chrisvoncsefalvay/vaers-outcomes huggingface dataset:
burning sensation; tingling; itching; stinging sensation; This case was reported by a nurse via call center representative and described the occurrence of burning sensation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced burning sensation, tingling, pruritus and stinging. On an unknown date, the outcome of the burning sensation, tingling, pruritus and stinging were unknown.   It was unknown if the reporter considered the burning sensation, tingling, pruritus and stinging to be related to Shingrix.  Additional details was provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix, and experienced burning, tingling, itching, stinging sensation. The reporter consented to follow up.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to an 11-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 31-OCT-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Pt was seen in ER on 2/19/03 with possible allergic reaction to hep B vac immunization. Seen by Dr in clinic on 2/21/03 developed systemic reaction given Kenalog to relieve this and Zyrtec.
Bilateral breast enlargement.  Have gone from an A to B cup.  No nodes felt under arms. No nodes felt in either breast.
pt on chemotherapy & radio therapy for cancer of the rectum exp nosebleed 11 days p/recvd flu vax; Neosynephrine nasal spray was prescribed to treat this adverse event;
pt recv vax & devel severe burns on arms, skin that felt like leather & itchy skin on 17OCT96, 1 day p/vax;pt went golfing p/vax & was exposed to the sun;pt med hx is remarkable for HTN, hypercholesterolemia & arthritis;
Have Diarrhea; This is a spontaneous report from a contactable non health care professional (Patient). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6Z04), via unknown route of administrated in left arm on 12Mar2021 (at the age of 25-years-old) as a single dose for Covid-19 immunisation. Patient received vaccine at public health Clinic/veterans administration facility. The patient medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19. The patient lab tests were not reported. Patient was not enrolled in the clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced diarrhea on 14Mar2021. Treatment was not received for the event diarrhea. Patient did not receive any other vaccine 4 weeks prior to COVID vaccine. The clinical outcome of the event diarrhea was not resolving. Prior to vaccination the patient was not diagnosed with COVID-19. No follow-up attempts are possible. No further information is expected.
Leg became swollen   A couple of weeks later I experienced mild heart attack.  Overall, I have need fatigued, short of breath
Patient seen in ER for fever, myalgia, cough, sneezing on 5/6/22.  Positive exposure by significant other. Patient prescribed paxlovid.
Member became vasovagal about 5 minutes after administering vaccine. Was given IV fluids on scene but still had low blood pressures Was transported to ED by EMS.
did not feel well; Initial information was received on 14-Nov-2020 regarding an unsolicited valid non-serious social media  case from the consumer.  This case involves an unknown demographic patient who did not feel well (malaise), after receiving INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  The patient had received flu shots in the past and had no adverse events post vaccination.  The patient's past medical treatment, family history and concomitant medication were not reported.   On an unknown date (same day), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer and a dose of suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient did not feel well (malaise), (unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on the batch number for this case.
Lethargic; Injection site is hot; Could not get off the couch all day; There is big Knot on left side shoulder when she rubbed her arm; Eyes burning type like feeling; Fatigue; Slight headache; Feeling feverish; Achy; Bump or lump; Red; This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is hot), FEELING ABNORMAL (Could not get off the couch all day), SWELLING (There is big Knot on left side shoulder when she rubbed her arm) and EYE IRRITATION (Eyes burning type like feeling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included OLMESARTAN, HIDROCLOROTIAZIDA and ACETYLSALICYLIC ACID (BAYER ASPIRIN) for Blood pressure.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is hot), FEELING ABNORMAL (Could not get off the couch all day), SWELLING (There is big Knot on left side shoulder when she rubbed her arm), EYE IRRITATION (Eyes burning type like feeling), FATIGUE (Fatigue), HEADACHE (Slight headache), PYREXIA (Feeling feverish), MYALGIA (Achy), VACCINATION SITE SWELLING (Bump or lump) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is hot), FEELING ABNORMAL (Could not get off the couch all day), SWELLING (There is big Knot on left side shoulder when she rubbed her arm), EYE IRRITATION (Eyes burning type like feeling), FATIGUE (Fatigue), HEADACHE (Slight headache), PYREXIA (Feeling feverish), MYALGIA (Achy), VACCINATION SITE SWELLING (Bump or lump) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        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 treatment information was provided by the reporter.   This case was linked to MOD-2021-286515 (Patient Link).
if I touched the injection site, it was very slightly tender; by the injection site only, it was such a slight amount of soreness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 21Feb2021 (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization. Medical history included epilepsy. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) as 150 mg (2x every day), and 75 mg (1x every day), lithium carbonate (LITHIUM CARBONATE) as 450 mg (1x every other day), topiramate (TOPIRAMATE) as 100 mg (2x every day), cobamamide (VITAMIN B12 [COBAMAMIDE]) as 1000 mcg, biotin (BIOTIN) as 5000 mcg, vitamin d3 (VITAMIN D3) as 1000 IU, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) as 500 mg, and Centrum Multivitamin. On 21Feb2021, the patient experienced if I touched the injection site, it was very slightly tender, and by the injection site only, it was such a slight amount of soreness. The outcome of the events was recovered on 21Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial report received on 11 October 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 20-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3570AA received on 11 January 2010, lot number C3606AA received on 15 March 2010 and lot number C3608AA received on 14 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and a cough on 18 July 2011, approximately 14 months after the last dose. On 22 July 2011, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Sleep apnea was reported as unknown. Laboratory testing included positive PCR on 23 July 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 23 July 2011 for five days. The subject was not hospitalized. At the time of final contact on 05 August 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender; None.
Patient required hospitalization due to breakthrough infection. Patient received J&J vaccine on 03/26/21. Patient was hospitalized from 09/05/21 - 09/18/21. Below is copied from discharge summary:   History of Present Illness: 93 y.o. male with Hx of HTN, DM, CAD s/p CABGx4, jaw cancer presents c/o worsening SOB and wheezing since this morning.    Pt reports associated productive cough, dehydration and no appetite. Denies fevers, N/V or abd pain. PSHx Bypass graft.    Vaccinated against COVID with J&J vaccine. Denies chest pain. Troponins are significantly elevated.    The history is provided by the patient. No language interpreter was used.  Shortness of Breath Severity:  Moderate Onset quality:  Gradual Duration:  1 day Timing:  Constant Progression:  Unchanged Chronicity:  New Associated symptoms: cough and wheezing   Associated symptoms: no abdominal pain, no chest pain, no fever, no headaches, no neck pain, no sore throat and no vomiting
postherpetic neuralgia; shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 23-JAN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was unknown. Causality assessment was related.
Went to emergency room with symptoms of CVA per client. Diagonses was Bells palsy per client. Right side of face "droopy". Weakness noted on right arms also per client. Slurred speech.
PULMONARY EMBOLISM; INJURIES; CHRONIC  FATIGUE; This spontaneous report received from a patient via social media via a company representative concerned multiple patients. It concerned two patients of unspecified age, gender, race and ethnicity. The patients' height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that the patients had experienced pulmonary embolism after the vaccination and had chronic fatigue since their vaccination. On an unspecified date, the patients also had injuries. On an unspecified date, it was reported "I refuse to take any of the vaccines, 2 of my friends had pulmonary embolisms after their shots and have had chronic fatigue since their''. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism, chronic fatigue and injuries was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220217362.  Version created to amend previously reported information on 04-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V2: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events.  20220213367-COVID-19 VACCINE AD26.COV2.S-pulmonary embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Severe chills and shaking. At first I only had stiffness in both arms from the injections. Then, as I was going to bed at about 9 pm, I began to shake quite a lot with chills. I tried to sleep, but by 11:00, it was impossible. I put on warmer pajamas and an extra double layer wool blanket over me to get warm enough to sleep. I continued to shake for another hour or so until I was able to sleep more soundly. NOTE: At the time I received the Covid vaccine, I also got a flu shot injection in my other arm.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot # M001200 (dose, expiration date, route and site of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Arm is swollen; Chills; Under his arm in his armpit its swollen and painful.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen), CHILLS (Chills) and AXILLARY PAIN (Under his arm in his armpit its swollen and painful.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), CHILLS (Chills) and AXILLARY PAIN (Under his arm in his armpit its swollen and painful.). At the time of the report, PERIPHERAL SWELLING (Arm is swollen), CHILLS (Chills) and AXILLARY PAIN (Under his arm in his armpit its swollen and painful.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Breakthrough Case of COVID. I had the worst sore throat ever, a low fever of about 101 for about 3 days, I was very tired, and that lasted for about a week and a half and a cough and congestion, which I am still dealing with right now.
This case was reported by a other health professional via sales rep and described the occurrence of swelling in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling, erythema, pain and fever. On an unknown date, the outcome of the swelling, erythema, pain and fever were unknown. It was unknown if the reporter considered the swelling, erythema, pain and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a Certified Medical Assistant. The age at vaccination was not reported. The patient experienced swelling, redness, pain, body aches and fever. The reporter had agreed to follow up.
When vaccine was administered went from feeling fine to having heavy perspiration for 15 minutes afterwards. My shirt was soaked through when i left the clinic. Felt fine and took some benadryl (to sleep) and (tylenol) to stop arm pain and then went to sleep. Woke up at 1am with chills, shaking, chattering teeth and body aches.  Took a hot shower and attempted to go back to sleep, but had intense body aches. Slept a few more hours. Woke up again feeling worse at 7am. fever of 101 degrees. Took more tylenol and more benadryl. Slept until 2pm. Woke up still had fever and body aches. By 530pm body aches stopped and fever went away. By 7pm i felt normal. Injection site soreness lasted for less time on 2nd shot than on first shot.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREGNANCY (Pregnancy). At the time of the report, PREGNANCY (Pregnancy) had not 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.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Fever - 10/23 - 10/25 fever blister - 10/27 - tired x 7 days. 10/28 - awakened during night tingling - pain (L) great toe - 10/31 - limping - swelling (L) knee - during night noted severe pain - both thighs and knees - and knees - hips - unable to walk - walked to BR with assistance only. Felt faint x 2 - took TYLENOL for pain - by 9 am able to walk but still experienced severe pain in both hips, groin, knees - thighs - numbness and tingling in feet - (much difficulty walking) symptoms continued 11/1 - 11/2 able to walk with assistance of cane - pain less during day - symptoms returned at night 11/3 - 11/4 - pain severe in (L) groin - severe pain when turning over on bed at night - swelling in (L, knee less by 11/4 - improved by 11/7 - Saw NP in phys. office on 11/11 - determined severe reaction to flu vaccine - referred to rheumotologist. (awaiting appointment)  1/17/09 continue with pain in both knees - rt upper leg - this is 1st time I have receive flu vaccine.
Redness/ swelling/ pain surrounding vaccine site. Developed overnight. 10x12cm.
Hospitalized 1/2/22 w/persistent non-progressive fatigue associated w/frequent falls and decreased appetite x2 days; no hypoxia; coumadin toxicity (INR >9); died from hemorrhage 1/2/22.
About 1 hour after receiving vaccine, mother reports patient had hives and throat tightening.  Benadryl given and symptoms resolved over next few hours.  Pt has had some vomiting with eggs in the past but tolerates it if "eaten with other foods" and reports no history of hives or airway swelling with egg ingestion in past.
left calve and foot swelled up; lower back pain between kidneys; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left calve and foot swelled up) and BACK PAIN (lower back pain between kidneys) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PERIPHERAL SWELLING (left calve and foot swelled up) and BACK PAIN (lower back pain between kidneys). On 08-Mar-2021, PERIPHERAL SWELLING (left calve and foot swelled up) and BACK PAIN (lower back pain between kidneys) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Erythematous, macula measuring approx. 7mm, poorly demarcated with a 4mm induration, cool to touch to right deltoid. Have tried to contact but unable to reach.
This is a spontaneous report from a contactable nurse via Company sales representative. A female patient of an unspecified age received PREVNAR 13 (Lot H65735, expiration date 07Jan2015) on 18Nov2014 at 11:42 am at 0.5 ml single in the left deltoid. Relevant medical history included ongoing rheumatoid arthritis, concomitant medication included methotrexate, six tablets weekly, for rheumatoid arthritis. No other vaccines were administered on 18Nov2014. On 19Nov2014 the patient experienced swelling arm, redness, pain. The patient recovered from the reported events on an unspecified date. The nurse mentioned that swelling of arms, redness and pain were due to PREVNAR 13.
Pale skin, Daily headaches, blurred to no vision, fatigue, loss of appetite, severe back pain, nausea, fever, chills, increased urination, loss of memory.
Skipped menstral cycles after first  and second shot and again after booster shot in November 2021