chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 12-Feb-2021 at 2:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 2:10 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 74.96.  Concomitant products were not provided.  On 12-Feb-2021, Excursion time was 09 AM, temperature was 29 and Excursion time was 10 AM and 11 Am, temperature was 35 respectively, total doses given for the day was 55, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 02-Feb-2021, vial was moved to clinic on 05-Feb-2021. 30 vials were sent to clinic. Vaccine BUD date was 03-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Chronic fatigue, feels exhausted; Nausea; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (Chronic fatigue, feels exhausted) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Reflex sympathetic dystrophy on 16-Feb-2011 and Pneumonia (occurred 17 times in the past). Concurrent medical conditions included Drug allergy (codeine,keflex), Allergy to chemicals (Sulphur,nickel), Tachycardia, Thyroid pain since 1982 and Migraine since 1999. Concomitant products included METOPROLOL, GABAPENTIN, MONTELUKAST, CYCLOBENZAPRINE, HCTZ, LOSARTAN POTASSIUM, PROGESTERONE, LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and ESTRADIOL for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Chronic fatigue, feels exhausted). At the time of the report, FATIGUE (Chronic fatigue, feels exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) negative for antibodies..         No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-027078 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Updated medical history, concomitant medications. Event headache outcome was changed from unknown to not recovered. On 25-May-2021: Added lab data and event fatigue.
Developed swelling, redness, itching, pain at injection site of 4th anthrax shot within 24 hours of receiving vaccine.  Edema at injection site 50-120mm start: 02/23/2008, erythema start: 02/23/2008, pruritis start: 02/23/2008, pain start: 02/23/2008.
On 1/6/00, pt was vaccinated. In May, 2000, the pt developed parainfluenza virus pneumonia and was hospitalized in the ICU. It was reported that he recovered from this experience. On 8/10/00, he was admitted for swelling of his left mandibular area which was dx'd as another "flare-up" of atypical mycobacteria infection and was started on amikacin sulfate. On 8/14/00, it was noted that he developed many disseminated vesicular lesions on the right side of his tongue, the right ear, and left hand. The pt's temp was 37.9C. The pt was dx'd with herpes zoster and placed on acyclovir. He also developed "Ramsay Hunt Syndrome" which was reported to be a complication of either herpes zoster or herpes simplex virus that involves facial paralysis. It was reported that the pt had right sided facial paralysis and was unable to smile or close his right eye. These experiences were considered to be other in addition to having lesions on the right side of his tongue and ear, that he also has lesions on his hand and arm. He feels the pt was disseminated herpes zoster. It was reported that a specimen was sent for PCR analysis. Additional information has been requested.
Regression of speech, walking. Regressed from walking to being fearful of taking steps. Emotional labile - temper outburst, banging head not as interactive with siblings.
On 3/22/13 client rec'd DTaP, IPV, Hib, HBV, PCV 13, et ROTATEQ. Mother reported to this RN that client cried for 24 h et had 3 episodes of emesis. Client received imm. at pvt. Dr's office.
A report was received from a health care professional on 12/3/03 concerning a female vaccinee of unspecified age who inadvertently received Fluvirin SC on 12/2/03. On 12/2/03 the vaccinee inadvertently received Fluvirin SC with a 27G needle instead of IM. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 4/16/04: Follow up information received from an unidentified source indicated that the adult vaccinee did not experience any adverse events. No follow up pending, all information received.
Patient was really nervous to begin with; After receiving second dose within 2-3 minutes patient fell from chair face on hitting her head against the floor and a minor cut on the outer eye was observed.; After receiving second dose within 2-3 minutes patient fell from chair face on hitting her head against the floor and a minor cut on the outer eye was observed.; The arms and neck area broke out into rash.; This is a spontaneous report from a contactable pharmacist. A 15-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via intramuscular, administered in left arm on 18Aug2021 16:45 (age at vaccination was 15years) (Batch/Lot Number: ew0185) as dose 2, single for covid-19 immunization at pharmacy or drug Store. Medical history included drug hypersensitivity to penicillin from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. It was unknown that the patient had been tested for COVID-19 since the vaccination. The patient received first dose bnt162b2 (BNT162B2), dose 1 via intramuscular, administered in left arm on 27Jul2021 (Batch/Lot Number: ew0186) as dose 1, single for covid-19 immunization and did not experienced any reaction. On 18Aug2021 Patient was nervous to begin with. After receiving second dose within 2-3 minutes patient fell from chair face on hitting her head against the floor and a minor cut on the outer eye was observed. The arms and neck area broke out into rash. gave her a benadryl tablet, tylenol for the fall, and we iced the eye and monitored patient for 30 minutes. The patient's mom took patient to the ER where she was getting a CT scan done for the eye. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient received benadryl, tylenol, and iced the area as treatment. The event nervousness was medically significant. The patient underwent lab tests and procedures which included computerized tomogram: unknown on unspecified date in Aug2021 CT scan done for the eye. The outcome of the events was unknown.; Sender's Comments: based on the close temporal relation ship the causality between the events rash , fall , eye injury and the suspect vaccine BNT162B2 cannot be ruled out 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
Approx 24 past receiving flu vax noticed painful lump in rt axilla - same arm that injection given low grade temp noticed temp 99.2.
Caller is asking if she can apply topical rubbing alcohol to injection site. She states with injections it can "minimize swelling and pain". Received first dose today.; Caller is asking if she can apply topical rubbing alcohol to injection site.  She states with injections it can "minimize swelling and pain". Received first dose today.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if she could apply topical rubbing alcohol to injection site. She stated with injections it could minimize swelling and pain. The outcome of events was unknown.  Information about lot/batch number has been requested.
At about 12 pm day of immunization patient began having the following symptoms: redness to neck and front chest,  injection site ( right arm) redness , itching, rash below and above injection, reports blood pressure 169/96 ( checked at site ) , dizziness with standing, denied shortness of breath or chest pain at that time.  En route home began having mid sternal chest pain , radiated to left side of chest, checked blood pressure at home 175/100.  Patient states took additional Benadryl 25mg PO .  After Benadryl chest pain subsided.  At this time reports headache, dizziness, vertigo, chills , and fever.  Vital signs stable, patient aaox3, report to Occupational Health provider.  No obvious distress noted.
several hr p/vax mottled appearance, fever, grunting rapid resp, clear nasal discharge;
cough; runny nose; sick; tired; Initial information received on 24-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves adult patient of unknown age who experienced cough, runny nose, sick and tired after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed non-serious cough, runny nose (rhinorrhoea), sick (illness) and tired (fatigue) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Unknown for all events.
mom reported that pt devel a fever of 103 & 7PM on 9NOV93 gave pt APAP; MD became concerned about a bruise on the lt arm & a reddened area on the rt arm;
Expired Dose of Heplisav-B Given; Initial Report Received 01-Oct-2021  A pharmacist reported that a 62-year-old female received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history was reported as organ transplant.   The patient had no known allergies.  Concomitant medications were not reported.   On 01-Oct-2021, dose 1 of HEPLISAV-B (Lot # 933623, Expiration Date 22-Aug-2021, NDC # 43528-003-01) was administered in the right arm.   The dose was expired at the time of vaccination.  No adverse reactions were reported at the time of report.    No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Very Itchy Injection Site; Little redness on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Little redness on the Injection Site) and INJECTION SITE PRURITUS (Very Itchy Injection Site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included CHOLESTEROL and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Little redness on the Injection Site). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Very Itchy Injection Site). On 23-Jan-2021, INJECTION SITE ERYTHEMA (Little redness on the Injection Site) had resolved. At the time of the report, INJECTION SITE PRURITUS (Very Itchy Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
had vaccine, got shingles next year/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 24-Apr-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated just because you get the Shingles vaccine did not mean you could not get shingles. The patient had vaccine and then got shingles next year, not very common for that to happen.  Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
A few minutes after vaccine was given patient notes hot flashes, severe palpitations, sweating, chills, hands shaking, nausea, confusion, headache and jittery feelings. Symptoms resolved within a couple of hours after being given IV fluids, tylenol and zofran.
Pain at injection site, large-scale rash that lasted 2 weeks, skin very warm to the touch, muscle felt 'hard'
This spontaneous report was received from a 62-year-old female patient reporting on herself. The patient's medical history included the removal of appendix and tonsils on an unknown dates, when she was a child and tubal ligation on an unknown date, many years prior to the date of vaccination with ZOSTAVAX. The patient had no allergies and previous drug reactions. On 29-APR-2014, the patient was vaccinated with ZOSTAVAX (lot # J011828, expiration date: 26-DEC-2014, in the left arm; dose and route of administration were not reported). Concomitant therapies included unspecified vitamins. In October 2014, the patient developed two lumps, one lump which was 1 inch in diameter and a second lump which was 1/2 inch in diameter. The lumps started off sore, red, pussy, then became hardened, and later turned a blackened color. The patient had two outpatient surgeries to remove the lumps, on 11-FEB-2015 and 27-FEB-2015. At the time of the report, the lumps have been removed. The patient had blood work and cultures obtained at outpatient surgery, at the time of the report the results of cultures were pending and no diagnosis were made. The outcome of the event was reported as not recovered. The relatedness between vaccination with ZOSTAVAX and the events was not reported. Additional information has been requested.
Shot given 2 pm-next am -Erythema that looked like it would bruise around injection site- Got 3 inches in diameter - The next day rash started, looked like hives (trunk) 4d later serpiginous and target lesions on trunk, face, upper arms and legs - Itchy-Temp. 99.9
PRETTY SICK FOR A WEEK; BAD HEADACHES; MUSCLE PAIN; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced pretty sick for a week, bad headaches, and muscle pain. The action taken with covid-19 vaccine was not applicable. The outcome of the pretty sick for a week, bad headaches and muscle pain was not reported. This report was non-serious.     .
Fatigue; Chills; Headache; Muscle pain; joint pain; Temperature 99.2; This is a spontaneous report received from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route administration in the left arm on 10Mar2021 at 10:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes 2 (type 2 diabetics) and neuroendocrine tumors in liver. The patient was allergic to sulfa (sulphonamide allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication includes levothyroxine (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); all drugs were started on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 13:00, the patient experienced fatigue, chills, headache, muscle pain, joint pain and temperature was 99.2 (body temperature increased) (unspecified units). The patient did not receive any treatment for adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events fatigue, chills, headache, muscle, joint pain and temperature 99.2 were not resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Received my booster 7 months after 2 initial shots of moderna .had giant hive 5he size of grapefruit on my arm. 3 days after receiving it.. Had to go to ER for prednisone shot and pills for 5 days to stop the reaction. Had slight chills and huge know under my skin next day.
Injection site was very high, blood dripped all the way down my arm. After about an hour, my arm started to become very heavy. After a few hours, I couldn't lift my arm. The heaviness and ache never went away. 16 hours later, it is heavier than ever and achey all up and down my whole arm. I have taken 2 Tylenol, every 6 to 8 hours as directed.  I have a bruise at injection site and have iced it a few times. It is still so heavy I can't lift it without the help of my other hand.
A few days post vax, pt developed weakness in her arms and legs, muscle aches and malaise. The pt felt slower with not much stamina.
A report has been received from a Physician concerning a 2 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 15-OCT-2014. Patient received two different flu vaccines within less than 30 days apart. The outcome of the event of patient received two different flu vaccines less than 30 days apart is unknown. The report was considered to be non-serious.
This spontaneous report was received from a 72 year old female patient (reporting on herself). On 19-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported) in the arm. Concomitant therapy was not reported. In 2013, the patient reported her arm was red at the injection site and the redness moved down to her elbow as well. Arm was red and it did not give a scar like the small pox vaccine did. The outcome of elbow redness and her arm was red at the injection site was unknown. Additional information has been requested.
1 of 3 pts who was vax from the same lot (different vial)  exp fever, swelling & excessive redness @ inject site; pt was treated w/ATB;
Fever; Chills; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Myalgia) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, 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 PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Myalgia). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Myalgia) had resolved.            The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-002894, MOD-2021-365426 (Patient Link).