chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna booster vaccine to a patient >12 hours post vial puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna booster vaccine to a patient >12 hours post vial puncture) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021 at 8:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Dec-2021 at 8:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna booster vaccine to a patient >12 hours post vial puncture). On 22-Dec-2021 at 8:15 AM, EXPIRED PRODUCT ADMINISTERED (Moderna booster vaccine to a patient >12 hours post vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial opened/punctured on 21-Dec-2021 at 02:00 pm, vial storage at refrigerator, date moved to refrigeration was 10-Dec-2021. The vial did not undergo any previous temperatures excursions. The patient did not experience any symptoms.  No treatment information was provided by the reporter.
Severe pain and tenderness in legs.  Seen by Dr. at Ortho Clinic and placed on steroids for seven days.
Patient is a 22 y.o. female , critically ill , admitted to ICU through emergency department of this hospital.  This lady is known to have diabetes mellitus.  She has insulin pump and is very compliant with management of diabetes.  For last 3 days her insulin requirement has gone up because of hyperglycemia and her endocrinologist has increased her basal nightly dose 3 days ago.  Yesterday she received her second dose of corona virus 19 vaccine at health center and she has been been vomiting since then.  Upon arrival in the emergency department her blood glucose level is 460 with anion gap of 28 and she is in ketoacidosis.
Paralysis of left side of face; left eye won?t blink: left side of mouth doesn?t move.   Went to facility on 2/6/2021 and diagnosed with Bells Palsy.
This study case was received from the investigator on 06 June 2011. A 21 year-old male subject whose medical history was not available for dizziness/fainting spells, blood clots, shortness of breath, asthma (include exercise induced), Diabetes (Type I or Type II), eczema, headaches, numbness or paralysis, seizures, memory loss, chronic fatigue syndrome, psychiatric illness, HIV, meningitis and encephalitis (all other medical history was not significant) was found to have acute pericarditis, unspecified and an unspecified disease of the pericardium 11 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 12 November 2010. He also received on 15 October 2010 Hepatitis A (Adult) (manufacturer, lot number, route and site of administration not reported) and on 13 October 2010 he received Influenza vaccine (manufacturer, lot number, route and site of administration not reported), IPV (manufacturer, lot number, route and site of administration not reported), Meningococcal MCV4P (manufacturer, lot number, route and site of administration not reported) and Tdap (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I result, an abnormal ECG and a normal Echocardiogram. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There was no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
12/16/12 baby fed less well. 12/17/12 found unresponsive. Did not respond to resuscitation efforts.
Patient received FLUVIRIN and a red rash broke out from the neck up the next day. Patient took about 2 days of BENADRYL and symptoms slowly resolved. Complete resolution occurred after a MEDROL Dose Pack.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Lot number: 048L21A), in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history was not reported. The patient had no known allergies. There were no concomitant medications. Other medication in 2 weeks was reported as no. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rapid Covid-19 antigen test was positive. Therapeutic measures were taken as a result of covid-19. Anti-viral details: product: COVID 19 Treatment, Brand: Pfizer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
RPh administered Shingrix instead of Fluzone by mistake. Patients mother reported patient woke up following morning with headache and fever. Symptoms were relieved with Advil.
Day 2 ongoing severe abdominal pain, vertigo and blurred vision. Treatment TBD
The patient submitted the incorrect date of birth. Their correct found. The patient was 17 years old at the time of inoculation.
pt developed bad case of shingles on Left abdomen to left side of back. Went to Urgent care  3/12 and was given acyclovir and cephalexin. pt is having stabbing pain on abdomen and back
This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. In approximately 2015, reported as "since 01-JUN-2015 on unspecified dates", unspecified patients were vaccinated with doses of VAQTA (Lot #K010577 Expiration date: 22-SEP-2016), which were exposed to temperatures outside of the recommended range (dose, route and anatomical location of administration were not reported). No adverse experience has been reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
body aches, sinus pressure, headache, going on for days; not relieved even by Tylenol #4
very very colds (covered with 3 blankets), weak (afraid to walk for fear of falling),stomach hurt. nausea, headache, left arm (injection site hurt - could not even flush toilet) , headache, I felt like I would be short of breath but never needed to use the emgerency inhaler. Highest fever was 100.1; The entire next day I was very tired but the symptoms seemed to gradually go away.
This spontaneous report was received from a health professional concerning an adult male patient of approximately 30 years of age. It was reported that the patient had no risk factors other than the patient had never had chickenpox. Approximately in 2013, reported as two years earlier, the patient experienced a varicella-like rash, after his young child had recently been vaccinated with VARIVAX  (dose, frequency, route, lot No. were not reported). No Product Quality Issue was reported. At the time of this report, the outcome of varicella-like rash was unknown. Additional information has been requested.
7 hours after administration, pt started sweating, became incoherent, and was lethargic for 24 hours. Pt reports eating food to relieved symptoms, but didn't help. Resolved after 24 hours.
A report has been received from a Health Professional concerning a 51 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 01-Nov-2013. The nurse reported they inadvertently gave FLUMIST to a person over 49 years of age on 01-Nov-2013. The outcome of the event of we inadvertently gave FLUMIST to a person over 49 years is unknown. The report was considered to be non-serious.
This spontaneous report as received from a nurse manager via company representative refers to a 60 year old male patient. On 25-AUG-2014 the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (dosage and lot number were not provided), instead of ZOSTAVAX. No symptoms reported. Additional information has been requested.
Patient received Varicella vaccine on 3-22-07. Moc returned to clinic on 3/26/07 to show vac site with 2" round, red, raised soft, no tender reaction right post arm.
On 6JAN92 pt recvd IPV/DTP & on 6JAN92 lt leg swollen & tender; Swelling described as 4" long  & 2" wide & about 1/2" raised; Rt leg also becam swollen on 7JAN92;
No (so far); Mother was notified of this error, and given instructions on what to watch for (adverse effects) and to seek medical advice or return to clinic or ER if pt demonstrates any concerning side effects. RN
Very large welt on thigh rt leg. About 6-7 centimeters round hot to touch painful.
I had a reaction after the first dose of the vaccine. I felt like there was a lump in my throat and my throat was scratchy. My throat was tingly and itchy. It lasted three hours but I take antihistamines. The palms of my hands were really red and a little itchy which happened on and off for a week. I felt a I also came down with the shingles which I am still recovering from after seven weeks. The shingles started about three and half weeks after my vaccine. My Chiropractor thought my rotator cuff was injured because my shoulder chest and left arm hurt. The pain was really intense. I started to get some spots on my shoulder and chest when I saw my doctor she diagnosed Shingles. I started and an Antiviral drug. The spots that had broken out first are still visible after seven weeks.  I have been advised not to get the second dose but I am unsure whether I will.
I awoke with vertigo on a Tuesday. On Tuesday and Wednesday I was vomiting.  I took some Bomine 75MG. It slightly improved and returned that evening. On Wednesday I felt better, but it worsened again that evening. It was gone that Thursday, but had lingering fatigue. I have not ever had vertigo.
Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report from a contactable consumer (Pfizer employee) reporting for a patient. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had positive COVID-19 test. The event was reported as non serious. It was unknown if treatment was received. The event was resolving.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Muscle aches upper body; neck stiffness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 25Mar2021 15:45 (Lot number: ER8733) at the age of 68 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Known Allergies: all cillins; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, the patient diagnosed with COVID-19; "Diabetic" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Coronary artery disease" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included: SYMBICORT; ATENOLOL; HUMALOG; FUROSEMIDE; SPIRONOLACTON. Past drug history included: Versed, reaction: "Drug allergy"; Epinephrine, reaction: "Drug allergy"; Cephalexin, reaction: "Drug allergy". The following information was reported: MYALGIA (non-serious) with onset 26Mar2021 04:00, outcome "not recovered", described as "Muscle aches upper body"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 26Mar2021 04:00, outcome "not recovered", described as "neck stiffness". Therapeutic measures were not taken as a result of myalgia, musculoskeletal stiffness.  No follow-up attempts are possible. No further information is expected.
I did not have a period in over a year, and the day after the first and second vaccination I had my period; More than 35 days between first and second shot; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (I did not have a period in over a year, and the day after the first and second vaccination I had my period) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second shot) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     Concurrent medical conditions included Menstrual cycle abnormal. Concomitant products included TESTOSTERONE for Menses irregular, ESCITALOPRAM OXALATE (LEXAPRO) and ARIPIPRAZOLE (ABILIFY) for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (I did not have a period in over a year, and the day after the first and second vaccination I had my period) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second shot). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (I did not have a period in over a year, and the day after the first and second vaccination I had my period) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported.   This case was linked to MOD-2021-291011 (Patient Link).
Sore arm; Blood sugar was 285; Bad headaches all night long; A spontaneous report was received from a Consumer concerning a 70-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed sore arm, bad headaches all night long and her blood sugar was 285.  The patient's medical history included receving first dose of COVID-19 vaccine on 02 Feb 2021. No concomitant product use was reported.  On 02 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (batch number: 012MZ0P) and received her second planned dose on 04 Mar 2021 (batch number: 029A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Mar 2021, the patient had bad headaches all night long.  On 05 Mar 2021, her blood sugar was 285 (unit not reported) in the morning when she woke up. Her right arm was sore. However, she did not have any fever, nausea or vomiting. Treatment information was not available at the time of this report.  Action taken with mRNA-1273 in the response to the events was not applicable.  The outcome of the events sore arm, bad headaches all night long and blood sugar was 285 was unknown. =; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Patient developed fever on day 8 post-vaccine followed by tachycardia, dyspnea and chest pain.  Elevated troponin in the ER.  ED echo confirmed pericarditis with likely myocarditis.
pt recv vax & exp high fever & rash for an extended period;pt recovered from high fever & rash;
Severe nerve damage pain and swelling at injection site 3? circular welt lasting more than 10 days
Client became unresponsive for about 15 seconds after sitting in the observation area. He was pale and diaphoretic but came to almost immediately and was AO x4. BP was 128/74. Client reported having a history of "passing out" with needles prior but it had been years since that had happened. He was observed until 4:14pm and EMT observer on site took a final BP: 120/84 and walked him to his car. He had a steady gait walking to the car and ate a muffin before driving away.
This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis. On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm). On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme. The reporter also noted that the arms continued to be tender. Pharmaceutical product complaint was also identified. It was not reported of the subject had previously received any influenza injections. Also any previous reactions following vaccinations was also not reported. At the time of reporting the events were improved. The healthcare professional considered the events were probably related to vaccination with Flulaval. Follow-up was received by the healthcare professional on 07 November 2007. At the time of the events, the subject was 54 years of age. Medical history included tobacco use of one-half pack daily and alcohol use reported as "few weekends." On 5 October 2007, the subject received an injection of Flulaval in the left arm. On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced tingling and numbness of the lips and tongue, body aches, bronchospasm, injection site soreness, arm tenderness and product complaint. Review of a hospital bill indicated that the subject was transported via ambulance to an emergency room on 5 October 2007 and hospitalized. The hospital bill indicated that the subject received Ketoralac tremetamol, Betamethasone acetate + betamethasone sodium phosphate, Ipratropium bromide + salbutamol sulphate and respiratory therapy. The events resolved with sequelae on 11 October 2007. The healthcare professional considered the events were probably related to vaccination with Flulaval.
Patient reported left arm soreness at sight of injection that has been ongoing w/o resolution. Patient seen physician. Has trouble exercising and cannot sleep on his left side due to soreness.
nausea; vomiting; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 7-year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 7 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset Nov2021, outcome "unknown", described as "nausea"; VOMITING (non-serious) with onset Nov2021, outcome "unknown", described as "vomiting"; DIARRHOEA (non-serious) with onset Nov2021, outcome "unknown", described as "diarrhea".  Additional information: The reporting parent stated that her daughter received the Pfizer vaccine on Saturday and has presented vomiting and diarrhea. She vomited 4 times, diarrhea does not go away because she went to the bathroom 3 times, she has nausea and vomiting. She wants to know if these are common or normal side effects caused by the vaccine. Reporter stated that she trust what they are studying the vaccine for something good. Reporter stated that her other two children, 9 and 11 years of age, had no side effects, but daughter did have a reaction to the vaccines. She spoke more than anything because her doctor told to talk to company to see if it was normal and in response, she was suggested to visit the website  for further information about the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Post COVID-19 Vaccination vulvar aphthous ulcers; Post COVID-19 Vaccination vulvar aphthous ulcers; This is a literature report for the following literature source(s): Journal of Pediatric and Adolescent Gynecology, 2022; pgs:226, DOI:10.1016/j.jpag.2022.01.089.  An adolescent patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for covid-19 immunization, reaction(s): "Without complications". The following information was reported: VULVAL ULCERATION (medically significant), APHTHOUS ULCER (medically significant) all with onset 2020, latency 2 days after the suspect product(s) administration, outcome "recovered" and all described as "Post COVID-19 Vaccination vulvar aphthous ulcers". The event "post covid-19 vaccination vulvar aphthous ulcers" required emergency room visit. The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: Negative; Epstein-Barr virus test: Negative; Physical exam: was consistent with a diagnosis, notes: of vulvar aphthous ulcers with no exceptional characteristics.; Sender's Comments: Based on the available limited information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events vulval ulceration, aphthous ulcer which cannot be fully excluded. The case will be reassessed if additional information becomes available. 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.,Linked Report(s) : US-PFIZER INC-PV202200042326 Same article/drug/event and different patient:;US-PFIZER INC-202201056247 Same article/drug/event and different patient:;
sore injection arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (sore injection arm) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection arm). At the time of the report, VACCINATION SITE PAIN (sore injection arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.
Shot right arm 10:00 AM. Ache at 11:00 in left wrist and increased pain with swelling and synovitis with extreme pain. Referred to ortho immediately. Seen 10/18/05.