chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 3 (booster), single (Lot number: GH9693) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "gout" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 26Dec2022 to 30Dec2022 for the treatment of COVID-19.
Swelling and soreness at injection site for approximately 4 days with redness and itching for approximately 8 days. Used ice packs and Tylenol for pain control.
About 1 hour later, noticed that ears started hissing and ringing.  Before the vaccine, patient had history of auditory issues but were under control.  The noise started getting louder and louder by midnight; it was frightening and awful.   Patient took Valium to relax but did not help.  Patient also reports severe arm pain at vaccination site.  Next day patient reports muscle aches, dizziness, nausea, and flu-like symptoms.   Patient took Oxycondin on Wednesday; medicine did not help with symptoms.    On Thursday, patient called the doctor and was told to give it a few day and to call back by Monday if symptoms continued.   Patient reported to the pharmacist as well. By Monday 5/6, auditory symptoms lessened but came back. Patient has been using Valium to keep symptoms down.  Doctor specified that there is nothing they can do about it.   Last night, auditory symptoms were very strong.  At this point, patient not planning to take the next Shingrix dose due to the aggravated auditory issues it caused.  Patient still has not recovered.
Developed sweating and chills with headache around 3:00 am. Got up at my usual time 5:30 am to use the bathroom and get dressed but felt nauseous with headache. Went to wash my hands and then walked back to bedroom but had syncopal episode along the way lacerating  my lower lip and injuring my knees. Still unable to extend knee due to injury  with pain and swelling
Received Pfizer vaccines on 3/10, 8/4/21 COVID-19 positive by PCR on  1/7/22 admitted to hospital on 1/7/22 d/t Acute on chronic hypercapnic respiratory failure, multifactorial, COVID positive
pt recvd vax & 16 hrs later devel fever to 101-102, myalgias, malaise, chills, tachycardia & tenderness @ the inject site;
Unknown. Reported via email by county coroner that patient was found deceased on 2/4/22. He stated in the email that it was reported by family members/friends, to the coroner, that the patient was ill after receiving his Pfizer Booster vaccine on 1/27/22. The coroner stated that it was his "opinion" that the patient died "as a result of complications from the COVID booster shot. The manner of the death is natural."   Unknown if the patient attempted to medical advice from his physician.
Patient's sister called on Sat, 4/9/22 around 9:15am.  She reported that patient had an adverse reaction to her second booster given on 4/8/22.  Patient was given the vaccne around 11:30am on 4/8/22.  Sister stated that patient felt flush (red in the face), chest pain, shortness of breath, "didn't feel good", palpitations, difficulty breathing, slight to moderate tongue swelling.  EMS was called an patient was given a HD of Benadryl IM.  Pt was taken to a hospital and IV fluids were given.  Patient was discharged and sent home.  This information was provided by patients Sister via her call the  pharmacy on 4/9/22.
Extreme weakness dizziness or sensitivity to motion behavior change - delusions 1/4/08-records received for DOS 10/26/10/29/07-DX:oropharyngeal dysphagia probably related to MS related fatigue but not necessarily a new lesion, weight loss, delirium.  One week history of progressively worsening dysphagia. C/O weight loss, generalized weakness. Neurology concluded that dysphagia is not MS in origin as MRI did not indicate significant worsening of the disease.
SEVERE ABDOMINAL PAIN; VOMITING; BODY ACHES; NAUSEA; This spontaneous report received from a patient concerned a 53-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient was non-alcohol user, and non-smoker. The patient experienced drug allergy (itching and redness) when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808480, and expiry: UNKNOWN) dose was not reported, 1 total administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) which was negative. On 13-APR-2021, the patient experienced severe abdominal pain, body aches and nausea and he went to Emergency room where he received IV pain medication and they performed MRI (Magnetic resonance imaging) and did blood work. Both were normal. Patient returned to the emergency room with severe pain after he took Tylenol and he vomited. He was administered with IV (intravenous) pain medication and started IV fluids. New blood work was done on 14-APR-2021 which was negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe abdominal pain, vomiting, body aches, and nausea on 15-APR-2021 and the outcome of drug allergy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210431932- COVID-19 VACCINE AD26.COV2.S-Severe abdominal pain, Vomiting, Body aches. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE. V0 20210431932- COVID-19 VACCINE AD26.COV2.S-Nausea. This event(s) is labeled per RSI and is therefore considered potentially related.
sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient got new shingles vaccine and had every symptoms. The patient asked how long this shot made you sick. The patient's sickness was on day 5 at the time of reporting.
Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022; No adverse event; 4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event) in an 18-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022).    Concomitant product use was not provided by the reporter. It was unknown if patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. The best used date was reported as 17-Aug-2022. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-700335, US-MODERNATX, INC.-MOD-2023-700086, US-MODERNATX, INC.-MOD-2023-700320 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Significant follow up appended: Patient information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700335:Patient 2 Out of 4 patient information received US-MODERNATX, INC.-MOD-2023-700086:Patient 3 Out of 4 patient information received US-MODERNATX, INC.-MOD-2023-700320:Patient 1 Out of 4 patient information received
The Moderna vaccine was given to a 16 year old and the minimum age to give Moderna is 18
Quarter size hive at site of VARIVAX. No other signs or symptoms. BENADRYL given.
1hr p/vax pt hot, shaking, eye rolling back in head, tongue rolling abm called transport to ER fever 104.5 motrin given temp down MD dx ear infect sent home w/med;1115PM fever 104 no sz activity states rxn from vax;
Rash 2"x4" red and very itchy on the arm around the injection site; Took about 24 hr to become red, and warm. Still itchy today 2/21, but less red, and less warm.
On 3/16/21 left arm began itching. On 3/18/21 small bumps (not hives) appeared and began to spread.
Difficulty moving "Pneumonia shot" arm, pain, swelling, raised bright red area covering upper arm to elbow, followed a few hours later by high fever in excess of 103F. Fever varied from 101.8 to 103.8 from the night of 10/13/2009 until around 5:00 AM 10/15/2009 when it briefly returned to normal. Was finally able to see Dr. (my primary care physician) at 8:30 AM 10/15/2009 (He had been out of his office for two days and my HMO will not pay for me to seek other medical help. My emergency room co-pay is NOT affordable unless it is a certain death situation).  "Pneumonia shot" arm extremely swollen, painful, and red.  Heavy cough had developed. Asthma symptoms. Bronchitis. Suspected pneumonia. Fever of 100.8 or 100.9 in the doctor's office. (NOTE: "Flu shot" arm normal.  No side effects from the flu shot administered at the same time as the pneumonia shot.) Chest x-ray done.  No pneumonia. Severe bronchitis. Asthma. Breathing treatment given.  Antibiotic shot given.  Antibiotics, Prednisone, asthma medicines prescribed.  Second breathing treatment given 1:30 PM 10/15/2009. Fever broke 10/16/2009. Following Prednisone administration swelling in arm receded. Redness and pain disappearing.
Hospitalized due to "unable to walk" one morning when she woke up - (12/7/2011) see enclosed medical records from before and after vaccine.
Swollen lymph nodes in head and neck; Rash to scalp; itchiness to scalp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Batch/ Lot number: Not Available/ Provided at time of report completion., Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Batch/ Lot number: Not Available/ Provided at time of report completion., Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovering", described as "Swollen lymph nodes in head and neck"; RASH (non-serious), outcome "recovering", described as "Rash to scalp"; PRURITUS (non-serious), outcome "recovering", described as "itchiness to scalp". The events "swollen lymph nodes in head and neck", "rash to scalp" and "itchiness to scalp" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of lymphadenopathy, rash, pruritus.  Additional Information: Prior Vaccinations (within 4 weeks) was reported as unknown. Relevant tests was reported as none. Specific relevant test for thromboembolic events with thrombocytopenia was reported as none. She did mention that she made an appointment with her PCP and was told this was a reaction to her booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
STARTED OUT AS SMALL RED MARK, BY 4/23/2016 GREW TO ABOUT 2 INCH OVAL, HAD PT TAKE ORAL BENADRYL AND OBSERVE, IF NOT BETTER IN 2 HOURS SEEK MED ADVICE.
Moderna vaccine that were stored for more than 30 days in the fridge were administered to no less than 27 patients.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine that were stored for more than 30 days in the fridge were administered to no less than 27 patients.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine that were stored for more than 30 days in the fridge were administered to no less than 27 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine that were stored for more than 30 days in the fridge were administered to no less than 27 patients.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Pt received 2nd dose of H1N1 at school based clinic 5 min after vaccination child c/o chest tightness and sore throat. Child vomited for approx 10 min. Resp distress continued. Oxygen & BENADRYL given per Fire Dept. Resp distress cont with skin welting noticed. EP1 0.15 given SQ per Fire Dept. Child showed improvement approx 5-10 min after. Client monitored for 30 min. Mom denied transport to hospital & took child home. Mother was encouraged to get allergy testing.
12/06/2021-12/07/2021 Low grade fever higher than the normal fever, very sick, feeling lethargic slept most of right arm downward bright pink and very hot, red and hot was all the way down the arm 12/10/201 redness was warm and streaks of read. Lymph node swelling under and upper neck area by collar bone. Called doctor on 12/9/2021 was able to be scheduled on 12/10/2021 in AM. Still have the under lymph node swelling at time of this report and still have low grade fever.
now her left arm is a little swollen after the vaccine; This is a spontaneous report received from a contactable consumer (Patient). A 83-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration on an unspecified date of Mar2021 as single dose for COVID-19 immunization. Medical history included high blood pressure and Her right arm was a little swollen before the vaccine (had car accident that can cause the arm swelling). The patient's concomitant medications were not reported. It was reported that patient received the second dose of the Pfizer vaccine yesterday (Mar2021) and patient's left arm was a little swollen after the vaccine. For high blood pressure, doctor changed her medication last week. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Severe Chills but no fever, muscle aches, tiedness, weakness, stiffness
On 06/02/2022 I began to experience a mild throat soreness around noon. The next day I woke up and my throat felt like I had a whole bunch of little incisions all around my throat and it was really painful. Toward the middle of the day it began to feel more like a head cold. These events normally occur when I get minor illnesses so I thought it was just a cold. By Saturday, my symptoms had progressed and I was having body aches and I was feeling really cold. By the time I was going to bed that night, I felt like my symptoms were less than normal so I took an at home COVID-19 test which was very obviously positive. When I woke up on Sunday, I was still feeling badly but was feeling slightly better than the day before. Since my primary care doctor is not available on Sundays, I called a local urgent care type facility. I was informed that I could not take Paxlovid due to a medication that I am currently prescribed so they suggested that I could receive a Monoclonal Antibody infusion. On Monday, when I heard from them about the monoclonal antibody therapy, I was already feeling better to the point that I did not feel that it was needed. It took 4 or 5 more days for my throat to begin feeling normal again but at this point, all of my symptoms have subsided with the exception of some changes to my voice that may have been caused by my extremely sore throat.
Information has been received from a physician concerning an approximately 2 month old male who on approximately 20-OCT-2006 was vaccinated PO with a 2.0 mL dose of rotavirus reassortant vaccine live (human-bovine). Concomitant vaccinations administered on that same day included "standard two month old shots". The physician reported that on approximately 20-OCT-2006, the patient was crying and appeared to be in abdominal pain. Unspecified medical attention was sought and the patient's mother was advised to take her son to the Emergency Room (ER) (it was unknown if patient was hospitalized). At the time of this report, the outcome was unknown. Additional information has been requested.
Fever & Rash Narrative: Fever and flu-like symptoms day after shot. Several days later, had raised bump on neck that lasted several more days.
Within a couple of weeks, I began having symptom of weak urine stream.  The symptoms progressively got worse until there was complete urinary retention requiring a catheter to drain the bladder.  Diagnostic tests showed a severely enlarged prostate.  I had to wear a catheter and foley bag for about 6 weeks until my prostate shrank down in size enough for me to urinate on my own.  At this time, I started taking Tamsulosin to help with urine flow.  In August of 2023, the doctor determined that my prostate had finally recovered enough so that I can stop taking the Tamsulosin, and he released me from their care.
Pt recvd 3 doses of Engerix-B 23APR91 & 17SEP91 p/receiving the 3rd dose the pt devel a fever of 102 & chills;
Symptoms: fatigue, dizziness, headache, nausea, shortness of breath, body aches, congestion, runny nose, ear pain, blurred vision starting at 5 pm day of injection, and swelling and rash at the injection site on 1/23/2021.
Patient reports rash under both armpits, red dots slightly raised. Patient also reports "just not feeling right"- tired, confused.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial report was received from a consumer, who was also the patient, on 31 October 2013. A 63-year-old female patient had received an intramuscular injection in the arm of FLUZONE HIGH-DOSE (lot number not reported) on 09 November 2010 and three days later began to experience very sore, very stiff muscles of legs. She was unable to get in or out of bed or a chair, it was like she "was paralyzed". The patient saw her healthcare professional numerous times over the next nine months. Treatment was BUFFERIN or TYLENOL and symptoms resolved after nine months. The patient had no illness at the time of vaccination and allergies to Tace, iodine and adhesive for Bandaids. Outcome was recovered. Documents held by sender: None.
Information has been received from a 73 year old female patient concerning herself. Concomitant therapies included atenolol. Concurrent condition included fibromyalgia. Drug reactions/allergies included penicillin and erythromycin. There has no other medical history. On an unknown date in 2014, the patient was vaccinated with a dose of ZOSTAVAX (1 time vaccine, strength, dose, route, lot # and expiration date were unknown) for preventing the shingles. The patient stated she got the vaccine 2 years ago but on 16-NOV-2016 she began to experience pain. She then realized she had 3 shingle spots in the left breast which later spread all the way to her sternum (vaccination failure). She sought medical attention from 2 different doctors. The first doctor prescribed acyclovir for the pain. Two days later another doctor prescribed ibuprofen and gabapentin 300 mg. The shingles were causing her to have very intense pain, burning sensation and stings. The outcome of the events was unknown. The causality assessment between the events and ZOSTAVAX was unknown. Additional information is not expected as there was no consent for follow up.