chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After completing both shots of the series: Chronic headaches, fluid build-up in left ear causing imbalance issues (have tripped and broken three toes on my left foot over two episodes, first 7/27/2021  broke two toes after stumbling into a bench, and the second 1/20/2022 broke one toe at a yoga class); fluid build up also causes hearing issues, either diminished ability to hear or  sounds echo through my head; intermittent chest tightness; intermittent shortness of breath
Father states patient's extremity became inflamed, swollen, and hot to the touch within 24 hours of receiving an unintended MMR vaccine.  Pt was seen at clinic by a physician and release home in his parents care.
Lesions like chicken pox (vesicles and pustules) over most of body, > 100
itch on her legs; broke out in a rash on her arms, back, chest, and hands; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in Feb2021 (Batch/Lot number and Expiration date were not reported) as a single dose for COVID-19 immunization and estradiol (IMVEXXY, strength: 10 µg), vaginal from an unspecified date in Feb2021 (Batch/Lot Number: 388209BC; Expiration Date: 10May2021) and ongoing, at 10 ug, twice a week for vaginal dryness (vulvovaginal dryness), which was an off label use. Relevant medical history included vulvovaginal dryness and thyroid disorder, for which the patient was taking an unspecified thyroid medication on an unspecified date in Feb2021; both from an unknown date and unknown if ongoing. Concomitant medication included an unspecified thyroid medication. It was reported that on an unspecified date in Feb2021 (reported as 4 weeks prior reporting, relative to 15Mar2021), the patient started treatment with samples of IMVEXXY. On an unspecified date in Feb2021 (reported as 3 weeks prior reporting, relative to 15Mar2021), the patient received a COVID vaccine. On an unspecified date in Mar2021 (reported as about a week and a half prior reporting, relative to 15Mar2021) after starting the products, the patient broke out in a rash on her arms, back, chest, and hands. On 14Mar2021 (reported as last night, relative to 15Mar2021), the patient noticed she had developed an itch on her legs. On an unspecified date in Mar2021, she treated her symptoms with diphenhydramine hydrochloride (BENADRYL). She was not sure if IMVEXXY was the cause of the rash or not. As of 15Mar2021, treatment with IMVEXXY was ongoing, and the status of further COVID vaccine administration was not reported. The rash was not resolved, and the status of the itch on her legs was not reported. The patient had an appointment for medical evaluation scheduled for 19Mar2021 (reported as Friday, relative to 15Mar2021). The action taken in response to the events for estradiol was dose not changed. The patient was not recovered from the event "broke out in a rash on her arms, back, chest, and hands," while the outcome of the event "itch on her legs" was unknown.  No follow-up attempts are needed, information about batch/lot number cannot be obtained. No further information is expected.
pt recv vax & pt exp inj site itchiness, sl pain, redness in a circle of hardness around the site, & pinpoint spots which pt felt were d/t scratching;
If it is normal to feel a little shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (If it is normal to feel a little shortness of breath) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (If it is normal to feel a little shortness of breath). At the time of the report, DYSPNOEA (If it is normal to feel a little shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
6/17 & 6/19 Massive reaction 18cm x 9cm, c/o itching Tx with BENADRYL as needed, progressively worse x 2 days. Tx BACTRIM 2 tablets 2x day for 14 days for cellulitis.
Headache, Myalgia, NauseaVomiting, chills, neck pain Narrative:  Other Relevant History
Developed chills, body aches and low grade fever starting at 5pm on 3/30 (more than 24 hrs after receiving vaccine), fever topped out at 101.7 degrees, fever remained overnight, broke by 10am next day, chills remained for about another 24 hours.   Likely unrelated, developed right knee, calf and foot pain and had numbness in 2 left foot inner toes, off and on for 3-4 days after fever broke.  Took 2 Advil, pain completely disappeared by 2 days later.  I have arthritis and have had 2 right/1 left knee surgeries, and the temperature rose right about the time the pain disappeared, but the cold has returned and no pain.  Just odd, almost like a side effect of producing anti-bodies was excessive inflammation in parts of my body prone to inflammation.   I get the flu vaccine every year, and I have flu-like symptoms (chills, aches, low-grade fever) for several days within 24 hrs every year.
itchy; FEELING UNWELL; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (FEELING UNWELL) and PRURITUS (itchy) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 28-Aug-2021, the patient experienced MALAISE (FEELING UNWELL). On 30-Aug-2021, the patient experienced PRURITUS (itchy). In 2021, PRURITUS (itchy) had resolved. On 28-Aug-2021, MALAISE (FEELING UNWELL) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Drugs Not Reported.  The reporter's causality for the event(s) of did not feel well and breakout on the anterior arms skin, inside of the muscle that was itchy with Humira(adalimumab) was no reasonable possibility.  Treatment Drugs Not Reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
delirious; left side of body feeling swollen; whole body sensitive; do not want to eat anything; have a metallic taste in my mouth; nausea/I still feel nausea; I woke up at 4am on Thursday feeling chills; This is a spontaneous report from a contactable consumer.   A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Left Arm on 21Apr2021 13:30 (Batch/Lot Number: ER8729) as SINGLE DOSE (at the age of 30) for covid-19 immunisation.  Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was given on 30Mar2021 16:45 lot number EW0150, in left arm for Covid-19 immunisation.  Medical history was none.   The patient did not have Covid-19 prior vaccination.  The patient had no known allergies.  The patient is not pregnant.  Concomitant medication included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for an unspecified indication.  The patient took no other vaccine except BNT162B2 in four weeks.  The patient experienced delirious (medically significant) on 22Apr2021 04:00 with outcome of recovering, left side of body feeling swollen on 22Apr2021 04:00 with outcome of recovering, whole body sensitive on 22Apr2021 04:00 with outcome of recovering, do not want to eat anything on 22Apr2021 04:00 with outcome of recovering, have a metallic taste in my mouth on 22Apr2021 04:00 with outcome of recovering, nausea and still feel nausea on 22Apr2021 04:00 with outcome of recovering, woke up at 4am feeling chills on 22Apr2021 04:00 with outcome of recovering.  The patient was not Covid tested post vaccination.
The next day I was really tired, so I just took it easy. On Monday, I noticed hives forming on the right side of my torso. It was covering the majority of my right hip by Tuesday. They then spread to my back, face, arms, hair and I could no longer stand to wear clothing. I went to the doctor and they said I needed a round of Prednisone, but I couldn't take it until 10 days after the vaccine. I started taking it on that Sunday (3/21). I started developing blisters on my arms and hands, but they just oozed on my torso since they were being rubbed. I went to the allergist and was told that she didn't believe that it was from the vaccine. She wanted to do testing because she thought it was an immunology issue. She had me take Zyrtec and an acid reducer in double doses. I cleared up for about 3 or 4 days, then I had a small breakout. It was confined to my right breast and it lasted about 5 days. I've been clear since. I went back to the allergist yesterday and it was confirmed that I was likely having a reaction to the vaccine due to my test results coming back normal.
This case was reported by a other health professional via call center representative and described the occurrence of uveitis in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ophthalmic herpes zoster (shingles on ophthalmic nerve). On 7th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site wheal. On 7th February 2019, the patient experienced uveitis (serious criteria GSK medically significant) and eye pain. The patient was treated with antivirals for systemic use (Antiviral). On 17th January 2019, the outcome of the injection site pain, injection site erythema and injection site wheal were recovered/resolved. On 9th February 2019, the outcome of the uveitis and eye pain were recovered/resolved. It was unknown if the reporter considered the uveitis, injection site pain, injection site erythema, injection site wheal and eye pain to be related to SHINGRIX. Additional details were provided as follows: The patient was a retired medical researcher. The patient received SHINGRIX vaccine in her left arm. On 7th February 2019, 31 days after receiving SHINGRIX the patient experienced uveitis and eye pain. The patient reported that she was seen by her physician for her eye and was prescribed an antiviral. The patient planned to continue follow-up with her physician on an unknown date. The patient consented to follow up.
aching; Fever; Growing and swelling up; Real bad pain into my arm and into my neck and they are so, sore; Real bad pain into my arm and into my neck and they are so, sore; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient) reporting for herself. This female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186, expiration date: unknown), via an unspecified route administered in left upper arm on 16Jul2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she took second COVID shot past Friday, the first one she took on the 16Jul2021 and that she already had COVID back in March and she told that I would probably have lot of symptoms with the first one but not with second one. We have both of them I mean I felt worst when I had the COVID I was aching, fever, growing and swelling up. The second one actually the symptoms came out a lot faster with second one but, because the first shot it was the next day when I started feeling the side effects, with the second shot I started feeling them within hours, I have got, my fever is gone and all that, but I have still got a real bad pain into my arm and into my neck and they are so, sore, and I don't know if that is normal'. The outcome of event aching is unknown, Fever, Growing and swelling up is recovered on an unspecified date in 2021 and real bad pain into my arm and into my neck and they are so, sore is not recovered.
About 2 weeks after the vaccine I developed Tinnitus. 5/21 I saw my PCP who referred me to the ENT. And On 6/1 I saw the ENT, but no treatment can be done but it is currently being monitored at this time and nothing they can do for me at this time.
Swollen back of tongue and throat with itching and some swelling and tingling of my lips
Dull headache occurred 3 hours post vaccination.; Pre-existing symptoms of tinnitus (ear ringing) decreased; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 02Mar2021 at 15:00 (Batch/Lot number: Not reported) (at the age of 68-years-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Mar2021 at 18:00 (occurred 3 hours post vaccination), the patient experience dull headache and pre-existing symptoms of tinnitus (ear ringing) decreased. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of pertussis infection in a 15-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included asthma. Previous and/or concurrent vaccination included VARIVAX (non-gsk); Merck; unknown given on 25 July 2007. On 25 July 2007 the subject received 1st dose of BOOSTRIX (.5 ml, unknown). On 8 January 2010, 2 years after vaccination with BOOSTRIX, the subject experienced pertussis infection, pertussis identification test positive and vaccination failure. At an unspecified time after vaccination with BOOSTRIX, the subject experienced cough. The healthcare professional reported that the subject was diagnosed with pertussis and confirmed by (PCR) on 08 January 2010. The subject received BOOSTRIX vaccination on 27 July 2007 at the appropriate age. The subject also has asthma. The subject had been sick, went to Urgent care offices on four separate occasions prior to being diagnosed with pertussis on 08 January 2010. The subject is improving but still had an occasional cough. At the time of the report, no further details were available. Relevant test results included Polymerase chain reaction confirmed pertussis diagnosis on 08 January 2010. At the time of reporting the cough was unresolved; pertussis infection and pertussis identification test positive were improved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc). for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH Significant for abnormal ecg, dementia, obesity, basal cell carcinoma. PT was 70 years of age. Pt was in a LTC nursing home per note 01/2021. Received most care at outside entity. No notation regarding cause of death, or any recent illnesses.
pt recv vax 17JUN98 & redness, swelling, beat of lt arm-entire upper arm from shoulder to elbow hot, sore;no c/o pain;
No adverse event reported Patient got 2 doses of Flu vaccination, 1 dose administered by flu clinic and second dose administered by flu clinic held by pharmacy. Pt is being monitored by assisted living every 2 hrs. for the week. Today on 9/30 the assisted living facility said Pt is ok but they will be monitoring her .
I had a covid breakthrough. I had no energy. I had a fever- unknown temp, it lasted less than 24 hours. I  lost my sense of smell for 2 days. I did a breathing treatment due to my asthma.  I was very apathetic. I was also prescribed paxlovid.
lung disease/ lung disease is Bronchiectasis; a couple days of nausea; arm hardly a sore; GI issues; dermatological issue; This is a spontaneous report from a contactable consumer (patient) or other non hcp. This 78-year-old female patient reported for herself.  A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EN6203, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 24Feb2021 (77-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EM9809, Expiry date: not reported) via an unspecified route of administration, administered in left arm (upper) on 03Feb2021 as dose 1, single for COVID-19 immunization. On an unspecified date patient took flu vaccine (she only remembers getting flu vaccines in the last few years). On an unspecified date, the patient experienced lung disease/ lung disease is bronchiectasis, a couple days of nausea, arm hardly a sore, gi issues, dermatological. Patient reported that after the second shot she might have had a couple days of nausea and her arm hardly a sore but that was it. She has GI issues, lung disease, and dermatological issue so what she experienced could be related to that; at first, she thought it was that. Patient clarifies that her lung disease is Bronchiectasis. Patient remarks that everything that happened could have been related to her previous issues but was not her normal pattern. She experiences things similar, but each thing was not her normal, they were a little more than her normal On an unspecified date, the patient underwent lab tests and procedures which included test for covid-19: negative, test for flu: negative and test for rsv: negative. The outcome of the events was unknown.  Follow-Up (29Oct2021): Follow-up attempts are completed. No further information is expected.
This case was reported by a healthcare professional via a sales representative and described the occurrence of hypertension in a 43-year-old male subject who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). The subject had none relevant medical history or concomitant medications none, has received previously flu shots the subject had none document reactions experienced with previous flu shots or any adverse events following previous vaccinations. On 15 September 2014, the subject received 1st dose of FLUARIX QUADRIVALENT (.5 ml, unknown route, right arm), which was the only vaccination received on that day. On 15 September 2014, within 1 hour after vaccination with FLUARIX QUADRIVALENT, the subject experienced hypertension and tachycardia. The subject was treated with TYLENOL and BENADRYL. At the time of reporting the events were resolved. The healthcare professional considered the events were hypertension was possibly related to vaccination with FLUARIX QUADRIVALENT and tachycardia was probably related to vaccination with FLUARIX QUADRIVALENT. This was one of the 3 reports received from the same field representative, and all 3 subjects were employees of the health system or facility.
Pain in extremity; sleep; Chills; Fever; Myalgia; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in extremity), HYPERSOMNIA (sleep), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Myalgia) in an 88-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.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in extremity), HYPERSOMNIA (sleep), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Myalgia) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Pain in extremity), HYPERSOMNIA (sleep), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Myalgia) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided. Patient arm was sore and almost unable to lift it, chills, fever, body aches, and tired- slept a lot.   Most recent FOLLOW-UP information incorporated above includes: On 05-Mar-2021: Reporter does not give consent for further followup
The patient received the above four vaccines. She stated that she had a history of fainting upon receiving vaccinations. 5 minutes after administering the vaccines the patient fainted and urinated on the floor.  After about 5 or 10 minutes the patient came to and was aware as well as normal physical functions. Stated that she felt great, and expected the fainting but had never urinated before. SHe stated she was fine and want to leave. Her motor skills normal, pupils normal, and no swelling or itching.
Initial report received from a health care professional (nurse) on 20 Dec 2010: This patient was vaccinated with MENVEO (batch number: 100003). intramuscularly on 17 Dec 2010. Approximately after 12 hours (on 17 Dec 2010), the patient began to experience pain and swelling at 3 inches below the injection site. The area is approximately 3 inches around the arm. The patient was later diagnosed with cellulitis and started treatment with KEFLEX 500 mg BID. The final outcome was reported as condition ongoing. Follow-up report received from the nurse on 03 Jan 2011: Patient demographics were added. The patient's medical history included high blood cholesterol and hypertension. The patient had been vaccinated with TDAP (manufacturer and batch number unknown) and INFLUENZA (manufacturer and batch number unknown) on 19 Oct 2010 without any problem. He was concomitantly taking CRESTOR 10 mg once daily for high blood cholesterol and DIOVAN 80 mg daily for hypertension from 17 Dec 2010. 24 hours after vaccination, he developed redness and swelling approximately at 3 inches below the injection site. It was hot to touch. He could not sleep on his arm and it was very painful. He was seen by physician 3 days after vaccination. Later, the patient was diagnosed with cellulitis. He received treatment with CIPRO. Outcome of the events was reported as complete recovery.
This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 22-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot #L008059, expiry date 18-DEC-2016) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.