chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022; Doses were administered past the 12 hour post puncture period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2022 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022 at 3:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered past the 12 hour post puncture period). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date the vial was initially stored in the refrigerator was on 09 Jun 2022. Date and time the vial was first punctured was 10Jun2022 at 1:05 PM. The vial was stored post puncture in a container to protect from the light and kept in the fridge.The vial did not undergo any temperature excursions It was reported that the vial did not undergo any temperature excursions and total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) approximately 5 times, but did not have a exact amount of time out exposed to room temperature for more than 24 hours It was unknown that Patient was experiencing any symptoms.  No treatment medication were reported.
Flu shot (L) deltoid 10-23-14. 2 days later; redness, warm (L) arm.
Patient received vaccine on 30AUG2022 from staff. Patient was told vaccine expired on 4NOV2022. Patient received vaccine on 13SEP2022. On 16SEP2022 it was discovered that vaccine expired on 31AUG2022.
began to bleed from the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number Y7JL5, expiry date 13th May 2022) for prophylaxis.   On 26th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th September 2020, immediately after receiving Shingrix, the patient experienced injection site hemorrhage. On 26th September 2020, the outcome of the injection site hemorrhage was recovered/resolved.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received dose of Shingrix via intramuscular in the left deltoid. Immediately after the needle was withdrawn the patient began to bleed from the injections site, a band aid was applied and the bleeding had stopped by the time the patient returned to home. The reporter did not consent to follow up.
Pt got vaccine and 10 min later started getting nausea and started puking. Was given water and gum to chew. Patient started feeling better
death  Narrative: Patient received Moderna covid vaccine #1 on 1/22/21 and #2 on 2/24/21. On 3/4/21, he was admitted to a facility for shortness of breath x 1 week. Upon admission, he was found to be in heart block and was admitted to the ICU and placed on pressors. He did have a negative COVID PCR test on 3/4/21. He has a noted history of COPD, CHF and OSA. On 3/6/21, he underwent a new pacemaker placement. His course was complicated by the development of AKI, paroxysmal V tach and new aflutter and was initiated on apixaban. He was discharged on 3/18/21. No further records available and a date of death was recorded as 4/3/21. No autopsy results available. 38 days from time of second vaccine to date of death.
5/21 Shortness of Breath and had PFT performed which showed mild COPD, one year later had another PFT performed with same results.  Visited heart doctor on 6/16 and discovered I had A-fib.  On 6/18 admitted to Hospital with low blood pressure and extreme fatigue.  Test at hospital included EKG still showed continuous A-fib and echo showed 35-40 EF.  Stress test showed no damage to heart.  Have appt with Electrophysiologist on 6/30.
Body aches and fatigue next day after injection  and lingering through present. Fatigue and joint aches worsened beginning 2/1/21
vasovagal response; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 28 year-old female patient received bnt162b2 (BNT162B2), administration date 06May2021 11:00 (Batch/Lot number: unknown) at the age of 28 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRESYNCOPE (non-serious) with onset 06May2021 21:00, outcome "recovering", described as "vasovagal response". Therapeutic measures were not taken as a result of presyncope.  Additional Information: I have a twin sister, who got her shot on the same day and time, and she also had a vasovagal response, but not nearly as many of the other symptoms. The patient had no known allergies. There was no covid prior vaccination. The covid was not tested post vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine Tdap & TIV influenza vaccines given 12/12/11. 12-14-11 knees, moderate joint pain bilaterally. 12-15-11 hands, bilateral swelling & joint pain/aches. 12-16-11 same s/s since 12/15/11.
Rash around injection site started1 week after injection site. Still have rash (5 days)
Immediately felt very hot.  The night of the vaccine I could not sleep, and severe insomnia continued for two weeks (3 to 4 hours of sleep per night).  I was experiencing a racing heart, very hot, agitation, severe heart palpitations, vertigo.  Approximately two (2) weeks after the vaccine I reached out to my primary care doctor because of my severe symptoms.  Dr. could not fit me in but her assistance  was able to see me.  Because of the severe heart palpitations, I was given an EKG and diagnosed with a Left Bundle Branch Block.
Severe body aches; vomiting; fever; headache; Sore arm at injection site; This is a spontaneous report from a contactable consumer.  A 25-years-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number EL3247, via an unspecified route of administration in left arm on 09Feb2021 10:30 at SINGLE DOSE (at the age of 25 years) for covid-19 immunisation.  Historical vaccine included dose BNT162B2 Product COVID 19, Brand Pfizer- BioNTech, on 19Jan2021 Lot number EL3247, Administration date 19Jan2021 at 10:30, Left arm. Medical history was none.  There were no known allergies. The patient's concomitant medications were not reported.  The patient experienced fever 102 degree Fahrenheit on 09Feb2021 23:45 with outcome of recovered with sequelae, vomiting on 09Feb2021 23:45 with outcome of recovered with sequelae, severe body aches on 09Feb2021 23:45 with outcome of recovered with sequelae, sore arm at injection site on 09Feb2021 23:45 with outcome of recovered with sequelae, and headache on 09Feb2021 23:45 with outcome of recovered with sequelae.  The patient underwent lab tests and procedures which included body temperature 102-degree Fahrenheit on 09Feb2021.  No treatment was received.  No other vaccine given in four weeks.  No other medications were taken in two weeks. The patient did not have Covid prior vaccination.  The patient was not tested for Covid post vaccination.    No follow up attempts are possible. No further information is expected.
Patient reports injection site reaction - swelling, mildly tender, firm, warm. Area is slightly lower on the arm than site of injection.  No fever, rash, or other symptoms.
Patient Developed Hives on body in random places around 4:00pm post vaccination. Patient given Benadryl PO 3.75ml with some stabilization. No fever or other issues noted, temperament good, eating and drinking as normal.  Hives seemed to increase 24 hours post vaccination. Health Dept. RN consulted via phone. Instructed patient mom to contact urgent care or pediatrician given worsening hives.  Follow-up call morning of 7/26. Mom reports pediatrician was called and recommended 3.75ml Benadryl PO every 4-6 hours for 48 hours. Patient given Benadryl dose of 3.57ml last night and greatly improved. Mom reports no more hives since last night. 7/25/2019.
rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (rash) in a 70-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) had resolved.        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. Treatment medications included antihistamine and steroids.   This case was linked to MOD-2021-378191 (Patient Link).
low grade fever for two days    Indurated and erythematous  on entire upper left arm for 4 plus days
Over subsequent two weeks, became increasingly fatigued, sensitive to cold, and mildly constipated (typical when my thyroid levels were low). At the end of two weeks, serum level of TSH had dropped to 0.406 from 10/21/2021 level of 0.643. T3 and T4 levels had increased (although remaining well within normal range, and had not triggered hyperthyroid symptoms). Since then, my symptoms have improved and my physician has recommended waiting until May to retest (unless symptoms worsen again).
Initial report received from a consumer (patient parent) on 19 June 2013. A 02-months-old female patient had received intramuscular dose of PENTACEL (lot number, dose number and site of vaccination was not reported), PREVNAR (Manufactured by Wyeth, lot number, dose number and site of vaccination was not reported), Hep B (lot number, dose number and site of vaccination was not reported) and administered rotovirus vaccine through oral route (lot number, dose number and site of vaccination was not reported) on 22 June 2013 at 9:30 am. The patient had medical history includes preemie born at 36 weeks with respiratory distress and concomitant medications was not reported. The patient had no illness at the time of vaccination. On 22 June 2013 after vaccination, the patient had experienced irritability and had intense crying spell for less than 3 hours, after the patient was calmed down, her breathing pattern was normal, but was gasping every now and then. For over a time the period between gasps became longer until it resolved. Corrective treatment was not reported and no laboratory tests were done. On 22 April 2013 at 17:00 hours, the patient had recovered from adverse events. Follow up information received from a healthcare professional on 29 July 2013: The patient received a dose of PENTACEL (lot number: C4340AA and expiry date: 14 April 2014), a dose of Hepatitis B vaccine (manufacturer unknown), (lot number: H020605 and expiry date: 13 March 2015), a dose of PREVNAR vaccine from other manufacturer (lot number: G75071 and expiry date: 30 November 2014) and a dose of "ROTATEQ" from other manufacturer (previously reported as Rotavirus vaccine) (lot number: J001615 and expiry date: 28 August 2014). List of documents held by sender: none.
Frompt. States he was in his office yesterday, received Pneumonia vaccine in rt arm. Report this was he second pneumonia vaccine. States approx 3 hours after receiving vaccine, his arm began to swell. Reports arm is swollen and painful. Denies red streaks. Denies fever. Denies difficulty breathing or swallowing. Denies rash. Symptoms: .1. Swelling of injected arm.
Head ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head ache) and PYREXIA (Fever) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 24-Apr-2021, the patient experienced HEADACHE (Head ache) and PYREXIA (Fever). At the time of the report, HEADACHE (Head ache) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Additional information received on 27 May 2021. Event outcome updated
I had second dose of covid 19 vaccination on Monday (2-1-2021) at 6:30am. i started having chills with headache around 2:00 pm on the same day , which increased its intrensity overnight and I am still having the same symptoms. I am regularly taking Tylenol every 6 hours.
arthritis of the knee; Very severe pain from her knees to feet, on both legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very severe pain from her knees to feet, on both legs) and ARTHRITIS (arthritis of the knee) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-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 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Very severe pain from her knees to feet, on both legs). On an unknown date, the patient experienced ARTHRITIS (arthritis of the knee). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Very severe pain from her knees to feet, on both legs) and ARTHRITIS (arthritis of the knee) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.  No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: TCR attached. Event updated.
Rash all over; Does not feel good; Light-headed/ Dizzy; Started to have chest pain; This is a spontaneous report from a contactable consumer. A 31-years-old female patient received unknown dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date in Jun2021 (unknown Tuesday night) (Batch/Lot number was unknown) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated, daughter had a shot on Tuesday night in Jun2021, does not feel good and got to take her to the hospital. She was dizzy, she was light headed, now she started to have chest pain. On 18Jun2021 yesterday, she had a rash all over, took Benadryl. Subsequently in Jun2021, the rash went away. The outcome of the event rash was reported as recovered in Jun2021 and for other events was unknown.  Information about lot/batch number has been requested.
Anaphylactic reaction to vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Anaphylactic reaction to vaccine". It was unknown if therapeutic measures were taken as a result of anaphylactic reaction. Clinical course included patient reported an AE from the Pfizer vaccine, but the patient didn't specify which vaccine. Reporter clarified that the patient took another medication that this pharmacy dispensed, and the patient reported the AE during a call regarding that other medication.   The lot number for bnt162b2 was not provided and will be requested during follow up.
845AM pt recv vax 847AM slid off chair sideways hitting side of head, unconscious under 1min, alert & oriented x 3, BP 110/40, P80, R24 extremely pale & lethargic, 02 via mass;
puffiness; pinkish arm 3inches by 2 inches wide; itchy; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (puffiness), VACCINATION SITE ERYTHEMA (pinkish arm 3inches by 2 inches wide), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE SWELLING (Swollen) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced SKIN SWELLING (puffiness), VACCINATION SITE ERYTHEMA (pinkish arm 3inches by 2 inches wide), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE SWELLING (Swollen). At the time of the report, SKIN SWELLING (puffiness), VACCINATION SITE ERYTHEMA (pinkish arm 3inches by 2 inches wide), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE SWELLING (Swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
on 04/06/23 during patient appt visit, patient requested her 2nd dose of primary series pfizer covid vaccine, patient was given the consent forms and had signed them, and I went ahead and by mistake grabbed the pfizer bivalent booster vaccine when I should've grabbed the pfizer monovalent vaccine. I ordered and administered the vaccine to the patient. patient waited 15 minutes and had no adverse reaction. once I placed the vaccine in patients' chart, I then realized my mistake. my supervisor was notified, as well as provider was informed to see what was recommended. Dr. advised that patient should not have an adverse reaction and patient does not need a 2nd monovalent vaccine or booster vaccine. I went ahead and contacted patient to apologize for the inconvenience and for the error I have made, informed patient my supervisor and doctor was consulted of my error, and she should not be concerned, no further covid vaccines dosages are recommended. patient was very understanding and stated she feels well and has no concerns and thanked me for letting her know of my error. VAERS was also submitted.
High Fever (102.74 for 2 days) 5 hours after the vaccination.   Tired for 3 days Mild Itchiness in throat for 2 days Painful arm for 5 days
severe lower back pain, mostly to left - a little to right. Pain spreads to left side, feels like skin tearing and hot sharp pain that wraps around to stomach area. Pain travels down to groin area, left testicle area, continues down to left knee cap area.  After second dose, reaction was extreme pain - ended up hospitalized - unable to determine cause. Blood work done, blamed on pancreatitis - four hours later - blood work showed no pancreatitis - no explanation. Had MRI on 1-11-21, showed minor nerve issue. reviewed info with Doctor office, pulled up information on Shingrix - found that all symptoms matched severe / rare reaction.
Pain at injection site since administered (greater then control at arm which received IPV, MMR). Redness, itch, surround site starting 3d after given prescribed ice, Benadryl oral.
Patient received 2nd dose too early.  First dose 1/7/23, second dose 1/28/23.
Had shots, however have had shingles/Suspected Vaccination Failure; had shingles, are hellish; shots hurt like hell; couldn't move the arm; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shots, however have had shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: had shingles, are hellish), pain (Verbatim: shots hurt like hell) and mobility decreased (Verbatim: couldn't move the arm). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and mobility decreased were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient interactive digital media. The patient stated that he/she would be honest the shots hurt like hell.  The reporter could not move my arm for four days.  However, the patient have had shingles and would take the shots anyway.  The patient stated that shingles were hellish. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Difficulty focusing, minor distractions causing me to lost my train of thought completely, difficulty remembering things
Pt had an episode of syncope for 10 seconds after getting vaccinated . Blood pressure dropped to 90/50, Hr 48. After repositioning the pt and giving some fluid Blood pressure raised to 113/96 Hr 72.
Fever (102.5) for 8 hours; achiness for 24 hours; injection site soreness for 48 hours
For the first dose, individual stated the only had a sore shoulder (at point of injection) and foggy head for the few hours; For the first dose, individual stated the only had a sore shoulder (at point of injection) and foggy head for the few hours; This is a spontaneous report from a contactable consumer (non-healthcare professional reporting for a patient). A 35-year-old male received first single dose BNT162B2 (Solution for injection, Lot number: EJ1685, exp date not reported), via an unspecified route of administration (anatomical location: shoulder [not further specified]) on 23Dec2020 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. For the first dose, patient only had a sore shoulder (at point of injection) and foggy head for the few hours on an unspecified date. No treatment was provided for the adverse events. It was unknown if patient had Covid prior vaccination. It was unknown if patient was Covid tested post vaccination. The patient recovered from the events on an unspecified date.