chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus got worse about 10 days after dosage. Feeling like water in ear when touch; Headache; This is a spontaneous report from a contactable Consumer (patient).  A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 08:30 (Batch/Lot number was not reported) at the age of 61 years,  as single dose for covid-19 immunisation.  Medical history included tinnitus from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient previously took z-pak and experienced allergy. On 18Feb2021 16:00 the patient experienced tinnitus that got worse about 10 days after dosage (feeling like water in ear when touch), and   headache (Headache off and on for 3 days starting on 3 rd after receiving shot). The patient did not receive treatment. The events were non-serious with outcome of not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient was 69 to 70 years old at the time of reporting. The caller stated that her friend experienced a red circle at the injection site that resolved in 3 days. This case has been linked with case US2018165372, reported by the same reporter.
A spontaneous report was received from a consumer concerning a 73-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced left arm sore/pain in extremity. The patient's medical history, as provided by the reporter included sinus infection and COVID-19. No concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On the night of 15 Jan 2021, the patient's left arm was sore and it was annoying. She had no other side effects. On a scale of 1-10 it was about a 6-7.  Treatment for the event were not reported.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, sore arm is unknown.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 28-AUG-2017 the patient was vaccinated with VARIVAX lot # M041513 for prophylaxis. Other suspect therapies included ZOSTAVAX. Concomitant therapies included sterile diluent (STERILE DILUENT). On 28-AUG-2017, 1 day after onset of therapy the patient experienced wrong drug administered. On an unknown date the patient experienced no adverse event. The outcome of wrong drug administered and no adverse event is unknown. The reporter considered wrong drug administered and no adverse event to be not related to ZOSTAVAX and VARIVAX. Additional information has been requested.
Cold symptoms, chest congestion, irritated eyes with discharge(redness, swelling) stuffed nose, aches/pains.  Difficulty sleeping, symptoms improved within 24 hr post vaccine admin and completely resolved by 36 hr post admin. Acetaminophen 650 mg once for pain relief.
Pt recvd Td vax & devel generalized rash & chills 35 minutes p/inject;
2 WEEKS AFTER VACC SHE STARTED WITH REDNESS AND BLISTERS ON VACCINATED AREA.
within 5 minutes of the vaccine she developed diffuse itching and flushing.  described similar reaction which presented to hives with both penicillan and quinapril.  never had respiratory, cardiovascular, or gastrointestinal symptoms.  BP and HR normal.  no hives developed.  itching resolved within 10 minutes.  she did take diphenhydramine upon onset of itching and then required several other doses throughout the night for itching.  never developed hives or other systemic symptoms.
Sore arm at injection site; very painful for 2 days; Runny nose for 4 hours; This is a spontaneous report from a contactable pharmacist. A 44-years-old female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3246) via an unspecified route of administration in Arm Left on 03Mar2021 (age at vaccination:44-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On Mar2021 the patient experienced sore arm at injection site; very painful for 2 days, runny nose for 4 hours on Mar2021. The outcome of the events pain in extremity, rhinorrhea was recovered.  Follow-up attempts are completed. No further information is expected.
Breakthrough covid case. Pt presented to ER on 6/25/22 with c/o nasal congestion, loss of smell and taste, cough, sob and fever. Pt test positive in 1/2022. Hx of Moderna vaccine x 3 doses. Prescribed Paxlovid. DC home.
Pt received his first dose of Pfizer covid vaccine and was advised to wait and sit in the waiting are for 15 minutes for post vaccination monitoring. Shortly few minutes after, pt's hand started shaking (almost seizing) and pt started sweating shortly after. Pt was given Benadryl & water and 911 was called. In the mean time pt was being monitored. EMS/EMT arrived few minutes after , monitored the pt and gave oxygen, monitored O2 levels and blood pressure. Few minutes after, pt was feeling fine and left to go home. advised pt to stay well hydrated and rest
Chills, fever, body aches,  exhaustion, arthritis and neuropathy symptoms worsened while ill. Symptoms lessened after 24 hours.  By third day just tired.
10 mins post inject rt arm red w/white swollen raised area 1" diameter; mom states later (approx 6 hrs) pt had t103-104 which reduced only sl w/APAP;mom used ice & DPH; MD advised no further pertussis;
days later, on 21Mar2021, they both tested positive for Covid-19; days later, on 21Mar2021, they both tested positive for Covid-19; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6204), via an unspecified route of administration on 16Mar2021 (at an age of 83-years-old) as 2ND DOSE, SINGLE for covid-19 immunization. Caller stated wife takes medications for arthritis and high blood pressure, no other information provided. Stated they are pretty healthy for being in their 80s. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6203), via an unspecified route of administration on 23Feb2021 as 1ST DOSE, SINGLE for covid-19 immunization. Caller stated his wife and he both received the first dose of the Pfizer Covid 19 shot on 23Feb2021, stated they got second shot on 16Mar2021. Five days later, on 21Mar2021, they both tested positive for Covid-19. Caller clarified that they came down with symptoms on 21MAR2021, then tested positive on 22Mar2021. Caller stated his wife dealt with Covid symptoms for about 3 weeks and has pretty much recovered, her symptoms were somewhat more mild that callers. Product details : EN6204, Second dose, exact dosage was not recorded on the patient vaccine record card. On 22Mar2021, the patient underwent lab test which included covid-19 test: positive. The outcomes of events were unknown.  No follow-up attempts are needed; No further information is expected.
It started at about 07:00 pm and I do have chronic hives but it exacerbated those symptoms extensively - the symptoms almost with going up my neck, and face and  up towards my mouth - Anaphylactic reaction kind of.  This was much worse than I had after having chronic hives for last seven years. I contacted Hospital. I wasn't short of breath. They said to go to ER but I was not feeling that I needed to do that. I went to a clinic  on the 23rd - and when I was there  the doctor could see more hives appear as I was sitting there. The doctor gave me a prescription for steroids in case I needed it. I doubled up on the Benadryl and the antihistamines - the hydroxyzine that I normally take for the hives. The doctor said the vaccine may not work if I took the Steroids. The medicine just made me sleepy so that I didn't care if it hurt or not. It was really really uncomfortable. It was really bad for a day and a half and within three days it was gone. With my chronic hives - I can have them come and go in a day but they don't usually linger at day or more at  a time.
Information was received on 06-JUN-2017 from a physician via a company representative regarding a 65 year old female patient. Medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2017 the patient received PNEUMOVAX 23 (lot # M043424, expiration date unknown, dose not reported) for the prevention of pneumonia. On 04-MAY-2017 the injection site "was hot to touch and patient's left arm swelled from the injection site down to her elbow." The patient sought medical attention by sending a picture of her left arm to the physician's office. Treatment was received (not further specified). The symptoms lasted for 4-5 days. The patient recovered. No further information was provided. The physician did not rate the causal relationship. Additional information has been requested.
I havnt had my second shot yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I havnt had my second shot yet) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I havnt had my second shot yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I havnt had my second shot yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.
I received a ZOSTAVAX injection on 4/12/2011. On 4/13/2011 I experienced a red, bumpy, itching rash at the injection site that appears at this time to be a mild form of shingles.
Redness, swelling (L) arm. Warm 9 cm x 6 cm very large.
Vaccine administered after expiration date.  Manufactured was notified with lot, expiration date, proper storage condition. Patient and caregiver indicated that there were no adverse events noted.
left abdominal pain/symptom; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (left abdominal pain/symptom) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (left abdominal pain/symptom). At the time of the report, ABDOMINAL PAIN (left abdominal pain/symptom) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided
No adverse symptoms reported; the patient received an improperly stored dose of ROTATEQ on 3/13/2020; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 13-MAR-2020, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot # 1660112, expiration date 18-OCT-2020 (dose and frequency were not provided) for prophylaxis. Administered doses of the suspect vaccine experienced the temperature excursion above 47 Fahrenheit degrees (F) (52.1F) for 15 minutes. There was previous temperature excursion reported. The administered doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced the temperature excursion above 47F (55F) for 21 minutes. The digital data logger was involved to capture the temperature excursion. No adverse symptoms were reported. The outcome of the event was unknown.
Began feeling achy and not well about 5 hours after receiving shot. I had a bad headache as well. About 8 hours after the shot  I felt severe chest pain and a tightness around my heart. It lasted all through the night. It lessened in severity by morning and went away by midday on day 2. All other symptoms persisted on day 2 and resolved on the 3rd day.
Blood in right eye; A spontaneous report was received from a consumer concerning a 74 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed blood in her right eye.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number:013l2o8) on 16 JAN 2021 for prophylaxis of COVID-19 infection.    Patient woke up on 26 JAN 2021, ten days after initial dose of vaccine, with blood in her right eye. She called to ask if this was a normal side effect of the COVID vaccine. Patient scheduled an appointment with an eye doctor for evaluation and reached out to her PCP. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, blood in right eye, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
PATIENT WAS GIVEN MODERNA (1ST DOSE)  AT THE AGE 15 1/2 YEARS OLD. PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS SUCH AS FEVER, RASH OR ANY ALLERGIC REACTIONS. PATIENT IS TOLEARBLE OF THE MODERNA VACCINE.
About 10-15 min after injection pt stated heaviness in chest & was a little hard to breath. Pt stated she's going to see her doctor. Spoke to doctor after and he stated he didn't find anything wrong with her lung function and she was fine when he saw her. Patient stated she had preservative free prev. with no problem.
This spontaneous report as received from a physician refers to a 72 years old male patient with penicillin allergy, diabetes and unspecified cardiac condition. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX lot# (670980/0731AA), on 17-MAY-2012. No other co-suspects were reported. Concomitant medications included JANUVIA, WARFARIN, colchicine, spironolactone, glipizide, digoxin, hydralazine, allopurinol, NEXIUM, folic acid, magnesium oxide, iron (unspecified), ferrous sulfate and testosterone. The physician reported that the patient possibly developed chickenpox in the beginning of June 2012. The patient had developed itching on both of his arms. He scratched so hard that this arms started to bleed. The patient visited the dermatologist who told him to use mineral oil, EUCERIN calming cream. The dermatologist did not diagnose the patient with chickenpox but the reporting physician thought it could possibly be chickenpox. The patient currently had scabs on his arms from the bleeding. The patient could not remember if he had chickenpox in the past. No lab diagnostic tests were performed. At the time of the report the patient was recovering from the adverse events. Additional information has been requested.
Client received MMR as part of a measles outreach clinic due to measles outbreak. Client reported that within 30 minutes she started coughing, felt shortness of breath, jaw became numb and face and chest started to flush.
Fever, soar and itchy arm, joint pains, sore throat, tiredness, unable to get out of bed for 3 days, headache.
BELLS PALSY diagnosed March 23, 2021 Treated with Prednisone and Valacyclovir Gradual improvement
death Narrative: Patient passed away on April 13, 2021 at home at 1810 He was 72 years old had severe aortic stenosis and hypertension and had an aortic valve replacement (TAVR) at hospital on Jan 20, 2021. He was readmitted to hospital for shortness of breath which was evaluated from Feb 19 - Feb 21, 2021 I spoke with his daughter today. She was with him at home when he went to the bathroom and since he had not come out for some time, she knocked on the door and found him collapsed in the bathroom. She called 911, who did CPR, however he had passed away. He was referred to the coroner. He had his first Moderna vaccine on March 15, 2021 after which he had not had any side effects. He received his second dose on April 12, 2021 and had not mentioned any side effects other than mild abdominal discomfort. Daughter said his shortness of breath had been improving after his discharge from the hospital. He had not complained of chest pain, cough, fever, diarrhea, in the last few days. I paid condolences to daughter and told here we would be reviewing the case to see if there was any relationship to him receiving the Covid19 vaccine and that the case had already been referred to the coroners office.
SOB, worsening resp failure w/ sepsis, diarrhea, weakness, headache, sore throat
Information has been received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients were each vaccinated with a dose of improperly stored GARDASIL 9 (lot # M023169, expiration date 13-JUN-2018) (route and dose were not reported). The vaccines were stored at 34.7 degree Fahrenheit for 11 hours and 47 degrees Fahrenheit for 45 minutes. The temperature excursions were detected by a "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Stomach cramps, chills.  Woke with "sore ankles." Ate breakfast okay. Tried to eat snack at school but couldn't. Sent to health room, where he vomited.  Temperature at 12:25 is 97.3 (so just a bit low).
I have exp significant chest pain I was diagnosed with Myocarditis. I have been treated at the hospitalized for 3 days given Colchicine.
Pt reported chills, body aches evening after shots through next day. Redness & swelling injection site. Recovered by 2nd day after.
Information has been received from a consumer concerning her child who in 2007 was vaccinated with a dose of ROTATEQ (Lot # 654423/0940F). The mother reported that her child was diagnosed with autism. The consumer stated that she "is not saying that ROTATEQ caused the autism". It was unknown if the patient sought medical attention. At the time of this report, the patient's outcome was unknown. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested.
The medical assistant at my OBGYN clinic: gave me the tDap vaccine incorrectly at my 28 week Obstetrical visit. She administered the vaccine via IM injection too high on my arm, possibly missing my deltoid muscle altogether. I have since experienced adverse reactions including: severe, abnormal pain, muscle weakness, limited range of motion, and numbness/tingling.
This spontaneous report was received from a nurse referring a patient of unknown age.  The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-SEP-2017, the patient was administered improperly stored dose of VARIVAX lot # N012619 with expiration date of 21-APR-2019, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 6°F (degrees Fahrenheit) to 14°F (12.2F) for 30 minutes. No previous temperature excursion was reported. The call was because of a "data logger". This one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA004378.
7am - light red rash around mouth and stomach 11am - vomiting, rash spread around body and turned darker red 1pm - rash became hives 4pm - gave 1ml Benadryl 6am following day - hives faded to light red rash
Severe tremors, body shaking, lots of tension on the body causing headache and discomfort and unsteady gait.
Autism; Dizzy spells at night; A bit anxious; This is a solicited report from a non-contactable consumer (patient).  A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 (at an unspecified age) as dose number unknown, single for COVID-19 immunisation; treprostinil diolamin (ORENITRAM), oral from 19Nov2014 (Batch/Lot number was not reported), at 5 mg (every 8 hours), oral from 19Nov2014 (Lot Number: 2101811; Expiration Date: 31Jan2023) and ongoing, at 5 mg (every 8 hours) for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medication included ambrisentan. On an unreported date, the patient experienced event of autism (medically significant) and the patient was a bit anxious. On an unreported date in 2021, the patient experienced event of dizzy spells at night. Clinical details: This case is a solicited report received on 23Sep2021, from a consumer from a patient support program. This 28-year-old, 200-lbs, male patient began therapy with Orenitram (treprostinil diethanolamine), on 14Nov2014 for primary pulmonary arterial hypertension. The patient was supplied with Orenitram 5 mg and the current dose was reported as 5mg, oral (PO), every 8 hours (q8h). Co-suspect medication included: COVID-19 vaccine. It was reported that, the patient had been getting some dizzy spells at night. The patient thought it was started back when he got a COVID vaccine at work in mid Feb 2021. The patient was a bit anxious during the call and mentioned autism. He was concerned that everyone was on same page with his medication. The action taken in response to the events for treprostinil diolamin was unknown. The outcome of the events was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Sender's Comment: The company has assessed the serious adverse event of autism spectrum disorder as not related to oral treprostinil. The cause of autism spectrum disorder is generally considered to be unknown although it has a higher frequency in some families indicating a possible hereditary link; it is commonly diagnosed in childhood, but can be identified in young adults as in this 28-year-old patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available and currently known drug safety profile, the reported events spectrum disorder, dizziness and autism more likely represented intercurrent illness hence, unrelated to BNT162B2.