chrisvoncsefalvay/vaers-outcomes huggingface dataset:
difficulty swallowing; dizzy; Flush; Felt very hot; lips tingling; tongue felt a little bit numb; shaky; really thirsty suddenly; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: Unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 13:45 (at the age of 39-years-old) at as a single dose for COVID-19 immunization. Medical history included allergic to Compazine and allergic to dogs, both from unspecified dates and unspecified if ongoing. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications (medications received within 2 weeks of the vaccination) included vitamins NOS and ibuprofen, occasional, both taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Apr2021 the patient experienced, difficulty swallowing, dizzy, flush, felt very hot, lips tingling, tongue felt a little bit numb, shaky and really thirsty suddenly. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was received for the events and included Benadryl, Prednisone and an Epipen was prescribed but was not used. The clinical outcomes of the events difficulty swallowing, dizzy, flush, felt very hot, lips tingling, tongue felt a little bit numb, shaky and really thirsty suddenly were all recovering/resolving. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot number cannot be obtained.
The vial was initially stored in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022; The pharmacy gave Moderna COVID-19 vaccine past its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The pharmacy gave Moderna COVID-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The pharmacy gave Moderna COVID-19 vaccine past its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The pharmacy gave Moderna COVID-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was 24-Jan-2022 and administered on 09-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna COVID-19 vaccine instead of 24-Feb-2022. The Moderna COVID-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022. The vial did not undergo any temperature excursions. The reporter did not know which dose the patient was received. The reporter did not have any other adverse events or side effects to report for the patient.  No treatment information was provided by the reporter.
Vasovagal syncope after first dose of Moderna Covid-19 vaccine. After event patient informed staff she routinely has this reaction to medical procedures (lab draws, etc).
The symptoms began with a fever during sleep.  When I woke up I had a fever, headache, and felt light header. I also felt very tired and had no appetite. I took ibuprofen for the fever, which continued to come back until about 07:30pm/08:00pm Saturday evening.  My headache persisted until later Saturday evening after taking over the counter Headache Relief. I gained my appetite early Sunday morning.
This spontaneous report was received from a nurse and refers to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (recombinant human albumin (rHA)), injection, lot # M042846 with expiration date of 21-OCT-2018, lot # M036544 with expiration date of 15-AUG-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour and 10 minutes. There was a previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 3 hours and 8 minutes. Digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA005079: US-009507513-1708USA005079:
Pt was given dose on 10/02/2022; expired 09/30/2022 then expiration updated until 10/19/2022
mild swelling of the inside of the cheeks and both sides of tongue; experiences a bad taste; mild swelling of the inside of the cheeks and both sides of tongue; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (mild swelling of the inside of the cheeks and both sides of tongue), TASTE DISORDER (experiences a bad taste) and SWELLING FACE (mild swelling of the inside of the cheeks and both sides of tongue) in a male 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 reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (mild swelling of the inside of the cheeks and both sides of tongue), TASTE DISORDER (experiences a bad taste) and SWELLING FACE (mild swelling of the inside of the cheeks and both sides of tongue). At the time of the report, SWOLLEN TONGUE (mild swelling of the inside of the cheeks and both sides of tongue), TASTE DISORDER (experiences a bad taste) and SWELLING FACE (mild swelling of the inside of the cheeks and both sides of tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On 5/20/01, pt developed swollen joints, facial flushing and itching of the hands and feet. She was seen in the ER. Additional information recvd from MD on 6/19/01 indicated that the pt was treated with prednisone tapered over 2 wks and diphenhydramine. She recovered.
pt recv vax & no further info was available @ the date of this report, which was received as part of litigation proceedings;
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, lot # L013203, expiration date 28-JAN-2017 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to the emergency room with fever, congestion, fatigue, and runny nose.  At the time of hospitalization, patient had one dose of Pfizer. Later, patient received another dose of Pfizer to complete the two doses. The patient was discharged on amlodipine and dexamethasone but otherwise good health.
patient had the flu within a week; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via Social media and transmitted to Sanofi on 19-Nov-2020.  This case involves a patient of an unknown demography who had the flu within a week (Influenza), while he/she received INFLUENZA VACCINE.  On an unknown date, patient got INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination when he/she was a kid and always had the flu within a week (Influenza). Then patient refused them when he/she was about 13 years old (in 1969) and never got another one. The patient had the flu about 3 times since then and is 64 years old now and the patient reported that he/she had 3 time flu in 50 years which is not bad.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was unknown, at the time of reporting.  There will be no information regarding the batch number for the case.
3pm 1/13: sore left arm at injection site 9am 1/15: swollen lymph nodes in left armpit and a raised, red, hot, painful patch of skin on left arm about 2 inches below injection site
sore arms; This is a spontaneous report from a contactable consumer or other non-healthcare professional from a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 11Feb2021 (Batch/Lot number and Expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medications included acetaminophen taken for an unspecified indication, start and stop dates were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) for covid-19 immunization. On an unspecified date in 2021, the patient experienced sore arms. The reporter stated that she had her 2nd dose of vaccine yesterday (11Feb2021) while waiting for more than two and half hours on the line, she decided to take a medicine called acetaminophen. She later found out that taking medicine before having the vaccine is the wrong thing to do, she said that she did not feel any side effects aside from having sore arms. She was concerned if the second shot will be diminished or if she can take another second dose because of the medicine she took prior to taking the 2nd dose. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Patient experienced light headedness, diaphoresis, stated "i could see black spots in my eyes," but did not loose consciousness.  She stated that she may have not eaten enough for lunch and has a fast metabolism that may have contributed to her symptoms.  Patient transported from hospital vaccine center to hospital ED for further evaluation.
Patient received Bivalent booster rather than first dose moderna vaccination.  This Bivalent booster is the only covid vaccination patient has received.
Left jaw swelled at throat, under ear and jaw bone area.  Advil, Tylenol, ice, moist heat, Arnica cream, triple antibiotic ointment over area Swelling reduced to normal and pain-free by 07/14/2021
The patient has a history of Type II Diabetes and COPD, on 2 L O2 at baseline. He was seen in the ED on 10/12/23 for evaluation of dyspnea on exertion, dry cough, sore throat, sinus congestion, and headaches for the past day. A COVID PCR test resulted positive in the ED. Ultimately, the patient was admitted 10/12/23 - 10/14/23 for acute COPD exacerbation secondary to COVID-19 infection, among other diagnoses.   Of note, the patient has received 3 doses of the Pfizer Monovalent COVID vaccine (given 3/13/2021, 4/3/2021, 5/3/2022) and one dose of the Pfizer Bivalent COVID vaccine (given 9/20/2022).
Felt faint, headache, nausea, laid down, elevated feet, pulse 40, rested, pulse rechecked 68, drank juice, still flushed but reports feeling better.
I experienced blurry vision after 1st dose to a mild extent,lasted approx 1-1/2 days. After 2nd dose is much worse, at this point lasted a day, not sure exactly what time it stated. Indicated the symptom to individual giving 2nd dose,she had not heard this as side effect and have not found online. I do wear glasses for far sightedness, astigmatism and reading. Not really adverse as life threatening but  did not see it reported as a side effect. Also have many of the other typical side effects.
Patient developed pain in left deltoid of moderate level x 15 days. Responded to Ibuprofen, but continues to have tenderness and occasional soreness.
A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal) 0.2 Millilitres. FLUMIST Quadrivalent (Intranasal) started on 17-Mar-2016. Nurse reported that FLUMIST which expired on March 9, 2016 was administered today March 17, 2016 to one patient. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
This case was reported by a physician via call center representative and described the occurrence of diffuse macular rash in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced diffuse macular rash. On an unknown date, the outcome of the diffuse macular rash was recovered/resolved. It was unknown if the reporter considered the diffuse macular rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient experienced a diffuse macular rash after receiving the first SHINGRIX dose. The healthcare professional did not had vaccine information.
Client was scheduled to receive Bivalent Moderna Booster, but was mistakenly given Moderna 6m-5y dose.
rush went through body, throw up - diarrehea, fever, inside of body felt like chemical burn / ok in 4 days
I received the first injection of Shingrix on March 11, 2023 and within a couple of days my face and neck turned red like the worst sunburn you can imagine. It burned and radiated heat and itched. After a couple of days the redness subsided and was followed up with 4 to 5 days of flaking and peeling (I could peel the skin off with tweezers just like a sunburn) Over the next 3 months it flared up 11 times so about once a week and since the beginning June the flare ups have been farther between and less severe, but it has not completely gone away.
PATIENT GIVEN SECOND DOSE OF MODERNA TOO EARLY. SECOND DOSE NOT DUE UNTIL 10/19/21
HEADACHE STOMACH ACHE, NAUSEA, SPOTS BEFORE EYES, EXTREMELY ANXIOUS. RELEASED TO HOME AND DAD WHO IS DOCTOR. FOLLOW UP PHONE CALL MADE AT 6:11 PM DOING WELL, NO PROBLEMS
Scattered nodules on arms, face, firm, red, not itchy, not painful; some nodules surrounded by arm erythema and patch. History of Benadryl. Depo Medrol 30mg IM.
redness; rash; skin warm (heat to the rash area); This case was reported by a consumer via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema, rash and skin warm. On an unknown date, the outcome of the erythema, rash and skin warm were unknown.   It was unknown if the reporter considered the erythema, rash and skin warm to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix and experienced redness and rash are common side effects. The patient enquired that does this include heat to the rash area, and asked long these symptoms does would last.
Narrative:  88 y.o. male who received dose #1 of the Moderna COVID vaccine (Lot #024M20A, exp 8/3/21) on 2/18/21. Past medical history of Alzheimer's dementia, hyperlipidemia, BPH, and vit D deficiency. Patient presented to emergency department on 2/5/21 with sepsis secondary to aspiration pneumonia. He had a decline in functional status during previous week. He was unable to feed himself, walk, and only spoke 1-2 words at a time. Antibiotics discontinued due to goals of care. Family opt for comfort care. Patient was transferred to CLC hospice team on 2/12/2021. Patient passed on 3/1/21 @ 0930. Reaction classified as severe as death occurred following vaccination.
09/13/2021 I started getting sick with cold symptoms but nothing serious with just congestion and I was cleaning with bleach wipes at work and couldn't smell them and realized this had to be more than a cold and so I took an over-the-counter test, and it was positive and the next morning I had to go for compliance for work and had to be tested and I was positive there as well. I had minor cold symptoms Monday-Friday. Saturday, I got really exhausted and felt really sick and I've never experienced that kind of exhaustion and I didn't get out of bed all weekend. Monday I was still sick and exhausted my oxygen saturation never dropped below 95, but on Tuesday I receive the monoclonal antibodies and Wednesday night I was feeling better and had more energy. I don't think I ever got a fever, and my taste and smell came back on Thursday and after the antibodies I felt recovered. Tested positive on 09/16/2021.
Approx 3 hours after infection patient woke from a nap screaming and crying. She was sleeping in her diaper and when her mother went to console her she noted a very well demarcated rash to the LE bilaterally. There was a well defined line to the upper thigh where the legs below were bright red and the heals were noted to be purplish in color.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered the vaccine that underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered the vaccine that underwent temperature excursion) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:53 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered the vaccine that underwent temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered the vaccine that underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19-Nov-2021, when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
PATIENT DEVELOPED SWELLING ON BOTH ARMS MORE SO ON THE LEFT ARM HOT TO THE TOUCH A BIT OF CELLULITIS GIVEN ATARAX 10 MG ADVISED TO APPLY COLD COMPRESSES.
Patient received Moderna (6mo-5yr) on 7/18/2022 when he was 5 years old and came back on 9/2/2022 for their 2nd dose of Covid 19 vaccine. Patient should have received the same vaccine, Moderna (6mo-5yr), however, was administered Pfizer (5-11yr). Patient did not experience any adverse reactions.
Began shivering; Upset stomach; Tiredness; Increased blood pressure / usually 110/65 and this morning it has been 147/75 and 145/75 respectively; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 11th May 2021, 5 days after receiving Shingrix, the patient experienced shivering, upset stomach, tiredness and increased blood pressure. On 12th May 2021, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the upset stomach, tiredness and increased blood pressure were not recovered/not resolved.   The reporter considered the shivering, upset stomach, tiredness and increased blood pressure to be possibly related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received Shingrix on the right arm. The patient began experiencing side effects that might be related to the Shingrix vaccine.  On 11th May 2021, the patient began shivering that lasted for about 12 hours and then resolved. On the same day, the patient had an upset stomach, tiredness and increased blood pressure that had not resolved till the time of reporting. The patient's blood pressure was usually 110/65 and on 11th May 2021 and on the morning of the reporting date, it had been 147/75 and 145/75 respectively. The patient was going to see his Health care provider on the reporting date. The reporter consented to follow-up via email but did not give permission to contact health care professional.
Extreme fatigue, weakness, dizziness the first couple of weeks. Muscle spasms in both legs 9/10 pain level. Swollen lymph node on neck the size of a tennis ball.
First day Tiredness, Muscle pain, Injection site swelling (quarter size)and itchy. using ibprophen 600mg.