chrisvoncsefalvay/vaers-outcomes huggingface dataset:
constipation; neck stiffness; headaches; fatigue; soreness/Body soreness; soreness (both body soreness and injection site soreness); This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 12:00 pm at single dose at left arm for covid-19 immunization. There were no concomitant medications. Patient previously had the flu vaccine and had what was described as a less reaction, like a sensitivity. He had a slight fever and fatigue, like his body was fighting something. The patient has no product name, NDC, Lot, or Expiry for that product. Patient had no other medical history (including any illness at time of vaccination). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the Pfizer suspect. On 07Jan2021 01:00, patient had the side effect of constipation after getting the vaccine, neck stiffness, and headaches, patient was experiencing these as well as fatigue and soreness (both body soreness and injection site soreness). The body soreness was like he worked out and his whole body was sore, the injection site soreness was more sore than his body but this was to be expected and it was about the same though didn't feel at first but felt it more on 07Jan2021. All the events started at about 1am on 07Jan2021. No history of all previous immunization with the Pfizer vaccine considered as suspect. No family medical history relevant to adverse events. Outcome of events neck stiffness, and headaches was recovering, and outcome of other events was not recovered. This report is considered as non-serious. The adverse events didn't require a visit to emergency room nor physician office.   Information on Lot/Batch has been requested.
The pharmacist gave me the injection low on my L arm. The next week I started to have pain in my thighs, leg weakness. I had trouble stepping off a curb, and would tire on my 30 min walk, which was usual for me at that time, I was very healthy, working full time. My legs weakness and fatique continued and I thought it was related to my lack of exercise, I tried to walk more and got worse and worse. I had an annual check up appointment with my doctor 10.11.2020. I told him my legs were weak, he said to watch and wait. I continued to have symptoms and got progressively worse. I fell on 11/18/20, had a head injury & went to ER.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received SHINGRIX (batch number 27K24, expiry date 22nd February 2021) for prophylaxis. On 29th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. The patient stated that he received a dose SHINGRIX and experienced soreness at the site on the next day. The soreness resolved after about 2 to 3 days. The healthcare professional information was not asked. This case has been linked with case US2018GSK151213 (same patient), reported by the same reporter.
experienced chills just for one night; had a red circle on his arm that did not hurt, but it went away eventually; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (experienced chills just for one night) and VACCINATION SITE ERYTHEMA (had a red circle on his arm that did not hurt, but it went away eventually) 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.   In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (experienced chills just for one night) and VACCINATION SITE ERYTHEMA (had a red circle on his arm that did not hurt, but it went away eventually). At the time of the report, CHILLS (experienced chills just for one night) and VACCINATION SITE ERYTHEMA (had a red circle on his arm that did not hurt, but it went away eventually) had resolved.            No concomitant drug was reported. The patient received the Moderna primary series and two boosters. No treatment drug was reported.   Reporter did not allow further contact
This spontaneous report as received from a physician refers to a 61 years old male patient. It was reported that the patient was given VARIVAX (Lot# not reported) instead of ZOSTAVAX due to an office error on 03-JUL-2012. No adverse events reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information has been requested.
Pt felt dizzy, had hot flashes, and hearing became muffled. Pt was sweating.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous)  Solution for injection in Prefilled pen. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication details was not reported.  Treatment details was not reported.  It was unknown if the patient was enrolled in a COVID-19 vaccine trial or not.  The reporter causality for the event of COVID-19 with the suspect vaccine Spikevax was reported as possible while the the reporter causality for the event of COVID-19 with the co-suspect drug Humira was reported as not related (no reasonable possibility).  Company comment: This spontaneous case concerns a female patient of an unknown age, with no relevant medical history, who experienced the unexpected non-serious of COVID-19 after receiving the dose of mRNA-1273 vaccine on an unknown date. The onset date of the event was not reported. Clinical course and treatment details were not reported. The outcome of event was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as non-serious based on medical judgement. Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no relevant medical history, who experienced the unexpected non-serious of COVID-19 after receiving the dose of mRNA-1273 vaccine on an unknown date. The onset date of the event was not reported. Clinical course and treatment details were not reported. The outcome of event was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as non-serious based on medical judgement.
This spontaneous report was received from a nurse and refers to a 19 year old female patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. The nurse reported that on multiple unspecified dates, the patient received a full 3 dose series of RECOMBIVAX HB (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis at unspecified ages. After the series were complete, on an unspecified date, the patient had "titers" drawn which showed that the patient did not seroconvert. The reporter stated also that on an unknown date, the patient was inadvertently vaccinated with one adult dose of RECOMBIVAX HB 10/1.0 microgram/ ml (lot #, expiration date, dose and route of administration were not provided). No other adverse events were reported. The outcome of the events and the relatedness between the event and RECOMBIVAX HB were not reported.
Fatigue-very tired; This is a spontaneous report from a non-contactable consumer. A 41-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot/batch number and expiration date not reported), via an unspecified route of administration in left arm on 18Mar2021 at 13:00 (at the age of 41-year-old) at single dose for COVID-19 immunisation. The patient's medical history was not reported. It was unknown if the patient had any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications included TYLENOL, multivitamin, and other unknown medications. On 18Mar2021 at 15:00, the patient experienced fatigue-very tired approximately 2 hours after took Pfizer COVID-19 vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fatigue-very tired was recovered in Mar2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. This follow-up report is being submitted to amend previously reported information, patient received first dose of BNT162b2 in US.
Information has been received from a doctor of pharmacy concerning a patient who on an unknown date, was vaccinated subcutaneaously with a 0.65 ml dose of ZOSTAVAX (Merck). On an unknown date, the patient developed a swollen knot at the injection site. On 07-JAN-2011, the patient recovered from swollen knot at injection site. The patient did not seek medical attention. Follow up information received from reporter doctor of pharmacy concerning a female patient with no illness at the time of vaccination, who on 28-DEC-2010 at 11:00am, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 665522/1765Y, expire date not reported), subcutaneously in the left arm. Doctor of pharmacy stated that on 28-DEC-2010 afternoon, the patient's injection site on upper left arm grew to be the size of a tennis ball and was itchy for 2-3 days. Doctor of pharmacy added that on 01-JAN-2011, the patient had recovered. No diagnostic/laboratory tests were performed. Additional information is not expected.
Expired vaccine was stored and then administered; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) and EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered). At the time of the report, PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) and EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        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.  Reporter stated that vaccine did not undergo any temperature excursion and patient did not experienced any adverse event and the date vaccine placed in refrigerator was on 18-Oct-2021.
Pt was given both vaccines in same location, then a few hours later had trouble breathing, rash from head to toe, soreness of thigh and "bumpy" thigh. Pt was brought to Hospital ER by parent and is doing well now.
Patient presents to ED due to SOB and cough.  Patient presented drowsy and disoriented.  He was found to be covid positive in ED, and was also covid positive in March.  In ED H/H was 6/19- 1 unit PRBC ordered.  CT chest showed subcutaneous emphysema and pneumomediastinum and bilateral airspace consolidation, patient was bradycardic in the 30's, atropine 0.5mg x 1 given.  Patient was admitted to hospital.  On 5/25/2022 patient was ESRD, permcath placed to be dialyzed.  06/06/2022  patient declined in condition, increased WOB on HFNC d/t hypoxia, more hypotensive and hypoglycemic.  Patient expired on 6/8/2022.
Having cold; 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 02Jun2021 (Lot Number: D21JBED; Expiration date: Unknown) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported as thinking of getting a cold on an unknown date in Jun2021. The patient wanted to know about getting second dose when having cold. The outcome of the event was unknown. The patient was scheduled to receive second dose of vaccine on 23Jun2021 13:00.  No follow-up attempts are possible. No further information is expected.
Arm pain on the Injection site radiating to the left Armpit 3-4 hours after injection.  Headache, chills, Nausea, dizziness and fatigue for 2 days.  January 10 is second covid vaccine date and January 12th woke up with a swollen left Armpit close to the breast.   Left axillary lymph node swollen ? Not sure until I see a doctor.  Will go to ER or Immediate Care to get it checked out.
Completed administering vaccines, patient and family refused to stay the 30 minute in office wait time, states "we are going downstairs, we will wait there", patient ambulated to check out counter, staff notified nurse, upon arrival patient was on floor unresponsive for approx 30 seconds, patient the opened eyes questioning what had happened, patient was then AAOx3, assisted patient to stand and ambulate to patient room, patient waited in office approx 30 minutes without any further episodes, aunt was called later that evening and did not voice any concerns.
first was lightheadedness;then a burning or raw & tingling under arm down to elbow 7 all across chest & breast, w/a feeling of having an resp problem & still having the same problem;
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Back surgery (3 years ago). Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included EVOLOCUMAB (REPATHA) for Cholesterol.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) First booster dose. In April 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            First booster dose: 22/Nov/2021 Lot#(first part of log unrecognizable)21A. Patient had surgery on their back 3 years ago and that was the same place where the itchiness was located. Patient took blood pressure medicine unrelated to the vaccine. No treatment information was provided.   This case was linked to MOD-2022-606180, MOD-2022-606193, MOD-2022-606199 (Patient Link). Company comment: This spontaneous case concerns a female patient of unknown age with current medical history of Hypertension and High cholesterol, who experienced the unexpected non-serious AESI of COVID-19. The event occurred approximately 5 months after administration of third dose of mRNA, the exact date of onset of the event was not specified, the initial two doses of unspecified brand were given approximately 8 months prior, the interval between the two doses is 28 days. The patient's current medical condition of Hypertension and High cholesterol could be confounders to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-606180, MOD-2022-606193, MOD-2022-606199 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient of unknown age with current medical history of Hypertension and High cholesterol, who experienced the unexpected non-serious AESI of COVID-19. The event occurred approximately 5 months after administration of third dose of mRNA, the exact date of onset of the event was not specified, the initial two doses of unspecified brand were given approximately 8 months prior, the interval between the two doses is 28 days. The patient's current medical condition of Hypertension and High cholesterol could be confounders to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient expressed she was very nervous about receiving COVID-19 vaccine. Patient vaccinated, minutes later started to c/o felling dizziness and lightheaded. Vitals were taken BP 78/55, HR 86, resp 14 O2 97% . Patient was then offered water and had her laid down. Patient started to feel better, vitals retaken every 5 minutes last vitals taken at 0935 BP136/85, hr 91, resp 14. Patient was was able to walk out feeling much better @0945
A report has been received from a Health Professional concerning a 16 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 11-Oct-2012. The patient experienced HEADACHE and SWELLING IN ONE NOSTRIL which started on 23-Oct-2012. At the time of reporting, the event of HEADACHE and SWELLING IN ONE NOSTRIL was ongoing. The report was considered to be non-serious.
swelling of left lower arm,Injection given in lower area of arm.Numbness,tingling with progressive weakness in left arm.Left arm started to become limited in range of motion.I received a steroid shot  which loosed  arm up a little so that I could take physical therapy which gave me alittle more range of motion but  the injection site started having stabbing pains which ran up into my neck and down into my thumb area on left arm which is not  helping with pain  .
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 10-OCT-2012 13:02, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperature below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
flu symptoms; fever; headache; This is a spontaneous report from a contactable consumer.   This male consumer (patient) of unspecified age reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) dose unspecified, via an unspecified route of administration on 07Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jun2021, he patient experienced flu symptoms, fever and headache. He had his Covid Vaccine Pfizer on 07Jun2021 and has had flu symptoms, fever, headache for 5 days. Outcome was resolved on an unspecified date in Jun2021 for all the events. No additional information was provided and if you require additional information, please contact the reporter directly.   Information on Lot/Batch information has been requested.
FATIGUE; WEAKNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN) .5 ml, start therapy date was 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 patient  experienced fatigue, and weakness. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and weakness was not reported. This report was non-serious..
pt recved flu vax in NOV91 & 2 months later 13JAN92 cancer screen (CA-125) test was performed w/result of 219; prev results for this pt has been in the range of 7-30; pt exp no apparent sequelae;
This study case was received from the investigator on 04 June 2012. A subject received the following vaccinations: On 13 February 2012: an injection of ACAM2000 (lot number not reported) and on 10 February 2012 an injection of anthrax (manufacturer and lot number not reported) and hepatitis A (manufacturer and lot number not reported). On 24 February 2012, the subject was diagnosed with non-specific myocarditis and on 27 February 2012, the subject was diagnosed with other and unspecified acute myocarditis. Medical history was not reported. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance study. Documents held by sender: None.
previously had Moderna covid vaccines and booster; pain in both lower legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 Immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 Immunization; Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2022, outcome "not recovered", described as "pain in both lower legs"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Dec2022, outcome "unknown", described as "previously had Moderna covid vaccines and booster".  Additional information: Patient previously had Moderna covid vaccines and booster. On an unknown date in Dec2022 (reported as last week), patient received the newest Covid booster, it was Pfizer. Since then, the patient had experienced pain in both lower legs, mostly at night. The patient inquired if it was a side effect and if so, how long did it last. The patient did not experience it after the other vaccinations.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Severe dizziness within 10 minutes of vaccination that persisted for several days. Paleness, weakness, & a fast heartbeat that lasted for several days.