chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It felt like my sinuses wanted to drain down the back of throat. I had a headache and I was tired and fatigued like I was coming down with something. I took TYLENOL and MOTRIN and increased my water intake. It did not help. Each day I felt like my sinuses got worse  and I had pain in left ear and the left side of my throat. The symptoms got worse and nothing would make it go away. My sinuses were super yucky and both sides of my throat and ears were hurting. My skin felt sore, my muscles felt achy and my bones felt like they were hurting. I kind of felt like I had the flu but I also could not smell or taste anything. I completed a home test for COVID-19 and it came back positive. I was nauseated, my lower intestinal area hurt and I developed a little diarrhea. I called the doctor and they called in PAXLOVID. I started it the 1st day Saturday November 12, 2022. I was super sick for a week. I developed sores on the roof of my mouth and inside of my cheeks. I was nauseous the entire time and didn't have much of an appetite. My chest was bothering me really bad like I had really bad bronchitis and pneumonia. I was having a hard time breathing. I called the doctor back. My oxygen saturation was at 93%. I was prescribed an albuterol inhaler. A few days later I was still having a hard time breathing so the doctor called in a steroid inhaler. The symptoms got a little worse in the next few days. I had a ton of congestion in my chest and it felt like my bronchial tubes and muscles in my chest were sore and hurting. I was breathing in shower steam as recommended. The headache was killing me really bad. The 2nd week I had chest congestion and a hard time breathing. I still had nausea and diarrhea and my throat was still very sore. My symptoms peaked at some point into the 2nd week. The 3rd week my headache was a lot better. I continued having issues breathing in the 3rd week. I am still on both the inhalers currently. My oxygen level remains around 95 to 96%. I tested positive until January 13, 2023. I was testing. I still have not completely recovered. I still feel tired, fatigued and sleepy all the time. I also still have problems breathing.
pt says a couple of weeks after taking the vax he has a significant amount of hair loss.  he said he would be covered with his hair.  he finds the hair in his  hairbrush.  he asked his PCP and Oncologist about this since he thought steroids could be the cause of this but he was told no.  Pt says he thinks this is because of the vax.  He thinks it is getting better now since he no longer is getting the big clumps of hair coming out.  Pt got his second dose on 2/25/2021 in the left arm.
Patient reports the day after receiving his second Pfizer COVID vaccination the inside of his mouth,  including his tongue and cheeks,  was red, raw and sore.  States he saw his MD who prescribed treatment for thrush.  States this treatment made no difference and he stopped using this medication after a couple of days.  Eventually the symptoms resolved.
Got the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. The patient's last menstrual period was on 12-Jan-2021 and the estimated date of delivery was date. On 26-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown; Sender's Comments: This is a case of product exposure during pregnancy (maternal exposure during pregnancy) with no associated AEs for this 40-year-old female. Reportedly, the second of the vaccine was administered during pregnancy. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The company causality for the event of maternal exposure during pregnancy is not applicable.
This case was reported by a pharmacist and described the occurrence of hypotension in a 44 year old female who received Engerix-B. The reporting pharmacist is also the pt. The pt received her 1st and 2nd doses of Engerix-B in 8/03 and 9/03. On 3/8/04, the pt received the 3rd dose of Engerix-B in her left arm. Later the same day, on 3/9/04, the pt experienced hypotension, dizziness, shoulder pain, back pain, lack of appetite and lack of sleep. The events resolved on 3/12/04. The pharmacist considered the events to be related to vaccination with Engerix-B.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (dose and route were not reported, lot # J015437 with expiration date: 09-OCT-2016). The patients received the vaccinations between 06-NOV-2015 and 10-NOV-2015. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left anterior thigh has an approximate 10cm area of swelling, erythema and warmth.
redness where I got the shot; Small blisters where I got the short; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site erythema and injection site blisters. On an unknown date, the outcome of the injection site erythema and injection site blisters were unknown.   It was unknown if the reporter considered the injection site erythema and injection site blisters to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had redness and small blisters where got the shot. The patient asked would this go in several days. The patient just had SHINGRIX vaccination and know to wait 2 months until get my 2nd vaccination. The patient was more likely to get shingles during this 2 month waiting period.
I started with the sore arm, joint aches, etc. By next day had 100 degree fever for a day, then 48 hours later broke out in raised rash all over chest, stomach,and very sore enlarged lymph node in left underarm...both rash and lymph node soreness remain now4 days later.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 12:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 at 12:00 as dose 1, single (Lot number: EN6199), in left arm, on 02Apr2021 at 12:00 as dose 2, single (Lot number: GR8737), in left arm, on 20Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 20Apr2022 at 12:00 as dose 4 (booster), single (Lot number: Fj4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: GERD" (unspecified if ongoing); "Other medical history: High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Dec2020, stop date: 13Oct2022; FAMOTIDINE, start date: 01Dec2021, stop date: 13Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Oct2022) Negative, notes: after completing first Paxlovid course and testing negative; (27Oct2022) Positive, notes: Positive COVID home test nine days after completing first Paxlovid course. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Positive COVID home test nine days after completing first Paxlovid course and testing negative and Known allergies reported as No
Allergy to Prevnar13; This is a spontaneous report received from a contactable physician. This physician reported same event for three patients. This is the 3rd of 3 reports.  A patient of unspecified age and gender received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for pneumococcal vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced allergy to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on an unspecified date. Outcome of the event was recovered on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019272499 same reporter/drug/event, different patient;US-PFIZER INC-2019272471 same reporter/drug/event, different patient
Raised rash; small bumps in large quantities spreading bilaterally from the hip, buttocks, back of the leg and down the side of the legs; tingly; itchy; whelped yup rash appeared on both arms around the elbow and wrists; This is a spontaneous report from a contactable other HCP (patient, self-reported). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08Jul2021 at 15:30 PM (age at vaccination: 37 years), as a single dose for COVID-19 immunization at doctor's office/urgent care. The patient was not pregnant at the time of vaccination. The patient's medical history included Covid-19 (if covid prior vaccination: Yes). Past drug included known allergies: Sulfa, gluten, and hydrocodone. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) and ibuprofen (MOTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 10Jul2021 at 09:00 AM, she experienced raised rash, small bumps in large quantities spreading bilaterally from the hip, buttocks, back of the leg and down the side of the legs. It was tingly and itchy, also a whelped yup rash appeared on both arms around the elbow and wrists but cleared within the night. The patient received Benadryl and hydrocortisone cream as treatment for the events. Outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Raised rash, Keratosis pilaris, Paraesthesia, Pruritus and rash cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Patient was given immunization in right arm.  Over the next 48 hours she experienced increasing pain in the injection site radiating down the arm.  The pain is worse with movement.  Patient seen in office on 10/9/20 for pain.  Decreased ROM.  Patient unable to raise arm over head.  Pain 1/10 at rest and 10/10 with movement.  Dr. diagnosed as possible frozen arm continue OTC pain medication will reevaluate on 10/12/20 may need physical therapy.  On 10/12/20 patient reported the arm was starting to feel better ROM coming back doesn't think she'll need PT.
Large rash (more than 4 inches long) on right upper shoulder at site of injection.
This spontaneous case was reported by a physician and describes the occurrence of THROMBOCYTOPENIA (thrombocytopenia after vaccine/thrombocytopenia in patient after using vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (thrombocytopenia after vaccine/thrombocytopenia in patient after using vaccine) (seriousness criterion medically significant), PYREXIA (fever after vaccine) and PRODUCT QUALITY ISSUE (Defective vaccine). At the time of the report, THROMBOCYTOPENIA (thrombocytopenia after vaccine/thrombocytopenia in patient after using vaccine), PYREXIA (fever after vaccine) and PRODUCT QUALITY ISSUE (Defective vaccine) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious (important medical event) AESI of Thrombocytopenia, unspecified days after receiving a dose of mRNA-1273 vaccine. Patient also had fever along with the event. Defective vaccine was also reported. No further information on clinical course and management of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up contains product quality complaint number added. Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious (important medical event) AESI of Thrombocytopenia, unspecified days after receiving a dose of mRNA-1273 vaccine. Patient also had fever along with the event. Defective vaccine was also reported. No further information on clinical course and management of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
15yo with Chronic ITP (since 2016) came to hematology clinic for routine follow-up and was noted to have palpable hepatomegaly on exam. LFT's were within normal limits. Patient reported possible scleral icteris but denied any abdominal pain. No splenomegaly. Did not pursue imaging as it would not change management and had normal LFTs. Platelet count was 104,000 prior to vaccine and 134,000 2 weeks after vaccine. She will return to our clinic on 6/22, 5 days after her 2nd dose of Pfizer vaccine to reassess labs and hepatomegaly.
reoccurring lung infections, on going fevers, joint pain, skin rashes, developmental regression all following the immunization. Still under care at hospital for each symptom.
I could not lift my arm that entire night. It hurt so badly that I was fighting back tears when I tried to lift my arm. I have gotten a flu shot yearly for probably about 20 years, and though  I have had soreness and bruising a day or few after receiving the shot, I have never had such pain (not soreness) immediately.   I continue to have upper arm pain when I lift my arm up high or fully out to the side. It is the worst when I first wake up, after it hasn't been used all night, but slowly loosens up throughout the day.  However, it always hurts when lifting it, as mentioned.
patient BP (blood pressure) was 58/50; Felt dizzy, light headed and sick; Felt dizzy, light headed and sick; Heart palpitations/The patient heart races with the littlest workout; Tremors; Extreme anxiety; Muscle twitching; sadness; This is a spontaneous report from a contactable consumer (patient). A 38-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (at the age of 38-years-old) as dose 1, single for covid-19 immunisation at Hospital. The patient medical history was reported as none. The patient had no known allergies. Concomitant medications included Multi vitamin, Tumeric and Garlic pill. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 10:15 AM, the reporter stated that within a few minutes of receiving the shot patient felt dizzy, lightheaded and sick. Went to the hospital and the patient BP (blood pressure) was 58/50. Two days later started having heart palpitations and tremors, extreme anxiety. The patient has also developed constant muscle twitching in the past month. The patient heart races with the littlest workout so therefore the patient cannot do usual Peloton. The patient was very scared because patient was so healthy before and now the patient full of regret and sadness. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: 58/50 on an unspecified date in Apr2021 (58/50). Therapeutic measures were taken as a result of events included IV, aspirin, imagining and blood tests. The events were assessed as serious (Hospitalization). The outcome of the event patient BP (blood pressure) was 58/50 was unknown and not recovered for other events.   Information on the lot/batch number has been requested.
Stools with blood 5/1/07. Neutropenia 5/1/07 which continued until 5/7/07. On 5/7/07 stools hemetest (+).
Headache, Myalgia, HYPERtension, Elevated BunSCr, Emp is being worked up by provider due to tremors, states she also had three hours of hypertension an flu like symptoms after ist vaccine.  Narrative:  Emp went to her PCP approximately four days after vaccine due to difficulty swallowing. Was worked up by GI and saw an ENT. States it was an issue with her esophagus, not swelling and she needed an EGD to further diagnose. Emp states she lost 20 lbs and a few weeks ago went to the ED because of this. States she had changes in her kidney function labwork. Emp complains of continued pain in left arm, causing her to not be able to sleep. Emp will continue to follow up PCP for issues she is having.  Other Relevant History:
Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Immediately afterwards, patient was dizzy, flushed feeling, tingling of my lips, and swelling of the right side of my face. These symptoms were not enough to seek medical attention but were there. After that, I had swelling down my arm and into my right hand, up my neck and face, up and down the right side of my back. I have been extremely tired and weak feeling. Some improvement but I am still really sore and the RSD is starting to act up. I have called into work, been eating well, drinking a lot or water, moving as much as I can, and using Advil and Tylenol for pain management.  Called into work for three days.
20 year old female, approximately 1-hour post-vaccine experienced lightheadedness, dizziness, vomiting x1, diarrhea x1, urticaria, "body on fire." Vital signs: HR: 108, BP 154/64, temp 98.2. Administered epinephrine x 1 dose and transported via EMS to  Medical center for further evaluation, treatment.
Chest pain for  three and half weeks. MD told me to take aleve.  Chest pain has disappeared over time.
Abdominal pain and fever of 102 degrees F, 24 hours after receiving a Flu vaccine. She did visit an ER and her Primary Care Physician. Abdominal US and CT w/contrast of abd, labs done.
hives all over her arms and legs; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported on Monday 21Dec2020 that she got the COVID-19 vaccine. Last night 23Dec2020, she got hives all over her arms and legs. The doctor was thinking of putting her on Prednisone and she wants to check to make sure that won't decrease the effectiveness of the vaccine. It was not provided if a sample of the product was available to be returned, if requested and if packaging was sealed and intact. The outcome of the event was unknown.  Information on lot/batch number has been requested.
ITCHING, SWELLING, RASH TO LEFT ARM Narrative:  Other Relevant History:
Left arm injection: extreme soreness (patient rated 7/8). Knot, redness, bruise at injection site. Injection administered 10/17/2017, reported adverse effects on 10/20/17. Still bruised, soreness improved but still present.
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in approximately 2016, the patients were vaccinated with improperly stored doses of VAQTA lot # L023232 with expiration date 25-FEB-2017 or lot # K005323 with expiration date 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of VAQTA lot # L023232 experienced a temperature excursion of 14.2 degrees Celsius for 1 hour 40 minutes on 03-FEB-2016, 9.4 degrees Celsius for 40 minutes on 23-FEB-2016, 8.5 degrees Celsius for 1 hour on 11-MAR-2016, 8.5 degrees Celsius for 30 minutes on 16-MAR-2016, 10.6 degrees Celsius for 1 hour 50 minutes on 23-MAR-2016, 17.2 degrees Celsius for 5 hours 40 minutes on 05-APR-2016 and 9 degrees Celsius for 4 hours 50 minutes on 19-APR-2016. Administered doses of VAQTA lot # K005323 experienced a temperature excursion of 14.2 degrees Celsius for 1 hour 40 minutes on 03-FEB-2016 and 9.4 degrees Celsius for 40 minutes on 23-FEB-2016. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009026: US-009507513-1612USA004686.
Bodyaches, fever, nausea,  hands still hurts, constant headaches and bodyaches since then along with breathing problems and palpitations, lethargy.
18 hours after the shot I had chills, fatigue, headache, muscle weakness, aches and pains. This lasted all day. The next day I was fine, but would tire easily by about 4pm for about a week.