chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient passed away after receiving the Covid vaccine; This is a spontaneous report from a contactable nurse.  An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular  into the right arm on 07Jan2021 at 0.3 mL, single for covid-19 immunization.  There was no medical history and no concomitant medications.  On 08Jan2021, the patient passed away after receiving the COVID vaccine.  The patient died on 08Jan2021.  An autopsy was not performed. Investigations indicate that unspecified labs were done, but nothing two weeks prior; no further details were provided. The patient received the first dose the day prior. The reporting nurse discussed it with the medical director, and he thought that he potentially passed away from the COVID vaccine. The relatedness of the event to the suspect vaccine was reported as related by the reporting nurse per The Agency.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the limited information available, it is medically not possible to make meaningful causality assessment, it is unlikely the vaccine could have contributed to the death of the patient based on the known safety profile. However case will be reevaluated when additional information is received during the follow-up  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Stated that the patient passed away after receiving the Covid vaccine
The vial was initially stored in the refrigerator on 23-Nov-2021 and administered on 02-Jan-2022; No adverse event; Dose given after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Nov-2021 and administered on 02-Jan-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Nov-2021 and administered on 02-Jan-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Nov-2021 and administered on 02-Jan-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 (Dose given after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Nov-2021 and administered on 02-Jan-2022).    Concomitant medication was not provided.  The vial was initially stored in the refrigerator on 23-Nov-2021. It was unknown if the vial underwent any temperature excursions. The vial was stored in the fridge between the temperature 36-45 F.  Treatment information was not provided
This case was reported by a nurse and described the occurrence of acute liver failure in a 58 year old male patient who received hepatitis B vaccine recombinant. The patient's medical history included hepatitis A in 1997, from which he had recovered with no known sequelae, and high blood pressure. Concurrent medications included Norvasc. On 1/11/05, the patient received the first dose of Engerix B (lot # AHBVB004AA). On 1/11/05, the patient also received injections of poliomyelitis virus vaccine and typhoid vaccine. Approximately 23 days following the administration of the immunizations, on 2/3/05, the patient experienced acute liver failure and a coma and was hospitalized. The immunization series with Engerix B was discontinued. The events were ongoing at the time of initial reporting, on 2/7/05. The nurse considered the events to have nothing to do with vaccination with Engerix B.
Crying unconsolably x 24-36 hrs; no mental status changes, seizure activity or shock;
Limp; Paralyzed (pain was so bad he couldn't move it); Low grade fever; Severe left hip pain; A spontaneous report was received from a consumer who was also a 85-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced left hip became paralyzed (pain was so bad he couldn't move it) (paralysis), low grade fever (pyrexia), limp (gait disturbance), and severe left hip pain (arthralgia).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Jan 2021, approximately 10 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09 Jan 2021, the patient woke up at 10:00 pm with severe left hip pain. His left hip became paralyzed (pain was so bad he couldn't move it), and he took 2 ibuprofens then went to bed.   On 10 Jan 2021, he was still in pain with a low grade fever of 98.8 which is 1 to 2 degrees higher than normal for him. He reported using his wife's walker to ambulate and took 4 ibuprofens which helped his hip.   On 11 Jan 2021, the patient was still in pain, had a limp, and ran a low fever until the afternoon. Treatment for the events included ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, low grade fever, was considered resolved on 11 Jan 2021. The outcome of the events, left hip became paralyzed (pain was so bad he couldn't move it), low grade fever and limp, was unknown.; Reporter's Comments: Based on the information provided, the events of low grade fever, gait disturbance and severe left hip pain are temporally associated with the administration of mRNA-1273 and a causal association cannot be excluded. Fever and arthralgia are consistent with the known safety profile of the product.  The event of paralysis is considered unlikely pending additional information.
knee was sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (knee was sore) in a female patient of an unknown age 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 ARTHRALGIA (knee was sore). At the time of the report, ARTHRALGIA (knee was sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
A report has been received from a Health Professional concerning a Child, subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started during Oct-2013. It was reported that two children inadvertently got FLUMIST in eyes during Oct-2013. The outcome of the event of two children inadvertently got FLUMIST in eyes is unknown. The report was considered to be non-serious.
Rashes on all over body except face. She took benadryl & also use Hydrocortisone cream (OTC). But did not help. Rashes have spread to face. Solumedrol 40mg given in-office with Medrol dosepack and benadryl
MODERNA COVID- 19 Vaccine EUA Shortly after receiving the second, scheduled dose of COVID-19 vaccine, patient experienced shortness of breath, weakness, and sensation of throat tightening. Was administered an Epi-pen and presented to ED for follow-up care. In emergency department patient received diphenhydramine orally. Patient was discharged with resolution of all symptoms after 5 hours of observation.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: vasovagal symptoms post injection
pale shadow; Quite substantial and developed into a raging; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PALLOR (pale shadow) and RASH (Quite substantial and developed into a raging) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PALLOR (pale shadow) and RASH (Quite substantial and developed into a raging). At the time of the report, PALLOR (pale shadow) outcome was unknown and RASH (Quite substantial and developed into a raging) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
No adverse reaction from administration on 3/22/2022.  New patient to our facility who requested Covid vaccination.  vaccination history reviewed on date of service and noted patient recieved Moderna 1st dose and 2nd dose of primary series.    Today received release of information from nursing home in which patient was recently admitted and started primary care with our facility.  Immunization records from facility were received.  Their records indicate they had administered both primary doses of Moderna and booster of dose of Moderna on 1/12/22.  Documentation of Moderna administered on 1/12/22 was not noted in registry at time that Moderna booster was administered at Clinic.  staff was notified and will continue to monitor patient for any adverse reactions along with her primary care provider notified.
I developed multiple pulmonary embolisms and three DVTS in right leg post vaccine. about 5 days or so after first vaccine i had cramping in right foot/calf and right calf soreness. Had interval shortness of breath starting around 10 or 11 days post first vaccine. after second vaccine the following day i noticed more shortness of breath with activity. By day 5 post second vaccine i could not catch my breath and pulse ox drops to 82 with any exertion. Went to emergency room on November 8th and was determined to have clots in lungs and right leg and right heart strain. was transferred to bigger hospital and required mechanical embolectomy to remove clots from lungs to reduce heart strain. Discharged from hospital on 11
This is a spontaneous case, initially received from the other health professional (nurse), concerns a 30-year-old, adult male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 2227 and expiry date: 31-May-2019] which underwent temperature excursion. The patient did not experience any adverse reactions after vaccination. The reporter assessed this case as non-serious. This case (201805346) was cross-linked to case 201805327 due to same reporter. Follow-up report received from reporter on 28-Nov-2018: The age of the patient, route of administration (intramuscular), anatomical location (right deltoid) were added. The reporter confirmed that the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Immediately after shot, had onset of headache dizziness. Onset of fever 12:00am 3/3/09, temp 103.9. Received Advil, water, cold pack. Headache, nausea, dizziness present AM 3/3/09. Also c/o joint pain, pain behind eyes- joint pain on right side of body. Advil brings fever to 101 measured. Denies headache relief. limited fluid intake while ill limited appetite.
Rotavirus given in error. Verbal discharge info given to patient by doctor on 1-16-2014 that pt had been given all 2 month vaccines. She did not name individual immuns due to vaccines given on day of discharge assumed rotavirus included.
Abnormal Lymph Nodes under right arm; Tingling sensation in both feet; Numbness in all toes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Abnormal Lymph Nodes under right arm), PARAESTHESIA (Tingling sensation in both feet) and HYPOAESTHESIA (Numbness in all toes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PARAESTHESIA (Tingling sensation in both feet) and HYPOAESTHESIA (Numbness in all toes). On 16-Mar-2021 at 2:15 PM, the patient experienced LYMPHADENOPATHY (Abnormal Lymph Nodes under right arm). At the time of the report, LYMPHADENOPATHY (Abnormal Lymph Nodes under right arm), PARAESTHESIA (Tingling sensation in both feet) and HYPOAESTHESIA (Numbness in all toes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Magnetic resonance imaging: abnormal (abnormal) abnormal lymph nodes under my right arm. On 16-Mar-2021, Mammogram: abnormal (abnormal) abnormality.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported. The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information was received on 18-May-2021 contains information regarding the reporter, the patient's demographics, and the outcome of the events.
Pt's mother states felt feverish Friday night then noticed welt (red) on arm started to swell then when came into office was a red swollen rash. Patient's mother was told to use cool compresses and Tylenol or Motrin and f/u if need be.
Day 1 none  3/21/21 at approx 8pm Dizziness  Nausea Joint pain Light fever Dehydrated Insomnia  3/22/21 all day Joint pain Dizziness  Nausea  Vertigo  Foot pain Insomnia
COVID positive on 27 Jun 22. Moderate symptoms: headache, fever, chills, coughing, congestion
Dizziness, Myalgia & NauseaVomiting Narrative:  dose: 1-nausea/ fatigue lasting till may 23 dose 2: within 15 min of vaccination nausea/vomiting/dizzy/felt like passing out-transported to ER for further care
Shingrix diluent mixed with Menveo diluent administered; Inappropriate dose of vaccine administered; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Herpes zoster (Shingrix) (batch number 7S279, expiry date 20-AUG-2024) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMXA950A, expiry date 30-SEP-2025) for prophylaxis.   On 10-AUG-2023, the patient received Shingrix and Menveo. On 10-AUG-2023, an unknown time after receiving Shingrix and Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix diluent mixed with Menveo diluent administered), inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: Receipt date: 10-AUG-2023 The vaccine administration facility was the same as primary reporter The reporter asked if there were any safety information available and when the dose of Menveo could be repeated. Shingrix diluent mixed with Menveo diluent administered to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The 11 year old patient received Shingrix diluent which led to inappropriate age of vaccine administered. The reporter consented to follow up.
Started with bumps on face and legs on 5/24 then progressed to vesicular lesions which crusted over. Diagnosed on 5/27/10 with chickenpox (<20 lesions in various stages).
Warm and red the evening of the administration (subcutaneously) painful to touch. Swelling "the size of a baseball", very hard, turned black and blue. Phone calls 5/3 and 5/14 to follow up.
R56.9 - Unspecified convulsions N93.9 - Abnormal uterine and vaginal bleeding, unspecified VAGINAL BLEEDING HEADACHE
This medically confirmed spontaneous report (initial receipt: 26-FEB-2016) concerns a 23 year-old female patient. On 12-OCT-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-JUN-2016 yet reported as 12-JUN-2016). The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. the outcome was not reported.
Left arm swelling of extremity with erythema, 2cm difference in arm circumference with erythema and induration within 24-48 hours of vaccine with Dtap in left arm.
Breakthrough case admission after 3 vaccines Pfizer 3/31/21 Lot# Ew0150;  Pfizer 4/21/21 Lot ER8729;  Pfizer 11/18/21 Lot# FH8028;
severe headache, onset 1/2 hour after vaccine. pain described as 9.9 of 10 on a scale of 1-10. Headache, neck ache, shoulder ache most severe during the first 24 hours, pain continued > 48 hours. Headache & all other pain gone by 55 hours post vaccination. Patient did not notice redness or swelling at the immunization site.
Exactly 12 hours after the shot, I experienced what I expected: 103 degree fever, body aches, joint aches, chills. Those symptoms wore off exactly 25 hours after I had received my second vaccine. But the next day, my asthma got terrible. Over the course of the next week, I was on my steroid inhaler twice a day, and on my nebulizer 4-5 times a day just to breathe. After about 5 days of not getting better, my doctor prescribed me liquid steroids to put in my nebulizer so that they would just target my lungs and not impact the efficacy of the vaccine. Several days later, I was still not better. At that point, I was 12 days out from the second shot. He then ordered me oral steroids that I would taper. After about 3 days without any improvement, he told me to hold at 20 mg of oral prednisone in addition to my steroid inhaler and steroid nebulizer solution. I am now 21 days out from the second shot, and my asthma has not improved. My lungs have had severe inflammation for three weeks now.
TOOK VIVOTIF WITH FOOD; A spontaneous case report was received from a nurse on 10-Jan-2019 for two consumers.  Based on the information obtained from the nurse, two individual case safety reports PVX2019-089 (PVX201901-000027; husband) and PVX2019-090 (PVX201901-000028, wife) were created and cross-linked in the database.  This case report describes an adult female consumer who "took Vivotif with food". The consumer was receiving Vivotif for unknown indication.  It was reported that the consumer took the three of the four doses of Vivotif with food.  The action taken with Vivotif with respect to event "took Vivotif with food" was not applicable.  The clinical outcome of the event "took Vivotif with food" was unknown  Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000027:
Patient developed red itchy watery right eye on 1/21/2022 (3 days after 2nd dose of Pfizer COVID-19 vaccine); and discovered to have anterior uveitis. As part of his workup for uveitis, it was found he had elevated liver enzymes (ALT 155 and AST 100). These liver enzymes were normal when last checked in 2019. Currently he is being treated with steroid eye drops. Liver ultrasound and GI consult pending.
Pediarix was given to patient (Dtap/IPV/Hep B) when Kinrix (Dtap/IPV) was all that was needed.  Patient had already previously received an extra dose of Hepatitis B,  so this was now the 5th dose of Hepatitis B that the patient received.  Mother was notified before leaving, that child received an extra dose of Hepatitis B.
Approx. 3 hours after receiving vaccines, child developed fever of 103 to 105 and mother reported child "having blank stare on face & eyes rolling back in his head". Fever decreased to 100 after giving child Motrin per advice of local hospital ER staff. Child's S/S continued into the next day, so mother took child to a larger hospital ER where child was diagnosed with having possible reaction to vaccinations. Child was referred to a pediatric neurologist for evaluation. I then received a call from child's family physician, Dr. on 4/16/07 to report that child was doing fine, duration of S/S lasted approx. 3 days, and that family was told by neurologist that child possibly had a reaction to the pertussis component of Pediarix vaccine.
30 minutes after vaccination, developed pain with a swelling in R c-spine.  Swollen painful R cervcial lymphadenopathy with radiation of pain into the R shoulder and also had a scratchy throat.
This spontaneous report as received from a pharmacist refers to a 64 years old male patient. The patient's medical history was not reported. The patient's concurrent conditions included allergy to cephalosporins, codeine and morphine derivatives, meperidine, naloxone, penicillins,  propoxyphene, methadone, opium alkaloids. On 16-AUG-2016, the patient was vaccinated with ZOSTAVAX, subcutaneously. Concomitant therapies included atorvastatin, bupropion, hydrochloride, mirtazepine,  es citalopram and diazepam. On an unknown date in August 2016, the patient developed a red, hard lump at the injection site following the administration of ZOSTAVAX. The patient was also vaccinated with an unspecified flu vaccine (manufacturer unknown) at the same time he received ZOSTAVAX. The patient received ZOSTAVAX in the opposite arm as the flu vaccine. The outcome of the events was report4d as not recovered. The causality of the events was not reported. Additional information has been requested.
- muscle aches, 4/10/21 from 6am-10pm  - supraclavicular lymphadenopathy with tenderness to palpation, 4/11/21 starting at 10am
Developed tinnitus (came on fairly quickly, loud high-pitch whining) and constant. The reason I associate with vaccine booster is after the previous booster I developed vertigo for six - eight weeks.  I don't have the vaccine info at my fingertips - it it's important I can look it up but it was the last available booster before they shut down the free program.
bloody nose, coughing blood, bloody bowel movements, lots of bleeding problems, everything lasted 1 month, left arm pain with bloodclot still there
Heard doctor say give Menactra & Gardasil vaccines. I did not check well child visit sheet to double check doctor's documentation of same
Patient reports taking dose #1 of live oral typhoid vaccine (Vivotif Berna)with her dinner at 5 pm on 2/1/2011. Sometime between 1 and 2 am on 2/2/2011 she experienced a seizure as reported by her husband.