chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine exposure via breast milk; Rashes on the face; This is a spontaneous report from a contactable consumer (mother). This consumer reported information for both mother (herself) and infant. This is the infant case.  A 15-month-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0169), via transmammary route, on 07May2021 (at the age of 15-months-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. The patient experienced vaccine exposure via breast milk on 07May2021 and rashes on the face in May2021. It was reported that the rashes on the face started one to two days after the vaccine dose. The clinical course was reported as follows: The mother stated she only breastfed at night and her son had woken up three times with rashes on his face in the morning. She stated that there have had no changes to the infant or the mother's diets or anything else, except the vaccine. The rash was still going on at the time of reporting on 13May2021 and the patient woke up on 13May2021 with rashes as well. The patient experienced rashes three times so far. It was reported that after a few hours, the rash goes away, gets better throughout the day, and is worse when waking up but, by evening time, it is gone. The mother stated that no treatment was sought for the patient because the rash does end up going away. On 13May2021, was the third time the rash had occurred, so the mother was going to observe how the day went and call the pediatrician if see needs to. Other than the rashes, the patient acts fine. The clinical outcome of vaccine exposure via breast milk and rashes on the face was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021542489 same reporter/drug, different patient/event
This is a spontaneous report from a contactable healthcare professional received via a Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA (lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested.
Headache, upper back and neck pain, chills, nauseated, dizzy. Patient woke up this morning to use the bathroom and had a syncopal episode with no known injury.
Contant backache beggining around 30 to 45 days after vaccination  backache seems to be consistant but not serious pain
fever; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient, self-reported). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on 07Apr2021, as single dose for COVID-19 immunization. Patient's medical history included COVID-19 positive (patient and her husband were positive) 3 weeks before they took their first dose of COVID-19 vaccine. Concomitant medications were not reported. On an unknown date in Apr2021, the patient had fever. Patient was asking if they still need to take the 2nd dose scheduled on 28Apr2021. Outcome of the event was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
rash all over the body; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (rash all over the body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Mar-2021, the patient experienced RASH (rash all over the body). At the time of the report, RASH (rash all over the body) outcome was unknown.      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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Child had vaccinations at health department on 2/9/07. Child presented with raised lesions 1-2 weeks after vaccinations. Lesions are fluid filled, red, irritated and itchy. Child has been fatigued since onset of lesions, no fever noted. Number of lesions has increase to 30-50 now, which are located "all over" childs body. RN advised parent to take child to PCP for assessment.
Day after adminstraion patinet concerned about redness on his arm where vaccine was given. Patient went to ER to check and they kept him for 2 days to treat his redness and monitored him. Called patient on sunday to check on him and spoke to his daugher and she told us that he was doing fine. It was not sore just redness at site of administration. Called patient again on sunday but no answer . Called again today 10/18 and he said he was fine. He said he came back home on monday and did need any help or assistance from us. We did report to standing order dr about this and they called back today to check on him.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 11:07 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 11:11 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 58.86 for dose administered on 02-Mar-2021 and 58.93 for dose administered on 30-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27 degrees Fahrenheit at 09:00 AM, 29 degrees Fahrenheit at 10:00 AM, 32 degrees Fahrenheit at 11:00 AM, 33 degrees Fahrenheit at 12:00 PM, 35 degrees Fahrenheit at 02:00 PM and 36 degrees Fahrenheit at 03:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021.  Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Three weeks after the first vaccine I had a rash at the injection site and a severe migraine that sent me to the emergency room.  After the second vaccine I started noticing some fatigue. By the third vaccine the fatigue had gotten much worse and the aches and pains all over my body started. Seven months and I have not recovered from the fatigue nor has the pain lessened.
No adverse event; lower than authorized dose of Moderna bivalent vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-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) .25 milliliter. On 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) 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 assessment was provided for ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients).    No concomitant medications were provided. It was reported that 18 elderly patients received 0.25 mL dose instead of 0.5 mL dose. The patients have not reported any adverse reactions at that time.  No treatment medication was provided. This case contains information for the 4th of 18 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666280, US-MODERNATX, INC.-MOD-2022-666278, US-MODERNATX, INC.-MOD-2022-666286, US-MODERNATX, INC.-MOD-2022-666290, US-MODERNATX, INC.-MOD-2022-666063 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666277: US-MODERNATX, INC.-MOD-2022-666278: US-MODERNATX, INC.-MOD-2022-666286: US-MODERNATX, INC.-MOD-2022-666284: US-MODERNATX, INC.-MOD-2022-666290: US-MODERNATX, INC.-MOD-2022-666280: US-MODERNATX, INC.-MOD-2022-666063:
RESIDENCE AND STAFF MEMBERS WERE ADMINISTERED VACCINE, WHICH WAS NOT VIABLE AT THE TIME; OUT OF COLD CHAIN/OUT OF TEMPERATURE RANGE; This spontaneous report received from a pharmacist concerned 56 patients.  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 expiry date: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced residence and staff members were administered vaccine, which was not viable at the time, and out of cold chain/out of temperature range. The action taken with covid-19 vaccine  was not applicable. The outcome of the residence and staff members were administered vaccine, which was not viable at the time and out of cold chain/out of temperature range was not reported. This report was non-serious.
Red raised rash all over body, runny nose, not feeling well. Spot around belly button was large and swollen. Went to the doctor and got antihistamine and was recommended oatmeal baths and lotion. On 6/28 some of the rash was better but it had spread and worsened on face and back. After nap in the PM child had over 104° fever. Gave ibuprofen and fever went down over a couple of hours.
Complaint of post cervical lymphadenopathy 1 week after injection with hyperesthesia about 11 days after injection, then rash onset 14 days with stiff neck, headache, generalized morbilliform rash. Complained of nausea, dysequilibrium, fatigue, malaise, arthralgias of knees and elbows, throat irritated and ears hurt. Erythema with itching and stinging at right deltoid site of injection; onset 3/14/03.
04/20/2006 received injection 4/21/06 site had soft tissue swelling, warm and hard to touch. Site was erythematous as well.
Shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number not reported) as unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to report a side effect, patient got shingles from the COVID vaccine on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Patient didn't want to get out of the shower; Chills; Headache; Tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient didn't want to get out of the shower), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) in a 56-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included COVID-19 ((Before receiving the vaccines)) in August 2021 and COVID-19 ((Before receiving the vaccines)) in October 2021. Concurrent medical conditions included Iodine allergy and Contrast media allergy (X-ray dye allergy).  On 23-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-May-2022, the patient experienced FEELING ABNORMAL (Patient didn't want to get out of the shower), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, FEELING ABNORMAL (Patient didn't want to get out of the shower), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive(Before receiving the vaccines). In October 2021, SARS-CoV-2 test: positive (Positive) Positive(Before receiving the vaccines).  The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.  Concomitant product use was not provided by the reporter.  Treatment for event included the patient took migraine pills and stated that he was feeling better at the time of report.
Pt called on 6/30/05 and left a voice messange that he'd taken 3 oral typhoid as directed and now had hives on his knes and elbows. He felt he was having a reaction to the vaccine. The pt was contacted and stated that after he had taken 2 doses of oral typhoid, he noticed some small hives on his knees and elbows. He thought he was allergic to the fabric on a chair he'd sat in at work. He took the third oral typhoid pill and several hours later noticed increased hives in size and location. He describes them as dime to quarter sized raised, red and itchy blotches. These blotches extended from his knees to mid-calf and mid-thigh. He also had them mid way between his elbow extending half way up his upper arm and forearm. He took Benadryl 25mg TID that day with mild effect. He did not call or seek medical attention from our Travel Medicine Ctr. A MD friend prescribed prednisone 6 pills for 2 days (? dose 5-10mg?), 4 pills for 2 days, 2 pills for 1 day and 1 pill for 1 day, which he has completed with resulting resolution of his hives. He did not take the 4th dose of oral typhoid. He denies eating any new foods, drugs or vitamins. He has not changed detergents or hygiene products nor has he been hiking or in the woods recently.
Information has been received from a nurse practitioner concerning a 23 year old female patient. Information regarding medical history and concurrent condition was not reported. ON unspecified date in 2008, the patient was vaccinated with a dose of GARDASIL (dose, strength, lot# and route were not reported). The patient received her second dose of GARDASIL on 28-JUN-12 (inappropriate schedule of drug administration), and received her third dose of GARDASIL (lot#: K008931, expiration date unspecified) on 10-APR-2015 (inappropriate schedule of drug administration). No adverse effect had been observed or reported. Additional information has been requested.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a female patient of an unknown age who was received vaccine FLUZONE QUADRIVALENT (batch number, expiry date, dose, route and site of administration were unknown) on 11-Feb-2018, while she was pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was case of vaccine exposure during pregnancy. The patient was 7 months pregnant when she received vaccine. On an unknown date, the patient developed a non-serious viral flu disease (Flu like symptoms) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The event outcome was unknown on an unknown date. List of documents held by sender- none.
moderately sore at test site; site was reddish for a couple days; Entire arm sore after shot; Stiff; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Oct2021 (Lot number: FF8841) at the age of 86 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic UTI", start date: 1970 (unspecified if ongoing), notes: Now under control; "Marrow degenration disease", start date: 2012 (ongoing). Concomitant medication(s) included: FOSAMAX taken for osteoporosis; BROVANA taken for lung disorder; AZITHROMYCIN taken for lung disorder; PULMICORT taken for lung disorder; CARDIZEM CD taken for heart rate; ESTRADIOL taken for bladder disorder; FLONASE ALLERGY RELIEF; LIDOCAINE taken for skin disorder; COZAAR taken for cardiac disorder; SINGULAIR taken for lung disorder; NYSTATIN taken for lip dry; PREDNISONE taken for lung disorder; PREVIDENT taken for teething; RESTASIS taken for eye disorder; SODIUM CHLORIDE taken for lung disorder; SPIRIVA taken for lung disorder; CALCIUM taken for bone disorder; ZYRTEC ALLERGY taken for antiallergic therapy; BENADRYL taken for pruritus; BENADRYL taken for pruritus; IBUPROFEN taken for pain, inflammation; KY taken for nasal dryness; LOPERAMIDE taken for diarrhoea; RETAINE CMC taken for eye disorder; LUTEIN ZEAXANTHIN taken for eye disorder; VIT C taken for bladder disorder. Vaccination history included: Bnt162b2 (dose 1, Anatomical location: L upper arm, Route of administration: Intramuscular, Time: about 15:00, Lot number: EL3249), administration date: 15Jan2021, when the patient was 85 years old, for Covid-19 Immunisation; Bnt162b2 (dose 2, Anatomical location: L upper arm, Route of administration: Intramuscular, Time: about 15:00, Lot number: GN5318), administration date: 05Mar2021, when the patient was 85 years old, for Covid-19 Immunisation, reaction(s): "Entire arm sore".  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "moderately sore at test site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "site was reddish for a couple days"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "Entire arm sore after shot"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "recovered", described as "Stiff". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, vaccination site erythema, pain in extremity, musculoskeletal stiffness.  No follow-up attempts are possible. No further information is expected.
By evening of 09/11/2001 child tired and not active. Child awoke with 103 degree temperature, hurting, trouble breathing, lethargic and problem swallowing. Only medicine for fever call doc by 9am 09/12/2001. He said due to three shots not properly given in the gluteus maximus caused the reaction. Child also suffered vomiting. Doc Rx Phenegram at over the counter drugs for fever. As of 09/13/2001 at 1 pm the child's fever is controllable and feeling very good.
Muscle soreness, shivering chills, sweating. Headache, fatigue ( flu like symptoms) did not verify fever with thermometer
Patient w/history of past allergy to egg, peanuts and strawberries. PMH significant for asthma. Tympanostomy tube placement in 2009. The mother called regarding advice regarding second dose on 7/12. The mother reports that about 1 hour after receiving her first dose of Pfizer vaccine she developed a rash consistent with hives all over her body. She did not have associated shortness of breath, vomiting or diarrhea. Unknown time course for resolution.