chrisvoncsefalvay/vaers-outcomes huggingface dataset:
back pain; chills; body aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization, reaction(s): "back pain", "chills", "body aches". The following information was reported: PAIN (non-serious), outcome "not recovered", described as "more intense pain"; BACK PAIN (non-serious), outcome "unknown", described as "back pain"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "body aches". Therapeutic measures were taken as a result of pain, back pain, chills, pain.  Additional information: Patient Age was not provided. Event Verbatim: Patient stated he received the second dose of the Pfizer Covid vaccine and has been experiencing more intense pain this time around than the first dose, In particular his back pain, although he was also having chills and body aches, but the most intense was his back pain. He was taking Tylenol which was not helping and would like to take Ibuprofen. Patient wanted to know if it was allowed to take Ibuprofen because Tylenol does not do anything for the pain. In the Pfizer-BioNTech COVID-19 vaccine study, people were allowed to take fever-reducing medications and pain relievers. The Centers for Disease Control & Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) has provided interim considerations for the use of COVID-19 mRNA vaccines (like the Pfizer-BioNTech COVID-19 Vaccine) during the Emergency Use Authorization. These interim considerations state that antipyretics and pain medications (like acetaminophen and non-steroidal anti-inflammatory drugs, like ibuprofen) may be taken after vaccination for treating symptoms, if medically appropriate.  No follow-up attempts are needed. No further information is expected.
Administered expired Vaccine on 03Jan2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-438074, MOD-2022-438047 (Patient Link).
Approximately 12 hours after injection, gradual onset erythema, edema and pain "ache". Extending about six inches distally from right upper arm which subsided after about 2.5days after. Advil and Bendaryl. Mild erythema, "ache and knot" remain. Night sweats and fever for 36 hours.
fatigue, chills, headache, body aches and pains, sore arm, nausea  and fever.  Fatigue persisted for 3 days. Chills, body aches and pains and nausea persisted for 2 days. Fever broke after 24 hours at which time I had a headache for the remainder of time. The soreness in my arm lessened over 3 days and by day 4 my arm was felling better. Initially, my arm hurt more after the 2nd dose than it did after the 1st dose. I was experiencing side effects for a total of 3 days.
rash appeared on lower extremities & both arms (henogh schoenlein purpura);
Itching on her face and abdomen; Headache; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itching on her face and abdomen) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching on her face and abdomen) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of 25 milligram Po. At the time of the report, PRURITUS (Itching on her face and abdomen) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received and contains no new information.
headache; chills; got warm and thinks he has small fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills) and PYREXIA (got warm and thinks he has small fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included CLONIDINE and AMLODIPINE for Blood pressure management, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ALPRAZOLAM for an unknown indication.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (headache), CHILLS (chills) and PYREXIA (got warm and thinks he has small fever). At the time of the report, HEADACHE (headache), CHILLS (chills) and PYREXIA (got warm and thinks he has small fever) outcome was unknown.            For treatment patient reported in middle of the night took migraine medicine, and today flu medicine (unspecified)
inj 12/16/09 -Developed soreness 5 hours post injection. Increased pain with some swelling the following day. 12/18 2:30 am, woke up w/some pain and swelling and redness halfway down the inside of arm. The swelling was down to elbow.  -Most likely chemical reaction but cant R/O cellulitis. CEPHALEXIN 550 mg QID x 10 days
After receiving the vaccination I experienced a rash and developed an irregular heartbeat, I visited my physician and was advised to wear a monitor for my heart. The results showed an irregular heartbeat.
Myalgia, Arthralgia, Arm is sore from vaccine, has a knot Narrative:
Initial report was received from an allergist on 23 August 2011. A two-month-old female patient had received a first dose intramuscular injection of PENTACEL (lot number not reported) and an unspecified amount of time later, she began crying, her lips turned purple and she developed a fever. It was not reported if the patient had been medically evaluated or received treatment for this event. The patient was seen by an allergist and had skin testing performed (date not reported) which showed delayed reaction. At the time of vaccination, the patient had no concurrent illness, no pre-existing medical conditions and she had not been taking any concomitant medications. It was unknown if the patient had received any other vaccines within four weeks of PENTACEL vaccination. Outcome was recovered. This patient experienced a similar subsequent event which has been captured in case number 2011-07442. Documents held by sender: none.
Patient called the next day and complained of knot in her arm that was sore to the touch. She also states she experienced facial swelling, headache and itching all over.
"Slight" fever for 2 days following immunization, feeling hot then cold. Then approximately 4 days after immunization blister/bumps appeared on right leg (some but not many) then a couple of days later blister/bumps appeared on left leg (many), still on both legs.
I am experiencing seizure like spasms in the area of the injection. It started a few hours after I received the vaccination and have continued consistently for the past 24 hours. The spasms last for several minutes before stopping for about 30 minutes.
This spontaneous report was received from a medical assistant and refers to a currently 4 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # N025894,expiration date 19-SEP-2019, lot#N025898, expiration date 19-SEP-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. It was unknown, which lot# of vaccine were administered to the patient. The doses of vaccines experienced the temperature excursion of 47.12 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA010333:Original Case : 1809USA008636, US-009507513-1809USA010335:Original Case : 1809USA008636, US-009507513-1809USA008636:Original Case : 1809USA008636, US-009507513-1809USA010336:Original Case : 1809USA008636.
Patient was nervous prior to immunization. After immunization, patient was seated and felt lightheaded and dizzy. Patient hit head on advertising sign. Pharmacy staff lowered patient to the ground and was provided ice packs while waiting for EMS. Pharmacist took patient's pulse which was normal; patient was sweaty and clammy. EMS escorted patient out.
Positive Covid PCR test; Positive Covid PCR test; booster; This is a spontaneous report received from a contactable consumer.  A 43-year-old patient received bnt162b2 (COMIRNATY), administration date Nov2021 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "unknown" and all described as "Positive Covid PCR test"; IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) positive, notes: Asymptomatic.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. The patient was reported to be allergic to penicillin, mycins and sulfa. On an unknown date, the patient received ZOSTAVAX. Other suspect therapies included PREVNAR 13. It was reported that the patient developed reaction to ZOSTAVAX that lasted a year. Reporting pharmacist enquired regarding PREVNAR 13 if it was made from any source of penicillin, neomycin, streptomycin or sulfa. Outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
Full of blood clots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Full of blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Full of blood clots). At the time of the report, THROMBOSIS (Full of blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications was not provided.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious AESI of Thrombosis. The event occurred an unknown number of days after an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Manual override done to remove seriousness criteria of Medically significant from event of Thrombosis based on medical judgement and review of source document that does not support seriousness criteria.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The age at the vaccination was not reported. The reporter reported that patient had received only 4 doses of Dtap vaccine at an inappropriate age. Health care professional asked Medical information for recommendations on how to proceed. According to the CDC -patient should be administered a Tdap which was indicated for 10 and older in place of the 5th dose of Dtap, which led to inappropriate age at vaccine administration. Consent to follow up was granted by email.
Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
pt recv vax 21MAY96 & pt became pregnant (LMP 9MAY96);it was estimated that pt conceived 4 days p/vax;ultrasounds 3JUL96 & 1OCT96 were nl;lab eval on 5SEP96 revealed a neg varicella titer;
Swelling under armpit, tenderness under armpit. A female patient received AFLURIA (prefilled syringe) on 15-Oct-2008 (PM) in the hospital and complained of swelling under the armpit on the morning of 17-Oct-2008 at 6:00 AM (06:00 hours). The injection was given in the left deltoid, IM injection. The nurse palpated the area and did not feel that a lymph node was involved, nor was any redness observed. The patient stated it feels tender. patient has allergies to sulfa and Tylenol(acetaminophen. Follow-up information was provided by patient and nurse on 20-Oct02008. The 50 year-old patient (DOB 11-Jan-1958) reports she is not yet recovered and that she is to visit with her physician on 20-Oct-2008. The patient reports she does not receive any other vaccinations within the past 4 weeks and reports no known pre-existing medical conditions. Patient had no illness at time of vaccination. Additional information has been requested.
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 49.62 years.  No concomitant medications were reported.  On 03-Apr-2021, at 09:00 AM, vial underwent excursion with temperature of 34. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021. 20 vials were sent to clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This case was reported by a nurse vial call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX. On 23rd January 2018, the patient received SHINGRIX. On 24th January 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site itching. The patient was treated with VASELINE. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site itching were recovering/resolving. The reporter considered the injection site pain, injection site erythema, injection site swelling and injection site itching to be almost certainly related to SHINGRIX. Additional details were provided as follows: The case was reported by a nurse practitioner who was the patient. There was no other medical history or medication history or concomitant vaccines reported by caller. The patient received SHINGRIX in left deltoid. The reporter stated that symptoms were getting better and no other medical treatment besides VASELINE at site had occurred. She did not have batch number or expiration. There was no address was provided for facility. The reporting nurse practitioner stated that she was not calling to report adverse event.
Note:  my Pfizer vaccine was a booster after receiving the J&J vaccine March 10, 2021.  I had sudden sensorineural hearing loss in the right ear in the lower frequencies commencing 4 days after the 10/27 vaccine and lasting for about 2 weeks.  It resolved with a course of high dose steroids (60 mg for 1 week with taper for 1 week) which were commenced on Monday 11/1.  This was identical to sudden sensorineural hearing loss which occurred after my J&J vaccine in March (for which I also filed a vaers report), though in the left ear.  At the time I took the Pfizer vaccine, Pharmacy offered the flu vaccine and said it was safe to do together.  This was my first flu vaccine so I cannot be 100% sure which caused my symptoms.  However the hearing tests for my right ear hearing loss were almost identical to the hearing tests for my left ear hearing loss from the J&J vaccine in March.
Potential Hyperplastic reaction; This case was reported by a other health professional via sales rep and described the occurrence of hyperplasia in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of supraventricular tachycardia (received 1st dose in February or march 2019 and experienced SVT).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced hyperplasia. On an unknown date, the outcome of the hyperplasia was unknown.   It was unknown if the reporter considered the hyperplasia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after receiving 2nd dose experienced potential Hyperplastic reaction. The reporter stated that oncologist following the patient. The reporter consented to follow up.
10 days after, I started having very severe hip and leg pain. Days later, I went to the doctor, and I was prescribed Prednisone and had X-rays. There was a little comfort, about 3 weeks later, both of my feet were numb. I still have numbness in my feet all day. The pain gets worse as the day goes by. I started physical therapy. Then I went to the pain doctor for the pain in my hips, feet, and legs.
bad headache, nausea and vomiting, chills, dizziness, fatigue, weak , 102 fever. Took Tyelonol
Patient fainted onto the floor minutes after receiving the vaccine. According to bystanders nearby, they observed seizer like appearance. When pharmacist came towards patient, patient was awake and alert without seizure symptoms. 911 was called, blood pressure and heart rate were normal. Patient was seated and allowed time to rest. After resting, he was fine to go home.
the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.    On 09-JUL-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dosage regimen was not provided) lot number S032355, expiration date 14-OCT-2021, administered subcutaneously, for prophylaxis; which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) lot number S032591, and expiration date 16-AUG-2022.     The improperly store dose experienced a temperature of 6 degrees Fahrenheit (°F) to 14°F (average temperature was 13.6°F) for 12 hours on multiple excursions; and 15°F to 46°F (average temperature was 16.0°F) for 30 minutes, with no previous temperature excursions. The call was performed due to digital data logger.; Sender's Comments:  US-009507513-2009USA001256: US-009507513-2009USA001233:
extreme fatigue and arm felt heavy/dead - started immediately or 3-4 hours after vaccine.  Fever of 102, chills, body aches, nausea - started 10 hours after vaccine and lasted a full 24 hours.  Did not start to improve until Thursday at 8:00PM.  Arm remained very red, looked like a rash for 3 days afterwards.