chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experiencing bad chills, tingling in left arm from finger tips to the area of the shot and half of the finger tips are a purplish color; Experiencing bad chills, tingling in left arm from finger tips to the area of the shot and half of the finger tips are a purplish color; Fingertips turning purple; This is a spontaneous report received from a contactable consumer. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FC3184) via an unspecified route of administration, administered in Arm Left on 13Sep2021 at 13:30 as DOSE 1, SINGLE (at the age of 47-year-old) for covid-19 immunisation. There were no concomitant medications. Medical history reported as none.The NDC number of Covid Vaccine was unknown. Patient received the first dose of Pfizer covid vaccine on 13Sep2021 at 13:30 and at 15:30 and all of a sudden started experiencing bad chills, tingling in left arm from finger tips to the area of the shot and half of the finger tips were a purplish colour. Patient got up and walked outside and she still has tingling from her left hand to where the shot was. Reporter asked if these were side effects after vaccination and if she needed to worry about them. The patient did not received treatment for the events. The outcome of the events was not resolved.  No further information can be obtained.
had swelled up lymph nodes; This is a spontaneous report from a contactable consumer. An unspecified aged female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported as her doctor said that there were patients who were having problems after the first shot. The patient had swelled up lymph nodes on an unspecified date. For some reason these adverse events happened about a week out when they started having problems.  Information on the lot/batch number has been requested.
Client reported one hour after receiving first dose of COVID vaccine Pfizer he developed a headache and dizziness that lasted one hour. The client only ate breakfast the day he received the first dose COVID vaccine Pfizer. The client ate breakfast today. He was provided a snack of chips and started eating them. Vitals obtained on 07/14/21 were as follows: BP 118/80, HR 87, O2 98%. The client denied SOB after first COVID vaccine Pfizer. The client did not follow up with a primary care doctor or allergist. The client denies any chronic conditions or medications. No known allergies.
Patient described severe muscle soreness at site of injection, headache the developed into migraine, chills of body, and increased skin sensitivity.
Patient presented very upset, confused initially, as well as hyperventilating. Her vital signs consistently stayed normal. Clear lung sounds and pulse oximeter of 99% on room air.  Patient then transported to hospital.
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 11:00 as dose 4 (booster), single (Lot number: KK9895) at the age of 75 years, in left arm for covid-19 immunisation; moderna coviD-19 vaccine (MODERNA COVID-19 VACCINE), on 26Jan2021 as dose 1, single (Lot number: 042L20A), in left arm, on 25Feb2021 as dose 2, single (Lot number: 010A21A), in left arm and on 21Oct2021 as dose 3 (booster), single (Lot number: 076C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), 18 days 13 hrs after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), 18 days 13 hrs after the suspect product(s) administration, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (15May2022) positive with milder symptoms, notes: positive with milder symptoms. Therapeutic measures were taken as a result of covid-19.  Clinical course- The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. and also received other medication in 2weeks.  No follow-up attempts are needed. No further information is expected.
Several months after the vaccine I woke up not being able to hear out the left ear. I felt like I was severely congested with the feeling of sinus issue.  After about 4 days of not being able to hear I went to the Patient First Urgent department (VA) and was given 10 days of steroids and an allergy medication.  It didn't clear up so the first part of September I went back and was given Flonase and advised to continue to take the allergy medication and advised I see and ENT.  On 9/20 I saw the ENT and an Audiology exam was perform and was diagnosed with having sudden hearing loss in my left ear and was put back on a 14-day steroid.  On 10/13 I revisited the ENT with the same hearing loss in the left ear.  An Audiology exam was performed and saw the mid tones had gone back to the normal level, but the low tones was where I am experiencing the moderate hearing loss.  I have a follow-up appointment in the next 2 months to see if there is any additional recovery at that time.
Patient completed online vaccine consent form for Moderna 3 (booster).  I verified in the vaccine room that patient was requesting the vaccine Moderna.  After vaccine was administered patient presented vaccine card which stated she got her first 2 doses of Pfizer at a pharmacy.  I then explained to patient she should have received Pfizer, patient stated she wanted Moderna.  She stated she had heard information that Moderna was a better option.  Patient stated the vaccine we administered is the one she wanted.
Pt was complaining about RLQ pain x 3 days post vaccine. Pt had positive rebound test, was taken to  Pediatrics. The MD exam concerning for Appendicitis.
Patient stated she experienced adverse reactions such as swelling, rash, and abnormally warm around her injection site to her wrist for a week. She has completely recovered and back to normal.
"Right arm where I got my shots became red, swollen, sore to touch yesterday. Still the same today, but darker red." Saw M.D. at Health Clinic who said there was 1 large red welt and 3 small ones and recommended ice pack to site, Benadryl, and cortisone cream.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 87-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 16-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported) which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805463 was crossed linked to original cases 201804863 due to same reporter.
December 28 developed large red edematous area around injection site. Hot to touch. The area continues at this time despite taking Benadryl and Pepcid every 12 hours as advised by PCP
No adverse event reported as of yet.  patient was given dose of Twinrix at wrong interval.  First dose 1/12/21, Second dose 2/13/2021, and third dose 6/6/21.  Vaccine # 3 was due 7/12/21.  Given at Pharmacy.  Tried to call to alert them of the error and was met with the pharmacist  stating she could come in for another dose next month.  Then stating that the dosage intervals are just guidelines.  Then tried to say the patient told him I told her it was due now.  100% is not true that I stated that and the patient was also shocked by that response when i informed her of the error what the plan would be to make sure she has immunity to Hep B. Human errors occur but the response of unprofessional, untruthful, and took no responsibility to disclose the error to the patient.   At this time she reports no issues and i will check a Hep B titer in 30-60 days to confirm immunity as she works at a high risk healthcare job.
After receiving both doses, my skin has cleared up / skin got better; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered on an unspecified date (Batch/ lot number and expiration date were not reported) as dose 1, single and administered on an unspecified date (Batch/ lot number and expiration date were not reported) as dose 2, single both via unspecified route of administration and for COVID-19 immunisation. Medical history included hypereosinophilic syndrome and rash (had 50 percent rash all over her body before getting the shot). The patient's concomitant medications were not reported. It was reported that the patient heard about all the new mutating variants of COVID virus in various countries and was querying if she needed to take a booster shot to be protected against the new variants. The patient wanted to know if the Pfizer vaccine studied and shown effectiveness against these new variants as she was concerned that she maybe more susceptible due to her pre-existing condition. It was also reported that she heard these variants can infiltrate antibodies; she stated that she called after receiving the first shot to report some good side effects; and that she was sent a document by mail in which she was surprised it got to her despite the fact they had her name and her city spelled wrong. It was reported that the patient was diagnosed with hypereosinophilic syndrome and had 50 percent all over her body before getting the shot. On an unspecified date after receiving both doses, the patient's skin has cleared up; it was reported that the lady who vaccinated her noticed her skin got better. It was reported that she was extremely happy and wanted this to be studied further as this disease was rare. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives on both sides of her body; lip swelling/upper lip, lower lip swelled; Fatigue; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of lip swelling in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to vaccine (Had allergy to Smallpox vaccine).   In April 2022, the patient received the 1st dose of Shingrix (intramuscular). In April 2022, several days after receiving Shingrix, the patient experienced fatigue and injection site pain. In May 2022, the patient experienced lip swelling. In June 2022, the patient experienced hives. On an unknown date, the outcome of the lip swelling, hives, fatigue and injection site pain were recovered/resolved.   It was unknown if the reporter considered the lip swelling, hives, fatigue and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine. The reporter sated that after few days of receiving Shingrix vaccine the patient experienced injection site pain and fatigue. One month after Shingrix she had swelling to her upper lip followed by swelling to her lower lip two days after the upper lip swelled. Two months after Shingrix she experienced hives on both sides of her body. The patient had nothing else to report. The reporter consented to follow up.
I had Covid at the end of Sep of this year, 2021; I had Covid at the end of Sep of this year, 2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2021 13:00 (Lot number: EK9231) at the age of 38 years as dose 2, single and administered in arm right, administration date 18Dec2020 13:00 (Lot number: ELO140) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VYVANSE. The following information was reported: VACCINATION FAILURE (medically significant) with onset Sep2021, outcome "recovered", COVID-19 (medically significant) with onset Sep2021, outcome "recovered" (2021) and all described as "I had Covid at the end of Sep of this year, 2021".  Clinical information: My husband and I had Covid at the end of Sep of this year, 2021. We recovered and our taste and smell were completely back to normal for many weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no Known allergies. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Injection site reaction aforementioned. Received vaccines 9/11/17, endorsed pain and swelling night on injection, returned to pharmacy 9/13/17 to pick up medication for injection site reaction (9/13/17).
Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F; Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 4:49 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 4:49 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. It was reported that the patient was administered the vaccine that underwent temperature excursion.The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion and minimum reached temperatures was negative 82 degrees Fahrenheit.The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19 Nov 2021, when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported. No treatment medication was reported by the reporter.
Information has been received from a nurse concerning a 10 year old male with no allergies and no reported medical history, who on 30-DEC-1997 received his first dose of varicella virus vaccine live (Oka/Merck). On 31-OCT-2007, the patient developed an itchy red rash and fever. He was seen by the physician in the office and on 01-NOV-2007, he was diagnosed with chickenpox. There were no laboratory or diagnostic test performed. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Chills and cold sweats throughout the night. Awoke with fever and severe pain throughout body. Chills subsided, but temperature left and came back. Pain was consistent. Sweat a lot and felt better but 1-2 hours later, symptoms began to reemerge.
Large bald spot on top of head!!! The size of a half dollar. No new soaps no no hair products no new medication. Nothing new.
collapses; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received via a consumer/non-hcp.  This case involves adult and unknown gender patient who collapsed while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine (strength, dose, route, formulation and frequency: unknown) produced by unknown manufacturer (lot number and expiry date: not reported) in unknown administration site as prophylactic vaccination (Influenza Vaccine).  The consumer commented that the list went on and on, and on and it was happening everywhere and was not normal. On an unknown date the patient a player collapsed; the game was canceled (syncope) (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (collapses).  At time of reporting, the outcome was Unknown for the event collapses.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns an adult and unknown gender patient who collapsed during game, after vaccination with vaccine Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, medical history and concomitant medication would be needed to rule out the alternative etiology. Based on the reported information, the role of an individual vaccine cannot be assessed.
Dizzy, Light headed, Confusion/Slurred speech, shaking of the hands( that evening). Symptoms lasted one day
Narrative: Patient received second dose of Moderna Cov-19 vaccine on 2/22/21 and 0n 2/23/21 was found by home health nursing staff found patient in bed "incontinent of bowel, weak in bed and had fever if 104.4. Nurse called 911 and patient was sent to emergency dept and admitted to hospital.
Mother notice hives on chest and back.  No change in behavior or routine noted.  Hives remained for three days, has an appointment with PCP on 11/16/2009.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant details were reported. No treatment details were reported.
Initial report received from the patient's parent on 15 April 2011. A 12-month-old male patient with no concurrent illnesses, or significant medical history had received a first intramuscular thigh (side not reported) injection of IPOL (lot number unknown) on 30 November 2010. That same day, the patient's face turned red and was warm, but the symptoms resolved the next day. No physician evaluation or treatment was required. No relevant diagnostic tests and / or laboratory data were performed. Documents held by sender: None.
On 07/14/2022 few minutes of the vaccine I had a sore arm ; fatigue; dry cough and on 07/15/2022 low grade fever and headache.  I tested positive on 07/15/2022  with a PCR test at work . On the same day 07/15/2022  I did a telehealth with a nurse. She didn't prescribed me with any medication but she advised me to  treat it as a cold. So, I  took Tylenol for 3 days it depended on the symptoms I had.  When my symptoms were gone I stopped taking Tylenol.
Flush, fever hot flashes, body aches that continued  at least 6 hours until I went to sleep
Swollen lymph nodes in left axilla, pain and tenderness to left shoulder.  Multiple Dr visits, CT scans, ultrasounds over a course of 3 months.  Outcome: surgery to remove multiple necrotic lymph nodes, 3 months of PT for decreased ROM Still experiencing pain, limited ROM
2 days of vomiting 2x a day on 8/2 and 8/3 then once a day went to ER on 8/8 got ZOFRAN and MIRALAX for constipation. First used that night.
got the shot had shingles/Suspected Vaccination Failure; shingles 2 times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the Shingles shot and had shingles 2 times. The patient stated get the shot it would help. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
LMP 04/27/2021, Miscarriage, 06/2021.
Patient remains hospitalized but respiratory symptoms are improving, AST/ALT are down-trending, & PT/INR returned to normal. Symptoms: Bleeding, Abnormal INR & ElevatedLiverEnzymes