chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant patient received the moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the moderna vaccine) in a 34-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 2014. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Jan-2021 and the estimated date of delivery was 12-Oct-2021. On 24-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  On 24-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that the data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients. The reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. Treatment information was not provided-
Information has been received from a registered nurse concerning an 8 year old male with a hernia, congenial diaphragmatic hernia (CDH) and a history of patent ductus arteriosus (PDA) who on 10-JUN-1999 was vaccinated with Varivax. It was unknown if there were any illnesses at the time of vaccination. On 25-NOV-2006, the patient developed 25-30 lesions on neck and trunk and the appearance of a classic varicella rash. The patient required a doctor visit. Symptomatic treatment included unspecified over-the-counter therapy. No diagnostic testing was performed. The patient recovered. No further information is available.
Couldn't eat or drink; Sore inside of her left cheek that started out as a circle she noticed after three days that has spread and it won't go away; Cheek had skin falling off; Fever; Nausea; Joints hurt; Couldn't get off couch for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Couldn't eat or drink), FACIAL PAIN (Sore inside of her left cheek that started out as a circle she noticed after three days that has spread and it won't go away), SKIN EXFOLIATION (Cheek had skin falling off), PYREXIA (Fever) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEEDING DISORDER (Couldn't eat or drink), FACIAL PAIN (Sore inside of her left cheek that started out as a circle she noticed after three days that has spread and it won't go away), SKIN EXFOLIATION (Cheek had skin falling off), PYREXIA (Fever), NAUSEA (Nausea), ARTHRALGIA (Joints hurt) and FATIGUE (Couldn't get off couch for 48 hours). At the time of the report, FEEDING DISORDER (Couldn't eat or drink), FACIAL PAIN (Sore inside of her left cheek that started out as a circle she noticed after three days that has spread and it won't go away), SKIN EXFOLIATION (Cheek had skin falling off), PYREXIA (Fever), NAUSEA (Nausea), ARTHRALGIA (Joints hurt) and FATIGUE (Couldn't get off couch for 48 hours) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.         Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: follow up received Additional information added on 15-JUN-2021 and added new event.
temp 104.6 R 6 days p/vax responded to motrin if given q 6hr (temp x 2 days average 103);
Hives, throat tightness approximately 5 hours after immunizations - patient visited ER - given BENADRYL.
Adverse Events: Tinnitus, Veritgo, Nausea 36 hours post injection there was a significant increase in volume of bilateral tinnitus which has been constant for 40 years with left side being louder and right side occasionally pulsating. Vertigo and nausea also set in 24x7 for the first week before reducing somewhat. Now 3 weeks post injection my tinnitus has increased from what was a volume of 4 out of 10 for 40 years to a solid 7/10.  The vertigo is present although not triggering nausea until I am lying on my back looking up in activities such as lying back to read a book, work under a car, read a phone/Kindle device. The increased tinnitus volume has made falling asleep in a quiet room or focusing on my work where I wear a headset for virtual meetings extremely difficult at times.
Received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  On 13-Jan-2022, the vial was initially stored in the refrigerator.  It was reported that as per the healthcare provider, the vials were set to expire on 12-Feb-2022 based on the stickers put on them. The healthcare provider was not sure and did not have the exact expiration date of the vial itself. The healthcare provider asked if they are going to revaccinate the patient or not.
Starting with headaches and lightheaded ness and neck pain that progressively has gotten worse over time and has turned into chronic pain. I have seen numerous doctors over time and have not gotten a real diagnosis. Several medications have done nothing from muscle relaxers, nsaids, anti depressants, anti inflammatorys.
Chills, body ache, cough, lethargy. Diagnosis: Questionable vaccinia or viral infection
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 03/11/2021 and 04/02/2021. On 7/12 he began developing symptoms of fatigue, chills, low-grade fevers, body aches, intermittent nausea, poor p.o. intake, poor appetite, some dry cough.  He tested COVID positive on 7/16 and continued symptomatic treatment at home. Patient was then admitted 7/24 and discharged on 7/30 with oxygen. Received decadron during this stay. Returned to ER on 8/12 due to worsening shortness of breath. Received vancomycin and cefepime. Started on BiPAP then eventually intubated on 8/17. Patient's respiratory status continued to worsen. Multifocular infarcts noticed on 8/22. Patient treated for PJP on 8/23. Family planned withdrawal of care on 8/24 after discussion of patient's poor prognosis. Patient expired on 8/25/21.
Cellulitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug hypersensitivity (sensitive to a lot of medications).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The next day after the injection, the patient developed a read patch that grew over time from injection site to elbow, to inside of arm, then up toward armpit. It did feel a little warm, then really hot. The patient's family doctor gave her an antibiotic and it was only slight pink at the time of reporting.  No relevant concomitant medications were reported.   Treatment information included, antibiotic unspecified.  This case concerns a 78-year-old female with a serious unexpected event of cellulitis. Latency 2 days after first mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No new information was provided.; Sender's Comments: This case concerns a 78-year-old female with a serious unexpected event of cellulitis. Latency 2 days after first mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included sinus infection. On 4th February 2019, the patient received SHINGRIX. On 5th February 2019, 1 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient reported a low grade temperature of 99.9 degrees Fahrenheit the morning after a SHINGRIX injection. The reporter did not consent to follow up.
pt recv vax 13SEP95 & p/vax pt was exposed to chickenpox @ daycare;25DEC96 pt devel itching;28DEC96 pt had devel a breakthrough case of chickenpox w/approx 30 lesions;to MD;30DEC96 pt mom reported 3x as many lesions;
Headache, Myalgia, Arthralgia, Fever, FATIGUE, PAIN AND SWELLING AT INJECTION SITE Narrative:
BAD HEADACHE; DIZZINESS; This spontaneous report received from a patient concerned a 58 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced bad headache. On 13-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and bad headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Entire left shoulder area was red, warm to the touch and extremely Painful for 3 to 4 days after receiving the flu vaccine. The patient experienced weakness, paleness, and aching throughout her body for 2 to 3 days. She felt very weak and passed out the day after the immunization was administered.
Pfizer 4/10/21 and 5/1/21. Positive on 1/28/22
Optic neuritis, onset one week after initial vaccination; second vaccination one month later and condition worsened.
Severe vertigo, nausea, vomiting ,  Patient hospitalized, still exhibits symptoms post discharge.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 04-JAN-2013, the patient was vaccinated with BCG. No lot number or expiration date was reported. No concomitant medications were reported. The physician stated that the patient received BCG via the intradermal route. There were no known adverse effect. Follow up information received from the physician regarding the 5 month old male patient. Contact details of vaccine administrator and patient were updated. The patient had no pre existing allergies. BCG (lot# 4511121-A) given intradermally instead of percutaneous. On 04-JAN-2013, the vaccination site became red and indurated and painful (medically significant-as events required medical intervention). The patient was seen by infectious disease doctor and was started on rifampin and isoniazid to prevent any adverse reactions. The patient did not have laboratory tests performed. Area was drained on its own and is now scabbed and healing. Medication was given for 6 weeks. Prophylactic anti T.B medicines to prevent abscess or lymph node enlargement. No surgical problems or other complications. Illness at time of vaccination was none. Twin sibling was also vaccinated with the same vaccine. This is 1 of 2 reports from the same source. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a 35 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of VAQTA (dose, route of administration, lot # and expiration date were not reported). It was reported that the patient received dose 2 of VAQTA 2 months after receiving dose 1. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt was getting routine flu vaccine given by co-worker: CRNA During injection, administrator noted resistance @ first then vaccine went in quickly and painfully - more than typical flu vaccine. She usually has injections. Site pain for about 4-7 days. but her left upper arm pain has persisted. There was slight swelling @ time. but it did not last long no shock type pain, no radiation of pain to rash of arm. 0 numbness or tingling. Some perceived weakness. ROM intact / strength intact increased pain with movement of upper arm persists
Very Dizzy; Legs collapsed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Very Dizzy) and LIMB DISCOMFORT (Legs collapsed) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Very Dizzy) and LIMB DISCOMFORT (Legs collapsed). On 26-Feb-2021, LIMB DISCOMFORT (Legs collapsed) had resolved. At the time of the report, DIZZINESS (Very Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
swelling; redness; heat sensation; the patient experienced pain in her deltoid muscle; This spontaneous report was received from a pharmacist and refers to a 56-year-old female patient. The patient's concurrent condition included asthma. Her concomitant medications and drug allergies were  not provided. She had seasonal allergy.  On 12-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, lot # S006778, expiration date 28-NOV-2020 (exact dose and dose # were not reported) for prevention of pneumonia. During the night of 12-FEB-2020, she experienced pain in her deltoid muscle, swelling, redness and heat sensation. On the same day, the patient went to Hospital emergency room and received an unknown antibiotic. The outcome of the events was reported as not recovered.   The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Pain in arm; Rash; Swollen; Itchy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), RASH (Rash), PERIPHERAL SWELLING (Swollen), PRURITUS (Itchy) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B217) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included VITAMIN B COMPLEX (B COMPLEX (B50)) and VITAMIN D3 for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm), RASH (Rash), PERIPHERAL SWELLING (Swollen), PRURITUS (Itchy) and CHILLS (Chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm), RASH (Rash), PERIPHERAL SWELLING (Swollen), PRURITUS (Itchy) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Patient does not want to share her email and does not have a fax. She provided Argus number On 09-Jul-2021: Non significant follow up
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.            No concomitant medication information provided. Patient took COVID-19 treatment medication on 03-Jun-2022.  On 03-Jun-2022 at 21.00 , patient reported nasty taste in mouth about 5 hours after taking first dose of COVID-19 Treatment.  Device date was reported as 03-Jun-2022.  Company comment: This spontaneous case concerns unspecified age and gender, with no medical history reported, who experienced the unexpected non-serious event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It is reported that patient had nasty taste in mouth about 5 hours after taking first dose. Patient started on unspecified covid-19 treatment. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns unspecified age and gender, with no medical history reported, who experienced the unexpected non-serious event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It is reported that patient had nasty taste in mouth about 5 hours after taking first dose. Patient started on unspecified covid-19 treatment. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
LR 7 Adverse event >120MM Distal to Elbow with Numbness
pt walk to lobby to sit & wait 20min a/leaving upon sitting pt head fell back & eyes rolled back & arms & legs had decenabrate posturing;pt remained alert & lethargic during event;BP 120/80;color pale;