chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Misses the 6 month second shot schedule; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter asked if the patient missed the 6-month second shot schedule, did they need to have two more shots. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule.
rash where she received her injection; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2021, the patient received the 1st dose of Shingrix. On 24th August 2021, 1 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself. The age at vaccination was not reported. The patient stated that, she got her first Shingrix vaccine yesterday and woke up this morning on day of reporting with a rash on her arm where she received her injection.  The patient declined to provide any additional information regarding this report.  The reporter did not consent to follow up. The patient declined to provide any additional adverse event details.
Initial unsolicited report received from a consumer via Pfizer (reference no 2016444890) on 03 Oct 2016. This case involves a female patient who was vaccinated with a dose of FLU SHOT (Batch number, expiration date, route of administration was not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient flu like symptoms. Relevant diagnostic tests/laboratory data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
maculopapular, puritive rash; 1st noticed on back & abdo on 19OCt; rash spread to chest, head, upper & lower extremities by 21OCT; pt devel lymphadenopathy, fever of 101; ER visit on 21OCT; dx as having react to MMR; 22OCT was walking stiff
Immediate left shoulder pain, no relief. Dx rotor cuff syndrome with tendon irritation. Cortisone injection ongoing PT
HCP stated patience received a vaccine after a temperature excursion; The maximum temperature reached is 22.1 F. The minimum temperature reach was unknown; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated patience received a vaccine after a temperature excursion), PRODUCT STORAGE ERROR (The maximum temperature reached is 22.1 F. The minimum temperature reach was unknown) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated patience received a vaccine after a temperature excursion), PRODUCT STORAGE ERROR (The maximum temperature reached is 22.1 F. The minimum temperature reach was unknown) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated patience received a vaccine after a temperature excursion), PRODUCT STORAGE ERROR (The maximum temperature reached is 22.1 F. The minimum temperature reach was unknown) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated patience received a vaccine after a temperature excursion) and PRODUCT STORAGE ERROR (The maximum temperature reached is 22.1 F. The minimum temperature reach was unknown).    No concomitant medication was reported.  It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. 1st lot number 066H21A. The excursion in the freezer was between the beginning of January to November 2022 for a total of 123 hour 10 minutes not in a row. Something was wrong with the freezer and the temperature kept changing. 2nd lot number 002M21A. The expiration date was 11-Sep-2022. The excursion in the freezer was between the beginning of January to November 2022 in 15 minutes increments in a course of a few hours. 3rd lot number 215K22A and the expiration date is 19-Aug-2023. The excursion in the freezer was between 10March2023 to 01May2023.  No treatment information was reported.   Reporter did not allow further contact
Extreme neck and head pain, dizziness, headache, ear pain, left ear extreme tinnitus. Received a brain MRI, Neck MRI, x-rays. Spinal stenosis was determined from neck MRI. Brain MRI was OK. Took physical therapy for neck pain. To date still have dizziness , ear ringing and neck pain
1 wk p/inject rt deltoid pt devel 3 inch large red area w/multiple size blisters around it w/itching @ site
Patient received the vaccine then went home and called back about 30-40 mins later and claimed he didn't feel good and had fallen.
cough; feels like he is getting a cold.; sore throat; severe headache; sleeplessness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (4 to 5 years ago).   On 17th December 2019, the patient received the 1st dose of Shingrix. On 17th December 2019, less than a day after receiving Shingrix, the patient experienced headache and sleeplessness. On 18th December 2019, the patient experienced sore throat. On 19th December 2019, the patient experienced cough and cold. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the sore throat was recovering/resolving and the outcome of the cough was not recovered/not resolved and the outcome of the cold and sleeplessness were unknown.   It was unknown if the reporter considered the headache, sore throat, cough, cold and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient had a dose of shingrix and experienced a very sever headache that kept him awake all night and most of the day yesterday. The bad headache all over but especially painful at the back on his head. The patient developed a severe sore throat and it was better but he developed a cough and feels like he was getting a cold. The follow up consent was not granted. This case has been linked with case US2019232406, reported by same reporter.
This spontaneous case, initially received on 20-Dec-2017 from other non-health professional, concerning a 34-year-old, adult, female pregnant patient of weight 136 lb and height 61.5 cm. The patient's history included, two previous pregnancies and one spontaneous abortion previously. The patient's family history had no congenital malformations. The patient had no habit of tobacco, alcohol or illicit drug use. The patient's current condition included anemia and cramps. The concomitant medication included Ferrousul for anemia, VITAFOL-ONE for healthy pregnancy and CALTRATE with vitamin D3 for cramps. The patient last menstrual period (LMP) was reported as 15-Mar-2017. On 05-Jun-2017, cystic fibrosis mutation analysis had performed and the result was normal (no major congenital malformations noted). On 10-Jun-2017, firs trimester screen and panorama had performed and the result was normal (no major congenital malformations noted). On 03-Jul-2017, alpha fetoprotein sequential screen (AFP-SEQ) had performed and the result was normal (no major congenital malformations noted). On 07-Jul-2017, amniocentesis had performed and the result was normal (no major congenital malformations noted). On 11-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644623A, dose, route of administration, anatomical location and expiry date: not reported), at 25th week of pregnancy. The nature of the pregnancy was reported as singleton. The estimated date of delivery (EDD) was reported as 20-Dec-2017. The reporter assessed this case as non-serious.
horrible headache; Body ache; shivering; fever; oxygen was very low; This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th February 2020, the patient received Shingrix. On 11th February 2020, 1 days after receiving Shingrix, the patient experienced headache, general body pain, shivering, fever and oxygen saturation decreased. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the general body pain, shivering, fever and oxygen saturation decreased were unknown.   It was unknown if the reporter considered the headache, general body pain, shivering, fever and oxygen saturation decreased to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient for self. The age at vaccination was not reported. The patient received Shingrix vaccine and experienced horrible headache, body ache, shivering and fever. The patient had a doctor appointment for another issue and oxygen was very low. The patient wanted to know the events were normal. Till the time of reporting the patient had headache.
3 days p/immun pt was limp, wouldn't suck, pt slip through mom hands when lifted under arms; pt was taken to MD 3rd day; MD felt poss shots; pt was treated for OM;
Sore arm , headache, and fatigue, but then the morning of my second dose, I woke up to a rash on my arm. It's been one month and it hasn't gotten better, gotten worse, or gone away.
injection site pain; Skin Breakout; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE PAIN (injection site pain) and RASH (Skin Breakout) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   In November 2008, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Skin Breakout). On 09-Mar-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 09-Mar-2021, INJECTION SITE PAIN (injection site pain) had resolved. At the time of the report, RASH (Skin Breakout) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up information was received and contain no new information.
lightheadedness; mild chest pain; feeling yucky; resting heart rate went up / had 3 episodes of rapid heart rate; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (mild chest pain), FEELING ABNORMAL (feeling yucky), DIZZINESS (lightheadedness), HEART RATE INCREASED (resting heart rate went up / had 3 episodes of rapid heart rate) and PYREXIA (fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 24-Apr-2021, the patient experienced FEELING ABNORMAL (feeling yucky), HEART RATE INCREASED (resting heart rate went up / had 3 episodes of rapid heart rate), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced CHEST PAIN (mild chest pain) and DIZZINESS (lightheadedness). In May 2021, HEART RATE INCREASED (resting heart rate went up / had 3 episodes of rapid heart rate) had resolved. At the time of the report, CHEST PAIN (mild chest pain), FEELING ABNORMAL (feeling yucky), DIZZINESS (lightheadedness), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-296280 (Patient Link).
Patient had a syncopal reaction: skin became hot and clammy, patient was dizzy, upon asking him to repeat a command or do a simple action (like wiggling fingers, lifting arm) he was not responding and his eyes were rolling to the back of his head and would not vocalize (when asked if ok, or what his symptoms were, or if he was having trouble breathing) at which time we called 911 since he was not responding verbally or physically.  Had him sit, take off his mask, gave him water to sip, took BP (102/60), within 5 minutes he started to come back around, was able to follow command (wiggle fingers) vocalize that he could breathe fine, and felt that there was water behind his ears. His temperature to touch seemed to start to go back down, and once paramedics arrived they evaluated him and released him as "ok" within 10 minutes.
Had it a few years ago on my face, even after the first vaccine; It's very painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age at vaccination was not reported but considered as adult as per vaccine indication. The patient received 1st dose of shingrix and experienced shingles on his face which was painful. The patient stated that received 2nd dose in 2019. The information rearding consent to follow up was not reported.
Initial report received from a health care professional on 19-November-2013. Five adult patients, whose age, gender, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID via intradermal route (lot number and site of vaccination not reported). They experienced 10 cm x 5 cm bruising at injection site, painful. Corrective treatment was not reported. At the time of this report the outcome of events was unknown. Documents held by sender: none.
Tongue swelling; Headache; Nausea; Tired; Chills; Muscle weakness; Fever 100.5; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 15Mar2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid polyarthritis, inflammatory polyarthritis, graves disease and allergy to bee stings and contrast dye. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN) dose of 20mg weekly and thiamazole (METHIMAZOLE) dose of 7.5 mg daily; both for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and codeine for unknown indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date in 2021 after second dose of vaccination, the patient experienced tongue swelling, headache, nausea, tired, chills, muscle weakness, fever 100.5 and joint pain. On an unknown date, the body temperature was reported as 100.5 (unit unspecified). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events tongue swelling, headache, nausea, tired, chills, muscle weakness, fever and joint pain was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Following her vaccination during the post-observation period of 15 minutes, she began to be dizzy, short of breath, and right-sided chest pressure. Also c/o headache. BP 156/102, pulse 76, O2 Sat 99%. She was evaluated by Dr. and determined to transfer to the ED
Vomit; Coughing; Felt like Throat was itchy; This is a spontaneous report from a Non-contactable Nurse. A 41-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899) intramuscular on Left arm on 21Dec2020 16:30 at single dose for COVID-19 immunization. Medical history included allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020, 10 minutes after the vaccine the patient began to vomit, felt like throat was itchy, and began coughing. Events resulted that she was taken to the ER (Emergency room). She received Epinephrine, Dexamethasone as treatment for events. Events outcome was recovered on 21Dec2020.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events vomiting, cough, and itchy throat cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
administered a Moderna vaccine to a 16 year old as a booster shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered a Moderna vaccine to a 16 year old as a booster shot) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered a Moderna vaccine to a 16 year old as a booster shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered a Moderna vaccine to a 16 year old as a booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient got the booster dose after getting the first and second dose of a COVID-19 vaccine, they don't know if they got the Moderna or Pfizer vaccine as the primary doses.   No concomitant medication information provided.  Patient had not reported anything after receiving the dose.  No treatment medication information provided.
This spontaneous report was received from an unspecified reporter referring to a 38 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 03-FEB-2018, there was a vaccine storage issue as the M-M-R II lot # N020925 for prophylaxis (strength, dose, route of administration and anatomical location were not reported) was incorrectly stored at 48.30°F during 0.08 hours. Then, on 06-FEB-2018, the patient was vaccinated with that vaccine which was in good conditions.
11MAR93 had t102 w/swollen lt leg about 3PM; pt stopped breathing; was taken to MD; also exp periods of apnea; adm to hosp 11MAR93 & 16MAR93;
The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 12Jul2017, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient's mother). A male patient of an unspecified age, race and ethnicity received the third dose of TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history was unknown. The patient was on a prednisone eye drop concomitantly. On an unspecified date, the patient experienced eye irritation. Patient's mother said it's just under his left eye lid, the eye itself was not red, just a little irritation was noted. Clinical outcome of the event was unknown at time of this report.
Had extra dose of zyrtec due to history of asphyxias. At 20 min after shot, very intense eye itching. NO airway swelling, SOB ect.  No rash. minor Lt deltoid soreness next day. Lasted 15 min.
No adverse effects noted. The incorrect flu shot (Fluzone HD) was removed from the fridge and administered to the patient instead of the correct flu shot (flucelvax)