chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient received five times the recommended dosage; the patient received the unreconstituted dosage; body aches; headaches; This is a spontaneous report from a contactable Other Health Professional (pharmacy student) reported on behalf of a pharmacist.  A 37-year-old female patient received first dose of BNT162B2 (Pfizer product, batch/lot #: EH9899, NDC number: 59267100001, Expiry Date: 31Mar2021), intramuscularly on 15Dec2020 at single dose (five times the recommended dosage) to prevent the development of COVID 19. There were no medical history and no concomitant medications and no investigation assessment. They did not reconstitute the vial. The patient received five times the recommended dosage and the dosage was unreconstituted on 15Dec2020. The patient experienced body aches and headaches on 15Dec2020 with outcome of not recovered. Reporter seriousness for the patient received five times the recommended dosage was: Medically significant. Seriousness of body aches and headaches was: Too soon to tell. The seriousness of receiving it unreconstituted was: unknown.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events body aches and headaches , there is a reasonable possibility that the events are related to BNT162 vaccine received unreconstituted and five times the recommended dosage. The case will be reassessed upon receipt of follow up information.
admitted to hospital with acute encephalopathy, COVID positive; placed on a nonrebreather; pt was a DNR/DNI; condition declined with AKI; comfort care received; pt worsened and died in the hospital
Extream fatigue, and inability to eat. Slept two days and nights (Thursday and Friday), could not stand to get out of bed on Saturday and Sunday. Began to experience stomach ache in the middle of the abdomen on Sunday. Had a visit at an urgent care facility on Monday, the doctor thought that I might have COVID and she requested a COVID test. Went to the emergency room and was informed that the gallbladder is infected. The surgeon ordered a HIDA scan, and informed me that gallbladder removal is not necessary. The attending physician informed me that the blood work test results do not indicate the presence of an infection. Did not eat for six or seven days. Had to eat before getting discharged.
Missed the window (2-6 months); This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of shingrix vaccine received on 12th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination for this case was not applicable. The patient received first dose of shingrix and missed the window period of second dose (2 to 6 months), which led to incomplete course of vaccination. The patient enquired about to get second shot now to complete the series or must start over.
This spontaneous case, initially received on 02-Nov-2017, was reported by other health professional and concerns a 29-year-old adult female patient. On 01-Nov-2017, it was reported that, the vaccine was stored at 39 degrees and later the temperature was found to be in between 32 to 34 degrees from 9:00 am to 5:00 PM. The temperature was adjusted but, again it went up to 36 degrees (explicitly considered as incorrect product storage). The vaccine was not frozen. On the same day, the patient was administered with FLUVIRIN Thiomersal (batch number: 1721001, expiry date: 31-May-2018, dose, route of administration, anatomical location: not reported) which underwent temperature excursion (explicitly considered as drug administration error). It was reported that the patient had no adverse event. Follow-up received on 04-Dec-2017: Added patient demographics (date of birth, age: 29, gender: female) and date of vaccination was corrected from 02-Nov-2017 to 01-Nov-2017.
This case was reported by a physician via call center representative and described the occurrence of headache in a adult male patient who received SHINGRIX for prophylaxis. On 18th May 2018, the patient received the 1st dose of SHINGRIX. On 19th May 2018, 1 days after receiving SHINGRIX, the patient experienced headache, arthralgia, chills, myalgia, nausea and fever. On an unknown date, the outcome of the headache, arthralgia, chills, myalgia, nausea and fever were recovered/resolved. The reporter considered the headache, arthralgia, chills, myalgia, nausea and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The lot number or expiration date was not provided. The reporting physician was the patient, who experienced the events lasting for approximately 24 hours. The vaccine was administered in a pharmacy. The healthcare professional did not provide further information.
Just wanted to drop you a line to advise that I believe I had a reaction to the Hep- A shot administered on Thursday, March 7th. Reaction started Friday evening late around 11pm, and peaked on Saturday around 4pm, with vomiting, joint pain, and a low grade fever 99.8. By late Saturday night I was feeling better, but still had the joint pain and mild diarrhea. Sunday morning, felt good enough to eat a bland breakfast, oatmeal and dry toast. Monday still slightly sore from vomiting episode, and a little weak. Everything else is all good.
CHIEF COMPLAINT:   89 y/o female presents to ED via EMS from Nursing Home. Per staff, pt has recent COVID and diverticulitis dx. Hgb drawn today 7.4. Hx of GI bleed. DVT RUE. Pre hospital BG 115 mg/dL.   HISTORY OF PRESENT ILLNESS:     Patient is a 89-year-old female who presents from nursing home with anemia on lab work.  Patient denies any rectal bleeding or dark stools at this time, states that she has never had a GI bleeding in the past with does think that she has hemorrhoids.  She was recently diagnosed with Covid and diverticulitis.  She is feeling generally more weak and fatigued than normal however denies shortness of breath.  Denies abdominal pain.
(L) ant lat thigh with 3 cm area in circumference of erythema and increased warmth. No induration or fluctuance.
STINGING; ODD METAL TASTE IN MY MOUTH; RAISED PROTRUSIONS ALONG A VEIN FROM MY ANKLE TO MY GROIN/ BLUISH PROTRUSIONS WENT FROM MY ANKLE TO MY KNEE; PRESSURE IN THIGH AND GROIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced stinging, odd metal taste in my mouth, raised protrusions along a vein from my ankle to my groin/ bluish protrusions went from my ankle to my knee, and pressure in thigh and groin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stinging, odd metal taste in my mouth, raised protrusions along a vein from my ankle to my groin/ bluish protrusions went from my ankle to my knee and pressure in thigh and groin was not reported. This report was non-serious.
Overall body aches, chills, night sweats, fever of 103.5, vomiting, diarrhea, nausea, tiredness, extreme swelling at injection site (right arm) with grapefruit sized knot and extreme soreness. The flu-like symptoms lasted for 5 days. The arm swelling and sorness lasted for 3 weeks.
Full vaccine information is not known as not provided by this provider, but rather potential side effect being reported was during an admission.  Developed chest pain, pressure several days post covid vaccine booster (reported as Pfizer per patient) and sought care at hospital. Troponins elevated, cath performed which was normal. Cardiac MRI suggestive of myocarditis.
Left arm where immunizations given - area itching and red. Dr felt it to be normal reaction.
body sore/ sore arm; Stuffy Nose; Chills; headcahe; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (body sore/ sore arm), NASAL CONGESTION (Stuffy Nose), CHILLS (Chills), HEADACHE (headcahe) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (body sore/ sore arm), NASAL CONGESTION (Stuffy Nose), CHILLS (Chills), HEADACHE (headcahe) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (body sore/ sore arm), NASAL CONGESTION (Stuffy Nose), CHILLS (Chills), HEADACHE (headcahe) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
This medically confirmed spontaneous report (initial receipt 23-Oct-2013) concerns a 80-year-old female patient. On an unreported date, the patient was administered an unspecified influenza virus vaccine (batch number not reported) and ZOSTAVAX (batch number not reported) concomitantly. On an unreported date, the patient developed a high fever and was hospitalised overnight. The patient responded well to unspecified treatment given and went home the next day. Outcome was not reported.
Varicella injection site LA with sensitivity, erythema and slight rash at date presented to clinic 4 days after vaccination.  Parent stated that the erythema, pain and rash were much worse on days 1 and 2 but have decreased and is getting better.  No fever reported at any time since vaccination.
Forearms red areas on both forearms. Welts appeared within a few hours. Areas are really warm, states "burning". Deny any contact/exposure to anything new.
Patient came into pharmacy clinic for his second Covid shot. Before verifying  the Covid questionaire and what type of manufacture dose the patient got the first time. As the nurse was injecting the dose halfway through, she was informed by the technician that it was the patient's second dose. While the patient handed his Covid card over to update it, the technician realized that the patient had gotten the Moderna as his first dose from another facility. The patient was told to sit around for 30 minutes to make sure that there was no adverse side effects. The patient was given paperwork from the CDC about incidences where people have received 2 separate doses from 2 different manufactures. The patient sat in the clinic for an hour with no adverse reactions and left the clinic.
p/vax pt screaming, constipation & sl fever (101); tx as if had reflux & given Mylanta & zantac; during week to recover pt cried 24 hours a day; in severe pain;
never had flu till i took the shot; Initial information received on 05-Nov-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an elderly patient (age in 70s) with unknown demographics who experienced never had flu till i took the shot after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date, the patient developed never had flu till i took the shot (influenza) (unknown latency) following the administration of Influenza vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (never had flu till i took the shot).  At time of reporting, the outcome was Unknown for the event never had flu till i took the shot.
diaphoresis, flushing, anxiety Narrative:  Began feeling symptoms during monitoring period-mildly diaphoretic, dizzy, flushing upon standing. Was anxious about second vaccine. Received monitoring of vital signs for additional 15 min and water provided. Released to home.
I got break through COVID 05/15/2022. My cough was mild, I had swollen glands and sore throat. I had severe very sinus pressure for 4 days. I brought over the counter nasal saline spray help. I only went to the Urgent care just to get tested. I didn't need anything, I just wanted to confirm my symptoms. I been quarantine for about 7 days. I feel fine now.
Went from having a regular period every month to not getting my period at all anymore. Confirmed not pregnant by doctor. Still no period 2 months later. Will be returning to doctor for answers but know it is because of the shot that my period stopped.
Day after the vaccination my child had diarrhea and within 15 minutes from BM to diaper change, developed rash so severe that it caused anal bleeding and severe redness of the skin. Prior to this event my child's bottom was clean without any signs of slightest skin irritation.  There were no new foods introduced in her diet in recent days, no increased intake of any particular food.
7-year-old female patient presented to Mass Vaccination Event at local facility at 12:25 pm to be vaccinated with pediatric (ages 5-11yrs old) Pfizer COVID-19 Bivalent dose and influenza vaccine. Vaccinator incorrectly administered an adult (ages 12yrs & older) Pfizer COVID-19 Bivalent dose; pediatric patient received 0.3mL of undiluted COVID-19 Bivalent vaccine Lot # GJ6739 EXP: 31 Jul 23. Parents was notified of medication error and provided with guidance based on CDC Guidelines COVID-19 Dose administration error as well as guidance received from on-call providers from PRIVATE.
she has no fever, she has elevated pulse, heartbeat; This is a spontaneous report from a contactable consumer (daughter). A 93-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 20Mar2021 (at the age of 93-years-old) (Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included she had a nervous problem with skin eruption but it's undiagnosed, did not know what it was. She always had this skin problem at some extent, and stated it was nervous problem. She had it from 15 years she had this nervous problem and sometimes it's worsen than other times. She was suffering from low thyroid, for 20 years. She had High blood pressure, but it got better for some reason and not now anymore (clarified as not suffering from it anymore). Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for hypothyroidism from an unspecified start date and ongoing; duloxetine hydrochloride (CYMBALTA) taken for nervous problem from an unspecified start date and ongoing; hydroxyzine taken for nervous problem with skin eruption from an unspecified start date and ongoing. She was taking Hydroxyzine and Duloxetine for 2 years. It was reported the patient didn't take any medication at the time that day. On 20Mar2021, the patient had the reaction to the Vaccine she had a high pulse. She had elevated pulse it went up to 107 last day (21Mar2021) and now its 96. She had no fever, she had elevated pulse, heartbeat and now its 96, that's the only reaction. Reporter stated, It's slightly improved. The patient had no treatment for it, the patient called the medical provider and they said to watch it, and the patient had a blood pressure machine at home, check every few hours, because it tells you the pulse. The 2nd shot will be on 12Apr2021. The recent lab test that the patient underwent was about 4 months ago and the reporter didn't remember what it was. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient reported pain down center of neck and pain and discomfort turning neck both left or right.  The pain and discomfort is not relieved by tylenol or ibuprofen.  Pain has continued for 5 days and not subsided.  We also had another patient report they experienced the same thing with their first shot but it was not given here.
low grade fever 99 16NOV; 17th temp went up to 101; seen by MD 18NOV93; ears were red-pt given ATB; mom gave APAP 430PM;
Headache, Myalgia, Fever, chills, swelling under armpit, pain in left breast, & Fatigue Worker states she was seeing PCP
A nurse reported that a 22 year old pregnant female inadvertently received an intradermal injection of Flu Shield '00-'01 instead of a tuberculin test on 11/30/00. That day, she developed an injection site reaction characterized by redness and a bruise. Follow up from the physician received 02/06/2001 indicated that the injection site reaction resolved.
Patient received doses of Varicella vaccine component as CMA administered MMR-Varicella (Proquad) instead of ordered MMR. (Vaccines ordered at time of visit: PCV13, Varicella, MMR, HepA, and Hib) Mother reported mild fussiness after vaccines, otherwise asymptomatic and at baseline 48 hours after vaccination
Anxiety-PAINAND HEAT IN ARM. HEAT PROGRESSED TO ENTIRE BODY. TINGLING IN FEET ON LEFT SIDE. 1222 STILL FEELING HOT/FLUSHED. 1232 FLUSING FONG Narrative:  1202 BP 151/101, HR 66, Temp 98.8, SPO2 98% RA. 1212 BP 176//117, HR 68, Temp 98.1, SPO2 98% RA. 1222 BP 151/100, HR 64, Temp 98.4, SPO2 98% RA. 1232 BP 153-101, HR 60, Temp 98.7, SP02 97% RA. Treated with Ice pack. Symptoms resolved.
Upset stomach; Inappropriate scheduled of vaccine administered; Severe fatigue; Headache; Severe muscle pain; Sore injection site left  arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered), FATIGUE (Severe fatigue), HEADACHE (Headache) and MYALGIA (Severe muscle pain) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21 and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered), FATIGUE (Severe fatigue), HEADACHE (Headache), MYALGIA (Severe muscle pain) and VACCINATION SITE PAIN (Sore injection site left  arm). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), FATIGUE (Severe fatigue), HEADACHE (Headache), MYALGIA (Severe muscle pain) and VACCINATION SITE PAIN (Sore injection site left  arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered) had resolved.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
Aches in arm; escalated to the point that she was unable to move, or use arm. Extreme pain 10/10; started day 3.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: tech stuck patient 3 times to give shot
Narrative: Patient developed chest and throat tightness following administration of Pfizer Covid vaccine and was transferred to community ED for evaluation for allergic reaction.
Fever, body aches, fatigue, chills, headache, loss of appetite, cough, chest tightness. Started around 9pm Thursday night and didn't subside till Sunday morning. Took 500mg of tylenol every 4 hours.
Patient's first flu shot: experienced dizziness, swollen tongue, fatigue, temperature of 99 degrees F. Took BENADRYL and ZYRTEC and felt a bit of relief. Made arrangements to check in with practitioner.
Patient came back to the pharmacy and said he went to the emergency room because he said cellulitis was forming on his right arm down to his elbow.
legs feel like lead in the morning; feel cold; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (legs feel like lead in the morning) and FEELING COLD (feel cold) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-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 LIMB DISCOMFORT (legs feel like lead in the morning) and FEELING COLD (feel cold). At the time of the report, LIMB DISCOMFORT (legs feel like lead in the morning) and FEELING COLD (feel cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Patient was seen today in clinic and reports coughing up bloody phlegm, along with, chest congestion and headache since last night.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 120, and 144 hours, with the lowest recorded temperature of 34, and 33 degrees Fahrenheit (1.11, and 0.55 degrees Celsius) respectively. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient came in to get a flu shot. She is 24 years old, so she should have gotten the Fluzone Quad. I mistakenly gave her the Fluzone HD. I personally spoke to her provider, PA and her supervisor, Dr. They indicated that she may experience increased side effects, but that was it. I called the patient personally and let her know what happened as well as repeated my conversation with PA and Dr. I reassured her that she would be fine, but may exhibit increased side effects (headache, pain at injection site, fever, redness at injection site.