chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 5 year old daughter with penicillin allergy who was vaccinated with MMR II (lot number not available) three years ago. There was no concomitant medication. 36-48 hours after vaccination, the patient developed a rash and a fever 104 degrees after receiving the MMR II and recovered 5-6 days after vaccination. She also stated that her daughter was on the autistic spectrum. No further information was provided. The patient sought unspecified medical attention. Upon internal review "autistic spectrum" was considered to be an other important medical event. Additional information has been requested.
Narrative: PER DEATH CERTIFICATE PATIENT DIED FROM CAD/HLD PEACEFULLY AT HIS HOME. Per chart review, this patients cause of death was not likely attributable to the COVID-19 vaccine
Case number PHEH2013US006553, is an initial spontaneous report received from a nurse on 18 Mar 2013, and with a follow up report received from nurse on 09 Apr 2013, with a follow up received from a nurse on 30 Apr 2013: This case refers to a 16-years-old female patient. Her medical history was not reported. Concomitant medications included BOOSTRIX (batch number: ACZ0BZ64AA) and HAVRIX (batch number: AHAVB90BA) both at a dose of 0.5 ml intramuscularly on 09 Mar 2013.She was inadvertently given only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X12010), intramuscularly without being reconstituted with Men A component on 09 Mar 2013 by a nurse, who was unfamiliar to the practice. The patient's parents informed of need for revaccination. No adverse reaction reported following this administration error. Follow up report received from nurse on 09 Apr 2013. Updated patient demographics, concomitant medications updated. Follow up received from a nurse on 30 Apr 2013: Updated reporter comment.
It was reported that a patient (5 of 6) received a Fluzone SV 2001-2002 vaccination (administration date and site information was not provided). Sometime after the vaccination (exact date not specified) the patient developed a local reaction at the injection site. Further information is requested. Linked cases: U200101055, U200101225, U200101226, U200101227 and U200101229.
sore arm; the nurse administered reconstituted covid vaccine 7 and half hours and it supposed to be 6/ Delayed administration kept cold at 6 degree C; This is a spontaneous report from a contactable Nurse other health care professional. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9266, intramuscular, administered in arm right, administration date 20Feb2021 19:00 (at age of 52-year-old) as dose 2, single for covid-19 immunisation. The patient medical history was none. There was no family medical history. Concomitant medications were not reported. Vaccination history included: Pfizer/biotech covid-19 (Dose:1, Batch/Lot: EL9264, Route:IM, Anatomical site of Injection: LA, No of previous Doses: 0), administration date: 28Jan2021, for COVID-19 immunization. On 20Feb2021, the nurse administered reconstituted covid vaccine 7 and half hours and it supposed to be 6/ Delayed administration kept cold at 6 degree C and on an unspecified date, patient had sore arm. Nurse kept COVID-19 vaccine refrigerated until patient arrived for her second dose. Patient had just been on vacation and flew in, arriving a little late. Call made to Pfizer medical department and received the authorization to administer the vaccine up to 18 hours after reconstitution if the product was kept cold. The patient received the vaccine 7.5 hours after reconstitution, well within time allowed. Because the CDC site states that any administration over 6 hours should be considered an adverse event, this was reported as such. There was no true adverse event. The patient reported a sore arm, but no other side effects. There was no relevant test. The clinical outcome of the event sore arm was unknown and for other event it was recovered.  Information on the lot/batch number has been requested.  Follow-up (20Apr2021): This is a follow up-spontaneous report from a contactable Nurse. Updated information: Age, gender, product information, start date, new event and narrative updated.  No follow-up attempts are needed. No further information is expected.
No adverse reactions. KINRIX given to patient on 7/15/14 - expired on 6/28/14. Patient has upcoming appt to be re-vaccinated.
It was reported that a 54 year old female received a Fluzone SV 2000-2001 vaccination on 11/08/00 administered IM in her left deltoid. The patient claiming vaccine was administered incorrectly. Nurse stated feels like I hit something soft and spongy. The patient developed immediate pain in the anterior deltoid. Diagnosed with Bursitis, physical therapy was used. Doctor feels the vaccine caused the adverse event not the nurses technique. The patient has recovered approximately 90% per doctor.
Patient received FLUZONE HIGH DOSE on the left arm. Half an hour later, she experienced swelling and pain. Her deltoid and upper arm were swollen and warm to touch. The area that swelled is 6" x 3" on her arm. Two days later, the swelling went down.
eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown.  Information on the lot/batch number has been requested.
Mom called on 12/9/20 stating that her daughter was lethargic, a rash had started on her right cheek and around the right eye and is now on her chest and back. Mom describes rash as little bumps. Also states that around the site it is read and raised, about a dime-sized. This writer encouraged mom to take her to a walk-in clinic to be seen, mom was worried that she would be told it is just a regular reaction and abut the cost of the office visit. Strongly encouraged mom to have her checked out, it could be a reaction, but hard to tell over the phone.
About 1.5 hours after injection: migraine, bad sinus pressures, major fatigue and chills.  All symptoms lasted about 22 hours.  I still have a minor headache and fatigue
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccinated.  Revax wanted
crohns disease aggravated; low level of humira in system; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CROHN'S DISEASE (crohns disease aggravated) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   In 2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) dosage form once a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (crohns disease aggravated) (seriousness criterion medically significant) and DRUG LEVEL DECREASED (low level of humira in system). At the time of the report, CROHN'S DISEASE (crohns disease aggravated) and DRUG LEVEL DECREASED (low level of humira in system) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CROHN'S DISEASE (crohns disease aggravated) to be probably related. No further causality assessment was provided for DRUG LEVEL DECREASED (low level of humira in system).    Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.  Based on current available information and the temporal association between product use and he start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and he start date of the events a causal relationship cannot be excluded.
pt recvd vax 26FEB92 & w/in 4 hrs pt felt dizzy & lightheaded; pt was not herself; pt reported to employee hlth, 1 wk later had exp joint pain, stiff neck & a fever; pt personal MD felt had exp some type serum sickness;
eye problem; Reaction to sucrose in vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (eye problem) and REACTION TO EXCIPIENT (Reaction to sucrose in vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE DISORDER (eye problem) and REACTION TO EXCIPIENT (Reaction to sucrose in vaccine). At the time of the report, EYE DISORDER (eye problem) had resolved and REACTION TO EXCIPIENT (Reaction to sucrose in vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were vinegar and vitamin C tablets reported by the reporter.  No concomitant medication reported   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021:
History:  pt had 2nd Moderna COVID-19 vaccine yesterday at 10am and since yesterday evening, pt has had chills, headache, dizziness, low back pain, and nausea.  Took Tylenol at 0030.  Pt denies runny nose, overt fever, cough, sore throat, vomit, diarrhea, rash, sick contact, visit to Area II or contact with COVID-19 hotspot/cases in last 2 weeks and no co-morbidities.
Soreness throughout her entire body; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness throughout her entire body) and HEADACHE (Headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness throughout her entire body) and HEADACHE (Headache). At the time of the report, PAIN (Soreness throughout her entire body) and HEADACHE (Headache) had not resolved.            No concomitant medications were reported by reporter. No treatment information was provided by reporter.
VACCINE GIVEN >24 HOURS AFTER MDV VIAL PUNCTURED  PT IS SCHEDULED TO BE RE-VACCINATED
On 09/09/2021, noted increased pain and scuffing right foot while walking, which resolved.  Then  on 09/10/2021, developed heaviness , difficulty moving in bilateral extremities, followed by light headedness with peripheral vision closing in, felt like I was going to pass out.  I was able to sit down and this subsided after about 10 minutes.  Then again later that same night, while sitting, developed the heaviness with difficulty moving of bilateral extremities, subsided after a couple of minutes.  Then throughout the next 3 days, I had intermittent periods of this same heaviness, difficulty moving that would occur and subside with a minute.  Each day the symptoms became fewer in number and shorter in duration.   I also had increased muscle pain throughout body and muscle tension.
Two months after vaccination, I started having a runny nose and headache. They were testing us weekly. It was about the middle of January 2022 when I tested positive. I was isolated with other positive cases and they were treating us with ibuprofen and 2 other medications that I do not know the name of. My symptoms lasted about a month. I am now better with no symptoms. I am reporting a breakthrough case of Covid.
Patient reported to pharmacy two weeks after administration symptoms of swollen and sore arm that injection was administered in.  No report of injection site reaction.
In March 2021, I suspect that I contracted COVID-19. There were no COVID tests readily available back then so I have never confirmed but I had increased respiratory rate (as measured by my WHOOP wearable health monitor) and I lost taste and smell completely for about 2 weeks. Since then, my taste and smell have come back but not to the levels they were before then. On 4/19/2021, I received my first does of the Pfizer COVID-19 vaccine. On 4/20/2021, I had notable trouble breathing throughout the day. I was able to exercise but with significant added difficulty. Did not notice anything else obvious. On 4/21/2021, My breathing returned to normal but I noticed that my senses of taste and smell were muted.  On 4/22/2021, my senses of taste and smell were completely gone. This became obvious when a coworker complained about a strong smell of burning plastic that I could not smell at all. On 4/23/2021, my sense of taste and smell started to come back. By 4/24/2021, my sense of taste and smell was completely back and better than it had been since March 2020, when I suspect I had COVID-19.  I received my second does of Pfizer today, 5/11/2021, and will monitor for symptoms.
Approximately 5 hrs after injection, pt experienced ++ swelling in her upper arm and said it felt "lumpy" and hurt to touch. No previous reaction to pneumonia shot.
eyes hurt; sees blurred; body felt weird; pain; chills; headache; very dizzy; weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very dizzy), ASTHENIA (weak), EYE PAIN (eyes hurt), VISION BLURRED (sees blurred) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS (very dizzy) and ASTHENIA (weak). On 06-Apr-2021, the patient experienced EYE PAIN (eyes hurt), VISION BLURRED (sees blurred), HEADACHE (headache), CHILLS (chills), FEELING ABNORMAL (body felt weird) and PAIN (pain). At the time of the report, DIZZINESS (very dizzy), ASTHENIA (weak), EYE PAIN (eyes hurt), VISION BLURRED (sees blurred), HEADACHE (headache), CHILLS (chills), FEELING ABNORMAL (body felt weird) and PAIN (pain) outcome was unknown.
felt like its patch not injection, he did not feel needle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (felt like its patch not injection, he did not feel needle) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE REACTION (felt like its patch not injection, he did not feel needle). At the time of the report, VACCINATION SITE REACTION (felt like its patch not injection, he did not feel needle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was reported.  No treatment information was provided.   This case was linked to MOD-2021-077828 (Patient Link).
Given shingles vaccine 6/14/2013. Developed redness, "welt". Initially unable to move arm, now she can.
Had two vaccine shots and still had shingles/Suspected vaccination failure; Shingles; Were far less painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had two vaccine shots and still had shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Were far less painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that the shingles vaccine was kind of like the Covid vaccine and it did not necessarily mean you would never got them but if you did, your case would likely be less severe or so had been his/her experienced. The patient had two shingles vaccine and still had shingles 6 or 7 times but the times after the vaccines were far less painful. The reporter further stated that showed yourself some love and get vaccinated and those first pre-shot times were very uncomfortable. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
mom reported pt recvd vax 18MAY93 & 19MAY93 exp edema of lt lower leg & t103 24 hrs vax; pt taken to ER; MD felt poss react to DTP;
pain; discomfort; swelling in neck on the right side; lymphadenopathy-multiple swollen lymph nodes on both sides of neck; Swollen arm; Red arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN (pain), DISCOMFORT (discomfort), SWELLING (swelling in neck on the right side), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tobacco user since an unknown date and Motor vehicle accident (Caused neck pain) on 29-Oct-2020. Concurrent medical conditions included Bipolar II disorder, Prediabetes, Anxiety, Hyperlipidemia and Drug allergy (Oxycodone and Chantix allergy.). Concomitant products included LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm). On 16-Feb-2021, the patient experienced PAIN (pain), DISCOMFORT (discomfort), SWELLING (swelling in neck on the right side) and LYMPHADENOPATHY (lymphadenopathy-multiple swollen lymph nodes on both sides of neck). The patient was treated with PARACETAMOL (TYLENOL) for Lymphadenopathy, at an unspecified dose and frequency and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) for Lymphadenopathy, at an unspecified dose and frequency. At the time of the report, PAIN (pain), DISCOMFORT (discomfort), SWELLING (swelling in neck on the right side), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE ERYTHEMA (Red arm) and LYMPHADENOPATHY (lymphadenopathy-multiple swollen lymph nodes on both sides of neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Computerised tomogram: abnormal (abnormal) revealed multiple swollen lymph nodes on both sides of neck.     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.