chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got flu like symptoms; broke out in hives; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).  This case involved  patient of unknown demographics who didn't get the flu for 30 years, took a flu shot and got flu like symptoms (Influenza like symptoms), while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, patient didn't get the flu for 30 years, took a flu shot and got flu like symptoms (Influenza like symptoms), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Initial misuse report received from a healthcare professional on 26 September 2013. The cases were received on 21 March 2014. A dose of FLUZONE ID was given to 17-year-old patient. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Fever 101.5 x 1 day on 4/22/2005, rash started 4/22/05 on entire body, pink macular rash. Atarax as needed for pruritus.
COVID-19 mRNA LNP-S, bivalent PF 6mos-5yrs (Moderna), 10 mcg/0.2 mL - Wrong dose given (under dosed)
Patient reported an egg intolerance at time of flu shot. then reported back that she has a scratchy  throat.
Injection site quickly became red and hard to touch. Swelling of injection site got as large as baseball. An extremely uncomfortable  amount of pain for first 5 days. Pain and swelling went to lymph nodes  under left arm (injection arm). Within 24 hours chills, fatigue that lasted 2 days. Diarrhea  also present days 2-4.
A few days after receiving his vaccines, patient began to show signs of head cold/upper respiratory infection. 20 days post vaccines, patient woke up unable to walk or put any weight on his legs and was admitted to hospital. The illness spread weakening upper body muscles, facial muscles, and shutting down his bladder functions. Patient was treated with IVIG and steroids. He was diagnosed w/Guillain Barre syndrome. As of 12/5, he is in inpatient rehab, still unable to sit up or use his legs at all.
Patient arrived to nurses office with c/o stomachache. Axillary temp 101.1. Informed dad, Tylenol given. Dad picked student up and took her to family doctor.
Pt seen in outside ED for head laceration requiring staples on 11/20/08. Recieved Td or DtaP (unclear as recieved elsewhere) booster as standard prophylaxis. On 11/24/08 returned to medical center for "swollen" right thigh at injection site. Patient has had all previous childhood immunizations without incident. Examined by pediatric infectious disease attending, who noted complicated history of HLHS and s/p OHT with chronic immunosuppression. There was no local fever or erythematous area noted on exam. No abscess or drainage noted and cultures were negative.
Right trigeminal neuralgia, facial pain into cheek, eye, jaw  off and on since morning after injection   taking tylenol
Fussy, very needy (wanting to be held all the time), soreness at vaccine site.  Next day (7/27) fever of 102.7 at 1:00pm.
This initial non-serious spontaneous case, was received on 20-Sep-2017, from a pharmacist concerning a 92-year-old female adult elderly patient. The concomitant medication included metoprolol extended release (ER) for an unknown indication. On 06-Dec-2016, the patient received AFLURIA (TIV) (anatomical location: left deltoid, dose, route of administration, batch number, expiry date). On 06-Dec-2016, the patient received non-company product PREVNAR 13 (anatomical location: left deltoid, dose, route of administration, batch number, expiry date). On the same day, within a day receiving the vaccine the patient developed some pain and discomfort in the same shoulder. The pain and discomfort persisted and got worse. The pain was at down her arm and even across her back. She was worried whether her arm may get worse. No treatment was taken. At the time of the report, the outcome of the events was not reported. Significant case correction received on 13-Oct-2017: The onset date was correct to 06-Dec-2016 for the events injection site pain and discomfort. The outcome of the events was corrected from not recovered to not reported. Narrative amended accordingly.
Information has been received from a physician concerning a patient in the neighborhood of 4 months who was vaccinated with a 2 ml second oral dose of Rotateq. Seven days after the second dose of Rotateq the patient developed hematochezia. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Upon internal review, hematochezia was considered to be an other important medical event. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. The patient's medical history,concurrent conditions, drug reactions or allergies and concomitant medications were not reported. On unknown dates (reported as a couple of years ago), the patient was vaccinated with a first and a second dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported) for prophylaxis, on schedule.  On 03-MAR-2017, the patient was vaccinated with a third dose in GARDASIL series as GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. The product quality complaint was not involved. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA002626:
Ringing in ear right ear has been happening after 10 days since my second dose. After the first dose it was there for few times but went away.
Initial flushing, profuse sweating, nausea and dry heaves, a little diarrhea. Slowed HR to 52 (normal above 70) - EKG done while at work-employee health gave me a Benadryl, sent to ER. Given Epi-pen Rx - diagnosed as allergic reaction to flu vaccine - am no longer allowed to take it - also had reaction to pneumonia vaccine given in Dr.'s office in Sept. (that was reddenned, swollen arm only - thought it was just local reaction) - I have COPD-tracheal brochial malacia - high risk - want to get it in the future - my question - do I go to an ER just in case I have a reaction? I am an RN. Please advise. Also - what about shingles vaccine - recommend I try to get that? If you can't answer this - what kind of a doctor would I go to to ask? Thanks.
had a reaction and wasn't feeling well post booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US093492 (Agency).  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER: UNKNOWN, DOSE NUMBER: UNKNOWN), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "had a reaction and wasn't feeling well post booster.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Recvd vax, 10/24/98 swelling & inflammation in Lt upper arm. On 10/26/98 had reddened area at inject site 11cmx7cm, used APAP, meds & ice. Pt notified HD 10/26/98, began to resolve 10/26/98.
MODERNA COVID-19 Vaccine use for COVID-19 under Emergency Use Authorization (EUA): Chest palpitations, headache. Patient received first Moderna vaccine 8/25/21 at 1645. Pre-screen negative. Reported feeling well, received vaccine to left deltoid. Observed for 25 min, pulse taken 2x, 15 min apart: 74, and 72. Patient went to emergency room at 2300 for headache and chest palpitations that were preventing her from falling asleep. Received adenosine IV. Continued with chest palpitations until morning; headache resolved. Advised to follow with PCP for any further management.
2 minutes after receiving the Gardasil vaccine patient had vagal episode and hit left frontal area of head on cement floor.  Resulted in 20 second tonic seizure.  After seizure patient remained dizzy and nauseated.  Taken to ER for cervical spine films and head CT - both negative.  Patient discharged from ER with Zofran and Motrin.  Almost 24 hours later patient still dizzy and nauseated.
This spontaneous report was received from an office manager and refers to a female nurse practitioner of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 26-FEB-2019, the nurse practitioner, while trying to prepare a dose of LIQUID PEDVAXHIB, lot # R004964, expiration date 26-NOV-2020 (dose and indication were not reported), got some of it in her eyes. No adverse effects were reported.
Within 5 mins of getting vaccination employee began coughing and complaining of itchy throat.  She then got very sweaty, pale and she felt throat closing up.
testing positive for coronavirus first of this month after completing both vaccines in Feb2021; testing positive for coronavirus first of this month after completing both vaccines in Feb2021; This is a spontaneous report from a contactable consumer (patient) and a contactable other health care professional. A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), via an unspecified route of administration on unknown date in Feb2021 at single dose (at age of 59-year-old) for COVID-19 immunisation, Lot number: unknown. Medical history included Psoriatic Arthritis. Concomitant medication included tofacitinib citrate (XELJANZ) taken for psoriatic arthritis from 22Feb2021 and ongoing. The patient received the first dose of bnt162b2 (BNT162B2) vaccine on an unknown date in Feb2021 (at age of 59-year-old) for Covid-19 immunization. Patient stated that she was testing positive for coronavirus on 01Apr2021 (first of this month) after completing both vaccines in Feb2021. Symptoms of cough/fever/chills/nausea, symptoms resolved after one and half days. Md unaware. Encouraged to notify MD. no additional information/details provided. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Caller is reporting a 4 year old given PROQUAD AND VARIVAX at the same time.; Caller reports no other AE with this event.; This spontaneous report was received from a caller and refers to a 4-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) at the same time (inappropriate schedule of product administration). Both vaccines were administered for prophylaxis. There was no other adverse event reported.
Patient attended Shingrix vaccination clinic and received Shingrix vaccine.  Upon entry into records, it was noted that patient already completed the series in 2019.
Patient received their second dose of the Pfizer pediatric vaccine from one of our pediatric vaccinators. A few minutes after vaccination, the patient passed out. The patient was given juice and an ice pack and laid down. The patient has fully recovered.
Swelling and itching of the left upper arm. Swelling 6" x 3" warm to touch. No erythema. Tender 6/10. No red streaks. Benadryl 25 mg TLD and cold compress. To flu if symptoms increase.
Rash that began on vaccinated arm 24hrs later and spread to entire body lasting 48 hours. Took Benadryl for 2 days to combat symptoms. Then on 01/07/2021 a week after receiving the vaccine a large hot welt developed randomly at the vaccine site, temp of the welt was 104 degrees but body temperature was normal.
Pregnant at the time of vaccination?: Yes; headaches; fatigue; chills; body aches; This is a spontaneous report from a contactable other hcp. This other hcp reported information for both mother and fetus/baby. A 38-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261, Expiry date: unknown, Last menstrual date: 30Oct2020, Delivery date: 08May2021, Gestational period: 17), dose 1 intramuscular administered in Arm Left on 24Feb2021 08:15 as dose 1, single for covid-19 immunisation administered at Doctor's office/urgent care. Medical history included ongoing dermatitis atopic Since childhood, hypersensitivity. No other vaccine in four weeks. Concomitant medication(s) included ongoing crisaborole (EUCRISA) taken for dermatitis atopic; loratadine taken for hypersensitivity; minerals nos, vitamins nos (PRENATAL VITAMINS). The patient previously took ibuprofen and experienced drug hypersensitivity, aspirin (e.c.) and experienced drug hypersensitivity, nuvaring and experienced drug hypersensitivity. The patient reported, she went into preterm labor on 29Mar2021 which was 12 days after my second Pfizer vaccine and delivered on 30Mar2021 at 21 weeks and 5 days. She was diagnosed with chorioamnioitis due to a staph aureus infection. Her baby did not survive. Leading up to the hospital admission and after my first and second vaccines she had frequent headaches, fatigue which she related to the vaccine. She also had chills and body aches. On admission she had a fever. She said she was very healthy and developed an unusual uterine infection after the vaccine. She felt that her immune system was affected post vaccine which may have contributed to my ability to fight off infection. Outcome of events was unknown.   Follow-up attempts completed. No further information expected.  Amendment: This follow up is being submitted to amend previously reported information: Amendment (PSSR): Events "off label use", product use in unapproved population" deleted, event "pregnant at the time of vaccination?: yes" recoded to "Maternal exposure during pregnancy, second trimester", narrative updated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392328 Mother/Fetus baby case
After J&J shot on 11/20, hemoptysis began on 11/22. Initially ignored, however, on Tuesday night (11/23) chest pain began with additional hemoptysis worsened and shortness of breath. Visited urgent care on morning of 11/24 and received EKG review indicating peaked T-waves. UC physician recommended that patient seek care at nearest ER for suspected pulmonary embolism.
Flashed face, tight face muscles, light pain in wrists (I have RA). Symptoms lasted about 3 hours
30 yo male previously healthy never previously immunized who developed fatigue and arthralgias that developed day following primary vaccination with Heb B, TdaP and MMR. Vaccines given 4/1/2011.  These symptoms continued for until 4/6/2011 when he developed low-grade fever and headache. This continued until 4/9/2011 when he went to ER. In underwent LP with CSF analysis remarkable for cell count of 448 in tube #4 with 94% lymphocyte predominance, glucose 59, protein 68, negative gram stain, negative HSV/enterovirus/varicella/CMV, and negative culture x 3 days at time of writing this.  He was admitted for two days and received rocephin, doxy, acyclovir and discharged home feeling improved on HD #2.
Child became short of breath, sweaty, pale, and was turning blue. He complained of blurry vision and trouble breathing.  Low HR. This happened between 5-10 min after shot.  It lasted about 30 min and he was still having trouble concentrating after 2 hours.
rash-small macular over face & trunk;no vomiting, no resp distress;
Bumps appeared in the right arm; She started getting blotches on her left arm and legs, were kind of bumpy and very itchy; The bumps were about 1-2 inches in diameter and it seems like the skin is elevated in these areas; She started getting blotches on her left arm and legs, were kind of bumpy and very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Bumps appeared in the right arm), PRURITUS (She started getting blotches on her left arm and legs, were kind of bumpy and very itchy), SWELLING (The bumps were about 1-2 inches in diameter and it seems like the skin is elevated in these areas) and RASH MACULAR (She started getting blotches on her left arm and legs, were kind of bumpy and very itchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, GLIPIZIDE, TRIAMTERENE, ENALAPRIL, GABAPENTIN, VITAMIN D NOS, MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (She started getting blotches on her left arm and legs, were kind of bumpy and very itchy), SWELLING (The bumps were about 1-2 inches in diameter and it seems like the skin is elevated in these areas) and RASH MACULAR (She started getting blotches on her left arm and legs, were kind of bumpy and very itchy). On 16-Mar-2021, the patient experienced RASH MACULAR (Bumps appeared in the right arm). At the time of the report, RASH MACULAR (Bumps appeared in the right arm), PRURITUS (She started getting blotches on her left arm and legs, were kind of bumpy and very itchy) and SWELLING (The bumps were about 1-2 inches in diameter and it seems like the skin is elevated in these areas) outcome was unknown and RASH MACULAR (She started getting blotches on her left arm and legs, were kind of bumpy and very itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided included hand sanitizer to stop itch.
This case was reported by a nurse via sales rep and described the occurrence of feeling bad in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 12th November 2018, the patient received the 2nd dose of SHINGRIX. On 13th November 2018, 1 days after receiving SHINGRIX, the patient experienced feeling bad, fever, headache and chills. The patient was treated with TYLENOL. On an unknown date, the outcome of the feeling bad, fever, headache and chills were unknown. It was unknown if the reporter considered the feeling bad, fever, headache and chills to be related to SHINGRIX. Additional details were reported as follows: The patient felt terrible the day after SHINGRIX shot. The patient was able to sleep after taking TYLENOL.
Redness, swelling,  bruisig and a hard knot at the injection site which lasted for 6 weeks. Pain in right neck and shoulder, bad enough to wake me from sleeping, still experiencing.  Approx. 10 days post injection right thumb and wrist went numb.  Still numb today.
A non-serious spontaneous report of headache, nausea, vomiting, and diarrhea has been received from a consumer concerning a five-year old male subsequent to FLUMIST.  No medical or medication history was provided for this patient.  The patient received FLUMIST on 13-Sep-2008.  The patient's symptoms started on 13-Sep-2008.  The symptoms were reportedly worse on 14-Sep-2008 and better on 15-Sep-2008.  The patient was not seen by a physician for treatment.  The patient did not receive treatment for the adverse events but had lots of rest.  The patient recovered from the adverse events on 15-Sep-2008.  The reporter assessed the relationship of the adverse events of headache, nausea and vomiting to FLUMIST as "not sure, but we think so."
1 day after the immunization, child developed ~ 2" red raised tender area surrounding VARIVAX site - no vesicules - now it brown skin surrounding site.
typical vesular eruption (pinhead to matchhead size) on erythematous base, distributed on trunk, neck, prox extremies;exposed to shingles & to varicella 27OCT-29OOCT95
After my first vaccine I developed a psoriasis like rash on my left side thorax. Over a period of a couple weeks it got a little larger and I developed a few more areas centralized on my chest. After my second vaccination, I started to get them throughout my body. They developed on my neck bilaterally, thorax bilaterally in my back and stomach.
Extremely restricted left arm range of motion cannot lift to 45 degrees abduction Chills  Fever (101.6) Aches (body) Headache
No fever pt received KINRIX vaccine on 8-5-15. Family reports area was slightly pink on 8-6-15. Early afternoon of 8/7/15 (R) thigh became red and was warm to the touch. Area of induration measured 7-8 inches by 4 inches. Treated with cephalexin 125mg/5mL taking 10mL by mouth twice a day for 7 days.
This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 22-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot: N021572; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
Approximately 15 min after receiving the vaccination pt. reported feeling lightheaded, having a headache, possible palpitations, feeling anxious.  Pt was able to ambulate and in no acute distress. Her B/P was 142/88, pulse 67, O2 sat 96%.  15-30 min later she stated she felt better but noticed her tongue was tingling and her vision disturbance was improved. She states her vision was hazy earlier. B/P at this time was 130/86, P 68, O2 sat 99%.  Benadryl was offered as well as water and juice. Pt. declined.  An hour after receiving the vaccine pt. stated she felt much better and left clinic ambulatory in no acute distress.  Advised if symptoms worsen to go to the ER or call 911, pt. voiced understanding.
SWELLING, PAIN AT INJECTION SITE. 10/09/2016 - PAIN, ITCHING, SWELLING, REDNESS; APPLIED ANTI-ITCH CREAM AND TOOK BENADRYL CAPSULES.
DTaP (Daptacel) given, custodian (grandmother) notified directly after (with in 15 min) of exp date. Provider and supervisor notified. CDC notified. Received consent from grandmother to give additional/corrected DTaP with Infanrix. Child monitored another 15 min after Infanrix. No distress noted in child after 15 min. and  Grandmother has VIS and number to clinic to call as needed.
Pt recv vax on 3/19/98; on 5/27/98 pt exp more lesions on the brain and spinal cord.  Pt dx=demylenating disease (possible MS)