chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Passed out; Felt lightheaded; Upset stomach; A spontaneous report  was received from a consumer concerning a 66 year old female patients who received   Moderna's  Covid 19 vaccine(mRNA1273) experienced loss of consciousness, dizziness and abdominal discomfort.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    The patient received first of two planned dose of mRNA-1273  for prophylaxis of Covid 19 infection on 14-FEB-2021 intramuscularly in left arm.   Patients felt lightheaded and fell unconscious at evening of vaccine administration. EMS was called ,but patient regained consciousness by the time EMS arrived. Patient also experienced abdominal discomfort on the day she got vaccinated. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event were considered as recovered/resolved.
Information has been received from a physician concerning a 66 year old female who on 03-OCT-2007 was vaccinated with PNEUMOVAX (lot# 0658075/0962U) in her upper arm (unknown which arm).  There was no concomitant medication.  On 25-OCT-2007 the patient was seen in the office with redness and swelling at the injection site.  Medical attention was sought.  There was no treatment.  At the time of reporting the patient was recovering.  Additional information has been requested.
Hard red swelling at site of vaccination on right arm followed by high fever of 105 degrees lasting 5 days and needing Tylenol/Ibuprofen q 3-4 hours to get fever down to 100 or 101 degrees x 5 days with symptoms of, lethargy, headaches, myalgia, lymphadenopathy, lack of appetite, delirium and difficulty moving off the bed or couch. Patient had never had a fever over 103 degrees prior to reaction.
light headed; heat inside her left arm then her chest; heart palpitations rapid; high blood pressure around 180/123mmhg; Neck stiffness; throat becoming stiff; Very difficult breathing; tightness in her chest; This is a spontaneous report from a contactable other health professional (patient). A 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration, administered in left arm on 18Apr2021 11:45 am (at 49-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included hypertension, Covid-19 from 09Jan2021. Tested positive for COVID on 09Jan2021 and have antibodies after infection. Patient took vaccine under 100 days after COVID infection. No known allergies. Concomitant medications included metoprolol; paracetamol (TYLENOL extra strength), and multi vitamin. No other vaccine in four weeks. On 18Apr2021 11:52 (reported as 7 minutes after BNT162B2 1st dose), the patient experienced light headed, heat inside her left arm then her chest, tightness in her chest, felt heart palpitations rapid, high blood pressure around 180/123 mmhg. Neck stiffness and throat becoming stiff. Very difficult breathing after all symptoms were present. The events resulted in emergency room/department or urgent care, hospitalization. The days of hospitalization was 1 day. Therapeutic measures were taken as a result of the events, which included aspirin/ 2 bags of 1000 ml Sodium chloride. The outcome of the events was recovering. No COVID tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
Fever, body aches, chills, nausea, vomiting, headache, cough for 2 days following vaccine starting 6 hours after injection.  Chest pain, shortness of breath and coughing (still ongoing at time of filling out this form)
Less than one month subsequent to receiving one dose of varicella virus vaccine live the pt developed about five chickenpox lesions. The pt was afebrile. One lesion was fluid filled but had already crusted over.
Severe vertigo; lasted approximately 5-6 hours.  Slept and the next am it was resolved.   Vertigo when head elevated; when lying down with eyes closed it was less impactful.
Body muscle aches, Headache, extreme fatigue, trouble sleeping even though I am exhausted. swollen armpit in left side
pt states that she woke up 5 days later today on 3/2/201 with extreme fatigue, headache, nausea.  Pt still has these symptoms but has not contacted her PCP at this time.
unable to work; feeling extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (unable to work) and FATIGUE (feeling extremely tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No medical history provided.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced IMPAIRED WORK ABILITY (unable to work). 17-Mar-2021, the patient experienced FATIGUE (feeling extremely tired). At the time of the report, IMPAIRED WORK ABILITY (unable to work) and FATIGUE (feeling extremely tired) outcome was unknown.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-DEC-2015 at 12:42, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.2 and 4.7 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Swelling on injection site- pain, hot, red rash approximately 3 x 3 inches- 3 days after injection
after the second covid vaccine shots can one have side effect symptoms after 7 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (after the second covid vaccine shots can one have side effect symptoms after 7 days) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (after the second covid vaccine shots can one have side effect symptoms after 7 days). At the time of the report, VACCINATION COMPLICATION (after the second covid vaccine shots can one have side effect symptoms after 7 days) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IMMUNOGLOBULIN HUMAN NORMAL (HIZENTRA) for Common variable immunodeficiency.    No medical history was reported.    In 2014, the patient started IMMUNOGLOBULIN HUMAN NORMAL (HIZENTRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, PAIN IN EXTREMITY (arm hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Treatment information was  provided.    Reporter did not allow further contact
Woke up on Monday 11/14 around 7 am with severe chest pain. Pain lasted for 1 hour before arrival to ED. Pain worse with inspiration and lying down. Pain relieved by sitting upright and NSAIDs. Saw cardiologist on Tuesday (11/15) and was diagnosed with pericarditis. Started on colchicine 0.6 mg po BID and ibuprofen 600 mg po q8h
I got hives after my second dose. I have an autoimmune issue. It might be related to the vaccine being too strong for my body. My issue was just related to a skin condition. I was given by the Dr. Desloratadine 5mg twice a day. Another medicine doctor gave me acupuncture and different medicine.
Retinal Detachments (2-4 areas) right eye, treated by emergency laser procedure, outcome - good. Symptoms - visual impairment from retinal detachment, affecting job performance until treatment recovery for months.
Body was hot; Body was hot and red; Left arm started killing me; Experienced the same symptoms as if he had Covid-19; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Body was hot), ERYTHEMA (Body was hot and red), LIMB DISCOMFORT (Left arm started killing me), VACCINATION COMPLICATION (Experienced the same symptoms as if he had Covid-19) and MYALGIA (Body aches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Exposure to COVID-19 in November 2020. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Clot blood.    On 21-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced FEELING HOT (Body was hot), ERYTHEMA (Body was hot and red), LIMB DISCOMFORT (Left arm started killing me), VACCINATION COMPLICATION (Experienced the same symptoms as if he had Covid-19) and MYALGIA (Body aches). On 23-Apr-2021, FEELING HOT (Body was hot), ERYTHEMA (Body was hot and red), LIMB DISCOMFORT (Left arm started killing me), VACCINATION COMPLICATION (Experienced the same symptoms as if he had Covid-19) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Patient had COVID antibodies in his blood before Moderna-Covidin-19 injection was administered on 21 Apr 2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had taken prednisone, antibiotics, acetaminophen and  acetylsalicylic acid since Nov 2020 due to Corona virus infection, but had been discontinued. No treatment information was provided.
red  patch at injection site with defend border (big oval) about 4" x2" ; Painful and tender; slight fever. this lasted for 7- 10 days
his only thing he had as a side effect from the first dose was tiredness and arm soreness.; his only thing he had as a side effect from the first dose was tiredness and arm soreness.; This is a spontaneous report from a contactable consumer (patient's wife).  A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, in right arm on 10Mar2021 at 10:00 (at the age of 74-years-old)  (Batch/Lot Number: EN6199) as 1st dose, single dose for COVID-19 immunization. Medical history included car accident in 1972 and had some injuries from that, and then 2012 slight stroke, and seizure disorder since his car accident in 1972.The patient had no concomitant medications. The patient's wife reported that the only thing he had as a side effect from the first dose was tiredness and arm soreness. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Leakage during administration, half of the vaccine leaked out; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Leakage during administration, half of the vaccine leaked out) and DEVICE CONNECTION ISSUE (Leakage during administration, half of the vaccine leaked out) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced UNDERDOSE (Leakage during administration, half of the vaccine leaked out) and DEVICE CONNECTION ISSUE (Leakage during administration, half of the vaccine leaked out). On 22-Feb-2021, UNDERDOSE (Leakage during administration, half of the vaccine leaked out) and DEVICE CONNECTION ISSUE (Leakage during administration, half of the vaccine leaked out) had resolved.        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.   Reportedly,patient did not experience any adverse reactions to vaccine given. Moderna dose that was given on 22-Feb-2021 leaked out during administration. Nurse that gave the vaccine stated that about half the dose of vaccine leaked out.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Information added to the narrative.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273, lot # 024M20A, with no associated AEs.
After receiving the vaccine, I had a slowly developing paralysis on the left half of my face occurring over a 2 to 3 day period. I was unable to close my left eye, and I couldn't talk because my mouth was paralyzed on the left side. My doctor said it was a grade 4 paralysis. It was diagnosed as Bell's palsy. I was prescribed prednisone and an anti-viral medication on the 4th day. The study of improvement occurred over the next 10 days. After 10 days the paralysis had ended with the help of the medications. I don't notice anymore paralysis on my face, and I am functioning back to normal now.
Shortness of breath; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, expiration date, NDC number and UPC number: unknown) via an unspecified route of administration on 03May2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced shortness of breath. The patient asked if that was one of the symptoms. Consumer was informed and provided the number of Pfizer medical information department. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Patient is a 75 y/o M who received herpes zoster vaccine during prime-new patient consult on 4/2/18 reported rash (vesiculopapular lesions like zoster on all limbs per PCP) on 4/16/18. This was attributed to the use of herpes zoster vaccine (ZOSTAVAX Lot # visit and Expiration Date: N026815/2018Dec25) 0.65 mL which was administered subcutaneously once on 4/2/18, ADR was entered 4/16/18.
pt recvd vax & was crying, fussy & LL red & swollen; temp ran 102 for 24-36 hrs then 100 for 24 hrs; pt not taken to ER;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive on rapid test after testing negative; Negative, notes: tested positive on rapid test after testing negative. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.
Patient had a reaction to first dose and came back for second dose. Hospital said she was fine to get it and it was not a seizure but she should eat before the dose this time. Pharmacist discussed incidence with her and she agreed to wait in lobby for 30 minutes. patient received vaccine and was walked to lobby to sit. She got up a few minutes later to report feeling dizzy. She walked over to consultation window and fainted before pharmacist could reach her. She came to immediately, 911 was called and they said she had a vasovagal reaction. She declined going to hospital as she felt fine and sat for 30 more minutes before leaving.
rash lasted 2 days; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash lasted 2 days) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) 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) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash lasted 2 days). At the time of the report, RASH (rash lasted 2 days) had resolved.            Concomitant product use was not provided by the reporter.   Treatment: Patients wife put some alcohol and salve on the rash.   This case was linked to MOD-2021-037506 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Patient details updated and first dose information updated.
Initial and follow-up information has been received from a physician and the consumer, a 67 year old female with doxycycline allergy who on an unspecified date was vaccinated with her first dose of PNEUMOVAX 23 (Lot # not reported). On 19-AUG-2009, the patient was vaccinated with her second doses of PNEUMOVAX 23 Lot# 661529/0868X. The patient received the second dose of PNEUMOVAX 23 "below the left shoulder joint" and the patient immediately stated that the "vaccine was given too high". On 20-AUG-2009, the patient complained of "instant pain and the symptoms worsened". Three hours later the patient had decreased limb ability/movement, pain in the left arm, sweating, nausea, fever chills and crying with insomnia all night. The patient's family called to primary care physician at 9:00 PM and the patient was told to take CELEBREX and to use ice packs on the shoulder joint". The patient went for a visit and was given and X-ray in the office of the shoulder (results were not provided) and a pain shot. The patient was also given prednisone 10 mg during six days. At the time of reporting, the patient's instant pain, decreased limb ability/movement, pain the left arm, sweating, nausea, fever chills and crying with insomnia all night persisted. No further information is available.
Pain and rash approximately 3-4 inch diameter surrounding the injection site in the left arm, redness, warmth, and sensitivity to touch first noticed approximately 30 hrs post injection.  Took 2 x 325mg Tylenol overnight for pain.  Currently 48 hrs post injection. The warmth and sensitivity to touch has decreased, but the extent of the rash remains.  No further medication taken.  Pharmacist and Physician notified
Two and one-half months after getting vaccinated, I developed shingles. [Have no idea if related to vaccine, but reporting just in case.]
Initial medication error report received from a healthcare professional on 04-Oct-2013. The patient had received yellow fever - inadvertently administered IM (intramuscular). (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Feels tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Feels tired".  Additional information: Caller stated he was calling regarding the Pfizer Covid 19 vaccine. While reporting his own symptoms, caller mentioned that his wife took the first shot and the only thing she experienced was that she feels tired. That was it. The reporter was husband. NDC number of Covid 19 vaccine was not provided. Reason for no lot number: of Covid 19 vaccine was not probed over call. Investigation Assessment was not Provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After my 3rd vaccine I started experiencing severe rectal pain. I was diagnosed with rectal spasms and prescribed nitroglycerin cream. I feel that I have recovered at this time.
Pt received J&J yesterday. Pt c/o having fever/ha/unable to sleep. Pt is walking w/o issue. Pt VSS and NAD.
Patient called pharmacy to report 2 inches below injection site a red, hot and very sore area of arm. Had noticed a hive on chin that had gone away.