decreasing the pain, swelling and the  redness. Client came to the clinic for the nurse to observe the adverse reaction. Client's right arm noted to warm to the touch, red from mid-forearm to mid-upper arm, and client had good range of motion in his elbow. Client reported that he did not want to go to his PCP since the ice was helping the reaction, however states he would contact his PCP if the reaction did not decrease in the next couple days. Contacted client today, and client reports that the swelling and redness has gone down significantly and he denies having any pain at this time. Client states he does not feel he needs to be seen by his PCP at this time.
pain in right shoulder worsened  so that by 6 pm it was intensity of 9/10, severe .couldn't lay on that side ,use right arm, unable to sleep at all night of 7-17/18  .was still very sore next morning, intensity 7-18 , 6/10.Reminded me of the aftermath of having been stung by a hornet or wasp, to which I am allergic .Note: there were no other Sx of allergic reactions, "just" the severe pain. Information sheet states that " some people have severe pain in the shoulder and have difficulty moving the arm where a shot was given. This hapens very rarely".
pt recv vax 15APR97 & devel fever 105 by 22APR:to ER on 24APR & 26APR transferred to hosp 26APR;rash devel on 24APR or 25APR on arms & legs w/some itching;eyes became blood shot on 24APR & listless;
Flu-like symptoms the day after injection with Fever 102.1F. Fatigue. Next day, fever down to 101.0F. Following days still running low grade fever - 99.4-99.8F with fatigue.
All information obtained from the record. Client began with symptoms started on 12/28/2021, when returning home from a family vacation. He developed symptoms of cough, congestion, sneezing initially.  He presented to ED on 12/30/2021 for extreme weakness and fever. He had syncopal event with vomiting in the waiting room. He is vaccinated for COVID-19 including a booster.
first dose 25Aug2022, second on 19Sep2022; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 2J5BF, expiry date 6th October 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 19th September 2022, the patient received the 2nd dose of Shingrix. On 19th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The patient was not immunocompromised. At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Did not take Vivotif according to schedule; Spontaneous report received on 05DEC2019.  A pharmacist reported that a 31-year-old female consumer who "did not take Vivotif according to schedule" (PT: Inappropriate schedule of product administration). She was receiving oral Vivotif for typhoid fever. On 22NOV2019 and 24NOV2019, the consumer took first and second dose of Vivotif respectively. Then, she did not take her remaining two doses according to schedule. Action taken with Vivotif with respect to the reported event was not applicable. Outcome of the reported event was unknown.  Company Comment: A consumer did not take last two doses of Vivotif according to the schedule (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.; Sender's Comments: A consumer did not take last two doses of Vivotif according to the schedule (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.
On the night of the 2nd day after the 2nd shot, I got fever and shivers; next day and next days I got hives, 6 or 7 on the left chest and 2 on the left upper back. Doctor prescribed Antiviral medication and Benadryl
FALL AM OF 2/18/2021 T 99.5 WITH LETHARGY
I received my 2nd booster shot on 04/08/2022 and my COVID symptoms started on 05/17/2022. I had runny nose, cough, along with headache and itchy eyes. It felt like allergies. On 05/18/2022 my boss and his wife was positive which made me think to do a COVID test. I went to the urgent care to get COVID test and on 05/19/2022 I was told by the urgent care that I was  positive. On the 05/20/2022 I had a Telehealth call with my doctor who prescribed me PAXLOVID for 5 days. My doctor also told me to quarantine for 5 days and wear masks for 5 more days.
Swollen, lymph nodes behind ears and axillae - mom noticed they started 2 days after vaccines.
Initial misuse report received from a healthcare professional on 17 January 2013. A patient (No information was provided reagrding the patient) was administered an expired dose of MENACTRA. No adverse event was reported. List of documents held by sender: none.
flu; Initial information received on 25-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient of an unknown age and gender who experienced flu after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect of INFLUENZA VACCINE produced by unknown manufacturer (lot number, formulation, dose, expiry date, strength: not reported) via unknown route in unknown administration site for flu.  On an unknown date the patient developed a serious event flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   It was reported that "Got my flu shot In November first week of December iwas hospitalized for five days still not totally well".  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.  Seriousness criteria: patient was hospitalized for this event.
Possible AE: consumer is scheduled to receive 2nd dose passed 42nd day window; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Possible AE: consumer is scheduled to receive 2nd dose passed 42nd day window) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced OFF LABEL USE (Possible AE: consumer is scheduled to receive 2nd dose passed 42nd day window). On 04-Jun-2021, OFF LABEL USE (Possible AE: consumer is scheduled to receive 2nd dose passed 42nd day window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.   Treatment information not reported.  Patient reported to pharmacist that 04-JUN-2021 would have been day 42 from 1st dose, but no proof of 1st dose.
at 3:22, Pt waved down  (EMT) on site. Clt sitting in vaccination observation area. C/o feeling hot, dizzy, and lightheaded with vasovagal like symptoms. Pt moved to reclined position, and reported immediate relief. Vitals taken at 3:35: BP 132/90, 66 HR. Denies other s/s allergic reaction. Clt sat up 8 min later, states symptoms resolved. Clt completed Vaccine observation period, ambulated self to bathroom and left site at 3:46 pm.
Initial report received from literature on 28 December 2014. This case is linked to case number 2015SA000156, 2015SA000157 and 2015SA000158 (same literature report). The following is the verbatim for the article abstract: A number of medications have been associated with uveitis. This review highlights both well-established and recently reported systemic, topical, intraocular, and vaccine-associated causes of drug-induced uveitis, and assigns a quantitative score to each medication based upon criteria originally described. An unknown patient (age and gender was not reported), whose medical history and concomitant medications were not reported, had received a dose of INFLUENZA VACCINE (manufacturer- unknown, batch number, route, dose number and site of administration was not reported) on an unspecified date. On an unspecified date patient had experienced secondary uveitis/bilateral panuveitis/recurrent panuveitis and acute posterior multifocal placoid pigment epitheliopathy. It was reported that the influenza vaccination has been implicated in the development of secondary uveitis in several case reports, including bilateral panuveitis, recurrent panuveitis and acute posterior multifocal placoid pigment epitheliopathy (APMPPE). Anterior uveitis can be controlled with topical corticosteroids and a cycloplegic/mydriatic agent, whereas posterior involvement may require systemic corticosteroids. Laboratory investigation and corrective treatment was not reported. At the time of reporting, patient outcome was unknown. Upon medical review, the case was considered as serious due to important medical event: secondary uveitis/bilateral panuveitis/recurrent panuveitis and acute posterior multifocal placoid pigment epitheliopathy. List of documents held by sender: none.
Father and patient state she has had episodes of losing sight and passing out ever since she received the first vaccine.  It has happened in February, August, September, and November.
thought she was having a stroke; in bed with a migraine; having an aneurysm; no one could touch her arm for 5 days; bed for 5 days with a headache; could not move her arm; This is a spontaneous report from a Pfizer sponsored Program from a contactable consumer reported for sister. A female patient of unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The reporter stated she knew a lot of people that had had been getting a lot sicker after getting the vaccine. She reported that the patient had an adverse event after the vaccine and was in bed for 5 days with a headache and thought she was having a stroke. The reporter said that the patient could not move her arm. The patient was in bed with a migraine, thought she was having an aneurysm, no one could touch her arm for 5 days. It was so severe and debilitating after she got her vaccine. The reporter said that she had had a bunch of family members that got the vaccine. The reporter confirmed that she had not received the vaccine. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt found unresponsive not breathing in crib at nap time. Attempts to resuscitate failed. Pt pronounced dead by sudden infant death.
Two main side effects:  1. Random twitching in joints throughout 1st and 2nd dose of Pfizer vaccine. Has lessened since vaccine but still comes and goes roughly once every 2 weeks.  2. Joint and muscle pain in legs. Legs, specifically in calves and shins, felt tight and in pain. Very similar to a prolonged Charlie horse. Came and went for 2 months. Strongest was 2-3 weeks after 2nd vaccine. Took Tylenol? sometimes helped. Also soaked in tub with Epsom salts.
Myalgia, pain at site x days 1-2 after first dose. Narrative:
Patient was admitted to the hospital with COVID infection on 10/25/21, after receiving a booster dose of Pfizer COVID vaccine (lot # FF2590) on 10/22/21.  Of note, this patient had previously received two doses of Pfizer COVID vaccine ( on 2/1/21 lot # EN5318,   and on 2/22/21 lot # EL9264, respectively).  The patient reported experiencing weakness, diarrhea, and myalgia for 2 days prior to admission.  Per provider notes, the patient reported that his diarrhea symptoms had started 4 days prior to admission. The patient tested positive for COVID via FLUVID test on 10/25/21. At the time of this report, the patient remains hospitalized and is being treated for COVID infection.
allergic reaction; This is a spontaneous report received from a non-contactable consumer (patient) via a Pfizer-sponsored program, COVAX US Support. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (batch/lot number not reported), as dose 1, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced side effects with her first dose of the COVID-19 vaccine. She was not sure if she had an allergic reaction to it or not. She also wanted to know if she should take the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1/7/23 weakness started. 1/17/23 went to the ER for increasing ascending bilateral weakness from lower and upper extremities. Admitted 1/17/23.  Given 6 rounds of IVIG with improving symptoms. Discharged 1/27/23 to acute rehab currently still in acute rehab walking with a walker.
Since around 1/26/2021 Having a very itchy rash on the injection side started as a little itchy bump is getting bigger, looks like a red ring very itchy, hot to the touch and hard too. Also I been having a headache since 1/28/2021 not sure if is related. Also felling  very tired not sure if is related as well.
Information was received from a nurse via a company representative and refers to patients of unknown age and gender. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On unspecified dates, it was reported that unspecified patients may have received improperly stored doses of GARDASIL (lot number, dosage and temperature unknown). The temperature and time frame were unknown by the reporter. The reporter also stated that it was unknown if there was a previous temperature excursion or if it was because of a data logger. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
Redness 3 inch diameter around injection site, itchiness 5 inch diameter around injection site, heat on upper arm. Took one Benadryl at 5:15 pm and symptoms returned by the following morning. Itchiness and redness gone by 11:00 AM 11/15/2012 but heat remains.
Information has been received from an office manager concerning a 51 year old female who on 08-NOV-2007 was vaccinated with Pneumovax 23 single dose series vaccine, injection, in the right arm (lot # 658673/0990U). Concomitant therapy included esomeprazole magnesium (NEXIUM), clonazepam (KLONOPIN) and promethazine. It was reported that after the patient received her Pneumovax 23 vaccine, she had developed an abscess in her right arm where she received the vaccination. The patient had gone to the emergency room (ER) and told the physician there that she had received Pneumovax 23 vaccine at her physician's office. Subsequently the patient was admitted to the hospital (date unspecified), and as of 13-NOV-2007, was still there and recovering from the event. Additional information has been requested.
2nd dose of the vaccine not being given on day 36 after the 1st dose 26Jan2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine not being given on day 36 after the 1st dose 26Jan2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history provided. No concomitant medication provided.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine not being given on day 36 after the 1st dose 26Jan2021). On 13-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine not being given on day 36 after the 1st dose 26Jan2021) had resolved.        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 product was reported.
DATA ENTRY SHOWED 1ST DOSE 4/14/2021 BUT CAME IN FOR A DOSE ON 4/17/2021 TOO.
Information has been received through a pregnancy registry from a LPN, two employees in the office and a 24 year old female with a history of 3 previous pregnancies (one live birth and two miscarriages) who on 29-DEC-2003 was vaccinated by her PCP with a dose of varicella virus vaccine live (lot# 644973/0195N) after first having a negative antibody test on 15-AUG-2003. Following vaccination the pt denied local reaction, varicella symptoms, or Herpes zoster symptoms. On 22-Jan-2004 the pt reported that she may have been 3-6 days pregnant at the time of vaccination. On 27-Jan-2004, after an ultrasound to determine viability which demonstrated positive fetal heart tone, the office reported that the pt was 7 weeks pregnant. Her LMP was 09-DEC-2003 and the estimated date of delivery was 12-SEP-2004. She was placed on prenatal vitamins daily. On both 23-APR-2004 and 26-JUL-2004 ultrasounds were done to follow renal pelvis dilation in fetus; this resolved. On 5-SEP-2004 (38 weeks and 4 days from LMP) an 8 lb normal male infant was born without congenital anomalies or complications. No product quality complaint was involved. No further information is available.