chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787 US-009507513-1805USA009900:Original Case : 1805USA006787 US-009507513-1805USA009901:Original Case : 1805USA006787 US-009507513-1805USA009902:Original Case : 1805USA006787 US-009507513-1805USA009903:Original Case : 1805USA006787 US-009507513-1805USA009904:Original Case : 1805USA006787 US-009507513-1805USA009905:Original Case : 1805USA006787 US-009507513-1805USA009906:Original Case : 1805USA006787 US-009507513-1805USA009907:Original Case : 1805USA006787 US-009507513-1805USA006787:Original Case : 1805USA006787 US-009507513-1805USA009909:Original Case : 1805USA006787 US-009507513-1805USA009910:Original Case : 1805USA006787 US-009507513-1805USA009911:Original Case : 1805USA006787 US-009507513-1805USA009912:Original Case : 1805USA006787 US-009507513-1805USA009913:Original Case : 1805USA006787 US-009507513-1805USA009914:Original Case : 1805USA006787 US-009507513-1805USA009915:Original Case : 1805USA006787 US-009507513-1805USA009916:Original Case : 1805USA006787 US-009507513-1805USA009917:Original Case : 1805USA006787 US-009507513-1805USA009918:Original Case : 1805USA006787 US-009507513-1805USA009919:Original Case : 1805USA006787 US-009507513-1805USA009920:Original Case : 1805USA006787 US-009507513-1805USA009921:Original Case : 1805USA006787 US-009507513-1805USA009922:Original Case : 1805USA006787 US-009507513-1805USA009923:Original Case : 1805USA006787 US-009507513-1805USA009924:Original Case : 1805USA006787 US-009507513-1805USA009925:Original Case : 1805USA006787 US-009507513-1805USA009926:Original Case : 1805USA006787 US-009507513-1805USA009927:Original Case : 1805USA006787 US-009507513-1805USA009928:Original Case : 1805USA006787 US-009507513-1805USA009929:Original Case : 1805USA006787 US-009507513-1805USA009930:Original Case : 1805USA006787 US-009507513-1805USA009931:Original Case : 1805USA006787 US-009507513-1805USA009932:Original Case : 1805USA006787 US-009507513-1805USA009933.
Pfizer COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 7/24/2021 and 8/15/2021. Presented to ED on 1/3/2022 with complaints of shortness of breath, progressively worse cough, and fever. Recently discharged four days prior due to GI Bleed. Admitted for acute respiratory failure with hypoxia due to HCAP/Covid. Treated w/remdesivir and BIPAP. DNR/COT upon admission. Exipred on 1/10/2022.
Fatigued; Headache; Vaccine administered to patients after 32 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator), FATIGUE (Fatigued) and HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 024C21A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol since 01-Feb-2021. Concomitant products included GEMFIBROZIL from 24-Feb-2021 to an unknown date for Hyperlipidemia.   On 08-Apr-2021 at 11:12 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021 at 9:52 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator). On 10-Jun-2021, the patient experienced FATIGUE (Fatigued) and HEADACHE (Headache). On 09-Jun-2021, PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) had resolved. At the time of the report, FATIGUE (Fatigued) and HEADACHE (Headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The second of the 2 doses of the Moderna vaccine was administered on the 38th day after it has been stored in the refrigerator, i.e. 8 days beyond its expiration date.   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2021: RA
Patient received the Pfizer Monovalent for their booster dose instead of the Bivalent.
After my vaccine, they had me sit there for 15 minutes and I was fine, but on the drive home which about 7 minutes away, I started feeling a tightness and tingling in my face from my sinuses to my chin which lasted about 30-45 minutes. For the next two days after that, I was really sick in bed with terrible nausea. I just stayed in bed and couldn't really get out of bed.
The night of 9/2, patient fainted and hit her head. Her husband helped her up and she did not go to hospital or call her Dr.  She was clammy and had chills.  Also she had a swollen, red and warm LEFT arm only (pneumovax arm).  The only professional visit was to stop in here (pharmacy) and tell me about it.
while administering Tdap (adacel) vaccine, the base of the syringe body broke off and cause a laceration to the RN's finger; while administering Tdap (adacel) vaccine, the base of the syringe body broke off and cause a laceration to the RN's finger.; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown age and gender and while administering diphtheria-2/tetanus/5 AC Pertussis Vaccine [Adacel], the base of the syringe body broke off and cause a laceration to the rn's finger.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Jul-2023, the patient received a unknown dose of suspect diphtheria-2/tetanus/5 AC Pertussis Vaccine Suspension for injection (strength, expiry date: not reported and lot U7869AA) via intramuscular route in unknown administration site for Prophylactic vaccination (immunization) and the base of the syringe body broke off and cause a laceration to the rn's finger. (occupational exposure to product) (latency: same day).  On an unknown date while administering tdap (adacel) vaccine, the base of the syringe body broke off and cause a laceration to the rn's finger (skin laceration) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
VARIVAX administered during a temperatute excursion; No additional adverse events reported; This spontaneous report was received from a physician regarding  to a 14 month old patient of unknown gender.  Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 13-JAN-2021, the patient was vaccinated with  an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S025608, expiration date 18-AUG-2021, 0.5 milliliter for prophylaxis (route of administration was not provided).         The improperly stored suspect vaccine experienced a temperature of 0.0 degree Celsius (°C) for 2 hours and 11 minutes with no previous temperature excursion.   The call was made due to a digital data logger. No adverse symptoms were reported.
small widely scattered rash on all parts of the body which consists of small pinpoint lesion bumps which were extremely itchy; small widely scattered rash on all parts of the body which consists of small pinpoint lesion bumps which were extremely itchy; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After 46 days of receiving the Pfizer COVID-19 vaccine, the patient developed a small widely scattered rash on all parts of the body which consists of small pinpoint lesion bumps which were extremely itchy on an unspecified date. The outcome of these events was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swelling on left side of neck; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling on left side of neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced SWELLING (Swelling on left side of neck). At the time of the report, SWELLING (Swelling on left side of neck) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
pt was under 15 mts observation and noted on the floor, reported he blacked out and regained consciousness with in seconds. never lost pulse, alert and awake, answers questions appropriately, seen by md, given crackers and juice, comfortable sending back home, pt sent home stable with family.
Gradual onset of erythema, pruritus, swelling of my right fourth toe which evolved to swelling of and the same symptoms on my left fourth toe and my left third toe. Additionally some blisters and peeling of the skin. It appears that there is starting to be resolution of my right fourth toe and I assume that I will have resolution of my left toe soon. Visited a podiatrist and the etiology was not known. Awaiting appointment with derm.
Cellulitis Left am at injection site  Dr put me on antibiotics for 10 dats
JOINT PAIN BILATERALLY: SHOULDERS, ELBOWS, WRIST, HIPS, KNEES AND FEET
supraclavicular lymphadenopathy; Swelling on thyroid gland; Nodules on right side of thyroid; benigh lesions on the left side of the thyroid.; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (supraclavicular lymphadenopathy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid hormones increased. Concomitant products included ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (MULTIVITAMIN[ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), CALCIUM CARBONATE, COLECALCIFEROL, PHYTOMENADIONE (CALCIUM PLUS VITAMIN D & K) and VITAMIN D NOS for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced LYMPHADENOPATHY (supraclavicular lymphadenopathy) (seriousness criterion hospitalization). On an unknown date, the patient experienced GOITRE (Swelling on thyroid gland), THYROID MASS (Nodules on right side of thyroid) and BENIGN NEOPLASM OF THYROID GLAND (benigh lesions on the left side of the thyroid.). The patient was hospitalized on 03-Mar-2021 due to LYMPHADENOPATHY. On 03-Mar-2021, LYMPHADENOPATHY (supraclavicular lymphadenopathy) had resolved. At the time of the report, GOITRE (Swelling on thyroid gland), THYROID MASS (Nodules on right side of thyroid) and BENIGN NEOPLASM OF THYROID GLAND (benigh lesions on the left side of the thyroid.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LYMPHADENOPATHY (supraclavicular lymphadenopathy) to be possibly related. No further causality assessments were provided for GOITRE (Swelling on thyroid gland), THYROID MASS (Nodules on right side of thyroid) and BENIGN NEOPLASM OF THYROID GLAND (benigh lesions on the left side of the thyroid.).    Treatment information was not reported Patient was told to wait 6-8 weeks to repeat the thyroid tests and six months to have the sonogram repeated to look for changes. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant Follow-up information received on 14-JUL-2021: Updated event outcome for lymphadenopathy, Pregnancy info as no .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Approximately 10 minutes after vaccination recipient presented with itching and soreness at site. Reddened cheeks, with a numbing sensation peri-oral. Recipient took her own BENADRYL 25mg oral.
Sore arm started feeling hours after vaccine administration and last 48 hours. Effect was transient.
This case was reported by a consumer via call center representative and described the occurrence of muscle induration in a 70-year-old female patient who received SHINGRIX for prophylaxis.  On 25th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th August 2018, less than a day after receiving SHINGRIX, the patient experienced muscle induration (serious criteria GSK medically significant), fever blister and injected limb mobility decreased. On an unknown date, the outcome of the muscle induration and injected limb mobility decreased were recovered/resolved and the outcome of the fever blister was not recovered/not resolved. It was unknown if the reporter considered the muscle induration, fever blister and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine in left arm. In the evening on the day of vaccination, the patient experienced fever blisters that was still unresolved. The patient claimed that, she currently had one blister under the skin on her lip but not as many as she did initially. She had the outbreak of blisters on her upper and lower lips and ever since, she had fever blisters on her bottom lip. She also reported that the muscle of her left arm got hard and she lost range of motion in her left arm where she had the injection. The muscle issues resolved after six weeks and the range of motion concerns resolved after 2 to 3 months. The patient had not receive the second shot yet because of the side effects she had experienced. The reporter consented to follow up.
shot 1 in received it around November 2021, but has not yet received shot 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in around November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 23-Sep-2022 Reporter's comment: The reporter was the patient sister. She did not wanted to share her email address. The patient was her brother. He lived in another country. He received the FDA approved Shingrix, shot 1 when he was visiting his sister. He was due to get Shingrix shot dose 2 around May 2022 but had not yet received Shingrix shot 2.  The reporter had limited information. The consent to follow-up was requested. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Arm turned red, ran fever, and gradually swelled until entire upper arm was swollen.  Visited doctor and got 40mg shot of Kenelog and prescription for Atarax
morning after the vaccine my mother couldn't walk and fell out of bed, released her bowels, was nauseous and weak. Called EMT and was taken to hospital. Her blood count dropped to 8.0, dehydrated and remains weak. I am awaiting more information from the hospital on her condition.
lower lip swelling present, felt throat closing and tongue swelling (resolved prior to ER visit).
Asthma symptoms (tightness in chest; shallow, dry cough) - no asthma symptoms prior to shot, only experience them annually in fall (sometimes spring), but never in February
Pt received Tdap due to laceration on LE from rusty metal. After 20 mins, began to feel itchy extremities, face, then torso. Very minimal fine rash. Denies any respiratory sx. No tingling of tongue or throat. Eval by provider, rash diminished, sx decreased. Pt left after 60 mins. BENADRYL 25 mg q 6 hours prn. 5/6/13 Pt states rash resolved arm pain decreased.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received bnt162b2 (BNT162B2), on 25Oct2021 as dose 1, single (Batch/Lot number: unknown) and on 12Jun2022 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in left arm 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) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid received).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300302805 Same patient, different vaccine dose and different event;
Initial misuse report received from a healthcare professional on 10 January 2014. This is invalid case as the individual patient identifiers missing. The patient had received FLUZONE HD vaccine on unspecified date and then the patient stated they may have had it already in last two months. No adverse event was reported. List of documents held by sender: none.
This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 24-OCT-2012 12:43, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
The patient developed itching 10 minutes after JOHNSON & Johnson vaccination was administered. No other signs/symptoms developed except worsening of the itching. Stat medications where given and observation was done. The patient eventually agreed to go to the ED for further observation.
Approximately 2 hrs after receiving the vaccine she developed severe pain in the upper arm area where vaccine was given. This pain has continued and causes the patient to seek treatment from her orthopedic doctor. She is scheduled for MRI on 1/13/11.
Rash over her body; very red (rash); This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash over her body) and RASH ERYTHEMATOUS (very red (rash)) in a 78-year-old female patient 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.).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced RASH (Rash over her body) and RASH ERYTHEMATOUS (very red (rash)). At the time of the report, RASH (Rash over her body) and RASH ERYTHEMATOUS (very red (rash)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.
I developed a sudden onset of tinnitus about 1 month after my 2nd Covid Vaccination. I have never had it before and it's  not gotten better since I noticed in last May. It's VERY loud chirping in both ears in the mornings to the point where it's harder to hear. And during  the days and evenings it's a constant metallic high pitch.
blurred vision; This is a spontaneous report from a contactable consumer (husband) from a Pfizer sponsored program. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 09Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced blurred vision in Mar2021. The clinical outcome of blurred vision was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt states as soon as the needle went into her arm it hurt very badly.  She waited her 15 minutes and when she started walking away she got a headache and was very weak, tired and sleepy.  As time went by her arm was still very sore and became very itchy at the injection site.  It has been been 3 months since she has had the vax and the arm still has a pain at the injection.  She cannot lift anything heavy because it is too painful and she cannot sleep on the left side.   Pt will contact her PCP for medical advice.
Swelling and erythema after 1 day post vaccination. To ice, massage and use Tylenol or Ibuprofen for pain.
Fever of 102, severe headache, muscle pain, joint pain, swelling and pain in injection site, itching at injection site 36 hours later