chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. A 60 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: husband being slightly immunocompromised. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "tiredness", "flu like symptoms", "Nausea". The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu/like catching a cold or the beginning of a flu/felt the same symptoms"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "with the second dose being even stronger". Additional information: Reporter stated that she and her husband are around 60 years old and received their third booster dose of the Pfizer BioNTech Covid-19 vaccine on 22Oct2021, 6 months after her primary series. Reporter reports history of her and her husband being slightly immunocompromised. Reporter reports no side effects (no body aches, fever, tiredness, nothing) after the booster dose as compared to the first two doses where she and her husband both experienced side effects with the second dose being even stronger. She did report mild tenderness at the injection site. Reporter concerned that the vaccine may not be working or she could have gotten the wrong dose since she did not experience any side effects. Reporter also mentioned that she read people with arthritis and inflammatory diseases are feeling side effects. Second dose: Unspecified Dates for Unspecified effects, after first vaccine: (From: Unspecified To: Unspecified) Reporter seriousness for Unspecified effects, after first vaccine: Unspecified Dates for Mild, warm tingling sensation at the injection site after booster: (From: Unspecified To: Unspecified) Reporter seriousness for Mild, warm tingling sensation at the injection. Reporter specified that after the second dose, they both had flu that lasted for 3 days. With the first two doses her and her husband felt mild side effects. Reporter stated that after the second dose of vaccine, she felt nausea, tiredness similar to feeling under the weather like she was catching a cold or the beginning of a flu. Reporter stated the second vaccine had stronger effects than the first one. Reporter stated she felt the side effects of the second vaccine every other day for 3 to 4 days. Reporter stated her husband felt the same symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Information has been received from a doctor of pharmacy concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed pneumonia approx 48 hrs after receiving the vaccination. Unspecified medical attention was sought. At the time of this report, no additional information was provided. Additional information has been requested.
Breakthrough case admission after 2 vaccines Pfizer 1/1/21 Lot# El3249;  Pfizer 2/8/21 Lot# EL9265
she has a little bit of a fever, '101 point something'; little bit of a cold; This is a spontaneous report from a contactable consumer or other non-Health Care Professional (herself). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date (next day after vaccination), the patient experienced she has a little bit of a fever, 101 point something and a little bit of a cold. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
ACUTE NON ST ELEVATION MI 3/7/2023 ASTHMA, UNSPECIFIED ACUTE PULMONARY EMBOLISM 3/7/2023 ASTHMA, UNSPECIFIED ACUTE RESPIRATORY FAILURE 3/7/2023 ASTHMA, UNSPECIFIED HYPOXIA 3/5/2023 ASTHMA, UNSPECIFIED ACUTE NON ST ELEVATION MI 3/7/2023 HTN (HYPERTENSION) ACUTE PULMONARY EMBOLISM 3/7/2023 HTN (HYPERTENSION) ACUTE RESPIRATORY FAILURE 3/7/2023 HTN (HYPERTENSION) HYPOXIA 3/5/2023 HTN (HYPERTENSION)
Site: Pain at Injection Site-Mild, Additional Details: PATIENT CAN'T LIFT UP RIGHT ARM 3 DAYS AFTER HE RECEIVED THE VACCINE.  COMPLAINS OF "HEAVY ARM"
Pain, heat and hard lump at injection site - ongoing.  Chills, headache, nausea have lasted most of the day.
After retracting the needle, small amount of blood squirted out along with immediate knot formation (bump) about 1 inch diameter & 1 & 1/2 inch height/ raised. Patient's mother called to ask questions & said she advised patient to go to ER due to the swelling. This was his 2nd dose. I am unaware if patient actually went to doctor or received any medical care.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. On 19-AUG-2014 the patient was vaccinated with PNEUMOVAX23 (dose strength was unknown) lot # J006921. No concomitant medication was reported. The pharmacist was reporting that the patient was inadvertently administered PNEUMOVAX23 lot J006921 on 19-AUG-2014 that had expired on 09-AUG-2014. No adverse event was reported. The outcome of inadvertently administered a lot which had expired was unknown. No PQC was involved. Additional information is not expected.
Came to ER with confusion. Was given monoclonal antibodies with improved and sent home.
Site: Bruising at Injection Site-Mild, Additional Details: hyperglycemia after covid shot. Fasting blood sugar above normal every day for 5 days consistently (above 200), patient reported to dr.
Left arm and shoulder felt heavy and painful.  Had difficulty moving same.  Had numbmees to left hand and electrical currents running down arm to fingers.  Also experienced abdomen/chest pain and went to emergency department and was admitted.  Cardiac problems ruled out but arm and shoulder continued and continues to hurt.  Seeing ortho and neurologist.  Have had MRI, xrays and medication.
10/5/10 midnight - increased pain over (R) deltoid pain (injection site) - limited ROM. 10/6/10 9AM - fatigue, malaise. 10/6/10 12 noon - vertigo, near syncope. 10/6/10 1-3pm felt ? and cold, "aching, tenderness with palpating over area.
Myocarditis; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown".  Clinical course: Something happened soon as after got the COVID-Vaccine (COVID-19 Vaccine) and it was the mRNA Vaccine (Unspecified Vaccine). But it was not confirmed if it was Pfizer or Moderna. Reporter saw a patient that had myocarditis.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and myocarditis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
It was reported that a 16 month old male received vaccines on 10/20/99. Reportedly, that same day, the pt experienced a large local reaction of redness, erythema and swelling. From additional information received on 11/8/99, it was reported that the pt experienced this adverse reaction on 10/22/99, rather than 10/20/99, as previously reported. The pt also experienced limited range of motion and was afebrile. The pt reportedly recovered from this experience. Additional information received on 11/30/99, stated the vaccination occurred at a private doctor's office with private funds. The pt also had 2 previous IPV doses. From mailed follow-up correspondence received on 07/05/01, it was reported that the patient did not receive OPV vaccineation on 10/20/99 as previously reported.the last OPV vaccinations given was on 06/21/99. This case is closed.
? Fatigue     fatigue, ache, intermittent fever, congestion since covid vaccine 2/6; chronic loss of smell and taste,  exposure to covid from daughter
flu like systems: chills, mild fever, body ache, head ache, sore arm, off balance, upset stomach
The patient experienced no symptoms; An improperly stored dose of GARDASIL was administered; This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.      On 13-MAY-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # reported and validated as R028656, expiration date reported and validated as 37-JUL-2021, administered intramuscularly as prophylaxis (dose, dosage schedule and site of administration were not reported). The vaccine was at a temperature of 27 F for 3 hours, there were no previous excursions and the data was analyzed by a digital data logger (product storage error). No adverse symptoms were reported.  This is one of two cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R028656; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA000707:
I went in to see my doctor for my knee, she noticed that my blood pressure was elevated. We thought this may be due to the pain of my hurting my knee, so we decided to watch my blood pressure, this was on October 20, 2022. On October 27 I went to my local fire department asked if they could check my blood pressure. My left arm was 215/100, my right was 185/85, they instructed me to contact my doctor immediately, which I did. I had a telehealth appointment on November 4, 2022, we discussed the blood pressure that the fire department had taken. She prescribed lisinopril for the blood pressure, currently it has been helping to keep my blood pressure normal, 101/60.
Very painful left arm pain. location where shot was given there is a lump under the skin. The pain is still going on when raising my are or supporting weight on it. . My Fiancée also had the shot in her arm before I did and her arm as well is having site pain. She had the same shot that I did at pharmacy.
No additional AE; VAQTA was administered to a patient 8 hours after expiration; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No medical history, concurrent conditions nor concomitant medications were reported.  On 03-MAR-2023, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) (1 mL, lot # W004865, which was verified as valid upon internal review, expiration date 02-MAR-2023, route of administration and anatomical location were not provided) for prophylaxis. A dose of Hepatitis A Vaccine, Inactivated (VAQTA) was administered to a patient one day after expiration (Expired vaccine used). Dose did not undergo any temperature excursions. No additional adverse event (AE). No product quality complaint (PQC).  Follow-up information was received from medical assistant on 21-MAR-2023.  Reporter refers to a 31-year-old female, therefore this is no longer non-valid case.   On 03-MAR-2023, Hepatitis A Vaccine, Inactivated (VAQTA) was administered intramuscularly to a patient 8 hours after expiration. The patient was fine.
Painful spot on arm that received the shot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-May-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient experienced painful spot on arm that received the Shingrix shot. The patient asked was it normal. Additional supportive information: The follow-up would not possible as no contact details were available.
Pt broke out with vesicles on left thigh (VARIVAX) given with redness 3 weeks after immunizations given.
Approximately 90 minutes after vaccine given, Reported headache, feeling hot, diaphoretic, denied difficulty breathing, skin appeared sl red, denied itching, Patient reports took 50 mg benadryl, 10 minutes later "jaw felt tight, tongue swelling, and throat started to swell". Went to ER.
patient experienced tingling and swelling on the injection arm after she got home. Pain in arm and swelling from the injection site to the index finger. she came for her 2nd dose on 09/07/2021, was given benadryl before receiving 2nd dose.
Information has been received from a licensed practical nurse concerning a 12 month old white male with no known allergies or pertinent medical history, who on 03-JUL-2007 at 10:27 was vaccinated SC in the right thigh with a first dose of PROQUAD (Lot#656647/0101U) (also reported as measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (MSD) and varicella virus vaccine live (Oka/Merck). Additional suspect vaccinations administered on 03-JUL-2007 at 10:26 included a third IM dose of PEDVAX HIB (Lot#654679/1126F) given in the left thigh. Additional concomitant therapy included a fourth IM dose of PREVNAR (Lot#608679h) given in the right thigh. There was no illness at the time of vaccination. On 09-JUL-2007 at 13:45 the patient developed a rash on his torso (also reported as entire body). Unspecified medical attention was sought. No lab studies were performed. No treatment was given. There was no adverse event following prior vaccinations. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Less than five minutes after receiving vaccine reported burning in stomach, followed by dizziness. Patient was then observed to be flushed. Patient then reported " I can't breath". EpiPen was administered into right thigh, oxygen initiated. Patient was mildly hypoxic, O2 saturation noted to be 88% after EpiPen and oxygen saturation increased to 99%. Patient was transported to ED via hospital rapid response team. Upon arrival to ED symptoms had improved. Patient was monitored in ED and discharged to home with short burst of prednisone and EpiPen. Per ED note unclear if event was true allergic reaction or vasovagal response
don't tell what it can do to you / like Rheumatoid Arthritis / Thanks for the life long disease; This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant). On an unknown date, the outcome of the rheumatoid arthritis was not recovered/not resolved.   It was unknown if the reporter considered the rheumatoid arthritis to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The reporter mentioned that, you better read the insert, then go to the manufacturers data information, they did not tell what it could do to you and all the side effects, like rheumatoid arthritis and much more. The reporter mentioned that, thanks for the life long disease. Follow-up would not be possible, as no contact details were available.
Severe chills, body aches, and nausea, beginning  the night of receiving the vaccine. The day after receiving the vaccine the symptoms were most severe, including vomiting numerous times. The following day the symptoms were less severe - there was no more vomiting, but still body aches and chills and nausea. By the day after that smptoms had almost entirely resolved.
diarrhea every day; very fatigue; 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 DIARRHEA (diarrhea every day) and FATIGUE (very fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHEA (diarrhea every day) and FATIGUE (very fatigue). At the time of the report, DIARRHEA (diarrhea every day) and FATIGUE (very fatigue) outcome was unknown.            No concomitant and treatment information was provided.   This case was linked to MOD-2021-163575 (Patient Link).
Patient was diagnosed with Covid 19 on 1/3/21, after experiencing congestion, drainage, cough, and chills for 3 days.  Patient's symptoms are improved now, and now just has mild cough, abdominal pain, dizziness, light-headedness, Patient received both doses of Covid vaccine and booster.
Fever 100 degrees, shakes, dizziness, nausea, headache, remains with these symptoms-no treatment, returned to clinic on 08/07/03 with symptoms-told mother to call family MD and see him.
Sore arm; A little tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little tiredness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Mastectomy (sentinel node or nodes removed - no cancer in nodes) in 2000. Concurrent medical conditions included Herpes NOS (Patient took Acyclovir to suppress herpes.) and Sleep disorder NOS (Patient took Lorazepam 1mg half a pill to help with sleep.). Concomitant products included ACYCLOVIR [ACICLOVIR] for Herpes NOS, LORAZEPAM for Sleep disorder NOS.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little tiredness). On 07-Feb-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little tiredness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-378306, MOD-2021-378678 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Details of medical history was updated.
Injection site erythema. From initial information received on 08/Jan/2004 from health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received a fifth dose of DAPTACEL, lot number C1624AA, administered in the right deltoid, a second dose of FLUZONE, administered intra-muscularly in the left thigh and a second dose of MMR, manufacturer Merck, lot number 0271A1, administered subcutaneously in the left arm at 4:00 PM on 06/Jan/2004. Two days later, on the morning of 08/Jan/2004, the patient developed an erythematous area surrounding the injection site, which was described as "resembling cellulitis". The patient was seen by a physician. The patient's recovery status was not reported. The reporter of this case is the same reporter of case number 2004-00089.
Chills, body aches, headache, temperature (101 degrees) Yellow nasal drainage
Local tenderness; Injection site induration; Injection site redness; Injection site swelling; Hot to touch at injection site; Blisters at the injection site/small vesicles at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE VESICLES (Blisters at the injection site/small vesicles at injection site), PAIN (Local tenderness), VACCINATION SITE INDURATION (Injection site induration) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE VESICLES (Blisters at the injection site/small vesicles at injection site), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling). On an unknown date, the patient experienced PAIN (Local tenderness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site), PAIN (Local tenderness) and VACCINATION SITE INDURATION (Injection site induration) outcome was unknown and VACCINATION SITE VESICLES (Blisters at the injection site/small vesicles at injection site), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) 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.   Patient had delayed injection site reaction. She was instructed to apply cold compress.
Waited 15 minutes after receiving the vaccine; went to car and when driving home about 30 minutes later my face and lips on the left side of my face went numb.  The vaccine was placed in my left arm.   The numbness lasted about 2 hours and then went away.
pt recvd vax & the same day exp swollen & red lt thigh (inject site); resolved;