chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine exposure during 6.5 months of pregnancy with no reported adverse event; Initial information received on 17-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves female patient of an unknown age and who was 6.5 months pregnant and was exposed to INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported vaccine exposure during 6.5 months of pregnancy.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE (dosage, strength, expiry date and lot number: not reported) via unknown route in unknown administration site for Immunization and was exposed to vaccine  during 6.5 months of pregnancy (exposure during pregnancy) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
6/13/13 Patient here for follow-up. Two days ago, he received HPV vaccine. He tells me when he was sitting in the waiting room he had a mild headache. He felt anxious. He tells me he gets nervous easily. At about 5:00 p.m., he developed nausea. Then about 7:00 p.m., after going out to dinner, he vomited and his headache increased. He was brought to the ER. ER note is on chart. Today, he tells me he is back to normal.
Recieved DtaP and IPV on 2/8/08.  Wkoe up 2/9/08 with red, swollen left arm.  Seen in our office and diagnosed with vaccine local reaction vs. cellulitis.  Treated wih Augmentin.
Terible surge of sleepiness; Vision blurry; Joints ache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Terible surge of sleepiness), VISION BLURRED (Vision blurry) and ARTHRALGIA (Joints ache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Terible surge of sleepiness), VISION BLURRED (Vision blurry) and ARTHRALGIA (Joints ache). At the time of the report, SOMNOLENCE (Terible surge of sleepiness), VISION BLURRED (Vision blurry) and ARTHRALGIA (Joints ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Presented with lower back pain and a low platelet count, in the hospital developed aphasia. Became unresponsive, developed seizure activity,  and was subsequently intubated.  Thrombotic thrombocytopenic purpura treated with plasmapheresis, caplicizumab. Patient is still intubated in the hospital but is becoming more responsive and follows commands.
Initial report received from a consumer (patient's friend) on 05 Feb 2010: The patient was vaccinated with RABIPUR (batch no: unknown) on an unknown date. After vaccination, the patient had unusual/strange behaviour, almost driven, restless and aggressive. The patient had extremely outgoing behaviour and it was unusual. As per the reporter, the patient also seemed to be driven by a kind of inner panic. The outcome of the events were not reported.
patient experienced nausea and dizziness followed by muscle weakness, whole body shaking, and possibly loss of consciousness  lasting less than 30 seconds.
Pain at site of injection, distal swelling and pain throughout rest of upper extremity x 2 months.  Prednisone helpful but caused allergic reaction.  Currently on trial of NSAIDs and natural anti-inflammatory meds.
Developed nausea, vomiting and diarrhea and abd pain which led to a diagnosis of gastroparesis. Symptom: Abdominal Pain, Epigastric pain, Anorexia, Nausea w/o vomiting, Diarrhea
Burning sensation and numbness on face immediately after vaccine administration; Chills; Low grade fever; Body ache; Joint pain; Not feeling well and feels worst than before; Burning sensation and numbness on face immediately after vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation and numbness on face immediately after vaccine administration), FEELING ABNORMAL (Not feeling well and feels worst than before), HYPOAESTHESIA (Burning sensation and numbness on face immediately after vaccine administration), CHILLS (Chills) and PYREXIA (Low grade fever) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BURNING SENSATION (Burning sensation and numbness on face immediately after vaccine administration). On 28-Apr-2021, the patient experienced FEELING ABNORMAL (Not feeling well and feels worst than before), CHILLS (Chills), PYREXIA (Low grade fever), MYALGIA (Body ache) and ARTHRALGIA (Joint pain). On an unknown date, the patient experienced HYPOAESTHESIA (Burning sensation and numbness on face immediately after vaccine administration). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Burning sensation and numbness on face immediately after vaccine administration), FEELING ABNORMAL (Not feeling well and feels worst than before), HYPOAESTHESIA (Burning sensation and numbness on face immediately after vaccine administration), CHILLS (Chills), PYREXIA (Low grade fever), MYALGIA (Body ache) and ARTHRALGIA (Joint pain) outcome was unknown.            The action taken with mRNa-1273 was Not Applicable. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), NASAL ALLERGY MEDICINE.  Aspirin is included as treatment medication.
I started losing my eye site and I now have to wear corrective lenses. Severe lower back/tailbone pain that started about 5 months after the second shot. Not able to sit for long periods of time. Very painful to stand from a sitting position.
On 6/1/11, pt was given vaccines below. On 6/10/11 started with fever & 1 episode of vomiting on 6/11/11, followed by itchy rash on face that afternoon, spreading to rest of body. Coalescing flat topped raised papules/macules. Resolved with 2 doses of BENADRYL on 6/13/11.
Patient over the age of 6 (7 year old) received DTaP=INFANRIX rather than Tdap. Not indicated for patients over age 6.
Fever to 104 6-7 hrs post DTP immun, "shaking", cyanotic hands, vomited approx 10 later OK by 2 day post inject;
chest- tired dranaged; nauseous; slept with some discomfort; Left arm sore with rash; Left arm sore with rash and hot to touch; sore joints; arm sore/ arm pit sore; sinuses; tired/dragging; Headache; right temple vain throbbing/Body aches; ear and neck pain; ear and neck pain; Draining in throat; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO183), via intramuscular route of administration on 20May2021 at 14:30 (at the age of 64-year-old), as dose 2, single in left arm for COVID-19 immunisation. The patient's medical history included sinuses-GER. Concomitant medications included antihistamine simethicone 120 mg two times per day and nasal decongestant pseudoephedrine hydrochloride; for unknown indication, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO167), via an unspecified route of administration on 29Apr2021 at 14:30 (at the age of 64-year-old), as single dose in left arm for COVID-19 immunization and experienced left arm pain. The patient's past drugs included sulfur, codein and experienced allergy to both. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021, 9 hours and 30 minutes after the administration of second dose of vaccine, the patient experienced tired, headache, right temple vain throbbing/body aches, ear and neck pain, nauseous at 20:30, slept with some discomfort, left arm sore with rash and hot to touch, sore joints, arm sore/ arm pit sore, sinuses, draining in throat and felt tired and dragging. On day 3, arm was still sore with rash, heat, headache, and sore joints. Patient called urgent care and told her to take Tylenol 2 times. On 24Jun2021, the patient experienced chest - tired dranaged. The events resulted in emergency room visit. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events tired, headache, right temple vain throbbing/body aches, sinuses, chest- tired dranaged was resolved on 24Jun2021. The clinical outcome of all other events was resolving.   No follow-up attempts are needed. No further information is expected.
On 6/11, he developed chest pain which began upon awakening.  During his evaluation in the ER that day, he was noted to have an elevated troponin level of 7.524, slightly elevated CRP level, normal D-dimer level, and otherwise, relatively unremarkable CBC and comprehensive metabolic panel.  A chest x-ray was described to be unremarkable. Echocardiogram revealed normal structure and function.   He was admitted and troponins were trended until 6/15. Therapy was initiated with Ketorolac every 6 hours.  Repeat troponin on 6/12 increased to 8.4, echo continued to be normal. Repeat troponin on 6/13 was 10.878. Troponin on 6/14 was 0.670 with continued normal EKG and Echo. On day of discharge, troponin had decreased to 0.110. Throughout admission, patient was monitored on telemetry and he remained in sinus rhythm without ectopy.  The day prior to discharge he was switched to Naproxen BID and will continued to be monitored closely for normalization of his troponin.
Upon administration, patient began to immediately complain of chest pain and slight SOB.  She did not have any rash, swelling, angioedema or lip swelling.  She then began to have a tremor of her bilateral Upper extremities, Left greater than right.  This continued for approximately 10 minutes.  Her vitals were normal other than tachycardia.  She then had multiple events in which she passed out, became limp but responded to verbal stimuli and awoke complaining of similar symptoms.  This persisted for approximately 20 minutes.  At that time, EMS was called.  She was transferred to the nearest ED.
On 01/19, this patient had weakness in all extremities and inability to walk. Diagnosis - Acute Guillain Barre' Syndrome.
This spontaneous report was received from a licensed practical nurse and refers to an 11 month old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 23-AUG-2016, at the age of 11 months, the patient was vaccinated with ROTATEQ (lot # L035511, expiration date 21-MAY-2017, orally, dose was not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
stiffness in the arm; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness in the arm) and MYALGIA (muscle aches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 046B21A and 071F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in the arm) and MYALGIA (muscle aches). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness in the arm) and MYALGIA (muscle aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. Patient has not taken any treatment medications.   This case was linked to MOD-2021-375541, MOD-2021-375542 (Patient Link).
5 hours post administration - fatigue, mild headache, arm soreness at injection site 9 hours post administration - chills, achy body, fatigue, mild headache, full arm pain on injected arm 13 hours post administration - chills achy body, fatigue, full arm pain on injected arm, joint/bone pain all over 15 - 20 hours post administration - chills achy body, fatigue, fever 101.5 temporal, full arm pain on injected arm, joint/bone pain all over 24 -48 hours post administration - achy body, fatigue, soreness around injection site only 72 hours post administration  - all resolved No treatment given other than rest and sleep.
Monday 5/10 felt fatigued, Tuesday 5/11 Diaphoretic and nauseous, 5/12 Syncope/Weakness, 5/13 Weakness, called 911 and brought to emergency room
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 23rd May 2019, for tolerance refer case: US2019GSK021357). On 17th July 2018, the patient received the 2nd dose of SHINGRIX. On 17th July 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. In August 2018, the patient experienced hair loss, dandruff and frontal fibrosing alopecia. On an unknown date, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the hair loss and dandruff were not recovered/not resolved and the outcome of the frontal fibrosing alopecia and drug dose administration interval too short were unknown. It was unknown if the reporter considered the injection site pain, hair loss, dandruff and frontal fibrosing alopecia to be related to SHINGRIX.  Additional details were received as follows: The patient had pain at injection site. The patient began to experience hair loss and dandruff in early August 2018. The patient followed up with the dermatologists who diagnosed her with fibrous alopecia. The patient reported that her hair was falling out in clumps. The reporter did not consent to follow up. The suspect vaccine lot number was unknown at the time of reporting.
I was 7 weeks pregnant and very okay prior to taking the covid-19 vaccine on 05/15/21  and my weight at the time was 70.76
Approximately 18 hours after vaccine, patient woke up in severe pain.  Headache, muscle and bone pain, shortness of breath.   Severe malaise and weakness.  Bedbound for 6 days.   Took 11 days for full recovery.   No fever, urticaria, swelling of tongue, loss of taste or smell.  Subsequent Covid testing negative.
tonic-clonic sz about 2hrs p/vax; no fever; mom took pt to hosp adm & observed; discharged next day; report to follow from clinic;
pt recvd vax & exp palpitations, tachycardia & agitation; resolved p/3 wks;
Headache, NauseaVomiting, c/o injection site sore,chills,feeling hot,back pain, fatigue. Told to see primary care physician if no improvement Narrative:
Ten minutes after vaccine administration, I experienced a tingling sensation at the injection site (left deltoid), which rapidly spread into the surrounding tissues, up my arm, and into my chest. My heart started to pound forcefully. I became tachycardic 110?s-120?s (my usual pulse is 60?s) and hypertensive 170?s-180?s/80?s-90?s (my usual BP is 100?s-110?s/60?s-70?s). I never felt faint or anxious. Approximately 20  minutes after vaccine administration my pulse came down to 100?s. I remained hypertensive. At one hour post-vaccine, my BP was 178/98. I was then transferred to the ED. At 90 minutes post vaccine my BP was 180?s/80?s and pulse was high 90?s. The BP gradually came down. I was discharged home three hours post-vaccine with BP of 140?s/80?s and pulse in the 90?s. The next morning, my VS returned to normal: BP 106/62, pulse 67.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (experienced severe case of Shingles in the throat in August 2018 that had cleared). On 9th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The batch number or expiry date for SHINGRIX was not provided. The patient experienced throat shingles in late February or in Early March, but not as severe as first one.
Very painful in the area where I got the shot. I usually have a little pain at the site of the injection but this was WAY worse which resulted in me icing the area and taking Ibuprofen. I also could not apply any pressure on the site so I had to make sure I only slept on my right side overnight. The intensity of the pain was MUCH better the next day, and today (2 days later) it is very bearable.  I also experienced lethargy the first evening after receiving the vaccine, but that went away the next day.  On the second evening since receiving the vaccine, I started to experience body chills and some minor body aches. I felt a sense of general malaise that I often experience when sick.
Sore arm where shot was administered.  It has progressed from sore to painful.  It has been 2 weeks of constant pain.  Pain increases at night to the point it wakes me up at night.
Patient received in RN triage area, post-COVID vaccination administration. Patient being observed for 15 minutes as recommended per CDC guidelines and facility policy on post-vaccination RN monitoring. Patient sitting in chair and reported feeling dizzy/lightheaded, blurred vision, ringing in the ears, patient noted pale, clammy, and diaphoretic, patient reporting feeling short of breath.   Rapid response called. 14:05 Vitals: 75/34, HR: 54, 97%    Patient placed on gurney, in the supine position. Patient and mother denies adverse reactions to vaccinations in past. Denies any medical history besides asthma.   14:10 Vitals: Bp: 105/53, Hr 83, 100% on 2L.  Patient now denies any dizziness/lightheadeness, blurred vision, ringing in ears, and shortness of breath. 14;15 BP109/65, HR: 72, O2: 100%.  COVID vaccination fact sheet and discharge information provided to patient on D/c from clinic, patient advised to review. Verbalized understanding. Appointment for 2nd COVID vaccination provided to patient. All questions and concerns addressed. Advised to follow up as needed.  Patient departed with mother at 1435 symptom free.
Patient received Menveo Vaccine at 11AM after receiving vaccine and waiting greater than 15 min office sudden outbreak of urticaria, periorbital swelling and erythema. Mother gave 50mg Benadryl AND RASH decreased. Advised to give 37.5mg Benadryl every 6 hrs for 48 hr. Call back with increased symptoms
I participate in high performance sport of rugby and I have been having troubles getting cardiovascularly fit and I have constant pain in my heart and lung area
This spontaneous report was received from a healthcare worker refers to a multiple patients of unknown age and gender. No pertinent medical history was reported. Since 28-JUL-2014, the patients were vaccinated with VAQTA inj 25/0.5 (unspecified units) (dose, route, lot# were not reported) after being improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
4 days after the shot I woke up with Vertigo and it was mostly annoying. It became worse on Sunday evening. It has persisted through today Friday, 10 days after the shot and shows no signs of letting up.
Employee c/o flu like symptoms. Achy all over, fever lasted 2-3 days past injection. Sent off work to go home.
Information has been received from a consumer concerning his 16 year old son who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 09-May-2007, the patient developed a breakthrough of chickenpox. The patient's status was not reported. Additional information has been requested.
Patient recieved vaccine 1 of covid 19 i 1/19/2021. She felt poorly on 1/20/2021. She felt dizzy and fell at 3 AM on 1/23/2021.  She felt poorly and did not know her son's name which was not normal.  She went to ER on 1/24.  She was assessed as not having fractures.  She was going to be transferred to a skilled nursing facility.  She was not having respiratory complaints.  She was awaiting transfer when her O2 levels started dropping substantially.   She declined aggressive intervention and she died within a few hours.
Patient had a breakthrough infection around 12/25/2021 after completing 2 doses earlier this year.  Has had severe COVID symptoms for over 2 weeks.; Patient had a breakthrough infection around 12/25/2021 after completing 2 doses earlier this year.  Has had severe COVID symptoms for over 2 weeks.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional).  An adult male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome "recovered with sequelae" and all described as "Patient had a breakthrough infection around 12/25/2021 after completing 2 doses earlier this year.  Has had severe COVID symptoms for over 2 weeks.". The event "patient had a breakthrough infection around 12/25/2021 after completing 2 doses earlier this year.  has had severe covid symptoms for over 2 weeks." and "patient had a breakthrough infection around 12/25/2021 after completing 2 doses earlier this year.  has had severe covid symptoms for over 2 weeks." was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.