chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little tired after the 1st dose; This is a non-serious spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable 40-year-old male consumer (patient) reported. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 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 had the vaccine series over 6 months ago, completed the series in Feb2021. The patient was a little tired after the 1st dose but fine after 2nd dose, on an unspecified date. Outcome of the event was unknown. Information about batch/lot number has been requested.
Lower back ache; Coughing; Blood shot eyes; Small amount of swelling on upper arm; Running  nose; Joint aches; Muscle aches; Pain around injection site; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), BACK PAIN (Lower back ache), COUGH (Coughing), OCULAR HYPERAEMIA (Blood shot eyes) and PERIPHERAL SWELLING (Small amount of swelling on upper arm) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (tested positive for COVID) on 23-Dec-2020.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm) and VACCINATION SITE PAIN (Pain around injection site). On 27-Jan-2021, the patient experienced BACK PAIN (Lower back ache), COUGH (Coughing), OCULAR HYPERAEMIA (Blood shot eyes), PERIPHERAL SWELLING (Small amount of swelling on upper arm), RHINORRHOEA (Running  nose), ARTHRALGIA (Joint aches) and MYALGIA (Muscle aches). At the time of the report, PAIN IN EXTREMITY (Soreness in arm), BACK PAIN (Lower back ache), COUGH (Coughing), OCULAR HYPERAEMIA (Blood shot eyes), PERIPHERAL SWELLING (Small amount of swelling on upper arm), RHINORRHOEA (Running  nose), ARTHRALGIA (Joint aches), MYALGIA (Muscle aches) and VACCINATION SITE PAIN (Pain around injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medications were not provided.
Patient stated arm was red and was so swollen she couldn't put on her shirt was sleeves. Arm still swollen and red after 2 days
developed a slight cough; 99.6 degree Fahrenheit fever; sore arm for 2 days; This spontaneous case was reported by a patient and describes the occurrence of COUGH (developed a slight cough), PYREXIA (99.6 degree Fahrenheit fever) and PAIN IN EXTREMITY (sore arm for 2 days) in a 76-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     Patient had no allergies Patient never had COVID positive test or diagnosis Patient had no medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination.     On 08-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Sep-2022, the patient experienced PAIN IN EXTREMITY (sore arm for 2 days). On 13-Sep-2022,  after starting mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COUGH (developed a slight cough) and PYREXIA (99.6 degree Fahrenheit fever). On 09-Sep-2022, PAIN IN EXTREMITY (sore arm for 2 days) had resolved. At the time of the report, COUGH (developed a slight cough) and PYREXIA (99.6 degree Fahrenheit fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2022, Body temperature: 99.6 degree Fahrenheit. In September 2022, SARS-CoV-2 test: (Negative) Negative and (Negative) Negative.         No concomitant drug was reported. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. On an unknow date patient received first dose of Moderna vaccine. On an unknow date patient received second dose of Moderna vaccine. On an unknown date patient received first booster dose of Moderna vaccine. On 31-Mar-2022 patient received second booster dose of Moderna vaccine (batch number: 046L21A).  It was reported that patient had no side effects for the other Moderna vaccines. The adverse event did not cause patient to seek medical care. It was reported that new symptoms appeared and adverse event outcome was reported as ongoing. No treatment drug was reported.
This spontaneous report was received from a registered nurse and refers to a 42-year-old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported. On 16-AUG-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N019838 with expiration date: 16-FEB-2019), intravenously (dose and frequency were not reported) for prophylaxis. No adverse effects were reported.
Generalized vaccinia with diffuse rash, myalgias, fever, and robust take.  Treatment with indocin and benadryl..
About 12 days after being vaccinated woke up with fever and chills and had trouble walking and went to ER 03-13-21. All tests came back normal.
Patient reported nausea, vomiting, diarrhea, headaches, fever, chills, pain in arm, and insomnia. This has been going on for the last 4-5 days.
Information has been received from a physician concerning a 6 year old female student who on 3/29/99, at 15 months of age, was vaccinated in the right deltoid with the first dose of varicella virus vaccine live (lot # 628246/1655H). The physician reported that on 4/3/04, the patient broke out in a rash on her right arm. A diagnosis of herpes zoster was made. Unspecified medical attention was sought and the patient was treated with Acyclovir for five days. Subsequently, the patient recovered from the herpes zoster. Additional information is not expected.
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 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a health department, 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 nurse practitioner for a vesicular outbreak, which was diagnosed as 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.
Large indented, erythematous, homogenous & tender area at (R) deltoid 4 x 4.5 circumference & warm to touch. Treat with OTC BENADRYL & cortisone cream; RTC of worsens.
patient received two immunizations (fluzone hd and pneumovax 23) on 9.24.20. patient presented to the pharmacy on 9.26.20 explaining adverse effects from the immunizations. The night of 9.24.20 she began experiencing these effects of feeling nauseous and vomiting.  She stated that this occurs every year with the flu shot and she is able to manage it without significant issues. However, this year starting 9.25.20 morning she had a slight fever and the injection site began to turn red, warm to the touch, and was painful. She treated it with calamine lotion with no relief. On 9.26.20, she came to the pharmacy and asked what type of treatments the pharmacist would recommend. She presented her arm and it did appeared moderately irritated with red slightly raise patches starting at shoulder and ending mid arm. She stated her fever, nausea, and vomiting was gone, but her injection site was still painful and warm to the touch. Pharmacist instructed patient to take diphenhydramine, ibuprofen, and a cold compress. Also, instructed patient to seek medical care if the reaction worsened over the next 24 hours despite treatment. Patient agreed that she would follow this advice.
pt recvd vax 1 dose of vax 29SEP93 pt inadvertently was given vax IV immed following error, pt was placed on hemodialysis as prev scheduled-did not appear to be manifesting any sx resulting from inadvertent adminstration of flu vax;
I had a bad headache all night and a very mild fever. The fever left by noon the next day, but I had a terribly upset stomach all day. By evening I was back to normal.
Bottom of the eyelid itching; progressed to swelling; feels like sand paper in my eye; real puffy; it looks like if someone getting scar; they are getting worse; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in Arm Right on 15Apr2021 (at the age of 58 years) as single dose for COVID-19 immunization. Medical history included High blood pressure, Thyroid problems, Acid reflux, Anxiety. Concomitant medications included Amlodipine besilate, Metoprolol, Clonazepam taken for Anxiety attack, Omeprazole (Prilosec [OMEPRAZOLE]) taken for Acid reflux. On 16Apr2021 the patient experienced bottom of the eyelid itching, progressed to swelling, feels like sandpaper in my eye, real puffy, it looks like if someone getting scar, they are getting worse. It was reported that Consumer stated, I took the Pfizer first shot on 15Apr2021 and started on Friday having my bottom of the eyelid itching and was progressed to swelling and it feels like sand paper in my eye. I have been putting some eye drop in my eye to kind of cure it but I noticed an hour ago, it started to run just a little bit. So, it started off in my right eye and I was noticing now this morning in my left eye the bottom lid was started the same thing. If you look at the bottom lid it looks like if someone getting scar or something like that and real puffy and then underneath my eyebrow was real puffy and the corner was puffy. When clarified the name of shot as Covid 19 vaccine, consumer stated, yes, was Moderna too Pfizer shot, or its two different shot (further clarification unknown) second COVID-19 Shot: 2May2021. Treatment: Consumer Stated, Biotrue Eye Drops Bausch & Lomb company name. Still experiencing: Consumer stated, yes, they are getting worse (not clarified for all the events).The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Facility administered 2 patients expired doses of the Moderna Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Facility administered 2 patients expired doses of the Moderna Vaccine) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Facility administered 2 patients expired doses of the Moderna Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Facility administered 2 patients expired doses of the Moderna Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Information has been received from a male patient of unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. In approximately August 2018 (reported as about a month ago), the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, batch/lot number and expiration date were not provided) intramuscularly or subcutaneously for prevention of pneumococcal disease. In approximately August 2018 (a day or two after the vaccination with PNEUMOVAX 23), the patient began experiencing dizziness, unusual hunger, swelling under eyes, fatigue, shaking, sinus inflammation and sinus infection. Information about treatment given for the event, lab diagnostics/studies and medical attention was reported as none. Action taken with PNEUMOVAX 23 was not applicable. The outcome of the events not recovered. The causality between the events and PNEUMOVAX 23 was not provided by the reporter.
Mensuration started within 48 hours of her first two vaccine doses even though her cycle was due 10-15 days later; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A 49-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single and intramuscular (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: MENSTRUATION IRREGULAR (non-serious), outcome "recovered", described as "Mensuration started within 48 hours of her first two vaccine doses even though her cycle was due 10-15 days later". Therapeutic measures were not taken as a result of menstruation irregular.  Additional Information: Mensuration started within 48 hours of her first two vaccine doses even though her cycle was due 10-15 days later. That was unusual for her. It was unknown if the patient had other vaccine in four weeks and other medications in two weeks. No treatment was received for adverse events. The patient did not have COVID-19 prior to vaccination and was tested for COVID-19 post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
inadvertently administered an expired dose of the Adacel with no reported adverse event; Initial information received on 29-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who had inadvertently administered an expired dose of the DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL); and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 27-Jun-2022, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6702AA and expiry date:  20-Jun-2022) via intramuscular in right deltoid for Immunization.  On 27-Jun-2022 the patient developed a non-serious inadvertently administered an expired dose of the adacel with no reported adverse event (expired product administered, Latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a physician and described the occurrence of arm swollen in a 27-year-old female subject who was vaccinated with Engerix B for prophylaxis. On 28 March 2007 the subject received 1st dose of Engerix B at 20 mcg in the left arm. On 28 March 2007, 30 minutes after vaccination with Engerix B, the subject's entire left arm started to swell. The swelling extended into the subject's hand. The arm swelling improved, but the hand swelling continued. The physician expected that the subject might have reflex sympathetic dystrophy. Additionally, the subject experienced pain in the left arm and hand. She was having a hard time using her extremity and she was only able to move it slightly. The subject was unable to dress herself. The physician considered the events were disabling and clinically significant (or requiring intervention). The subject received pain medications, anti-inflammatory agents and antibiotics as treatment for the events.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced injection site pain, fever, chills, joint pain and general body pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, fever, chills, joint pain and general body pain were recovered/resolved. It was unknown if the reporter considered the injection site pain, fever, chills, joint pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist was the caller and the reported for herself. With 1st dose of SHINGRIX vaccine she experienced soreness and pain at the injection site. Along with fever, chills, joint pain and body ache. The pain at injection site started next day while the other symptoms started within 4 to 6 hours. She took ibuprofen the next day which took care of the fever, chills, joint pain and body ache. The soreness and pain at injection site lasted for about 4 to 5 days. The reporter gave consent to follow up. No further details were provided. Transferred call to medical information vaccines for further information. For tolerance after 2nd dose of SHINGRIX, refer case US2018223314.
Fever up to 104 F requiring ER visit within 12 hours after immunization. High fever persisted for 4 days requiring lab work, urine cultures and blood cultures. Also accompanied with irritability and not eating.
I received my first Pfizer COVID vaccination on 3-1-2021.  Seven days later I had a Shingles outbreak, which I've never had before.  My doctor advised that I should continue to get the second vaccination as it's a two step process, which I did on 3-25-2021.  I'm now experiencing numbness and loss of sensation that started in my foot and hand which has now progressed up my leg to my hip and from my hand up my arm.  My doctor ordered a MRI scan which showed lesions on my spinal cord.  Based on the results of the first MRI scan my doctor has ordered a second scan (showing more of the spinal cord) and a brain scan.  She has also scheduled me an appointment to speak with a Neurologist to try to determine the cause of this.  I can't help but feel that this vaccine was the cause of this as it all started shortly after I was given my first dose.
After receiving the Jannsen shot around 8:50 am at the morning on Tuesday August 3rd 2021, later within an hour I had a mild pain at my forehead. In addition, I had fatigue, muscle pain, and low blood pressure, and weakness for five days, which slightly got better after the first two days following vaccination day. However, my forehead pain first disappeared from left forehead completely to right forehead. And Today, by the time of writing this report in August 7 early morning I feel less pain and more numbness in my right forehead. However, after morning, now around 11 am, the numbness distributed to my whole right side of my head, and now dizziness also appeared. I searched for Jannsen Vaccine side effects, since I did not see similar symptoms, I felt to report this. I do not know what will happen or how the symptoms will change,  and look forward to hearing from you.   Thanks
Patient complained of redness and swelling to arm at the site of the vaccination.  Said she had a rash.
Information was received from an unspecified health professional regarding a patient (demographics unknown), who on an unknown date, was vaccinated with VARIVAX (Merck), lot # J003539, expiration date 25-MAR-2013, which had been improperly stored. Follow up information has been received from the nurse who called and stated all patients (who received VARIVAX (Merck) that was exposed to unknown temperatures for 4 hours) had been revaccinated. No symptoms reported. This is one of several reports received from the same source (linked MARRS#:1311USA000056, 1310USA014891, 1310USA014881, 1310USA014883, 1310USA014888, 1310USA015417, 1311USA000071, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000021, 1311USA000020, 1311USA000022, 1310USA015101, 1310USA014853,  1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739, 1311USA000040, 1310USA015096, 1311USA000642, 1310USA014958, 1311USA000072, 1311USA000053, 1311USA000085, 1311USA000741, 1311USA000744, 1310USA015134, 1311USA000083, 1310USA015141, 1311USA000006, 1311USA000005, 1310USA014900, 1310USA015268,  1310USA015264, 1310USA014896, 1310USA014909, 1311USA000627, 1310USA015396, 1310USA015270, 1311USA000637, 1310USA014962, 1311USA000039, 1311USA000037, 1311USA000034, 1311USA000032, 1311USA000002, 1310USA014897, 1309USA011086. Additional information is not expected.
Information has been received from a nurse referring to a patient of unknown age and gender.      On 29-JUN-2017, the patient was vaccinated with improperly stored ZOSTAVAX (lot # M037015, expiration date 22-NOV-2017; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown).    No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009387:
Malaise, brain fog, fatigue, fever (100.8), cough, runny nose, sore throat over the last 24 hr.