chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 28Mar2021 at 16:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The medical history of the patient included fruit allergy (melon) and vegetable allergy (carrot). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 07Mar2021 at 14:30 as a single dose for COVID-19 immunisation. On 29Mar2021 at 08:00 the patient experienced headache and fatigues that increased through the day for the last 4 weeks since vaccination, beginning the day after his second shot. Blood work and urinalysis was looked normal, doctor believes that to be vaccine related. Since the vaccination, the patient had been tested for COVID-19.  On 05Apr2021, the patient underwent Nasal Swab and the result was Negative. On an unknown date, the patient underwent Blood test and the result was Normal. On an unknown date, the patient underwent Urine analysis and the result was Normal. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events headache and fatigues that increased through the day was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
After shot #2 I continued to experience tenderness at the injection site.  About 72 hours after the shot, I had a red rash at the injection site that was a bit itchy.
Patient experienced itching, redness, warmth to the touch, raised knot and hardness and body aches. No treatment. Monitoring only.
Feels like the sides of my throat is swollen day after I took my first dose of Pfizer, causing a sore throat; Sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 13:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 22Apr2021, the patient felt like the sides of throat were swollen day after she took first dose of Pfizer and also caused a sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event felt like the sides of throat were swollen and sore throat were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arm is red around where he got the shot/ arm is all red; It feels a little warm.; This is a spontaneous report from a contactable consumer(wife).  A 86-years-old male patient received bnt162b2 (PFIZER-BIONTECH, COVID-19 vaccine, formulation: solution for injection) via an unspecified route of administration, administered in Arm Left on 05Feb2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medication were not reported. In Feb2021, the patient's arm was red around where he got the shot and it felt a little warm. It was about a 4-inch circle.The reporter stated that It was not red Saturday and don't know about it on Sunday,but when he got out of the shower on 08feb201 (day of reporting) his arm was all red. The patient's wife asked was this normal, is there anything she should be aware of for him. The reporter explained it was on the left arm and this was the side that he got the shot on. Outcome of the events were unknown.  Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
c/o h/a, dizziness, constant sweating, pain @ inj site w/soreness radiating to rt neck & shoulder, SOB especially when walking
coughing; temperature of 101; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (coughing) and PYREXIA (temperature of 101) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced COUGH (coughing) and PYREXIA (temperature of 101). At the time of the report, COUGH (coughing) and PYREXIA (temperature of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, Body temperature: 101 (High) temperature of 101.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  The patient queried about how likely it was to experience COVID symptoms such as coughing and having a temperature of 101 after receiving the booster dose of Moderna vaccine.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-MAR-2015 (also reported as "today") the patient was vaccinated with a second dose of GARDASIL (dose volume, route of administration, lot number were not reported). The patient was administered a first dose of GARDASIL (dose, volume, route of administration, lot number were not reported) on 01-JUL-2014. No adverse events were reported. Additional information is not expected because the reporter did not give a consent for the follow-up attempts.
12 year old received a dose of Moderna vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received a dose of Moderna vaccine.) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041JZ (2)1A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received a dose of Moderna vaccine.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received a dose of Moderna vaccine.) outcome was unknown.        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 provided by the reporter.  Patient did not get the second dose.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2022: Follow-up received and contains no new information.
Pt was given Pedvax HIB when not indicated.  Pt had aged out of eligibility.  No adverse reaction.
Became more exhausted throughout the night. Left work early since I was so tired I could barely see straight. Woke up the next day with trouble breathing and nausea, along with still feeling exhausted.
On March09 Tetanus shot was administered. After the tetanus shot I experienced tremendous pain. I was able to use the arm at all for anything, bathing, dressing, sleeping I had surgery and occupational therapy & the pain still there.
This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient of an unspecified ethnicity received the first dose of PREVNAR 13 (lot T88778, expiry date Mar2020, NDC 00005-1971-05) intramuscular on 06Feb2018 at approximately 12:15 at 0.5 ml single in the left deltoid for pneumococcal prevention (immunisation). No other vaccine was administered the same day. Medical history included ongoing blood pressure disorder. She was taking other unspecified concomitant medications. The patient was administered with the vaccine at the drug store, she stayed at the back area for observation for 15 minutes and did not have any issues. Then the patient went throughout the store and did the remaining of her shopping and while trying to purchase items she fainted. They had to call an ambulance and the patient was taken to the hospital where she was admitted the same day. The patient recovered on 06Feb2018. The event faint was assessed as serious as medically significant and per initial hospitalization. Causality assessment was possible but it was unknown if event depended also from other medications taken by the patient and other ongoing conditions. Sender's Comments: Based on the information currently available, there was not a reasonable possibility that the event fainted was related to the suspect drug PREVNAR 13, it is more likely related to underlying history of blood pressure disorder for this elder patient. This case will be re-evaluated upon receipt of additional information. 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.
Hospital 8/28/21.  2nd Pfizer COVID vaccine on 4/18/21 with LOT ER8730
Skin moderately irritated over torso and legs but not face.  No rash.  Lasted 24 hours.  No treatment
She got sick and had to go to the hospital and they hospitalized her. They diagnosed her with C. DIFF and Norovirus. She had nausea, vomiting, fever, and diarrhea. They gave her TYLENOL, ZOFRAN, and saline solution in addition to her regular medication. They didn't give antibiotics because she had C. DIFF. She is better now.
Arthritic joint pain, stating "it's inflamed my arthritis in my joints like 3 fold/joint pain; It's inflamed my arthritis in my joints like 3 fold." "My left hand was worse; Already have arthritis it's inflamed it by 3 times the pain level; Can't even pick up anything from my left hand/he couldn't hold anything over a few ounces; Arthritis/Joint pain; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) reported for himself. A 62-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA7484), via an intramuscular route of administration in Left on 10Aug2021 as dose 1, single for COVID-19 immunisation. Medical history included Type 1.5 diabetes, HIV infection (I have like HIV from past 20 or somewhat years), osteoarthritis, arthritis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not received any other vaccines prior to the COVID vaccine. Patient stated he received his first dose. 4 days later on 14Aug2021 he developed arthritic joint pain, stating "it's inflamed my arthritis in my joints like 3 fold. On unknown date 2021 my left hand was worse. It's joint pain, I already have arthritis it's inflamed it by 3 times the pain level, the first shot later, the joint pain in my Arthritis refill. I mean I can't even pick up anything from my left hand/ he couldn't hold anything over a few ounces until today. He states it was dissipating. Everything I had read so far, said a second shot may increase the side effects. I am leery now about getting a second shot unless somebody could tell me that usually these side effects dissipate over time. Consumer stated, I just called, I had 3 called you guys, and all just got ran away. Okay I am not even sure anymore I said, I called this number five times it bounced around and they told to call the medical and option 3, I went to them talk to somebody that bounced back to somebody who was a Pharmacist assistant, who then took some information to make a report and then told me to call back if I have other question and hit option 3, so I did option 3 but I get nowhere so, I come back to option 1 because I just wanted some information about the side effects, I had the shot, I got side effects and I just want to know if there was any historical data so far in your system this said how long things should last. Consumer stated, I wanted to know that they said that, whatever the thing was out, whatever the thing 'gene'. All I tried to find out if you have the historical data cover after a year of collecting information, was something that generally disappear. Yeah, I mean do they generally in you historical data disappear because it said the second shot, which I had not received yet was worked. Consumer stated, I had no idea, it was there in the car. I do not had it with me right this minute, it was in the car. Patient received treatment for events as gabapentin and aspirin. The outcome of the events arthralgia, arthritis, inflammation was reported as recovering and while other events was unknown.
12/31/20  7:30 pm mild fever  99.8.   take Tylenol  01/01/2020   3;30pm   fever  100.8,  muscle aches , headache, fatigue.  at 5;30 taken 2 Aleve,   slept it off , walks up about 7:30am 1/2/21 still feeling a little fatigue,  no fever
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated by a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
not feeling well after second Moderna booster; her body felt hot; felt a bit weak; a bit of nausea; sore arm; very bad headache; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling well after second Moderna booster), FEELING HOT (her body felt hot), ASTHENIA (felt a bit weak), NAUSEA (a bit of nausea) and PAIN IN EXTREMITY (sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052B22A and 939904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     On 2Jun2022 patient tested positive to COVID-19, and 4 days later she tested negative. It was reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Thyroidectomy (patient had no thyroid) on 09-Jan-2017. Previously administered products included for COVID-19 vaccination: Johnson & Johnson (Dose no : 1 Route of administration : Intramuscular Lot number : 1305029) on 22-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson. Concurrent medical conditions included Drug allergy (Methylprednisolone) and Allergy to antibiotic (cephalosporins). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroidectomy.   On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2022, the patient experienced FEELING HOT (her body felt hot), ASTHENIA (felt a bit weak), NAUSEA (a bit of nausea), PAIN IN EXTREMITY (sore arm) and HEADACHE (very bad headache). On 29-Jul-2022, the patient experienced MALAISE (not feeling well after second Moderna booster). On 28-Jul-2022, NAUSEA (a bit of nausea) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, MALAISE (not feeling well after second Moderna booster), FEELING HOT (her body felt hot) and HEADACHE (very bad headache) had not resolved and ASTHENIA (felt a bit weak) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2022, Blood pressure measurement: 124/65. On 28-Jul-2022, Heart rate: 72 pulse was 72 bpm.         The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experience a similar event in the past. After 2nd booster dose patient experienced a bit of nausea, and sore arm. She woke up at night and felt symptoms like having COVID-19. No treatment has been given for her symptoms.   This case was linked to MOD-2021-368752 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2022: Live Significant follow up received contains Reporter email id added, patient details, concomitant product updated, Event added, Case narrative updated.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored oral, ROTATEQ, lot# L006184, expiry date 13-DEC-2016. No adverse effects reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of four reports received from the same reporter. Additional information has been requested.
03/04/2017 itchy red rash to left elbow then spread to thighs, arms, torso, back. also c/o bilat armpit tenderness and can feel lump. states had 2 vaccines on 03/02/2017 -Hep B, HPV. denies fever/chills, st, cough. denies facial or throat swelling.
Possible administration error. Unable to verify if 0.5 or 0.3 ml was drawn up and administered to the patient. Alerted patient to possible error and filled out report to record incident. Verified that correct vaccination was given but when drawing up vaccine, did not recall properly verifying dosage before administering vaccination. Patient showed no signs of adverse reactions during time of event.
It started off with aching joints and fever on the evening of the 10th. Treatment of this event was rest in bed till the next morning. The morning of the 11th aching joints went away but the site of the injection was swollen, hot to the touch, and sore. No treatment was done and still no treatment.
She had no side effects after the first vaccine and was tender on the first day, which went away; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 19Dec2020 10:30 at single dose for Covid-19 immunization. The patient's medical history included hypertension. The patient had an X-ray back in Sep2020 (unknown result). The patient's concomitant medications were not reported. On 19Dec2020, the patient had the first dose and stated that she had no side effects after first vaccine and was tender on the first day which went away.  The outcome of the event was recovered on 20Dec2020. The event was treated with unspecified treatment. The reporter assesses the event as non-serious.
Increased Tinnitus in right ear.  Already had mild case, now it is very loud in only my right ear.
Extreme dizziness, nausea, vomiting  that started Saturday May 29th and has not subsided.  Trip to the emergency room and appointment with provider.
Muscle soreness; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Muscle soreness) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 014M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy (Penicillin).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021 at 2:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Muscle soreness). At the time of the report, MYALGIA (Muscle soreness) had resolved.     No concomitant medication information was provided. It was reported that, patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination were Levothyroxine 125MCG, losartan 50MG, Atorvastatin. The patient was not diagnosed with COVID-19 Since the vaccination, had not been tested for COVID-19. Administration Time of dose to was 01:15 PM. The device date was given as 08-Oct-2022. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Follow up received contains significant information: Suspect details updated.