chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX. On 20th April 2018, the patient received SHINGRIX. On 21st April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, injection site warmth and injection site itching were recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site warmth and injection site itching to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient experienced hot feeling at injection site.
Swollen and painful lymph node in the right armpit. Pain started the night of the shot and progressed. The greatest pain and largest swelling was at 48 hours and persisted for the next day (total of 72 hours) at day 4 the swelling had started to subside and pain was dulling. The node was normal (or at least felt normal) by day 6. Just treated it at home with a heat pack, gentle massage, water, and ibuprofen. Was painful enough to affect sleep but not enough to seek professional help.
Doctors believe my wife has developed Gillian-Barre Syndrome as a result of the covid vaccine. We have visited the ER, 2 different Nuerologist, 2 different Internalist, a eye specialist (optometrist) and today the a spine Center.  Healthy 35 year old pre vacine, post-first vaccine shot developed numbness and shooting pain in feet, it has spread to fingers, mouth and rectum.  Eye prescriptions have changed drastically in last 3 weeks, extreme weight loss (down 20lbs), insomnia
Developed fever of 102-103 on evening of 25MAR slept occasionally through night; @ 8AM 26MAR tremors of hands started & sz (mom described sz as child would lose all muscle control & became unresponsive) duration 1-2min;
When I got out of bed in the morning I started to walk across the room to the bathroom but instead took off at a run to the left, only stopping when I ran into the dresser.  I scheduled an appointment with an ENT doctor, who I saw on 09/27/2022.  He found no ear infection.  He made an appointment for an inner ear exam on 10/05/2022.  I also had a hearing exam on 09/27/22 at Dr. office, showing loss of hearing, with a hearing aid presentation scheduled for 10/12/2022. My existing hearing loss is worse after the 09/10/22 incident, as is my existing unsteadiness on feet.  I also have some dizziness that comes and goes.
Arm pain at injection site; Injection site redness; Injection site warmth; Felt like coming down with something; Body aches; Out of breath; Weak; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth, feeling unwell, general body pain, shortness of breath and weakness. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, feeling unwell, general body pain, shortness of breath and weakness were recovered/resolved.   The reporter considered the injection site pain, injection site erythema, injection site warmth, feeling unwell, general body pain, shortness of breath and weakness to be possibly related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right deltoid. The reporter stated that local side effects on 1st day after vaccination as arm pain, redness and warmth at injection site. Less than 2 years after vaccination, the patient had systemic effects like felt like coming down with something which included body aches for several days, out of breath and weak. The patient was not hospitalized. The reporter indicated suspected link to vaccine. The reporter consented to follow up.
This is a spontaneous report from a contactable pharmacist. A 75-year-old female patient received PREVNAR13, intramuscularly on 29NOV2014. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced itchiness at the injection site, swelling at the injection site, and redness at the injection site on an unspecified date. The outcomes of the events, itchiness at the injection site, swelling at the injection site, and redness at the injection site, were unknown. The causality was assessed as related for itchiness, swelling, and redness at the injection site. Follow-up (14JAN2015): Follow-up attempts completed. No further information expected.
Large knot on right arm-massage therapy, tylenol Knot still has fever in it and is hot, sore, swollen
This spontaneous report was received from a medical assistant regarding a 4 year old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 31-MAR-2018, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # N027002 and expiration date: 28-SEP-2019), (strength, dose and route were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiry date were not reported). It was reported that the vaccine was stored in 13 degrees Fahrenheit (F) for 100 hours. There was previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the many reports from the same source. Sender's Comments: US-009507513-1804USA008748: US-009507513-1809USA007362.
Pt stated that her husband had a bad reaction to the flu shot and he went to the Dr. the Dr. confirmed cellulitis and asked to see her arm as well. Dr. then told her she also had cellulitis and gave oral and topical antibiotic.
Numbness and coldness in left hand, lethargy, rash at upper left arm down to elbow.  Now 05/25/2011 home from school today with lethargy and malaise.  Referred to PMD seen at 10:15am.  Per mother MD states "probably not related to Tdap but perhaps a flu like illness he (ct) picked up in the community.  The doctor also said the shot was given a bit low between the deltoid and another muscle so he said a nerve may have been hit.  The doctor also said that his being tired may be related to his medications."  POC: mother to contact PHN if child gets better and to contact PMD if worse and then contact PHN.  PHN to cb for f/u on 05/27/2011 or later today if after consulting with SPHN there is further contact needed.  Mother grateful.
Days after recieving the 1st anthrax vaccine, pt reports right facial weakness. 3/25/2014 seen by doctor. Doctor's note states that pt has slight pain over v3 section of face and slight tearing of eye. Pt reports to Imms nurse today that Bell's Palsy lasted 2 months.
hives; sensitive skin; itchy; nauseous; Some brain fog; Weight loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2022 as dose 3 (booster), single (Lot number: 330258D) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (dose number 2, Prev dose product - COVID 19, Prev dose brand - Pfizer Bio Tech, Prev dose lot number - EN6202, vaccine location - Left leg,), administration date: 11Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (dose number 1, Prev dose product - COVID 19, Prev dose brand - Pfizer Bio Tech, Prev dose lot number - EN6201, vaccine location - Left arm), administration date: 18Feb2021, when the patient was 68-year-old, for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 07Feb2022, outcome "unknown", described as "Some brain fog"; WEIGHT DECREASED (non-serious) with onset 07Feb2022, outcome "unknown", described as "Weight loss"; URTICARIA (non-serious) with onset 07Feb2022, outcome "unknown", described as "hives"; PRURITUS (non-serious) with onset 07Feb2022, outcome "unknown", described as "itchy"; NAUSEA (non-serious) with onset 07Feb2022, outcome "unknown", described as "nauseous"; SENSITIVE SKIN (non-serious) with onset 07Feb2022, outcome "unknown". Therapeutic measures were taken as a result of urticaria, sensitive skin, pruritus, nausea, feeling abnormal, weight decreased.  Adverse event: With recent vaccine, a month after consumer began having hives after eating. She have been tested for the foods and don't have an allergy. She also began having very sensitive skin, very itchy. Sometimes feel nauseous. Some brain fog. Weight loss due to the unknown problem with food. Ae treatment: Have seen many doctors, on Claritin Pepcid.
Nauseous; Fatigue; A regulatory authority report was received from a health care professional concerning a 60-year old, female patient who received Moderna's COVID-19 Vaccine (m-RNA-1273) and experienced very nauseous and fatigue.    Concomitant medication was not reported.  On 13-Jan-2021, prior to the onset of the events, the patient received their first of two doses of mRNA-1273(Batch no: 41L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 15-Jan-2021 patient experienced very nauseous and fatigue and got better but still feels it.  The final diagnosis made on was Nausea and Fatigue.  Patient medical history and Lab data was not reported.  Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events was  Unknown.
Information has been received from a physician concerning a male patient with Crohn's disease who on an unspecified date was vaccinated with VARIVAX (Merck).  Concomitant therapy included immunomodulatory drugs.  It was reported that the patient did not seroconvert from VARIVAX (Merck) vaccination.  The patient had received 2 doses of VARIVAX (Merck) in the past.  But when titer was drawn recently, his titer came back as 0.43 which is less than the protection level of 0.9.  At the time of the report the patient had not recovered.  The patient sought medical attention.  Additional information has been requested.
Pt developed Varicella zoster. Two years post immunization. Not culturd to verify whether W. lol tyle vs vaccine. Normal course of illness.
Pt had a positive COVID test on 8/8/22; 9/25/22 EMS called to home due to pt in cardiac arrest; rhythm showed Ventricular Fibrillation; resuscitated 45 mins before ROSC achieved; pt to ICU; shock, acute renal failure, metabolic acidosis; ABX given; pt evaluated by neurology services; nuclear brain flow study showed no flow; transitioned to comfort measures and pt passed away in the hospital
Itching, red swollen chest (hot to touch), hives on neck to chest area, metal taste in mouth.
severe headache about 12 hours after shot. Medicated with OTC headache meds and was ok until next dose was due. I am currently 36 hours post injection and the headache is still going stong.
Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
11/12/2020 Employee states she began feeling irritation to her arm, state her fiancé felt the arm and it felt warm, reports feeling nauseated and "not feeling herself", reports feeling more tired than usual. Employee states she has not done anything to treat it up until this point. Was instructed to apply ice.
On the day I received the shot, I developed a headache and fatigue about 6 hours after administration. I was fine by the next morning. 48 hours after the vaccine was administered, I developed diarrhea that resolved within 24 hours. 8 days after the vaccine, I developed itchiness and a rash at the injection site. The rash persists.
Pt recvd 3 doses of Engerix-B vax on 23JAN91, 20FEB91, & 10JUL91 & 10OCT91 post HBSAB was 0.5 RU which is interpreted as neg (no immunity);
itchy rash on upper torso. no treatment yet. Will start Benadryl and steroid cream.
Patient vaccinated with Moderna COVID vaccine 1/26/2021 and 2/26/2021, then presented to area ER for GERD-related sudden onset epigastric pain. Tested positive for COVID via NP at area ED, then transferred to reporting hospital for admission. Remains admitted at time of submission with primary diagnosis of COVID-19, GNR bacteremia, and concern for early cholecystitis versus choledocholithiasis. Estimated discharge date unknown at time of writing.
Sat evening started w/fever 100-101.7, headache, sore throat, swollen neck, low back pain, vomiting, diarrhea, stomach cramps, severe pain at injection site. IV fluids, doxycycline, prednisone.
Extreme fatigue, increase in palpations, ears ringing off and on, tightness in chest (could be anxiety but am VERY concerned about my Cardiac Ectasia (Bulge) on my Aorta due to news of Serious Adverse Events reported by others who received J&J Vaccine.
Around 3 am he woke me up saying he couldn?t feel his legs and had a stomach ache.  He got up in the morning to use the bathroom and almost passed out. Headache stomach ache , slight nauseous feeling lasted until about 12/1 pm.  Very tired slept all day until around 6 pm. Very tired into the next day.  Around noonish the following day he seemed to be back to normal.
Within 4 hours, patient began coughing and sneezing.  Eyes and lungs began to hurt.  Patient advised to contact personal physician who prescribed Prednisone, Kenalog and Claritin D.  Patient felt better within one day.
varicella despite vaccination; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to 128 children of unknown gender, who took part in active surveillance for varicella outbreaks and clusters in schools from 2012 to 2015. Outbreaks of varicella were defined as  equal or more than 5 cases in a school within at least 1 incubation period (21 days). No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patients was vaccinated with first or second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis.        On an unknown date, 42 patients experienced varicella despite vaccination after 1 dose and 68 after 2 doses in outbreak group; 7 after 1 dose and 11 after 2 doses in cluster group, respectively.   The outcome of vaccination failure was unknown.  The reporter considered vaccination failure to be related to varicella virus vaccine live (Oka/Merck) (VARIVAX).     A copy of the published article is attached as further document of the patients' experience.
25JUL91 pt recvd DTP/HIB; 26JUL91 t101-102 AX; 27JUL91 t100-101 AX, fussy, refusing to eat; 28JUL91 temp, fussy; 29JUL91 no fever, rash little red bumps appeared from waist up-rash would come & go; 30JUL91 taken to MD;
Right thigh cellulitis, induration, rash per emergency room notes 6-15-2014. Given ROCEPHIN (ceftriaxone) (737.5 mg IM) IM 6/15/2014. Seen 6/15/2014 in ER for following, seen 6/24/2014 at clinic for f/u.
Within 2 minutes of receiving the first dose, My skin became red, I experienced numbness in my mouth, hands, and feet. My blood pressure elevated to 194/110 and I experienced tachycardia. I also became confused and disoriented and my speech became slurred.  I was moved to a private room and monitored by the doctor administering the vaccination and an EMT unit. I was then taken to a nearby hospital by ambulance to have my blood pressure and heart rate monitored. I was also treated for nausea. After an hour and a half,  my blood pressure and heart rate had stabilized and I was discharged to continue my recovery at home.
Myocarditis, presenting with chest pain and positive troponin and cardiac MRI meeting diagnostic criteria with LGE and T2 edema
Resident received Pfizer dose 3 on 10/26/21. Resident had PRC swab done and 10/28/21 r/t state guidelines for response testing, results returned positive on 10/29/21. Resident remained asymptotic during this time. on 11/1/21 resident presented with shortness of Breath and lethargy, treated with Breathing exercises, supplemental oxygen, increased PO intake, and medications.
Dizziness; confusion; This is a spontaneous report from a non-contactable consumer(patient).  A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on left arm on 24Mar2021 at 15:30 (at the age of 54-year-old) at a single dose for COVID-19 immunization. The patient was vaccinated at Pharmacy/Drug store. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination has not been tested for COVID-19. Medical history included Pencillin allergy. Concomitant medications included Multivitamin and Vitamin D. The patient experienced dizziness and confusion on 24Mar2021 at 15:45. The events were reported as non-serious. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial unsolicited case received from a consumer (patient herself) on 28 Jul 2017. This case involves a male patient (age not reported) who was vaccinated with dose one of IMOVAX administered in arm, and dose one of IMOGAM administered in four places in hand (also reported as fingers) (Batch number, expiry date, dose, dose in series, route of administration were not reported for both vaccines) on an 24 Jul 2017. After kitten bite. The patient also receive Day 3 IMOVAX (Batch number, expiry date, dose, dose in series, route of administration were not reported), on an unspecified date. The patient medical history, and concomitant medications were not reported. On 24 Jul 2017, same day after the vaccination with IMOVAX, and IMOGAM (also reported as since Day 0 doses of both products), the patient had tingling in hand at injections sites in hand, had some nausea and headache. It was reported as the patient will see HCP for f/u and further doses of post exposure series. The patient relevant lab tests and corrective treatment were not reported. The outcome of the events were reported as not recovered. List of documents held by sender: none.
DTAP site on right thigh appears 1.5 x 2.5 cm mass, nonflucient, not hot, erythemious
reddened approx 1cm round area w/nodule afeb;was examined by MD & told was a sterile abscess as of 13AUG98 the nodule was dec in size;
PATIENT WAS VACCINATED ON TUESDAY 10/04/22 AT OUR PHARMACY WITH COVID BIVALENT VACCINE AND THE FLUZONE HD VACCINE. HE CONTACTED ME ON SATURDAY 10/08/2022 STATING HE HAD A EACTION TO THE VACCINES GIVEN HIM AND THE REACTION OCCURED LATER IN THE EVENING ON THE SAME DAY HE RECEIVED THE VACCINES. HE STATED HIS PCP DR AND HIS DENTIST STATED HE HAD BELL PALSY AS A RESULT OF THE VACCINES. HE STATED HE WAS EXPERIENCING PAIN IN HIS EYE, NECK AND SHOULDER.
Vaccine administered after 11 days of puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 11 days of puncturing the vial) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 11 days of puncturing the vial). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 11 days of puncturing the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains updated event verbatim.
CLIENT CALLED 11/15/07 TO REPORT THAT ONE DAY AFTER INFLUENZA ADMINISTRATION (10/19/07) SHE BEGAN TO ITCH ON BOTH ARMS.  SHE REPORTS THAT SHE HAD TO BUY A CREAM TO CONTROL THE ITCHING.
This case was reported by a physician via call center representative and described the occurrence of subconjunctival hemorrhage in a 77-year-old female patient who received BOOSTRIX (batch number B4G4G, expiry date unknown). Previously administered products included BOOSTRIX (on 28th February 2013). On 19th August 2016, the patient received BOOSTRIX .5 ml. On 19th August 2016, less than a month after receiving BOOSTRIX, the patient experienced extra dose administered. On an unknown date, the patient experienced subconjunctival hemorrhage (serious criteria GSK medically significant), purpura and edema of lower extremities. On an unknown date, the outcome of the subconjunctival hemorrhage and purpura were not recovered/not resolved and the outcome of the edema of lower extremities and extra dose administered were unknown. It was unknown if the reporter considered the subconjunctival hemorrhage, purpura and edema of lower extremities to be related to BOOSTRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient received BOOSTRIX vaccine on right deltoid. The physician reported that the patient experienced unilateral oedema in right lower extremities, bilateral eye sub-conjunctival haemorrhage and purpura in upper extremities. The right sub-conjunctival haemorrhage was resolved and left sub-conjunctival haemorrhage was not resolved. The physician reported that, the patient previously received BOOSTRIX on 28th February 2013, but again on 19th August 2016, the patient received BOOSTRIX, which led to the extra dose administered.
Second dose of Tdap given to patient as part of primary Td series.  Pt. rec'd Tdap 6/19/2006 and 3/8/2007