chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; Short of breath; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (Short of breath) and URTICARIA (Hives) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DYSPNOEA (Short of breath). On 27-Feb-2021, the patient experienced URTICARIA (Hives). The patient was treated with PREDNISONE at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Short of breath) outcome was unknown and URTICARIA (Hives) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was prescribed with steroids and advised not to get the second dose. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up information received on 30-APR-2021 contains no significant information. On 21-Jun-2021: Followup information included additional treatment medications and action taken was updated.
Local reaction on left and right anterior, upper thigh, 2 inch by 3 inch red, indurated area. Pain eliated due to pt. crying upon touch. No fever. TYLENOL for pain. Ice for pain and or swelling.
pt recvd vax & had sore & tender feet on 4DEC95 by 15JAN96 devel numbness thought to be diabetic neuropathy however presented 19JAN,22JAN & 29JAN w/progressive numbness in lower extremities;adm to hosp 29JAN then to nursing home for rehab
Moderately sore arm around the injection site; mild fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 13:45 (Lot number: EW0158) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; PHENYLEPHRINE HCL. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Apr2021, outcome "recovered" (Apr2021), described as "Moderately sore arm around the injection site"; FATIGUE (non-serious) with onset 08Apr2021, outcome "recovered" (Apr2021), described as "mild fatigue". Therapeutic measures were taken as a result of vaccination site pain, fatigue. Additional information: Clinical course: Moderately sore arm around the injection site over a 24 hour period, beginning 1-2 hours after the injection and continued for 48 hours after injection; also experience mild fatigue for 6-12 hours, starting the day of the injection. Both symptoms were resolved the by the morning of an unspecified date in Apr2021. Treatment included ibuprofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician and a nurse concerning a patient who was vaccinated with "a single dose" of Zostavax, SC. Subsequently the patient experienced vesicular rash with a few lesions on the right leg, ten days post vaccination (also reported as 48 hours post vaccination). The physician reported that the rash looked like herpes simplex rash. The symptoms resolved without treatment. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007.
Nausea and vomiting same day, pain in arm, fatigue, hot and cold
Glucose level has gone very high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE taken for diabetes mellitus; TRULICITY taken for diabetes mellitus; TRESIBA taken for diabetes mellitus. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset Mar2021, outcome "unknown", described as "Glucose level has gone very high". The event "glucose level has gone very high" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased.  Additional Information: Patient have taken the shot in the beginning of Mar and patient have changed medicines and patient cannot seem to get it under controlled (further details unknown). Patient stated, it was 1st but after 2nd it got even worse, it started to get elevated like 2-3 days after the first shot but after the second booster, my sugar was elevated. Patient further stated, the only major side effects having is elevated glucose level and it is getting dangerously high were patient cannot get them lower and patient have consulted with my Primary health care profession about it and he changed and increased level of medication and still on 400 to 500 range.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash, localized reaction. KINRIX given 11/18/14. On 11/19/14 pt scratching arm. (L) arm red and swollen. No seizure. No previous reaction to Iz in the past.
Upon vaccination patient bled and I applied pressure to the site. It appeared to be bleeding under the skin and formed a knot on her arm that was quarter-size in diameter. It puffed up a little. I asked her to stay 15 min and at that time it was about the same size. (Still has a bruise 2 days later). I called to check on the patient.
Developed hives 3 hours after receiving vaccine. Has taken Benadryl at home without resolution.  Started on Prednisone 60mg x 5 days and Pepcid 20 mgs x 5 days
Pt received vaccine on 1/22/21.  On 1/31/21 he presented to urgent care with fever and morbiliform rash.  He tested negative for the flu and was given empiric oseltamivir.  He had persistent fever and was given doxycycline and ceftriaxone by urgent care on 2/2.  On 2/4 at urgent care he was noted to be hypotensive and referred to ER.   He had findings of cardiogenic shock and intra-aortic balloon pump was placed.  He was treated for acute heart failure with improvement in symptoms.  He was also treated for pneumonia with piperacillin/tazobactam as well as amoxicillin / clavulanic acid.  He was discharged with resolved fever, resolved rash, and improvement in EF based on cardiac MRI.  Workup for other viral causes of myocarditis was negative.
pt recv vax 4OCT96 & on 14OCT966 pt exp pain & a rash which was draining fluid;
VACCINE WAS ADMINISTERED TO A 16 YEAR OLD PATIENT. PATIENT'S MOTHER REQUESTED THE VACCINE BY NAME AND SHE WAS ADDED TO OUR SCHEDULE. WHEN SHE ARRIVED AND FILLED OUT HER SCREENING FORM THE VACCINE WAS ADMINISTERED BEFORE REALIZING SHE WAS YOUNGER THAN THE APPROVED AGE. WE HAVE SINCE SPOKEN WITH THE PATIENT AND HER MOTHER ON MULTIPLE OCCASIONS. NO ADVERSE EFFECTS HAVE OCCURED. WE HAVE NOT ADMINISTERED THE SECOND DOSE.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 40 years old male of an unknown ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 014A21A, expiry: Unknown) dose was not reported, 01 total administered on 06-APR-2021 to left arm for prophylactic vaccination.  The patient was 40 years old at the time of his primary vaccine. No concomitant medications were reported. On 06-JAN-2022, the patient additional received Non-company suspect vaccine included: Spikevax (Elasomeran) (Dose number in series 2) (Form of admin and route of admin were not reported, batch number: 028K21A and expiry: Unknown) dose was not reported, administered to left arm for prophylactic vaccination. The patient was 41 years old at the time of his booster vaccine. On 26-MAY-2022, the patient had congestion and slight sore throat (suspected covid-19 infection) (dose number in series 2). The patient thought he had a cold later he developed a cough, body aches, back pain and his limbs feeling tired and achy (dose number in series 2). On 28-MAY-2022, Patient tested positive for Covid-19 Binax test (suspected clinical vaccination failure) (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s and with Spikevax (Elasomeran) was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report associated with product quality complaint: 90000233816.; Sender's Comments: V0-20220562528-Covid-19 vaccine ad26.cov2.s -Suspected Clinical Vaccination Failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
I had symptoms of a fever, a sore throat, body aches and joint pain on 12/27/2022. I tested myself at home and the result was positive on 12/28/2022. I reached out to my PCP and he called in Paxlovid for me. I started to take the medication right away. My whole GI tract seemed to become affected and I was experiencing diarrhea. It also seemed that my skin started to shed as well. I feel that I have recovered from COVID as of today, 01/12/2023.
got super super sick and didn't get the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "got super super sick and didn't get the second dose". Therapeutic measures were not taken as a result of illness.  Additional information: The caller stated he got the first dose of the Pfizer-BionTech Covid-19 Vaccine a little before June, in May, around there. He got super sick and didn't get the second dose. He may go back and get the second dose but asked if they must restart the series if it has been this long. The caller asked if it is super dangerous to just get one dose instead of two. He stated he does not want to end up dying. The caller stated it might scare people away from getting the vaccine at all [if they don't have any data on how safe it is to get just ONE dose and it was only studied as a two-dose series]. He did not provide lot number. He stated they did not give him a card. He only got the first dose not the second dose. He stated that, he might get the second dose later, but he is not sure yet.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Approximately 10-15 minutes after vaccine administration patient reported mild purtius. flat blotchy areas of redness noted on  both sides of neck.  Denied any difficulty breathing.  Client already took 25 mg of bendaryl, singulair and pepcid at 9 am as prophalaxis.  Denied having any side effects from 1st vaccine other then soreness at injection site.  Declined epipen  when blotches occured.  Case did agree and take bendaryl 25mg approximately 10:15-10:20.  Puritus continued to increase.  redness only around neck and upper chest.  no other rashes.  Pulse 104  Respirations 24.  Developed slight coughing.  Did report has history of cough and chronic cystic lung.  Denied any difficulty breathing, however, puritus  increased and still with occasional coughing.  Alert and oriented.  Mother was also present and had received vaccine at same time today.  Agreed to take epi-pen since symtpoms were not improving.  Sheriff's dispatched 911, before this nurse administered epi pen into Left thigh.  Case remained alert and oriented.  No respiratory distress.  EMT arrived at scene, followed by paramedics and ambulance.   Paramedics administered nebulizer outside of facility prior to getting in ambulance.  Case was taken to Medical Center.  Case had already called and notified her MD. Called hospital tonight at pm. Spoke with nurse who reported she is stable and in the ICU for observation.  She received additional epinepherine and solumedrol in hospital.  She is alert and oriented x3
Pt received vaccine on 10/18. On 10/19, she noticed her arm (in the fat layer of the back of her arm) was red, warm, and swollen. She went to have evaluated at a health clinic and was told vaccine had been administered in the fat layer and not intramuscularly. Pt was prescribed cephalexin and reaction site is improving.
Information has been received from a physician concerning a 12 month old female daughter of her husband's coworker who on 10-SEP-2010 was vaccinated with a dose of VARIVAX (Merck) in one leg (dose, route and lot number unspecified). Concomitant therapy included a dose of influenza virus vaccine (unspecified) and a dose of PREVNAR in the other leg. Within 45 minutes (on 10-SEP-2010), the patient experienced fever, swelling and redness at the VARIVAX (Merck) injection site. The patient developed few varicella-like lesions on her trunk, five days later, (on approximately 15-SEP-2010). At the time of the report the outcome of the patient was unknown. Additional information has been requested.
This spontaneous case reported by an other healthcare professional (subsequently medically confirmed), describes the occurrence of hypoesthesia (numbness of upper extremities) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included Crohn's disease since November 2018. Concomitant products included Stelara (ustekinumab) for Crohn's disease. On Feb 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. February 2021, patient experienced hypoesthesia (numbness of upper extremities). At the time of the report, hypoesthesia (numbness of upper extremities): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments.
Cellulitis (warm, pain, swollen at the site of injection. Patient received oral antibiotics (cephalexin 500 mg).
was feeling around my arm pit area after the first dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Thyroid cancer" (unspecified if ongoing); "diabetic" (unspecified if ongoing); "tetanus toxoid" (unspecified if ongoing); "scoliosis" (unspecified if ongoing); "Car accident" (unspecified if ongoing), notes: brain bleed 15 years ago; "Back surgery" (unspecified if ongoing), notes: Back surgery wasn't effective. The patient's concomitant medications were not reported.  The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "was feeling around my arm pit area after the first dose".  Additional information: I am in a really small town, I had a GYN appointment and was feeling around my arm pit area after the first dose, before the second, and they told me that Pfizer says this can happen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The second dose of Pfizer vaccine was administered on 01/19/21 at 6:00am. By 11am, I felt extremely tired and took a nap (something I never do). By 12pm, I had significant joint pains in knees, fingers, toes, and elbows, with muscle soreness soon to follow. By 3pm, I had a moderate headache. By 7pm, I had a 104*F fever with chills and very severe rigors. Acetaminophen and Ibuprofen, when taken at maximum strength and rotated, helped reduce the fever to 101-102*F. Spikes of 103-104*F persisted for 36-48 hours. By 01/21/21, the fever had subsided. By 01/22/21, the muscle and joint pain subsided.
Pt experienced marked erythema of anterior lateral thigh with swelling. Inguinal node enlarged.
High fever 102.8 at the above time. Fever over 101 lasted 10 hours. But initial symptoms of tiredness, headache and unsteadiness began about a few hours after the vaccine. Called facility for advice after fever peaked at 102.8. My wife, who is a chiropractor, gave me sponge baths and aspirin.
Swelling, redness, warmth left upper arm of 23cm x 16cm.
On 11/17 or 18 developed significant pain, chills, fatigue and then developed blisters on 11/21. Made MD appointment & diagnosed with Shingles on 11/23 and began 7 day treatment with Valtrex. Still having pain in shingles area, slowly seems to be improving.
Cold sweats began 1 d. after vaccination. Slight arm discomfort at site of injection. Fatigue. All Sx subsided in 24 hrs.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media through a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. The patient reported as "Know this 1st hand, three of us had COVID19 positive, sick for 10 plus days, despite Pfizer, Moderna and JNJ vaccines". Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000212246. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220130852.  Version created to amend previously reported information on 31-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V2: Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event.  20220130649-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This case was considered medically important for the events of developmental delay, nervous system disorder, immune system disorder, immune system disorder and speech disorder developmental. A legal complaint regarding Hib Titer vaccine was received from an attorney regarding a male patient who received the third dose of Hib-Titer along with the third dose of Diphtheria/Tetanus toxoids/Acellular pertussis vaccine on 07-Oct-1998 at the age of 6 months. The patient was allegedly exposed to very high doses of mercury from thimerosal containing vaccines. On an unspecified date, the patient experienced neurological damage, immunological damage, loss of language and developmental delay. On 07-Oct-1998, the patient received the third dose of Hib-Titer vaccine along with another childhood vaccine. During the first fifteen months of life, the patient was exposed to very high doses of mercury from thimerosal containing vaccines. On an unspecified date, the child experienced developmental delay, neurological damage, immunological damage and loss of language. It was unknown if the patient recovered from the events. No additional information was available at the time of this report.
Injection site developed "egg shaped raised area"; Injection site became "hot to the touch"; Injection site became red; Injection site became painful; Injection site became swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Injection site developed "egg shaped raised area"), VACCINATION SITE WARMTH (Injection site became "hot to the touch"), VACCINATION SITE ERYTHEMA (Injection site became red), VACCINATION SITE PAIN (Injection site became painful) and VACCINATION SITE SWELLING (Injection site became swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Anxiety and Thyroiditis NOS. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN, VITAMIN D3 and VITAMIN B12 NOS for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site became "hot to the touch"), VACCINATION SITE ERYTHEMA (Injection site became red), VACCINATION SITE PAIN (Injection site became painful) and VACCINATION SITE SWELLING (Injection site became swollen). On 01-Apr-2021, the patient experienced VACCINATION SITE MASS (Injection site developed "egg shaped raised area"). At the time of the report, VACCINATION SITE MASS (Injection site developed "egg shaped raised area"), VACCINATION SITE WARMTH (Injection site became "hot to the touch"), VACCINATION SITE ERYTHEMA (Injection site became red), VACCINATION SITE PAIN (Injection site became painful) and VACCINATION SITE SWELLING (Injection site became swollen) had resolved.            The other concomitant medications include Thyroid Medication, High Blood Pressure Medication and Anti-Anxiety Medication. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up information received on 14-May-2021 and outcome of the event was updated.