chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US023686, is an initial spontaneous report from a consumer (patient) via Agency received on 24 Nov 2014. This report refers to a male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1412301, expiry date: 30 Jun 2015) from a multidose vial on 03 Oct 2014. After 5 minutes of vaccination, the patient fainted. The patient also complained of pain to head and left ankle. The outcome, seriousness and causality of the events were not reported. Seriousness assessment of faint was upgraded based on information in the source documents.
Information has been received from a pharmacist concerning a female patient with sulfa allergy who on 18-FEB-2009 was vaccinated with ZOSTAVAX (Oka/Merck) S.Q.. On 19-FEB-2009 the patient experienced injection site reaction.  The area is red, itchy and had a "knot".  The patient went to see the pharmacist for medical attention.  The patient's adverse effect persisted.  No further information is available.
This spontaneous prospective pregnancy report as received from a physician via company representative refers to a female patient of unknown age. The patient's pertinent medical history and drug allergies were unspecified. On an unknown date, the patient was vaccinated with GARDASIL (one dose of three doses) intramuscularly, when she was 3-4 weeks pregnant. The patient was not showing signs of pregnancy when she was vaccinated. It was not specified which dose in the series the patient had received. The patient was not experiencing any untoward effects. The patient did not sought medical attention. Additional information has been requested.
My back aches; Very sore arm; My injection site arm aches and is sore; tired; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (My back aches), PAIN IN EXTREMITY (Very sore arm), VACCINATION SITE PAIN (My injection site arm aches and is sore) and FATIGUE (tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (amoxicillin allergy). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), MONTELUKAST SODIUM (SINGULAIR), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and CALCIUM for Allergy, VITAMINS NOS (MULTIPLE VITAMIN) and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced BACK PAIN (My back aches), PAIN IN EXTREMITY (Very sore arm), VACCINATION SITE PAIN (My injection site arm aches and is sore) and FATIGUE (tired). On 24-Jan-2021, BACK PAIN (My back aches), PAIN IN EXTREMITY (Very sore arm), VACCINATION SITE PAIN (My injection site arm aches and is sore) and FATIGUE (tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up information included, reporter details, patient demographic details, medical history, concomitant medication, event start date and stop date.
Got a shot and still caught it; Got a shot and still caught it. Very ill; Initial information was received on 16-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves Adult and unknown gender patient who experienced flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, strength, expiry date, lot number not reported) via subcutaneous route in unknown administration site for prophylaxis.  On an unknown date the patient developed a serious event of event of got a shot and still caught it. very ill (vaccination failure) and a non-serious got a shot and still caught it (illness) (unknown latency) following the administration of influenza vaccine..  No lab data was reported.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for the event (Got a shot and still caught it. Very ill).  Outcome: Unknown for both events.  Seriousness Criteria: Medically Significant for vaccination failure.; Sender's Comments: Sanofi Company Comment Dated 26-Dec-2022:  This case involves Adult and unknown gender patient who experienced flu after receiving vaccine influenza vaccine. The time to onset is not reported with the role of the vaccine. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Loss of taste; Loss of smell; Cough; Sinus pressure; Extreme fatigue; Headache; Temp of 99.8; Tested positive for COVID-19; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), BODY TEMPERATURE INCREASED (Temp of 99.8), ANOSMIA (Loss of smell), COUGH (Cough) and PARANASAL SINUS DISCOMFORT (Sinus pressure) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 07-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). On 08-Jan-2021, the patient experienced BODY TEMPERATURE INCREASED (Temp of 99.8). On 11-Jan-2021, the patient experienced ANOSMIA (Loss of smell), COUGH (Cough), PARANASAL SINUS DISCOMFORT (Sinus pressure), FATIGUE (Extreme fatigue) and HEADACHE (Headache). On 08-Jan-2021, BODY TEMPERATURE INCREASED (Temp of 99.8) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), ANOSMIA (Loss of smell), COUGH (Cough), PARANASAL SINUS DISCOMFORT (Sinus pressure), FATIGUE (Extreme fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events( Fatigue, headache elevated temp) , a causal relationship cannot be excluded. However, the event of COVID-19 is Unlikely related to mRNA-1273. Further information has been requested   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events( Fatigue, headache elevated temp) , a causal relationship cannot be excluded. However, the event of COVID-19 is Unlikely related to mRNA-1273. Further information has been requested
Patient's arm became red, swollen, and hot around injection site. However affected area is still getting larger after 5 days.
pt arm turned red & slightly swollen after vax given. was given antibiotic to prevent infect
I filed the V-Safe for one week. Originally my arm was firm and red, and swollen...that went away in 2 days, and I felt fine. Oddly yesterday, my arm started another identical reaction from the vaccine, where it was a small white area, then became red and inflamed in an hours time. It was warm to touch. Very itchy this time. I used a no touch thermometer on it and it read 100.4. My forehead temp was 97. It is feeling better and going away again, but I thought it was odd and that you should know. Thanks.
Client was vaccinated at the site on March 1 (approx) and on March 29 (definite) with Pfizer vaccines for Covid.  Symptoms started on October 11 - cough, headache, myalgia, sore throat.  Received monoclonal antibody infusion at Hospital on 10/13/2021.  Reported as a case of breakthrough Covid illness in a previously vaccinated person.
Female patient of 82 years of age came to get vaccinated to the center and at the time of administration she had pressure on chest and could not breathe. She was transferred to area of observation to be evaluated at 12:44pm by EMT. Her vitals 180/80 mmHg, 108 Dxt, Sat 99% and pulse 70. At 12:50pm consultation was done with Dr. who indicated to elevated her lower extremities. She was put on Trendelenburg position since possibly she might have some anxiety and that way she can relax. At 1:25pm she was reevaluated vitals were 140/70mmHg, 99 saturation at 1:27 consultation was done with Dr. and patient was discharge.
5 minutes after administration of flu vaccine patient started coughing continuously: complained of feeling hot, sneezing and shortness of air.
Swelling underarm; He experienced mild headaches, swelling under his arm, and pain at injection site.; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling underarm), HEADACHE (He experienced mild headaches, swelling under his arm, and pain at injection site.) and INJECTION SITE PAIN (Pain at injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced HEADACHE (He experienced mild headaches, swelling under his arm, and pain at injection site.) and INJECTION SITE PAIN (Pain at injection site). On 24-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swelling underarm). The patient was treated with IBUPROFEN for Headache, Peripheral swelling and Injection site pain, at an unspecified dose and frequency. On 25-Feb-2021, HEADACHE (He experienced mild headaches, swelling under his arm, and pain at injection site.) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling underarm) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
ADMINISTRATION ERROR/ VIAL WAS PUNCTURED ON 10-FEB-2022 BUT WAS ADMINISTERED TO A PATIENT NEXT DAY; INCORRECTLY STORED VACCINE ADMINISTRATED; OFF LABEL USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-FEB-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-FEB-2022, the patient experienced administration error/ vial was punctured on 10-feb-2022 but was administered to a patient next day, incorrectly stored vaccine administrated, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error/ vial was punctured on 10-feb-2022 but was administered to a patient next day, incorrectly stored vaccine administrated and off label use was not reported. This report was non-serious.
10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0196), second dose via an unspecified route of administration, administered in left arm on an unspecified date in Jun2021 at 09:30 (at the age of 41-year-old), as a single for COVID-19 immunisation at pharmacy or drug store. No relevant medical history and concurrent conditions. No known allergies were reported. The patient's concomitant medications were not reported. Historical vaccine given to patient was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), first dose via an unspecified route of administration, administered in left arm on an unspecified date in May2021 at 09:30 (at the age of 41-year-old), as a single for COVID-19 immunisation at pharmacy or drug store. No relevant past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Reported Event: 10 days after the second dose on 27Jun2021 at 02:00 the patient experienced high fever, hives, and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night. No treatment was received for the event. The events had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. The reporter reported events as non-serious. Adverse events result in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jun2021 (Nasal Swab). The outcome of events was reported as resolving and outcome of the event high fever was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Temp 103, N/V,  chills, muscle aches, severe h/a, dizziness, urinary incontinence, muscle weakness that lasted for 12 hours.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (full body itch) and RESPIRATORY DISORDER (respiratory issues) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013LQ0A, 010AQ1A and 014F21A) for COVID-19 vaccination.No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (full body itch) and RESPIRATORY DISORDER (respiratory issues). At the time of the report, PRURITUS (full body itch) and RESPIRATORY DISORDER (respiratory issues) outcome was unknown. Patient had allergy to tromethamine.  Patient had the event doctor says they see "100 patients a week" with inflammatory process response to booster dose access to VAERS data and has seen 500,000 reactions from Moderna booster pure tromethamine should not be used as a stabilizer as others have this allergy and it is statistically significant. Concomitant medication information not provided. Treatment information not provided. Email received to provide pictures. Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Non significant Follow-up.
Patient received immunizations today and had syncopal episode when checking out of clinic around 1015. Fell from standing and hit head on hard surface. Loss of consciousness for approximately 1 min. Vomit x1.
pt recv vax;devel light rash behind legs;devel a hardened suboccipital node the size of a pea;not tender;as of 24oct95 resolved but hardened lymph node persisted;
Redness and itching to the injection site 10 minutes after injection.  Treatment included bandaid removal and oral Benadryl 50 mg.  Itching resolved with the removal of the bandaid.  Patient was observed for 30 minutes with no further symptoms.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a male patient who received TWINRIX. In August 2015, the patient received TWINRIX. In August 2015, less than a week after receiving TWINRIX, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the tiredness to be related to TWINRIX. Additional details were provided as follows: The patient reported that he had a TWINRIX vaccine, about a week before reporting and he has been tired since then. The patient did not want to provide any further details on this report.
Child was limping and rubbing leg. Child did not want me to touch leg, sore to touch. By 9PM thigh was swollen size of golf ball by next morning thigh doubled in size. Called Physician, was told give child Ibuprofen and ice thigh.
First Dose (5/3/2021): Ten days after my first dose, my eyeballs became very red and teary, and I felt a lot of pain. At the time, I thought I had sunburned my eyeballs, but immediately after the second dose, symptoms became more extreme.  Second Dose (6/1/2021): The day after the second dose, I could barely keep my left eye open. The pain was agonizing. For the first time in my life, I was very sensitive to sunlight. My left eye was extremely swollen and itching and burning. It was red and tearing up constantly, with copious amounts of discharge.
Mental confusion; foggy brain; Nausea; Headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CONFUSIONAL STATE (Mental confusion), FEELING ABNORMAL (foggy brain), NAUSEA (Nausea) and HEADACHE (Headache) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, the patient experienced CONFUSIONAL STATE (Mental confusion), FEELING ABNORMAL (foggy brain), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, CONFUSIONAL STATE (Mental confusion), FEELING ABNORMAL (foggy brain), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Patient received 2nd Pfizer Vaccine after only 11 days between doses. First dose given on 22Feb2021. Patient has thus far experienced no adverse reactions.
Had patient stay to be monitored. Patient stated her heart rate was 95. She said she felt she couldn't catch her breath a little bit. I asked if she wanted me to call ambulance and she denied. She went to urgent care and we called to tell them she was on her way. Called again to confirm she made it their safely.
intense period clotting, more painful period, made period late by about 4 days late. Told gynecologist but they did not investigate. They did a pap smear and abnormal cell result came back. I will be following up about it October.
pt brought to hospital via EMS; diagnosed few days prior to hosp admission, positive for COVID; pt on supplemental O2 at home (5L via NC); O2 sats 70% on 5L via NC; pt c/o weakness, fatigue, headache and cough; COVID test came back positive; pt admitted; abnormal renal function; COVID pneumonia; treated with antibiotics, dexamethasone, convalescent plasma; pt's condition worsened and he passed away in the hosp
Redness , swelling and heat felt at injection site within an hour of vaccination.  Approximately 18 hours after, experienced muscle aches, fever and chills.
Seizures nightly x 4 nights in a row with severe H/A esp. back of head - started the night vaccine received - have had seizures since Dec. 09 (Epilepsy)-saw PCP in 1 wk due to cont. sx-Doc's felt may be related to MMR-advised pt not take 2nd dose.
Full body excruciating pain/Paralyzing pain in the evenings from chin down; Get so bad in evenings cannot walk, legs lock up, hips killing him, knees, fingers, and toes hurt.; Get so bad in evenings cannot walk, legs lock up, hips killing him, knees, fingers, and toes hurt.; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced full body excruciating pain, paralyzing pain in the evenings from chin down, get so bad in evenings cannot walk, legs lock up, hips killing, knees, fingers, and toes hurt on an unspecified date with outcome of not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) :PFIZER INC-202101008979 same product/event, different patient
2nd dose given 8 days early  Narrative:  Employee was scheduled for 2nd dose vaccine in clinic on 5/27/21. Nurse contacted patient for reminder and was informed that this was not necessary as the previous dose received in clinic was actually 2nd dose and that she had received first does in community. Patient provided vaccination card showing both vaccines given, with the first given 4/9/21.
Increased temperature, flu-like symptoms, cough, runny nose, decreased appetite and diarrhea.
Child presented with 10-20 chicken pox lesions on trunk and arms. Symptom began on 03/27/2002. Child received varivax on 08/31/1995.
Patient reported on November 7th that she was experiencing "a prolonged flu-like reaction".  This reaction consisted of fever, runny nose, sneezing, coughing, and sinus infection and began on Oct 10th.  Went to the MD's office three times and was given several different antibiotics.  She is in the beginning stages of feeling better.  She wanted us to inform and document this adverse event.
The pt developed a rash all over her body, a few seconds into the Prevnar being administered.