chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable. No adverse reactions reported for the patient.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-675735 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675735:Master Case
Initial and follow up information has been received from a certified medical assistant concerning a 79 year old retired white female with allergies to azithromycin (Zithromax), sulfamethoxale, trimethoprim (Septra), and ciprofloxacin hydrochloride (Cipro), who on 10/29/2004 (previously reported as September 2004), at 12:30PM, was vaccinated intramuscularly in the left arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P).  Concomitant therapy included fexofenadine hydrochloride (Allegra), lisinopril (Zestril), acetaminophen/hydrocodone bitartrate (Vicodin tablets), calcium carbonate cholecalciferol (Caltrate + D), alendronate sodium (MSD) and clonazepam (Klonopin),  Subsequently, the patient developed a local site reaction of slightly raised area, painful, red, hot.  It was reported that on 10/29/2004, at 5:00PM, the patient developed swelling, redness, fever in arm, pain, and induration (area hard to the touch).  The patient sought unspecified medical attention.  The patient recovered on 11/20/2004.  It was reported that the patient had a sore throat, cough and runny nose at the time of vaccination.  It was also reported that the patient had one previous dose of pneumococcal 23v polysaccharide vaccine in October 1999.  It was also reported that 4 other female patients experienced adverse events within the last 2 months.  No product quality complaint was involved.  No additional information is expected.
Thrombocytopenia - Information has been received from a health care professional concerning an approximately 12 month old female who in Feb 1991 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  It was reported that the patient experienced thrombocytopenia a short time later.  unspecified medical attention was sought.  No other information was available.  Follow up on 08/09/02: "Follow up information has been received from a health professional who states the pt "did not have the reaction in our practice."  She reports that there is no way for them to obtain additional information .  No further information is expected."
excrutiating pain from the right arm to the back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (excrutiating pain from the right arm to the back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (excrutiating pain from the right arm to the back). At the time of the report, PAIN IN EXTREMITY (excrutiating pain from the right arm to the back) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No treatment information and concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Started out with soreness in injection site; Then migraine on afternoon of 12/24; Later on evening of 12/24, dizziness,  seizures and blacked out. Vomited whole dinner; 12/25 still dizzy. Possibly another seizure. Went to ER
got her 2nd dose and then experienced atrial fibrillation, cardio version; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "She had had ablation for the tachycardia in the past" (unspecified if ongoing); "She had had Afib treated in the past" (unspecified if ongoing); "She had had ablation for the tachycardia in the past" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "abdominal pain", "lightheadedness", "tachycardia". The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 29Jan2021, outcome "unknown", described as "got her 2nd dose and then experienced atrial fibrillation, cardio version". Therapeutic measures were taken as a result of atrial fibrillation including cardioversion and unspecified medications. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the event atrial fibrillation and the suspect drug BNT162B2 cannot be excluded.  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.
Swelling, erythema and pain around shot site, 9 1/2 cm of swelling and redness.
HA, fatigue, low grade fever, body aches treatment include Tylenol with improvement.
Pt recvd 3 doses of Engerix-B 30OCT90, 6DEC90 & 9MAY91 & 9SEP91 & it was determined that pts titer was neg p/3 doses of Engerix-B;
pt with c/o rash onset 6/28/2009 and was seen in office. pt had varicella vaccine 6/18/2009.
vaccine aggravated issues she already had; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "vaccine aggravated issues she already had".  Additional Information: The report not related to a study or program. the patient also the reporter. Covid Vaccine a Pfizer product. Caller states she had her first shot and was scheduled to come back 25Mar2021, but she had to cancel it because she was having some issues and she went to see her primary care doctor today and he said it was okay to take the shot. States she got her first shot at Facility. Caller was asking to schedule her second vaccine. Caller clarified she was having some health issues, they weren't from the vaccine, but the vaccine aggravated what she already had.  Caller declined to answer additional questions or complete a safety report at this time. Further details unable to be obtained.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, Nausea, Swelling in arm and redness.  Described as being sickest she has ever been.  LAsted about a day to a day and 1/2.  Fully Recovered
She mentioned that she needle phobia and was already anxious when she got to their facility.; She mentioned that she had difficulty in breathing because of her double mask.; she felt light headed.; her lips started to tingle; This is a spontaneous report from a contactable consumer (patient). A female patient (Age: 54; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown, Expiry date: unknown), via an unspecified route of administration on 26Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history included needle phobia and concomitant medications were not reported. The patient reported, she received the 1st dose of the Pfizer vaccine about an hour ago today. She mentioned that she had needle phobia and was already anxious when she got to their facility. She mentioned that the person who injected her was really quick that she didn't feel it. They made her stay for 20 minutes and she was fine, she mentioned that she had difficulty in breathing because of her double mask. As she was walking to her car, she felt lightheaded. As she got in the car, her lips started to tingle. The outcome of events was unknown.  Information about Lot/Batch request has been requested.  Follow-up attempts completed. No further information expected.
Patient developed flu-like symptoms on day of COVID vaccination (third dose). Also reported occipital headache and myalgias. One month after vaccine, patient continued to feel headache and fatigue. Noted to have new renal failure.  Hospitalized 12/9/21. Initially thought to have scleroderma renal crisis. But biopsy consistent w/ ANCA vasculitis.
Fever of 99.9, slight body aches, "head felt strange" - she took 3 baby ASA - completely resolved in 48 hrs.
HEADACHE; FEELING LETHARGIC; CONCENTRATING; HARD TIME WALKING FROM BED TO THE KITCHEN; PAIN WAS CONCENTRATED TO THE NECK; FEVER PERSISTED; MUSCLE PAIN AROUND NECK AND SHOULDER BLADE, EXPANDING TO THE BACK OR MUSCLE ACHES; NAUSEA; FEEL BADLY, FEEL LIKE PUNCHED; DIFFICULTY WALKING; CHILLS; ARM SORENESS AROUND THE SHOULDER; JOINT PAIN, SPECIFICALLY ON THE KNEES/JOINT PAIN; MUSCLE WEAKNESS; FELT PRESSURE ON THE FRONT OF THE FACE; COULD NOT SLEEP ON SIDE; COULD NOT EVEN HOLD UP PHONE; MIGRAINE; FLU LIKE ILLNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included overactive immune system. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 13:00 to the right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced migraine. On MAR-2021, the subject experienced flu like illness. On 26-MAR-2021, the subject experienced feel badly, feel like punched. On 26-MAR-2021, the subject experienced difficulty walking. On 26-MAR-2021, the subject experienced felt pressure on the front of the face. On 26-MAR-2021, the subject experienced could not sleep on side. On 26-MAR-2021, the subject experienced could not even hold up phone. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced arm soreness around the shoulder. On 26-MAR-2021, the subject experienced joint pain, specifically on the knees/joint pain. On 26-MAR-2021, the subject experienced muscle weakness. On 26-MAR-2021, the subject experienced muscle pain around neck and shoulder blade, expanding to the back or muscle aches. On 26-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced feeling lethargic. On 27-MAR-2021, the subject experienced concentrating. On 27-MAR-2021, the subject experienced hard time walking from bed to the kitchen. On 27-MAR-2021, the subject experienced pain was concentrated to the neck. On 27-MAR-2021, the subject experienced fever persisted. Treatment medications included: ibuprofen. On 28-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, and chills on MAR-2021, was recovering from fever persisted, muscle pain around neck and shoulder blade, expanding to the back or muscle aches, feeling lethargic, nausea, muscle weakness, joint pain, specifically on the knees/joint pain, and flu like illness, and the outcome of feel badly, feel like punched, arm soreness around the shoulder, difficulty walking, headache, felt pressure on the front of the face, could not sleep on side, could not even hold up phone, concentrating, hard time walking from bed to the kitchen and pain was concentrated to the neck was not reported. This report was non-serious.
This spontaneous report was received from a pharmacy technician concerning an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with a dose of improperly store PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No symptoms were reported. This is one of the two reports from the same source. Additional information has been requested.
COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications was provided by the reporter.  No Treatment medications was provided by the reporter.
Out of the blue I noticed I had trouble getting a deep breath while laying on couch or daily activities. I was walking doing my normal walks and couldn't get a deep breath. After a couple of weeks I called my doc and was told to go to ER. Did EKG, COVID test, checked fluid around heart and everything came back fine. Was told to f/u with family doctor. Went to see her and she put me on Singulair and was told to take 1 pill a day. Also had albuterol and was told to do two puff several times a day. I was also told to take Prilosec for a month. Only did Singulair for two weeks because I had side effects only did Prilosec for 3 weeks. The symptoms stopped after 2- 3 months.
On day 2 and on day 12 after injection I got visual migraines - no headache. On day 12 + 13 a very low grade headache. On day 15, I had redness at site of injection, with some texture change I could feel with my fingers. By day 16 it had disappeared.  I did take a CBD 25mg capsule and a turmeric capsule before going to bed which could have made it go away by morning.  Nothing serious at all, just late reactions.  I had typical tired a d hurt arm reactions in the  normal time frame in addition to what I am reporting.  I have not contacted my doctor.
This is a spontaneous report from a contactable consumer(the patient, reported for self). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration on an unspecified date (at the age of 65-year-old) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced back pain, arm fell asleep and patient noticed tingling needle like sensation around the tip of fingers (Medical Information Potential AE). Reporter, the patient wanted to know if this side effect has been reported with the vaccine. Seriousness of the event was reported as non-serious. The outcome of events was unknown.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained
Very dizzy; trouble walking the short distance; sense of balance was gone; nauseous; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Very dizzy), GAIT DISTURBANCE (trouble walking the short distance), BALANCE DISORDER (sense of balance was gone), NAUSEA (nauseous) and HEADACHE (bad headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031MZ0A and 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CICLOSPORIN (RESTASIS) for Dry eye.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (Very dizzy), GAIT DISTURBANCE (trouble walking the short distance), BALANCE DISORDER (sense of balance was gone), NAUSEA (nauseous) and HEADACHE (bad headache). On 12-Feb-2021, DIZZINESS (Very dizzy), GAIT DISTURBANCE (trouble walking the short distance), BALANCE DISORDER (sense of balance was gone), NAUSEA (nauseous) and HEADACHE (bad headache) 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.   The treatment information was not provided.  Patient reported that she had similar experience 3 years back, while using a herbicide.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: NNI
08/20/2021 I had symptoms of Covid-did an at home test and tested positive.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to FLULAVAL QUADRIVALENT.  Additional details were reported as follows: The age at vaccination was not reported. The caller reported that she spoke with a nurse at her physician's office. The nurse stated to the reporter that she had received her flu vaccine that year and her arm hurt for 2 days. She stated that this was unusual and she did not usually had any problems with the flu vaccine. The reporter was told that the physician's office used FLULAVAL QUADRIVALENT and that they did not have flu vaccines without thimerosal.
G47.30 SLEEP APNEA 3/30/2023 SEVERE OBESITY, BMI 45-49.9, ADULT
Rash around the injection site, inability to move the arm for 1 month, discoloration of the arm red/yellow. Vaccine given 9/12/13. Patient only notified us of reaction now.
The sore arm was the same as the first two/arms were sore for a couple days; got a full dose (100 mcg shot) as opposed to a half dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The sore arm was the same as the first two/arms were sore for a couple days) and OVERDOSE (got a full dose (100 mcg shot) as opposed to a half dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 022M20H and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 15-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (got a full dose (100 mcg shot) as opposed to a half dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (The sore arm was the same as the first two/arms were sore for a couple days). On 15-Oct-2021, OVERDOSE (got a full dose (100 mcg shot) as opposed to a half dose) had resolved. At the time of the report, PAIN IN EXTREMITY (The sore arm was the same as the first two/arms were sore for a couple days) had resolved.            Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-363645, MOD-2021-363625 (Patient Link).
Positive COVID-19 test with symptoms within 7 days from 1st vaccination; This is a spontaneous report from a contactable female consumer (patient's mother). This is 1 of 3 cases from the same family, and refers to the daughter. A  female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, via an unspecified route of administration, on 15Apr2021, at the age  years old, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the BNT162b2 vaccination on the same day of her old mother and father with whom she was living. Within 7 days after the vaccination (exact date unspecified), the patient began to experience a temperature and a cough that lasted for 3 days. The patient was therefore tested for COVID-19, and tested positive, always on an unspecified date within 7 days from the vaccination. The patient had not recovered from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021453064 same reporter, same product, different patients, similar events;US-PFIZER INC-2021448634 same reporter, same product, different patients, similar events