chrisvoncsefalvay/vaers-outcomes huggingface dataset:
whole lip, lips were swollen; swollen tongue; swollen mouth; couldn't swallow; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (swollen tongue), MOUTH SWELLING (swollen mouth), DYSPHAGIA (couldn't swallow) and LIP SWELLING (whole lip, lips were swollen) 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 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced SWOLLEN TONGUE (swollen tongue), MOUTH SWELLING (swollen mouth) and DYSPHAGIA (couldn't swallow). On 24-Jan-2021, the patient experienced LIP SWELLING (whole lip, lips were swollen). At the time of the report, SWOLLEN TONGUE (swollen tongue), MOUTH SWELLING (swollen mouth) and DYSPHAGIA (couldn't swallow) was resolving and LIP SWELLING (whole lip, lips were swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided  It was reported that on 23-Jan-2021, the symptoms went down after a while.
Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  in prior hepatitis B vaccine nonresponders: a case series. Medicine.  24 September 2021.  In a case series by (2021), patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records.    Patient ID 2 received an initial hepatitis B series at 56-year-old and a second hepatitis B series at 57-year-old.   A total of 6 doses of the standard hepatitis B vaccine were administered. The patient was considered a non-responder.  At 71-year-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Received egg free flu vaccine on 10-9-17 at hospital pharmacy started itching 35 minutes after shot local reaction 2.2X1.6 cm raised redness patient reported increased heart rate and head after injection and still itching all over today.
Extreme arm pain. Next morning felt fluish at first. As day progressed, fatigue set in. Lymphnodes in throat started to swelll.  Sinuses started to plug. By end of day, extreme fatigue set in. Slept from 6:30 PM until next morning 6:30 AM. Extreme fatigue, coughing up phelgm, sinuses hurt, lymphnodes were tender. 04/28/2016 still  experiencing fatigue, sinuses and lymphnode swelling/discomfort. No arm pain (lasted only two days). Ibuprophen 600 mg, twice per day helped. Symptoms getting better.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 23-MAY-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L044707 exp date 06-OCT-2018) (dose and route not reported). The temperature and time of excursion was 53 degrees C for 120 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Received vaccine at 230pm, by 500pm - scratchy throat. At 700pm that day - swelling noted with trouble swelling. Patient states, she self treated with 2 Loratidine 10mg tabs, 2x4mg Medrol tabs, ALBUTEROL and ADVAIR inhalers. She did not go to clinic or hospital.
Patient fainted 10 minutes after receiving vaccination. Ran to check on patient and started tapping him and checking breathing. Patient started to convulse then he woke up and acted as if he was okay.
Joint Stiffness; pain at injection site (right); This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Joint Stiffness) and VACCINATION SITE PAIN (pain at injection site (right)) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included TOCILIZUMAB (ACTEMRA) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced JOINT STIFFNESS (Joint Stiffness) and VACCINATION SITE PAIN (pain at injection site (right)). At the time of the report, JOINT STIFFNESS (Joint Stiffness) and VACCINATION SITE PAIN (pain at injection site (right)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
pt recv vax & exp abd cramps, back pain, retroperitoneal (kidney) pain, & arms & shoulders felt heavy;these sx resolved 1hr later;
pt recv vax 28APR97 started high pitched crying & then started running 104 fever lasted approx 14hr a/mom took pt to MD;mom called 30APR97 @  12PM to report rxn to clinic;pt now doing fine;
rash on her arms, legs, and torso; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a female patient.   A female young patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Expiry Date, NDC number: not provided) via an unspecified route of administration on 06Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included Penicillin allergy (had a previous allergic reaction to penicillin) from an unknown date and unknown if ongoing and no other products were provided. The reporter stated that the patient developed a rash on her arms, legs and torso (on an unspecified date in Aug2021). The mother of the patient gave antihistamines to treat; it was not anaphylaxis, but the patient was treated with antihistamines. The reporter was seeking information if the patient should receive a second of the Pfizer BioNtech COVID 19 vaccine in a clinic versus pharmacy for safety reasons due to previous reaction to the first vaccine, he read on the withheld website that a major rash was a contraindication. The reporter told the patients mother that he would reach out and find out more information for her. The event outcome was unknown.  No follow-up attempts were needed. No further information was expected.  Follow-up (17Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Initial report was received from a health care professional on 15 October 2009 which involved a cluster of seven patients, male and female, who were 26 years of age and older. This case represents one patient who experienced an event of fainting. A patient (age and gender not reported) with no known allergies and no concurrent illness had received a 0.5  mL intramuscular deltoid injection of FLUZONE, lot number U3216AA on 16 September 2009 and 30 minutes later, the patient fainted. The patient was taken to the emergency room and received corrective treatment with fluids. An EKG performed was within normal limits. The patient was released; however their recovery status was reported as unknown. No additional information was provided at the time of the report. The remaining six patients have been captured in case numbers 2009-04358 (one patient), 2009-04359 (four patients) and 2009-04360 (one patient). Documents held by sender: None.
fainted; generally feeling fatigued; little dizzy; headache; cuts on her face and a bump on her head; This is a spontaneous report from a contactable consumer (reporting for herself). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included marijuana taken for an unspecified indication, start and stop date were not reported. On 01Apr2021, the patient fainted. The patient also been generally feeling fatigued and a little dizzy. The patient fainted after going to the restroom, stood up after finishing her business and blacked out and woke up on the floor with cuts on her face and a bump on her head. The patient is fine now just a little tired, dizzy and headache. The patient did not received treatment for the events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.   Information on the lot/batch number has been requested.
Threw up within a minute of vaccine. Fever began (102.8) approx. 3 hours after. Waves of sick feeling shivers, Stomach upset, severe headache, area of frequent post-herpatic neuralgia worsened in burning pain. Was ill for almost 3 days post vaccination. then--One week after vaccine, gallbladder pain/spasms and red eyes/conjunctivitis in both eyes, feeling of severe joint pain in many joints continues ever since, daily/all day.
Fever 103 Chills Body pain Heart palpitations  Diarrhea  Vomiting Vertigo Redness at injection site Rash Burning  Swelling All last 4 + days All of these last 4 days
patient vaccinated from vial with 1st punctured more than 12 hours prior; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (patient vaccinated from vial with 1st punctured more than 12 hours prior) 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 04-Jun-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 ADMINISTRATION ERROR (patient vaccinated from vial with 1st punctured more than 12 hours prior). At the time of the report, PRODUCT ADMINISTRATION ERROR (patient vaccinated from vial with 1st punctured more than 12 hours prior) 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.
No Stamina; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Dec2020 (Batch/Lot number: unknown) as dose 1, single and administration date 08Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "No Stamina".  Additional information: Caller states after she had the first vaccination, she noticed that she didn't have the stamina she had prior to that vaccination. Caller states she went ahead and got the second one and it has been a really long time and she still is not back to herself.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediately after vaccine, no significant ones other than I reported on v-safe permanent a fib - my heart rate/vitals changed dramatically; usually I'm stable 115/75 BP normal to 100-110 - Pulse rate; dropped to as low as 39 pulse rates. Average heart rate was 78 and BP 124/74. The lowest being as low as 39 for heart rate. I had a little shortness of breath and my O2 saturation dropped to 90 a nd that happened over a couple of day period. Normally I can't even force it down to 94. I had general fatigue. Persistent headache - slight pulse rate is coming back up. At the beginning of the episode periodic discomfort at my left pec and shoulder. Increased anxiety levels with this - didn't trust me to go out to get the mail. Spoke with a doctor - did not see a doctor - the facility is two hours away; did it via message service. They decreased the Metoprolol to 50 mg, and they are monitoring it now. And then we'll examine it again. I am free to message them at any time. I have confirmed that I am feeling better as I am compliant with the decrease, and I will be getting back to them on Tuesday of next week. So, it's an ongoing monitoring process. The average on the Pulse rate is 64 now. Anxiety has come down - but I do still have some recognized fatigue - I'm easily fatigued. We're still maintaining self-quarantining - over this last year and a half. Not being very social at this time.
Golf ball sized swelling in armpit. Muscle twitching in face. Arm painful and hurts to move it.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-OCT-2010, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date (reported as on or about 27-SEP-2010), the patient was treated for shingles. The patient was prescribed Valtrex for management of his painful symptoms and chronic pain. 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
17year old received the 1st dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received the 1st dose of the Moderna Covid-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received the 1st dose of the Moderna Covid-19 vaccine). On 06-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received the 1st dose of the Moderna Covid-19 vaccine) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
UTI  began August 29, contacted my PC doctor was prescribed antibiotics., finished round 08/29/22. Reported this development on my V safe report. Received call asked to report.  In looking back at vaccine schedule. Also had UTI after Moderna booster received 12/12/21. Had to do 2 rounds of Antibiotics to fully knock out infection.
Initial information received from a healthcare professional on 03 June 2013. A 25-year-old female patient, had received an intramuscular dose 1 of ADACEL (Lot number C4311AA) on 06 March 2013. The patient's last menstrual period date was on 03 March 2013 and estimated delivery date was reported as 08 December 2013. At the time of the report, the patient had not experienced any adverse events. The patient's health during pregnancy, specific risk factors (e.g. : alcohol, tobacco or recreational drugs) was none. Treatment for infertility was not reported. Concomitant medications were not reported. At the time of this report, the patient's outcome was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 09 October 2013. The patient receive ADACEL on 03 June 2013. The patient was concomitantly receiving CELEXA 40 mg daily. The patient has history of dog bite.
PATIENT COMPLAINED ABOUT THE ARM PAIN AFTER TAKING THE IMMUNIZATION. PHARMACIST ASKED THE PATIENT TO STAY SEATED AND WATCHED HER. AFTER A MINUTE PATIENT COMPLAINED ABOUT BEING LIGHTHEADED AND KEPT SAYING THAT IT'S GETTING WORSE. IN A MINUTE OR LESS PATIENT STARTED SHAKING AND PASSED OUT. HER EYES WAS OPEN AND SHE WAS SNORING. PHARMACIST ASKED THE PHARMACY TEAM TO CALL 911 AND PATIENT WAS CONSCIOUS IN 20-30 SECONDS. PARAMEDICS SHOWED UP IN 10 MINUTES AND MEANWHILE PATIENT WAS LAID DOWN. PATIENT VITALS WERE NORMAL BUT SHE COMPLAINED ABOUT NAUSEA  AND SHE ALSO HAD DIARRHEA. PATIENT WAS TAKEN TO ER FOR FURTHER EXAMINATION.
ERYTHEMA & INDURATION 10X10 MM OVER (L)ARM (PCV7) NO TREATMENT EXCEPT FOR WARM COMPRESSES.
Pt developed fever 103.8 degrees 12 hrs after receiving 2nd dose of flu vaccine. No other cause found for fever. Pt did not have vomiting, diarrhea or rash, or urinary tract infection. Fever spike to 105.
Tender; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tender). At the time of the report, TENDERNESS (Tender) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication was not provided by the reporter. Treatment medication was not provided.
Very red, bloodshot eye; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Very red, bloodshot eye) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Very red, bloodshot eye). At the time of the report, OCULAR HYPERAEMIA (Very red, bloodshot eye) had not resolved.            Additional information the patient noticed that her right eye was "Very red, bloodshot". This symptom is still ongoing.  Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided    This case was linked to MOD-2021-073107 (Patient Link).
8/14/06 at 7:30 am. Started a rash on Left arm and both feet then right arm and face. Rash is macropapular and diverse. Pt with difficulty breathing.
Patients administered with vaccines that have undergone temperature excursion; Patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reporter stated that the vial was stored in refrigerator at the time of excursion. Vial was thawed on 28-Jan-2022. It was patient's booster dose.  On 28-Jan-2022 Maximum or minimum temperatures reached range was positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit, on 30-Jan-2022 temperature range was positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit which occurred approximately for 48 hours, on 31-Jan-2022 temperature range was positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit for 12 hours and on 04-Feb-2022 temperature range was positive 35.2 degree Fahrenheit to positive 41.7 degree Fahrenheit for 12 hours.  Reporter also stated that no patient had reported any adverse events.  No treatment drug information was provided.
4/4/12 4:00 PM BP 90/68 99.4 Pulse 132 c/o HA, dizziness, nauseated, body aches, vomiting, chills, myalgias. Given ZOFRAN 8mg SL 4:20. Given TYLENOL 650mg PO 4:45. IV fluids NS 1 Liter. 5:00 PM feeling better no N/V, HA improved, IV Dc'd. 4/4/12 BP 98/68 99.8 Pulse 100 5:30PM
Information has been received from a registered nurse concerning an 8 year old male with no medical history who on 11/29/95, was vaccinated in the right arm SQ with the first dose of varicella virus vaccine live (lot # 609298/0438B). Concomitant vaccinations included the fifth dose of HIB conjugate vaccine in the left lower thigh and the first dose of MMR vaccine (Lot # 613559/0879B) in the left arm SQ. There was no other concomitant therapy. There was no illness at the time of vaccination. The RN reported that on 3/17/03, the patient had a chickenpox outbreak. No laboratory tests were performed. Subsequently, the patient recovered from chicken pox outbreak. It was also reported that four other patients in the same school also developed chicken pox after being vaccinated with varicella virus vaccine live. Additional information is not expected.
The next morning, 14 hours later, the patient was very dizzy, cold sweat and vomited. One week later the patient was dizzy again in the morning.