chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A facility has been using a batch with lot #046c21a for 6 weeks now and the batch had expired on the Nov 06, 2021; This spontaneous case was reported by a non-health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A facility has been using a batch with lot #046c21a for 6 weeks now and the batch had expired on the Nov 06, 2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046c21a) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A facility has been using a batch with lot #046c21a for 6 weeks now and the batch had expired on the Nov 06, 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A facility has been using a batch with lot #046c21a for 6 weeks now and the batch had expired on the Nov 06, 2021) had resolved.            No concomitant medications were reported. No treatment medications were reported.
A few day after my shot I broke out in haves and red rashes all over my body. My toes all the way up to my fingers etched non stop. My ankles on both feet were swollen for many days and my face and eye swollen shut. My period also was 4 weeks late. After my second shot I have the same reaction only this time is was the same day I got my shot. I also have not had a period since then. I am not sexually active and have no chance of pregnancy
1410 - Pt approached table reporting feeling dizzy and requested for water. RN approaches pt. Client appeared pale. Head nodded downward. RN guided client safely to the ground and propped legs on top of chair. No injuries sustained. Called EMS.  1411 ? Instantaneously woke up and insisted he was okay. Pt wanted to sit up and informed pt to remain laying. NP, site director, & EMS approached. NP assessed client. Pt diaphoretic, pale, denies nausea, denies chest pain, denies blurry vision, no SOB. Hx of ADHD, no hx of DM, reports smoked marijuana before arrival, denies taking medications. Last meal was breakfast consisting of oatmeal, coffee, and green tea.  1413 ? Pulse ox 98% HR 64. Diaphoretic, clammy, yellow pale. Says, ?feeling fine. I feel somewhat better.? In laying position  1417 ? BS 101, pt reports weighs 155lbs, 6 ft tall, bp 99/64 laying, pulse ox 100% hr 61  1420 ? Pt sat up on ground with assistance. Given fluids. No dizziness reported. When asked how he is feeling reports, ?I am 98%?.  1421 - VS 99% ox saturation, p 64, bp 122/80 while seated on ground  1422 ? seated in chair, color returning 1425 ? VS 115/81 HR 92 pulse ox 100% seated in chair, denied weakness  1430 ? Vs BP 106/80 hr 89 ox sat 99% 1432 ? VS BP 103/75 HR 84 standing o2 sat 100%, per NP negative orthostatic hypotension, no diaphoresis, denies chest pain, no SOB, dizziness subsided, denies blurry vision. Client stayed for another 12 minutes.  1447 ? NP okayed client to leave, escorted to car with RN
Headache , muscle ache , nose bleed , fatigue,  red itchy rash,
4 days: unable to lift arm, general weakness, chills, fever, painful eyelids
Was NPO, had sports physical and given Tdap, Menactra, PPD and Hemocult. On the way out, felt dizzy and nearly fainted.
Swollen, red area on thigh 4 cm x 6 cm treated with Keflex x 7 days
Information has been received from a physician concerning a female who was vaccinated with ZOSTAVAX. Subsequently, the patient developed a mild case of shingles. Additional information has been requested.
after first dose of the Moderna vaccine she became very ill and was hospitalized on 3/13 - 3/23.  After 2nd dose of the vaccine she seemed to be doing ok but gradually declining and less and less to be able to do for herself, it slowed down greatly after the vaccine. There was a gradual decline, but on May 2 she woke up and was semi conscious and said she thought she was dyeing and was in pain and discomfort and was taken into the ER and she was DC'd and started hospice and two days before she passed she got the hospice care. My mother was in a semi coma and could not communicate properly.  Many test were done at the hospital during her stay even though they never identified what the cause was. At the last ER visit they diagnosed her with pneumonia
"Patient was found on floor, unresponsive. Patient passed out after shot. Patient regained consciousness checked for head and neck injuries no ached pains or deformities. vitalized and released to mom. Patient given water and cookies feeling better."  (From written statement by emt)
One week after I received my second dose of Moderna I started having 20-30 hot flashes a day. It was to the point that I couldn't sleep at night due to the frequency. One month after receiving this shot I went to a warmer climate and they stopped. I don't know if it was due to the heat or what, but it was very strange and hasn't happened since.
Increased Heart Beat for about 2 hours on 1/13 and again on 1/16.     Contacted dr. Office and they said to file this report.
Aggressive fungal infection in her left eye 16 weeks after second dose of Moderna Covid-19 vaccine. Epiretinal membrane s/p PRK and had complication with pseudoepithelization and is on abx and anti-fungals and PRP. Treatment: Monifloxacin 0.5 % eye drops, doxycycline 100 mg
inj site golf ball size & hardness, hot to touch, extremely tender, red, swollen, flu like sx, t101, n&v;
Dizziness; Vomited within 60-90 mins; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 28Aug2021 at 12:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included gliclazide (CLARITIN), PRENATAL VITAMIN and vitamin D NOS (MANUFACTURER UNKNOWN); all started on an unknown date and for unknown indication. The patient had no known allergies to food, medication or other products. On 28Aug2021 at 13:45, the patient experienced dizziness and vomited within 60-90 mins. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness and vomited within 60-90 mins was resolved on an unknown date in Aug2021.
tardive dyskinesia; Cold; feeling strange/states she it was strange/felt surreal/did not know if she was dreaming or if this was real/she felt like she was floating; Scratch; She felt like she was in never never land; It scared her; Pins and Needles all over her body/like when the arm or foot falls asleep; Woke up and thought she was still sleep (Dream State)/did not know if she was dreaming or if this was real; felt like inside her body was cold; Nightmares; joint pain; Chills/had the weirdest chills she ever experienced/they were not normal chills; Fever; Nausea; Vomiting; Headache; Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of TARDIVE DYSKINESIA (tardive dyskinesia) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO), METOPROLOL and LEVOTHYROXINE for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 11:22 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced TARDIVE DYSKINESIA (tardive dyskinesia) (seriousness criterion medically significant), NASOPHARYNGITIS (Cold), FEELING ABNORMAL (feeling strange/states she it was strange/felt surreal/did not know if she was dreaming or if this was real/she felt like she was floating), SCRATCH (Scratch), EUPHORIC MOOD (She felt like she was in never never land), FEAR (It scared her), FEELING OF BODY TEMPERATURE CHANGE (felt like inside her body was cold), ARTHRALGIA (joint pain), VOMITING (Vomiting) and MYALGIA (Muscle pain). At the time of the report, TARDIVE DYSKINESIA (tardive dyskinesia), NASOPHARYNGITIS (Cold), FEELING ABNORMAL (feeling strange/states she it was strange/felt surreal/did not know if she was dreaming or if this was real/she felt like she was floating), SCRATCH (Scratch), EUPHORIC MOOD (She felt like she was in never never land), FEAR (It scared her), FEELING OF BODY TEMPERATURE CHANGE (felt like inside her body was cold), ARTHRALGIA (joint pain), VOMITING (Vomiting) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 101.5 (High) 101.5 F.         No treatment information was reported. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 : dose details, events and case seriousness was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (did not receive the 2nd dose between 25-35 days of the 1st dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 048B21A) for COVID-19 immunization. No medical history reported. On Jun 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced product dose omission issue (did not receive the 2nd dose between 25-35 days of the 1st dose). At the time of the report, product dose omission issue (did not receive the 2nd dose between 25-35 days of the 1st dose) had resolved.  The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported. Sender's comments: This is a case of medication error. Dose omission for 2nd dose of COVID-19 (mRNA-1273) vaccine. Causality for medication error not applicable.
Case number PHEH2013US020538 is an initial spontaneous report from the nurse received on 30 SEP 2013 and a follow up report from the nurse received on 04 FEB 2014. This report refers to a 24-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014) at a dose of 0.5 ml via intramuscular route in the deltoid muscle on 27 SEP 2013. It was reported that the vaccine which was given to the patient was stored at room temperature during shipment for 72 hours. No adverse event reported following this medication error.  Follow up report from the nurse received on 04 FEB 2014: Site of vaccination was updated.
SHOULDER SORENESS PRESENTING IN THE EVENING OF THE VACCINATION. DURING SAME NIGHT PATIENT AWOKE WITH FLU-LIKE SYMPTOMS RESULTING IN BODY ACHES AND LOW ENERGY THE FOLLOWING DAY. THE FOLLOWING NIGHT PATIENT REPORTED NIGHT SWEATS WHICH LASTED UNTIL FOLLOWING MORNING. THAT MORNING ALL SYMPTOMS  RESOLVED.
Patient started having a headache in the temple area of head starting the day of his booster vaccination (10/11/21) and has had the headache every day up until today (12/7/21) almost 2 months long.  Patient also states his blood sugar has been 50 points higher than his normal average and has been unable to get the blood sugar to come down also starting the day of booster vaccination and continuing until this day.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On OCT-2014 the patient was vaccinated with RECOMBIVAX HB dose 2 for prophylaxis. On OCT-2014 the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to RECOMBIVAX HB.
severe and possibly life changing neurological or other side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (severe and possibly life changing neurological or other side effects) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (severe and possibly life changing neurological or other side effects). At the time of the report, NEUROLOGICAL SYMPTOM (severe and possibly life changing neurological or other side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. List of concomitant medication were not given.
On both shots, within 24 hours I had full bodyaches and my body temp dropped to 96.1. I had chills every time I drank anything. Lasted 24 hours both times. After the 1st shot I had horrible muscle cramps for 2.5 weeks. After the 2nd shot, within 5 days the tastebuds on the back of my tongue got swollen and I feel like I've burnt my tongue on the back and sides of my tongue, but I haven't. Brushing my teeth and using mouthwash twice a day has not helped, neither has warm salt water rinses. My tongue also feels slightly swollen so I have been taking anti-inflamatories.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 23-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 23-Jul-2022) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 23-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 23-Jul-2022) 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 (Administered the vaccine to patient after the 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 23-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  Vial did not undergone any temperature excursions.  No treatment information was provided.
Circular rash 8cm x 9cm around injection site. Patient's 1st PREVNAR 13 - but 4 previous doses of PREVNAR 7.
Pt stated she had a flu shot 11/27/2001 and had an allergic reaction to shot. Left upper arm reddened, inflamed, swollen and itching since shot on Tuesday. Pt's states she is now having breathing difficulty at this time, that she is allergic to latex and when comes in contact to latex, had to go to ER for breathing difficulties.
I had numbness in left inner elbow and base of left middle fingers; later major swelling and extreme pain in left wrist, hand, and fingers, followed by tightness and pain in neck muscles with minor swelling. I saw my chiropractor/nutritionist and started taking Inflamma Control (IFC).
30 minutes after receiving the vaccine report numbness in the right cheek  progressed to numbness to the right side of the face and numbness to the right portion of the mouth upper and lower lip, with altered sensation in chewing ,  and abnormal sensation to the teeth upper and lower on the right side,  this afternoon noted pain in the right hand between 2nd and 3rd metacarpals , a slight facial asymmetry noted on the right side of the face.  Also developed pain to the right side of the neck and shoulder 1 hour after the vaccine
This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. Approximately in 2015 (reported as "on unspecified dates between 27-JUL-2015 and 03-AUG-2015"), the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL (lot # K011562, expiration date 08-APR-2017) (dose, frequency, route of administration were not reported). Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
One week after my vaccination, March 12th, my arm became very painful and the site was swollen and there was a lump below the injection site.  The two days following this I felt extremely tired, weak and nauseous.
Running fever day p/inject; temp 102F, 2 days p/inject c/o sore throat, local rxn - lump & pain x 2 days; Rash in "hot spots" - inside elbows, neck; Wheeze, glands inside throat & parotid glands swelled; Seen by MD dx Strept throat;
Information has been received from a Registered Nurse (R.N.) concerning a 4 year old male patient, with rhinitis allergic and a history of croup and none drug reactions/allergies, who on 26-MAR-2012 was vaccinated with a dose of PEDVAXHIB (lot # 66775/1475AA, expiration date 11-NOV-2012), 0.5ml, IM in left thigh. Concomitant therapy included a dose of PREVNAR vaccinated on 26-MAR-2012 in right thigh. It was reported that on 27-MAR-2012 the patient developed a fever of 101 Fahrenheit with a headache. The patient's parent called the office and was advised to administer MOTRIN or TYLENOL. On unknown date the symptoms resolved. On 05-APR-2012 the patient's parents called the office to report the patient had developed fever, left thigh soreness and limping. Nurse reported that the patient was seen in the office on 06-APR-2012 and was found to have an elevated white blood cell count and C-reactive protein level. On the same day, 06-APR-2012, the patient was admitted to the hospital. On unknown date the patient had a magnetic resonance imaging (MRI) and was diagnosed with left femoral osteomyelitis. A peripherally inserted catheter was inserted and the patient was started on IV antibiotics (unspecified type). The patient was discharged from the hospital on 10-APR-2012. The patient continued IV antibiotics therapy at home. On 26-APR-2012 the antibiotics and peripherally inserted central cathered ("PIC line") were discontinued. On 26-APR-2012 the patient recovered. Left femoral osteomyelitis was considered to be disabling, immediately life-threatening and other important medical event by the reporting nurse. Additional information has been requested.
pt fussy p/shots; t100 mom called clinic; slept well during noc; 1520 found unresponsive & not breathing; mom started CPR until ambulance arrived; brought to hosp; 1555 in full cardiac arrest;
Headache, Myalgia, Arthralgia, Left Arm Weakness, swollen lymph nodes in neck Narrative:
When can I book my second shot when first shot was May 6; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (When can I book my second shot when first shot was May 6) 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 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (When can I book my second shot when first shot was May 6). At the time of the report, PRODUCT DOSE OMISSION ISSUE (When can I book my second shot when first shot was May 6) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sudden sweating-heavy, nasal drainage causing coughing attack, nausea, vomiting for several hours and subsequent fever chills horrible body aches , fever broke 10:00AM, still weak achy as of 2:00PM.
injection site pain; tiredness; headache; chills; joint pains; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 04May2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient past drug history included lactose. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 06Apr2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 01:00 the patient experienced injection site pain, tiredness, headache, chills and joint pains. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events injection site pain, tiredness, headache, chills and joint pains was recovering at the time of this report.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: an agency (coding updated for known_allergies: Lactose Reaction from Lactose intolerance to Drug allergy), Events detail (Treatment updated as No for events), updated narrative ("The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events" added).
Vaccine administered to left deltoid on 10/17/2013 (approximately 2pm as stated). At approximately 7pm, began to develop hives to the upper body.
When giving vaccine, when the plunger was pushed down the dose leaked down his arm. It appeared a large volume leaked out so dose of Moderna was re-administered.