chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired vial was initially stored in the refrigerator on 20-Sep-2022; No adverse event; Expired vaccine was administered after the manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry) and PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022).    No concomitant medication were reported.  It was unknown that patient had ever been diagnosed with nor tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination up to one month before. It was unknown if patient had any chronic or long standing health conditions.  It was reported that patient received 0.5 dose of vaccine during PM time.  It was reported that HCP gave Moderna Covid 19 vaccines and it was discovered after they had given 21 doses that it was expired recently from monovalent Individual vials of Vial size 5.5 ml. The vial had not undergone any temperature excursions.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Follow up received contains no new information.
feel weak; vomiting; violent headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feel weak), VOMITING (vomiting) and HEADACHE (violent headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concurrent medical conditions included Thyroid disorder, Hypertension and Heart disease, unspecified.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VOMITING (vomiting) and HEADACHE (violent headache). On 12-Mar-2021, the patient experienced ASTHENIA (feel weak). The patient was treated with MORPHINE for Headache, at an unspecified dose and frequency. At the time of the report, ASTHENIA (feel weak) had not resolved, VOMITING (vomiting) was resolving and HEADACHE (violent headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported taking concomitant medication for thyroid, blood pressure, and heart (not specified).  The patient went to the ER on 11MAR2021 due to violent headache and vomiting. medicine for vomiting (not specified).
Patient received vaccinations and about 5.5 - 6 hours later experienced weakness, fatigue and fever of 102.5 axillary.  No other symptoms other than muscle weakness in all 4 extremities
Patient developed red, itchy rash at vaccination site a week after vaccine was given. Patient said it was also warm to the touch.
Information has been received from a consumer concerning his sister's child who was vaccinated with a dose of MMR (second generation)(lot number not reported). The reporter stated that the child had been diagnosed as being autistic shortly after receiving MMR (second generation). Upon internal review, the patient's autism was considered an other medical event. The reporter also stated that his sister had an adverse experience post vaccination with MMR (second generation). Additional information has been requested.
Pfizer fall 2023 dose. I had the same intense reaction as previous with two days of joint pain, chills, mild headache. My one new concern was atypical menstrual spotting only 10 days after start of last period, on a typical 27 day cycle. age 43 with regular 26-28 day period cycle.   Manufacturer and pharmacist should warn women or research why this is happening.
Several hrs p/vax pt broke out w/urticaria & c/o SOB was treated w/DPH;
Case number PHEH2014US025074, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 32-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 23 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Pt had VZV / Tdap on (R )-side on 11/28/12. On 11/29/12 pt started having TTP / redness / swelling on (R) upper arm. Tx - KEFLEX, BENADRYL & icing.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-JAN-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-JAN-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-JAN-2022) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022 at 4:08 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Jan-2022 at 4:08 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-JAN-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-JAN-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. No treatment information was provided by the reporter.  Vaccine administration time was given as 18-Jan-2022 16:08:41.     This case was linked to MOD-2022-542869 (Patient Link).
Patient came to clinic 9/10/19 with complaint of redness & warmth that started on left arm 35mm below where vaccine had been given. Area 70mm x 50mm irregular shaped & warm. Pt also reported this started 3 days after shot given but pain in arm started 1 day after shot.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 67-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 6th July 2018, the patient received SHINGRIX. In July 2018, 1 day after receiving SHINGRIX, the patient experienced headache and nausea. On an unknown date, the outcome of the headache and nausea were not recovered/not resolved. It was unknown if the reporter considered the headache and nausea to be related to SHINGRIX. Additional details were received as follows: This case was previously not reported anyone. The pharmacist reported that the patient received a dose of SHINGRIX and began to experience nausea and headache, which began approximately 24 hours after the vaccination. At the time of reporting, the symptoms were unresolved.
Blood pressure spike, associated with flushing, headache, dizziness beginning 4.5 hours after dose
Patient came into the pharmacy with a rash on arm that spread. Area was slightly raised with a red coloration. Patient reported itching for which an antihistamine was recommended.
This spontaneous report as received from a consumer via Clinic refers to a currently 6 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M020073, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Pt stated she felt really bad all day after vaccination.  Pt stated the next day she had severe itching on back that moved to the front torso and shoulders.  Pt said she has been taking Benadryl  for the itching .  Stated she called her PCP and they advised her to take Benadryl and to come to the office tomorrow  for an appt.
Nausea started approximately 17 hours after vaccination.  Was debilitating for about 4 hours and lasted about 6.  By the next day I was back to normal
Blood Clot in Bowel resulting in illeostomy, amputation and due to being unconscious and on a ventilator for over 2 weeks, my voice was lost and didn?t return fully.  I had all five toes on my left foot amputated due to medication given to keep blood flowing to vital organs.  I was hospitalized in some form for 4 months beginning March 9, 2022 until the end of June 2022.  I have become disabled and have lost my job.
severe dizziness, passed out twice, nausea, severe headache, body ache, chills alternating with sweats lasting for 24 hours.  She had a similar reaction after the 1st dose, but less severe.
I started having this in my arms. The pain was worse in my right arm. It isn't cramping, but they would tighten up. Then, I started having symptoms with my hands. It became pretty severe, and I decided to go to the doctor. She prescribed an anti-inflammatory, but it didn't make a difference. I saw a Rheumatologist, and he told me that I have Inflammatory Arthritis. He prescribed hydroxychloroquine. I am still dealing with this at this time.
Headache  fatigue  ringing ears . Rash all over but concentrated mostly on legs . Puss filled bumps/blister  little boils  ...varying in size but like bug bites, mostly itchy and a little painful.   I have used cortisone cream, Calgary lotion and  taken benadryl
2nd vaccine 2/8/21 Pfizer COVID19, LOT EN5318, site IM, Hospitalized 12/16/21
Patient stated they were diagnosed with COVID in March 2021.; had their heart shocked 3 times.; on a ventilator; lung damaging; This spontaneous report was received from a male patient of unknown age referring to himself. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On an unknown date (also reported as in the past and unsure if it was before COVID diagnosis or after), the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  In March 2021, the patient was diagnosed with COVID (covid-19). On an unknown date, the patient was hospitalized for covid-19, was on a ventilator (dependence on respirator), had a temperature of 104.1 degrees Fahrenheit and had their heart shocked 3 times (cardiogenic shock). On an unknown date, patient stated he had lung damaging (traumatic lung injury) and still experienced shortness of breath. The outcome of the event of traumatic lung injury and covid-19 was reported as not recovered. The outcome of the events of dependence on respirator and cardiogenic shock was not reported.  The causality assessment between the reported events and the suspect vaccine was not provided.  Upon internal review, the events of cardiogenic shock and dependence on respirator were considered to be medically significant.
Following vaccination, the pt experienced a hot, red, sore spot at the injection site. Acetaminophen (Tylenol) was given as treatment. The most recent information received on 4/27/00 reported the symptoms resolved on the second day.
Redness, swelling around injection site/shoulder (L) deltoid. Pt physician treated wtih KEFLEX, uncertain if infection actually present.
This spontaneous report a received from a licensed practical nurse refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-MAY-2015, the patient was inadvertently vaccinated with an expired dose of M-M-R II (dose and route of administration were not reported, lot # H020255, expiration date 08-NOV-2014). No adverse effects were reported. Additional information has been requested.
the administration of the liquid component of Menveo without reconstitution of A lyophilized conjugate vaccine component; the administration of the liquid component of Menveo without reconstitution of A lyophilized conjugate vaccine component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA677A, expiry date 30th April 2023) for prophylaxis.   On 11th October 2022, the patient received Menveo. On 11th October 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's comment: The nurse called and asked for information about the administration of the liquid component of Menveo without reconstitution of A lyophilized conjugate vaccine component. The reporter asked if the patient had to receive an extra properly reconstituted dose. The consent to follow up was granted. Additional Supportive Information: The patient received Menveo without reconstitution of A lyophilized conjugate vaccine component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient presented to the ED with cough, significant dyspnea on exertion, and easy fatigability for least several days.  Diagnosed with Covid on June 12, 2021.  CT scan on June 15, 2021 showed scattered groundglass patchy infiltrates.  He was treated on an outpatient basis with Regeneron, oral steroids, and an inhaler.  He seemed to improve but became acutely worse several days ago.  Respiratory rate was 24.  He was afebrile.  Room air oxygen saturation was in the high 70s, and he was put on supplemental O2.  When I saw him in the ED he was mildly tachypneic.  He had very faint scattered crackling rales without wheezing. CTA chest for PE showed more extensive groundglass infiltrates throughout the lung fields mainly in the right lower lobe.  Patient was admitted to ACU for further evaluation and treatment. Patient still tested positive for Covid yesterday.  He has had Covid for almost a month.  His CT scan yesterday was worse than the one done on June 12.  Treated in the hospital for COVID pneumonia with Decadron 6 mg p.o. daily, Symbicort inhaler, albuterol inhaler, and supplemental O2.  He has improved and only needs 2 L/min nasal cannula.  Lungs with very faint crackling rales.  Mild dyspnea on exertion.  I believe he can be safely discharged today with follow-up by pulmonary medicine and his primary care physician within a week or 2.
Patient is 12 year old and attended clinic where the pediatric Pfizer-BioNTech vaccine was administered instead of the correct Pfizer 30mcg dose vaccine.  Patient tolerated vaccine well, parent (mom) is aware of the medication error.  Upon returning for 2nd dose on December 2nd, patient will receive the correct 30 mcg dose.   Our facility has also reviewed our processes and will implement a number of changes to ensure this mistake does not happen again.
nausea, no vomiting, felt this way on going home p/shot;intermittent h/a;nothing tastes good; no fever;for 2 wks had hives; had loose bowels day p/shot; one day only
UNCONTROLABLE SHAKING , FEVER OF 103, SEVERE ABDOMINAL PAIN, WHICH LED TO MUTLIPLE ORGAN ISSUES WITH LIVER, KIDNEYS AND GALL BLADDER-  DIAGNOSIS   "SIRS"
THE PATIENT RECEIVED HIS IMMUNIZATION, HE THEN FOLLOWED ME TO THE CASH REGISTER FOR PAYMENT, AND HE PASSED OUT. HIS WIFE CAUGHT HIM AND WE PLACED HIM ON THE FLOOR. HE DID LOSE CONSCIOUSNESS, BUT WAS AWAKENED RIGHT AWAY. WE MONITORED HIS BLOOD PRESSURE AND IT WAS NORMAL.  HE WAS PALE, AND MENTIONED THAT HE FELT TINGLY AND THEN GOT COLD. NO OTHER SIDE EFFECTS OCCURED. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL TO BE CHECKED OUT
This was a booster shot. Left foot pain, numbness and tingling at base of left leg, top of foot and wrapping around front of toes. Began around 36 hours after booster was given.
11/19/07 - Reports received immunization 111607 (DTAP, HBV3 and Varicella).  Seen 11/18/07 emergency room with complaint of "ball size" hard and hot area to right thigh. Emergency room told mother it was "staph infection at injection site".  History of whelps and swelling with immunization done at primary doctor's office 2/07.  Reports noted improvements this morning.
This spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age and gender. The concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored PROQUAD, (dose, route, lot number were not reported). No adverse effects were reported. Additional information has been requested.
Pulmonary embolism diagnosed through CT scan on 2/27/2021.  Pain started on 2/23/21.
Mother reports that some weeks after vaccine was given, pt had hair growth at site of immunization. No inflammation.
vesicular rash 8-10 lesions in two areas lower back & around belly button;flat red rash in pub area;irritable & feverish;however mom did not take pt temp;
Chills; Achy joints; Arm puffed up; Redness on the left shoulder; Nauseous; Gassy; Tired; Weak; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), ARTHRALGIA (Achy joints), PERIPHERAL SWELLING (Arm puffed up), ERYTHEMA (Redness on the left shoulder) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (Chills), ARTHRALGIA (Achy joints), PERIPHERAL SWELLING (Arm puffed up), ERYTHEMA (Redness on the left shoulder), NAUSEA (Nauseous), FLATULENCE (Gassy), FATIGUE (Tired) and ASTHENIA (Weak). At the time of the report, CHILLS (Chills), ARTHRALGIA (Achy joints), PERIPHERAL SWELLING (Arm puffed up), ERYTHEMA (Redness on the left shoulder), NAUSEA (Nauseous) and FLATULENCE (Gassy) outcome was unknown and FATIGUE (Tired) and ASTHENIA (Weak) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
patient came for covid vaccination  form was filled for covid vaccination .by mistake flue vaccination was administered..after the shot was given  patient mother said patient had flu vaccine at doctor's office .patient did not report any discomfort or any other problems
Redness that is spreading below the injection site; Warmness of arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warmness of arm) and VACCINATION SITE ERYTHEMA (Redness that is spreading below the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warmness of arm). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness that is spreading below the injection site). At the time of the report, INJECTION SITE WARMTH (Warmness of arm) and VACCINATION SITE ERYTHEMA (Redness that is spreading below the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received updated reporter contact details and is considered non-significant.
lower back pain (in the area of the kidneys on both sides) emerged within 12 hours after receiving the Moderna booster (3rd shot), and was similar to back pain experienced previously after the earlier doses on 2/1/21 and was progressively worse on 3/3/21... eventually resolved after several weeks... then returned again with 12 hours of the booster on 1/16/22... lower back (kidney area on both sides) improved after about 3 days.
Swollen lymp nodes under armpit the very next day of vaccination. Chest pain took place 3 days after vaccination. Left side chest pain and more noticeable when deep breaths are taken. There are less chest pain now exactly 1 week after booster vaccination.
Approximately 3 min after her 2nd Covid vaccine, patient had episode where she slumped in chair and became unconscious. she had no issues with 1st vaccine per family. Patient has hx of seizures and medications. Per family, last seizure approximately 1 mos ago. She began to have shaking seizure activity and was assisted to the ground by LVN and RN. Patient did not fall. VS checked 1715: 150/80 HR 125 regular and pulse of 99% on room air. Patient breathing , color good. 911 called. Patient assisted to stretcher with total lift, remains unresponsive with eyes rolling upward and fluttering eye lids. VS rechecked at 1725: EMS arrived. Report given. Medic checked blood sugar 111. She is now speaking to her family at bedside. Awake, appears groggy. Recheck VS 1740: 147/87 HR 102 RR 16 Pulse Ox 100% Patient refusing to go to the hospital. Family (son and niece at bedside) agreeable and want to take patient home. AMA signed with EMS ad patient left with family. She was alert and oriented, talking with family. Advised patient and family to seek treatment in ER for any issues.