chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I suffer from a genetic condition called Hereditary Angioedema.   Prior to preventative medicine (Tahkzyro) availability, I treated each attack acutely with Firazry/Icatibant.   My swelling attacks were rare (no more than 6 times per year, and one injection stopped the attacks.    When Tahkzyro was approved as a prevention (every two week injection), in Oct. 2018, I began to administer this medicine 2x per month.   This eliminated ALL attacks to my extremities, but not to my abdominal area.   Those attacks were reduced to 4/yr, with a recurrence of attack within a day of first attack.  Firazry/icatibant had to be injected again (after six hours) and within a day, the attack would stop.  Tracking my triggers, I found consistency in the following (all three situations would have to be present).   1. Near my menstruation cycle. 2. Some viral-like symptom (scratchy throat/allergy, virus/illness). 3. Some stressor (activity, emotional, or weather-related).   None of these things, alone, set off an attack.  They have to occur around the same time.  My Johnson and Johnson vaccine was administered on March 18.   My period was due on April 3.  My period is 95% on time, always.  Depending on the timeframe for PMS/horomones, I would say that the injection was proceeded by my body entering into this phase.   On Mary 21, I experience my first abdominal attack in 6-8 months.  I injected Icatibant and after 6 hours, had to inject again due to a recurring attack.  I ordered a refill on my injections.   On April 2, I travelled to for vacation.  On April 4, I experienced the first of several abdominal attacks.  I ran out of medicine and had to have a new order shipped to my hotel (this had never happened before).   My menstruation was also late.  By April 9, my menstruation arrived, with a flow extremely higher than I recalled ever having in my adult life.   My abdominal attacks also ceased by that point.  I believe that having received this vaccine (which I am told has some form of the virus), during my PMS stage, along with over exerting myself with activities, created the three situations that occur to create a very painful, debilitating, abdominal attack.
Patient experienced a hypotonic-hyporesponsive episode within hours of receiving the vaccine.   She had an acute diminution in sensory awareness accompanied by a loss of consciousness. She was able to be awakened but did not return to normal behavior for remainder of the day. Following days she had improvement of hypo-responsiveness, however exhibited a regression of motor skills and eye contact.  Most symptoms resolved with five days, except hypotonia which has been diagnosed and remains to this day.
prominent lymph node on left side; fever; body aches; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced enlargement of lymph nodes, fever and general body pain. On an unknown date, the outcome of the enlargement of lymph nodes, fever and general body pain were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: On Friday, the patient received Shingrix vaccine and had fever and body aches over the weekend.  The patient had scheduled annual mammogram on Monday.  The patient was called to come in for an ultrasound because of a prominent lymph node that the patient had on left side, the same side of vaccination.  The patient asked, whether this could be due to the Shingrix vaccine.
The patient is a 83 y male presenting to the ED for monoclonal antibody infusion for treatment of COVID-19. The patient recently had a prolonged hospitalization at an ICU for a CHF exacerbation. Family reports that the patient was discharged 10/09/2021 and began developing symptoms like cough and increase in secretions. The family denies the patient being hypoxic and states that the patient's work of breathing is at baseline. They report that the patient tested positive for COVID-19 and the patient is present to receive the monoclonal antibody infusion treatment for COVID-19. At this time the patient and his family voice no additional complaints.  on 10/13/21. patient had progressive worsening of dyspnea, productive cough, and fevers 101.9 F. Bumex given by family at home over concern of possible CHF exacerbation however his symptoms did not abate. Brought to ED for further evaluation. Transferred to the ICU and placed on BiPap. Also started on vasopressors. 10/15 remains in ICU. Off pressors. Weaned to nasal cannula 10/16 intubated 10/18 PT remains in ICU on the vent and with sedation. Continues on IV abx. 10/19 continues in ICU, remains on the vent and sedation. abx d/c'd. 10/20  continues on the vent, weaning sedation 10/21 Continues in ICU currently. Remains on the vent, on vasopressors. C. Diff sent. 10/22 continues on the vent, tolerating CPAP. Weaning off pressors. 10/24 extubated to BiPAp 10/25 remains in ICU at this time. Continues on BiPap 10/26 continues in ICU at this time, tolerating nasal cannula, subsequently discharged.  Patient was readmitted multiple times after this initial hospitalization for respiratory failure along with other comorbidities.
Woke up swelling and redness to left arm. Used cold compress. No fever. Redness and swelling increasing in size. Area measures 5 x 8 cm.
Redness and swelling which spread from the injection site, around the arm. Pt stated that swelling began on Wednesday and spread from the IM injection site area around to the back site of the arm. Pt reported reaction to the pharmacy the Monday after injection. Pt was instructed to take Ibuprofen and Benadryl and use cool compresses. Watch for spread of reaction and report to MD if site spreads.
2-3 minutes after MMR vaccine administered, pt developed red blotchy rash on face only, no difficulty breathing. No other signs of reaction noted. 6.25mg benadryl given. Rash disappeared within 10 minutes after benadryl given.
Pentacel DTaP-IPV liquid vial given without the ActHIB powder portion; Initial information received on 18-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional.  This case involves a 2 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, concomitant medication and family history were not provided.  On 17-Jun-2019, the patient received a first dose 0.5ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number, expiry date not reported via unknown route in unknown administration site.  It was an actual medication error due to Inappropriate reconstitution technique.  It was reported that patient was give Pentacel DTaP-IPV liquid vial given without the ActHIB powder portion.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none. Information on batch number was requested for this case
CDC told her it was an allergic reaction; numbness in left jaw, cheek, ear and leg on the same day. /left ear went numb/left face got numb down from her eye first/left cheek went numb/left jaw went numb; left face got numb down from her eye first; headache only on the left side; injection site was painful but did not get numb; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported), via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:00 (at the age of 57-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took biaxin for rash and experienced rash and couldn't breathe. Patient had severe side effects. When she received the Covid 19 vaccine everything was fine. Then about 4-5 hours later, she can't really remember, her left face got numb down from her eye first, then her left jaw went numb, then her left cheek went numb, then her left ear went numb. She also got a headache only on the left side. Of course, later on she felt the injection site area was painful, but it did not get numb. What she is talking about is her left face, jaw, cheek and ear all on the left side. Numbness was on the surface; she thinks it was all on the surface. Later on, her left leg got numb, and this was very scary. The numbness only lasted for 3 days. She thinks her left leg went numb a few hours after her face went numb, maybe 6 hours. She doesn't remember exactly. The headaches began on her left side early also. Her left leg went numb much later than the rest of her face. The reason she is calling is because it's time for her to get her second Covid 19 vaccine. She's not sure if she should get the second vaccine. When probing weight, she reports she is very heavy, over 30 on the BMI scale. She spoke to doctor, and he told her that this is a known side effect and to wait 2-3 days. If the numbness still persists then she needs to go to a doctor. The CDC told her the numbness was an allergic reaction. She knows with the second dose it will be worse. If this is really an allergic reaction, she's totally scared to get the second Covid 19 vaccine. She wants to get the vaccine because she thinks getting the vaccine is important. She thought the Pfizer Covid 19 vaccine was the best option and she was very happy to know she received the Pfizer Covid 19 vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hives and redness appeared around the injection site 5 minutes following the vaccines. 1tsp of children's Benadryl was given and patient was observed at the office for half an hour and then observed an hour after the reaction occurred. After the hour was up, the hives and redness around the injection site started to disappear and patient seemed to be doing well.
2 Oct 2020 About 09:30 PM fever (about 100 F) within a couple of hours chills and muscle aches started.  3 Oct 2020 About 02:00 AM nausea and headache started. These symptoms continued till 4 Oct 2020 about 04:00PM. 5 Oct 2020 symptoms are all gone but general fatigue remains.
Pt reports severe headache that lasted almost all day, polymyalgia, no fever, injection site was sore, but no swellng. At time of reports no headaches n/v or weakness.
I started having a Mild persistent asthma attack 2 hours after the shot for 8 hours straight. Eased off with use of inhaler, but came back very shortly after inhaler was used. Still have some pain in chest today 05/28/2021.
Same day of receiving vaccine patient had head ache body ache muscle pain which lasted about 5 days. Treated with tylenol and bed rest he was perfectly fine before receiving the vaccine.
I almost always have a poopy rectum. this occurs even if I just need to urinate.   this is very bothersome.  do you have any remedy to get over this as it hasa been going on for over a year?  I did not have it in the hospital with covid.  Started after they gave me a booster as I left the hospital.
My 16 initial COVID symptoms in Nov'20 were all inflammation related, including skin hypersensitivity that after about a week turned into hives that would come about every 5-7 days w/ 2-3 days of itching w/ wheals disappearing after about 5-7 days, as well as inflammation in my eyes that caused excessive dryness but also watering & blurred/loss of vision. My eye issues had disappeared by the time I had the vaccine, but not the hives. Regardless, both the hives & eye issues came back within a day of the vaccine. My eye issues have gotten better (but not disappeared), but the hives have increased in intensity, size & frequency.
Muscle soreness shoulder, chest and neck. Increased pain with deep breathing. Red raised lesions neck, chest, back all on (L) side.
Pt admitted for + Covid test with acute pneumonia, COPD exacerbation, acute on chronic HFpEF
Dry heaves, nausea, extreme fatigue, malaise, muscle weakness, stiff knee joints, back ache from between shoulders down to lower back
Mom states patient started with joint pain about 2 weeks after 1st injection. 1st dose given 3/3/16, 2nd dose given 5/18/16.
Swelling and redness from top of shoulder to below elbow. Feels like lumps.
Lethargy at 12 hours post injection - resolved by 24 hours post injection Headache at 12 hours post injection - resolved by 24 hours post injection
Pediarix was given instead of DTAP for 5 year old shots. Client received Pediarix, IPV and MMR, so he got 2 Polios.
Patient signed up for a Shingrix second dose and the Pharmacist provided/immunized the Patient with a second 0.25ml booster that was due and the timing was correct. error was in the vaccination provided was not what was requested at the time of the shot.
vaccine expired on the 4/1/2020 and was mistakenly given to a patient/no AE; Initial information received on 09-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 72 years old female patient who received an expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Apr-2020, the patient received a 0.5 ml single first dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ221AB via unknown route in unknown administration site.  It was of actual medication error due to Expired vaccine used. Nurse said this is the second time patient has been given vaccine because the first dose had been thru a temperature excursion and was considered invalid.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
DTaP 5 given on (L) arm that resulted with 4 inches (10 cm) induration and redness with local pain.
Patient resides in an assisted living facility and received the second COVID-19 vaccination.  She experienced fatigue in the morning following vaccination.  She fell on 2/22/21.  Ambulance was called and she was transported to the hospital.  Initial symptoms included fever of 101 F, disorientation, left face droop, unresponsive to commands and loss of memory.
rash first noticed on (R) arm where varicella vaccine was administered. rash is warm; pruritic, erythematous, 15 mm papules; increased in size
17JAN95 pt recvd vax & 15 hrs later pt had brief febrile sz, t102-104; spinal tap neg;
Pt developed redness at injection sites on arms shortly after injections. Approx. 20:00, she became feverish, lethargic, unresponsive but not unconscious. She also became "stiff". Parent reports fever of 102F. EMS crew reported fever of 102.7F. ER recorded her fever at 100.2F to 100.5F. She had 89% O2 sats, retractions. She was taken to another hospital and seen. O2 per tent at 30%. Hydrocortisone 50mg was injected IV. She was given fluids and observed over night. Dismissed at 12:00 on 6/24/01. Diagnosed with allergic reaction to immunizations.
Significant muscle pain, soreness and redness  at the  injection area for 5 days Chills, fever for 1 day, beginning the day after dosing  Abdominal pain for 2-3 days
30 days after I got my 2nd dose vaccination I contracted COVID 19 and it was my assessment that the vaccine weakens my immune system because from previous experience with the 1st dose I got bronchitis. I was a completely healthy person before getting vaccinated.
Information has been received from a physician concerning a 12 year old female with no pertinent medical history who on 15-JUN-2007 was vaccinated with the first dose of the Gardasil (Lot # "03894"). There was no concomitant medication. On 15-JUN-2007, the patient fainted within a half hour of receiving the Gardasil. The patient sought unspecified medical attention, "was given ammonia salts and came to immediately." Laboratory tests performed on 15-JUN-2007 included a thyroid function test, hemoglobin urinalysis, and cholesterol test (results not provided). Subsequently, the patient recovered. No further information is available.
Loss of hearing four hours after receiving the vaccine (second dose). Developed ringing in the ears. Left ear hearing loss. April 21 hearing evaluation showed approximately 30 dB hearing loss at 2,000 and 3,000 in the left ear only. Right ear hearing is similar to prior to the vaccination.
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Clinical depression" (unspecified if ongoing); "type 2 diabetes" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine"; Bnt162b2, start date: 01Apr2022, stop date: 01Apr2022, for Covid-19 Immunization, reaction(s): "sore arm", notes: DOSE 4 (BOOSTER), SINGLE , vaccine lot Number: FK9895, Vaccine location: Left arm; Bnt162b2, start date: 27Sep2021, stop date: 27Sep2021, for Covid-19 Immunization, reaction(s): "sore arm", notes: DOSE 3 (BOOSTER), SINGLE , Vaccine location: Left arm, Lot number not provided.; Bnt162b2, start date: 02Mar2021, stop date: 02Mar2021, for Covid-19 Immunization, reaction(s): "sore arm", notes: DOSE 2, SINGLE , vaccine lot Number: EN6199, Vaccine location: Left arm; Bnt162b2, start date: 02Feb2021, stop date: 02Feb2021, for Covid-19 Immunization, reaction(s): "sore arm", notes: DOSE 1, SINGLE , vaccine lot Number: EN5318, Vaccine location: Left arm. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: No reactions to vaccinations other than sore arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231836 same patient, different vaccine dose/event;US-PFIZER INC-202300231837 same patient, different vaccine dose/event;US-PFIZER INC-202300232004 same patient, different vaccine dose/event;
weakness; pain; chills; fatigue; headache; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (weakness), PAIN (pain), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 026L20A) for COVID-19 vaccination.     No Medical history information was reported.  Concomitant products included MIRTAZAPINE (REMERON) and ALPRAZOLAM (XANAX) for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Dec-2020, the patient experienced ASTHENIA (weakness), PAIN (pain), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 03-Jan-2021, ASTHENIA (weakness), PAIN (pain), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, COVID-19: negative negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-022370. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (weakness), PAIN (pain), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 026L20A) for COVID-19 vaccination.     No Medical history information was reported.  Concomitant products included MIRTAZAPINE (REMERON) and ALPRAZOLAM (XANAX) for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Dec-2020, the patient experienced ASTHENIA (weakness), PAIN (pain), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 03-Jan-2021, ASTHENIA (weakness), PAIN (pain), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, COVID-19: negative negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-022370.
1. left arm soreness so severe that I could not hold up a cup; 2. Vomit and chills on 2nd day; 3. fatigue, slept 36 hours straight; 4. back to normal on day 4