chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Fever; Injection site swelling; Feeling unwell; Difficulty breathing; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the arm left on an unknown date in 2021 (at the age of 49-year-old) and the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0175) via an unspecified route of administration in the arm left on 26Apr2021 at 12:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:00, the patient experienced dizziness, difficulty breathing, injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, fever, injection site swelling (vaccination site swelling) and feeling unwell. The clinical outcome of the events dizziness, difficulty breathing, injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, fever, injection site swelling (vaccination site swelling) and feeling unwell were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Unable to walk; Diarrhea; A spontaneous report was received from a consumer concerning a 75-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea, unable to walk/gait inability.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, after the vaccination, he walked 3 miles back to his house. On the 3 Mar 2021, he was unable to walk and he started having diarrhea.  On 18 Mar 2021, he was admitted to the hospital because he still could not walk. The relevant lab tests included MRI, EKG, blood test and CT scan with the result all negative. On 20 Mar 2021 the patient is reported to being still admitted to the hospital and his physician stated considering recharging him to a rehab facility.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event unable to walk was not resolved. The outcome of events diarrhea was unknown.; Sender'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.
Became lightheaded and developed a funny taste in mouth within 15 -20 mins, as day progressed raw sore feeling in mouth like I burnt my tongue and roof of mouth but did not burn it.  Next day woke up with a severe headache and low grade fever which lasted until following day. Raw feeling in my mouth went away by mid day Monday.  Developed severely dry lips that weekend which lasted for 3 weeks. Developed mouth and lip sores the within week  after and lasted for 2-3weeks.
Patient received FLUZONE HD and PNEUMOVAX, one in each arm on 9/8/16. Patient called pharmacy on 9/9/16 spoke with clerk. Patient stated she her arm was swollen and red. Clerk told patient to use ice, BENADRYL and follow up with MD if necessary. On 9/10/16 patient arrived at the pharmacy from the urgent care. Urgent care had diagnosed her with cellulitis in her right arm. Patient was prescribed an antibiotic. I filled prescription and went over instructions. Patient had new RX today for cream for pain.
Notified on 3-3-20 that patient was seen and evaluated in the emergency room for Abdominal pain with nausea and diarrhea.
tired; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient received both Pfizer shots at work. She stated she did not have any reactions, then she stated that following the second shot, she was tired and stuff but the effect wore off. The outcome of tired was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Onset of acute epigastric abdominal pain, mild to moderate pain constantly with intermittent severe colicky pain lasting 30-60 minutes.  Presented to our office for evaluation on 7/16, ultrasound done was normal but pain still severe. Evaluated in the ED at hospital where labs done, lipase found to be elevated to 2479, patient admitted for treatment.  Lipase decreased over the next 2 days, discharged home and continues to decrease, most recent level on 7/21 was 572. Abdominal pain improved.
no adverse event; patient at the office today, 12/2/2021, who was scheduled to receive GARDASIL 9. The patient inadvertently received a dose of PNEUMOV AX 23 instead of GARDASIL 9.; patient at the office today, 12/2/2021, who was scheduled to receive GARDASIL 9. The patient inadvertently received a dose of PNEUMOV AX 23 instead of GARDASIL 9; patient at the office today, 12/2/2021, who was scheduled to receive GARDASIL 9. The patient inadvertently received a dose of PNEUMOV AX 23 instead of GARDASIL 9; Information has been received from the office manager, referring to a 11 years-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-DEC-2021, the patient was scheduled to receive hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), however, instead of this vaccine the patient inadvertently received a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # U018309, expiration date 08-JAN-2023 (anatomical location and administration route were not reported) for prophylaxis.  The reporter stated that the patient missed his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), but the patient did receive a flu shot (manufacturer unknown) also on 02-DEC-2021. No additional adverse events were reported.
Vaccine  dose 1 rash and itchy for 3 weeks and  slight shortness of breath and tightness  Dose 2  severe rash on neck and chest with mild shortness of breath and tightening in chest lasting  24  hours.
DIZZYNESS; WEAKNESS; FATIGUE; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tiredness. On 05-MAR-2021, the subject experienced nausea. On 06-MAR-2021, the subject experienced dizziness. On 06-MAR-2021, the subject experienced weakness. On 06-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and nausea on 08-MAR-2021, and was recovering from weakness, fatigue, and tiredness. This report was non-serious.
Narrative:  78 yo male with PMHx of GBM (multifocal glioblastoma- brain cancer), DM, HTN, h/o pacemaker, COPD, HTN, OA, dementia, retinopathy, venous insufficiency, h/o asthma, OSA, h/o anxiety, GERD, who died on 10:21/21 at home in home hospice care. Pt had received 3 covid vaccines on 1/20/21, 2/26/21, & 8/24/21. Death is not related to vaccines.
PT PASSED OUT AND FELL OUT OF HIS CHAIR HITTING HIS HEAD ON THE CONCRETE FLOOR.
no adverse event; Patient given expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (no adverse event) in an 84-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose).    It was unknown if the patient had experienced any additional symptoms/events.  Concomitant medications were not reported.  No treatment information was provided by the reporter.
Swollen lymph nodes appeared near collar bone on side of injection site within 72 hours of receiving first Moderna vaccine injection. Lymph node swelling subsided within 10 days of injection.
Recurrent vomiting of formula for the rest of the day with mild accompanying dehydration.
Pt c/o rash that started on lower back x1 week.  Rash has spread to upper back and left shoulder.  There is no rash on front of chest or stomach or other parts of the body.
pt recv vax & devel flu-like sx w/in 3 days of vax;
Patient had received the Moderna COVID-19 vaccine on 1/26/21 and 2/25/21, so was fully vaccinated when they tested positive for COVID-19 on 8/30/21.
Phlegm; Arm Soreness; had a raised area that was quite large; Energy levels have decreased; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Phlegm), LIMB DISCOMFORT (Arm Soreness), VACCINATION SITE SWELLING (had a raised area that was quite large) and FATIGUE (Energy levels have decreased) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (Phlegm), LIMB DISCOMFORT (Arm Soreness), VACCINATION SITE SWELLING (had a raised area that was quite large) and FATIGUE (Energy levels have decreased). At the time of the report, PRODUCTIVE COUGH (Phlegm), LIMB DISCOMFORT (Arm Soreness), VACCINATION SITE SWELLING (had a raised area that was quite large) and FATIGUE (Energy levels have decreased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: TCR: information added which provides 2 new non serious events and patients address
severe incapacitating headache starting several hours after vaccine and lasting at least through today 13Jan2021. Steroids prescribed today; This is a spontaneous report from a contactable nurse (patient).  A 55-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 09Jan2021 11:30 at single dose for covid-19 immunisation. The patient's medical history included Asthma and hypertension. The patient's concomitant medication includes unspecified medication. On 09Jan2021 23:00, the patient experienced severe incapacitating headache starting several hours after vaccine and lasting at least through today 13Jan2021. The patient event resulted in doctor or other healthcare professional office/clinic visit and Steroids prescribed today. Treatment includes prednisone.  The outcome of the event was unknown.; Sender's Comments: Based on the compatible time association and drug's safety profile, the event headache is possibly related to suspect BNT162B2 administration. 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.
I still have a quite enlarged superior super clavicle glands on my shoulder blades on both sides and they are quite large; This is a spontaneous report from a contactable female consumer reported for herself. A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8737), via unspecified route, administered in left arm on 08Apr2021 (at the age of 69-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6198), via unspecified route, administered in right arm on 05Mar2021 (at the age of 69-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications include Tramadol, Lyrica, Diclofenac, Arthrotec, Atorvastatin and Lipitor. No other vaccines were taken prior 4 weeks. On an unspecified date, after the vaccination, the patient experienced a quite enlarged superior super clavicle glands on her shoulder blades on both sides and they are quite large and enlarged lymph nodes. Consumer said even about 3 weeks after vaccination, still have a quite enlarged superior super clavicle glands on my shoulder blades on both sides and they are quite large and she have never had anything like that before and she went to her regular doctor and performed a scan with nothing abnormal, upon her reference in internet she found this happens in other women as a side effect of the vaccine. She was planning for an MRI because the first lab and the scan didn't show anything, and so doctor have ordered an MRI. Patient lab investigation data include blood test on unspecified date with results unknown and scan with results unknown. No treatment options were taken. The outcome of the event was not recovered.  No follow-up attempts possible. No further information expected.
Sore all over for 2 days and lower back pain for 4-5 days after that
Just one case LSIL due to 6/58; This spontaneous report was received from a physician via a company representative referring to unspecified patients, one of them a male patient of unknown age. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot # and expiration date were not reported), as primary prevention of anal cancer.  Information was identified on a slide presentation. The following information was reported:  Long-term follow up studies of 4 valent human papillomavirus (HPV) vaccine in male Data 11.5 years No new cases of condilomas fue to HPV 6/11 nor external genital lesions due to 6/11/16/18 No lesion high grade squamous intraepithelial lesion (HSIL) 6/11/16/18 Just one case low grade squamous intraepithelial lesion (LSIL) due to 6/58  On an unknown date, the patient experienced (LSIL). The outcome of the event was unknown.  The causality assessment was not provided by the reporter.
Headache - approximately 2-3 days productive cough - ongoing fever - 1 day  Doctor prescribed:  Albuterol Sulfate HFA 108 (90 Bae) MCG/ACT  - 4 times a day as needed for cough/ wheezing or chest tightness Paxlovid (300/100) 20 x 150 MG & 10 x 100 MG
Body discomfort; bone pain; body aches; Left arm was a little swollen but not like the first time with the 1st dose; My body was hot and cold; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Body discomfort), BONE PAIN (bone pain), PERIPHERAL SWELLING (Left arm was a little swollen but not like the first time with the 1st dose), FEELING OF BODY TEMPERATURE CHANGE (My body was hot and cold) and MYALGIA (body aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 040B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METFORMIN, LOSARTAN, VITAMIN D [VITAMIN D NOS], ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PERIPHERAL SWELLING (Left arm was a little swollen but not like the first time with the 1st dose) and FEELING OF BODY TEMPERATURE CHANGE (My body was hot and cold). On 20-Apr-2021, the patient experienced DISCOMFORT (Body discomfort), BONE PAIN (bone pain) and MYALGIA (body aches). At the time of the report, DISCOMFORT (Body discomfort), BONE PAIN (bone pain), PERIPHERAL SWELLING (Left arm was a little swollen but not like the first time with the 1st dose), FEELING OF BODY TEMPERATURE CHANGE (My body was hot and cold) and MYALGIA (body aches) outcome was unknown.            Treatment medication was Panadol before and after the 2nd dose.   This case was linked to US-MODERNATX, INC.-MOD-2021-058154 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058154:Dose 1
Minimal side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minimal side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Minimal side effects). At the time of the report, VACCINATION COMPLICATION (Minimal side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided.  No Treatment medications was provided.
flulike sx--undocumented fever, chills, uri symptoms (cough, runny nose), nausea (no vomiting), some loose stools x 3 days
developed an itchy rash about 11 hours after administration that remained isolated to chest, abdomen and arms in the office, she was slightly tachycardic 108
fever; nausea/intense nausea; extreme muscle pain; pain at the injection site; congestion; Couldn't eat much; headache; extreme fatigue; cold sweats; chills; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration in the left arm on 07Feb2021 at 09:45 (at the age of 22-years-old) as a single dose for COVID-19 immunization. Medical history included depression and anxiety, both from unknown dates and unknown if ongoing. The patient had no allergies to medication, food or other products, and did not have COVID-19 prior to vaccination. Concomitant medications included duloxetine from an unknown date for an unknown indication; ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE) from an unknown date for an unknown indication; ibuprofen from an unknown date for an unknown indication; and acetaminophen from an unknown date for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, it first started as a headache and extreme fatigue about two hours after the vaccine. She took two ibuprofen and felt better for a few hours, but the fatigue kept growing and then she started to get cold sweats and chills. The day after was the worse. She had fever, nausea, extreme muscle pain and fatigue, pain at the injection site, and congestion. She took acetaminophen through-out the day and couldn't eat much. The second day the fever and cold sweats went away but she still had intense nausea. It was the third day (as of 10Feb2021) and she felt better but still had fatigue and minor nausea. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of headache, extreme fatigue, cold sweat, chills, fever, nausea, extreme muscle pain, congestion, couldn't eat much and pain at the injection site were reported as recovering. It was also reported that since vaccination, the patient had not been tested for COVID-19.
Pt here for a reaction to pneumonia shot on the L-arm site is swollen from top of arm to 2 inches above elbow. Called yesterday with notification that her arm had gotten red and large. Improved moderately after taking 100 mg of BENADRYL.
Patient experience loss of muscle control and fell down on his buttocks, as well as loss of bowel control. Patient says he experienced at least 3 bowel movements. After at least 1+ hour of loss of muscle control, he was able to call for an ambulance. At the hospital, they ran a head scan and found no abnormal brain activity, so the hospital staff thinks it may be related to the vaccine he received the day before.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 23-MAR-2015, the patient was vaccinated with an improperly stored dose of Gardasil "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had four temperature excursions: 336, 152, 1172 and 80 hours respectively. The lowest recorded temperatures were 30 (-1.111111111 Celsius degrees) and -3 (-3 Celsius degrees). The highest recorded temperatures were 47 (8.333333333 Celsius degrees) and 59 (15 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.