chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 21-month-old patient who received FLUARIX QUADRIVALENT (batch number 7TU92, expiry date 30th June 2015). On 26th December 2014, the patient received the 1st dose of FLUARIX QUADRIVALENT .5 ml. On 26th December 2014, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
achiness in joints (more left side than right side), specific to knee, ankle and elbow. Additional tingle/numbness feeling in extremities (fingers and toes).
headache; great pain in the arm/now only a little pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (great pain in the arm/now only a little pain) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Blood pressure high and Gastritis. Concomitant products included LOSARTAN for Blood pressure high, OMEPRAZOLE (OMEPRAZEN [OMEPRAZOLE]) for Gastritis.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (great pain in the arm/now only a little pain). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (great pain in the arm/now only a little pain) was resolving and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Oxygen saturation: 95 OTHER.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not reported.   Reporter did not allow further contact
Exhaustion Erratic blood pressure spikes Switch from am active time to pm active  Afternoon naps  Shortened less active dog walks
heart attack; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 31Jan2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The consumer wanted to schedule her second dose since she missed her second dose due to heart attack two weeks after the first dose. She was taking heart medications (unspecified). The outcome of the event was unknown.    Information about the Lot/batch number has been requested.
This spontaneous report as received from a consumer, the husband of the patient, refers to a 61 year old female patient. On 16-APR-2014 the patient was vaccinated with ZOSTAVAX (dose and lot number were not provided), subcutaneous. Concomitant therapies included lisinopril (manufacturer unknown), simvastatin (manufacturer unknown) and aspirin (manufacturer unknown). On 20-APR-2014 the patient experienced shingles on her lower abdomen. The patient visited her physician. The patient was treated with acyclovir. The outcome of shingles on her lower abdomen was reported as not recovered/not resolved. Action taken relatedness were not provided. Additional information has been requested.
About 12 hours after my first vaccine I developed chills, sore arm and gradually a low grade temp. I also began to noticed an elevated heart rate. This went on for about another 12 hours. Early in the morning on Sunday 1/17, I woke up sweating and still high increased heart rate. I went to the ER and was treated like an adverse reaction to the vaccine. I was not able to work both Saturday the 16th or Sunday the 17th.
left arm swelled up; rash at the injection site; very painful; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jul-2021 and was forwarded to Moderna on 01-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swelled up), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE PAIN (very painful) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (left arm swelled up), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE PAIN (very painful). At the time of the report, PERIPHERAL SWELLING (left arm swelled up), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE PAIN (very painful) outcome was unknown.            No concomitant medications were reported No treatment Information was provided
pt recv vax 28APR99 & 29APR99 exp outbreak of red hard bumps of different sizes on both arms;they spread to the sides of the trunk & buttocks, back of legs, thighs & calves;none on abd;being tx w/ prednisone
Symptoms included: swelling of throat, constriction of airway, difficulty swallowing and breathing, and loss of voice
First, immediately after receiving the vaccine, I cycled 25 miles.  Almost immediatly thereafter, my arm got very sore, I had a dull headache, my resting pulse went up about 20 bpm, and my blood pressure dropped from about 120/70 to 102/60. I felt "rough".  I played couch potato for the rest of th eday, and was fine the next morning.
Pt wanted injection in R buttock so this is where it was given.  Developed redness/swelling/pain at injection site on 1/7/21 which worsened and turned to cellulitis on 1/8/20 requiring antibiotics.  Also had R inguinal lymphadenopathy.  No symptoms prior to 1/7/21.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: PATIENT RECOVERED AFTER PUTTING HEAD DOWN
Developed significant fatigue approximately 6 hours after the vaccination that lasted at least 8 hours.  Awoken from sleep by vivid dreams, chills, "feeling hot" and general myalgias and headache.  These symptoms have persisted throughout the subsequent 12-24 hours, though improved with OTC Tylenol.
The moment I received the vaccine, my throat immediately tightened, but I could breathe fine. It just caught my attention. I pulled forward for the required 15-minute wait.  The end of my tongue became numb, so I told the observing staff what was happening. As I was talking, I became light-headed, dizzy. I was told to drive over to the nurse station. I was able to drive slowly, down the parking aisle to the nurse station. She watched me for 15 minutes.   Before releasing me, she told me to report to the nurse station after I get the 2nd vaccine shot for 30-minute observation.                   The numbness faded. I was light-headed for a few hours. I had a headache when I woke up the next morning, lasting most of the day. The next few days  I had a sore arm, as expected.
11mins post vaccination pt reported flushing/sweating, pinched spine nerve pain, and dizziness Vitals: 109/58, 72, 18, 100% Pt stable and released from the vaccination site
Went to ER because felt like having heart attack with pressure and pain in chest; Could barely talk or walk. Was diagnosed by cardiologist (after discharge) with pericarditis.
2hrs post dose, arm started felling tightened up around injection site just like someone punched me really hard. (normal) lasted couple hours until went to sleep. woke up couple hours later, sweating/(fever?), ,migraine (covid like headache), body aches (avg), whole left arm was in pins and needles and couldn't move it. The pain and affects continued all night and for the next 36 hours+ (approx) pins and needles started tapering about 2p Wednesday. everything else continued until about 2p Thursday (slowly tapering off). This whole time my arm felt like it was completely broken and needed to be in a cast. (everywhere hurt beside the actually site of injection). I  had to hold my left arm with my right hand in order to move around and about and still would be in excruciating pain. I couldn't work or get out of bed all day Wednesday and most of the day Thursday. At times I actually thought my left arm may have gotten paralysed.
Rash/hives developed on both twins; location included front chest & back; there was also a group of red bumps surrounding near the injection site on thigh.
This spontaneous report was received from a medical assistant regarding to an 14 month old patient of unknown gender. There was no information about the patient's concomitant medications, concurrent conditions or pertinent medical history reported. On an unknown date, the patient was inadvertently vaccinated with GARDASIL 9 lot # 1586749 with expiration date 13-FEB-2021 per intramuscular route (dose, strength, frequency and anatomical location were not provided) for prophylaxis instead of an intended dose of HAVRIX. No adverse effect was reported and no product quality complaint (PQC) was involved.
Rash onset 2 weeks after vaccine - Gianotti-Crosti suspected diagnosis.
Tired; Sleepy; This case was reported by a pharmacist via other manufacturer and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced tiredness and sleepiness. On 30th January 2020, the outcome of the tiredness and sleepiness were recovered/resolved.   It was unknown if the reporter considered the tiredness and sleepiness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced tired and sleepy for the next few days. No further information was provided.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 8-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the third dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 13-JAN-2014 at 2:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). The reporter reported that it was decided not to revaccinate the patient. No adverse event was reported for the patient. Outcome was also reported as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Severe aches pain\muscle weakness N\V\D. Neck pain\head pain\HA.
12 hr p/vax pt noted itching;called 48hr p/vax to report pt had large bruise (5cm by 2.5cm);warm, swollen visibly primary care MD-applied hydrocortisone cream, took Claritin;studies WNL;local rxn
Tired, no energy; congestion; sneezing; coughing; low appetite; sleeping during the day; achy; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 at 14:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not have any allergies to medication, food or any other products. Concomitant medications included naproxen sodium (ALEVE), vitamin nos , minerals nos  (CENTRUM) all for unknown indication, unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 14:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 20:00 the patient experienced tired, no energy, achy, congestion, sneezing, coughing, low appetite and sleeping during the day. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures was taken as a result of the events. The clinical outcome of the events tired, no energy, achy, congestion, sneezing, coughing, low appetite and sleeping during the day were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient received the Pfizer Covid vaccine for his first dose on 09/22/2022. He received the Moderna Bivalent Covid vaccine as his second dose on 05/05/23. He SHOULD HAVE received the Pfizer vaccine instead of the Moderna. No adverse reactions occured as a result.
This case was reported in a literature article and described the occurrence of herpes zoster keratitis in a 89-year-old male patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. The patient's past medical history included herpes zoster keratitis (herpes-zoster-associated stromal keratitis,controlled for 1 yr on loteprednol etabonate1% once day). Concomitant products included loteprednol etabonate. On an unknown date, the patient received the 1st dose of Herpes Zoster vaccine. On an unknown date, 21 days after receiving Herpes Zoster vaccine, the patient experienced herpes zoster keratitis (serious criteria GSK medically significant), keratic precipitates (serious criteria GSK medically significant), corneal edema, corneal infiltrates and eye inflammation. The patient was treated with prednisolone acetate. On an unknown date, the outcome of the herpes zoster keratitis, keratic precipitates and corneal infiltrates were unknown and the outcome of the corneal edema and eye inflammation were recovered/resolved. The reporter considered the herpes zoster keratitis, keratic precipitates, corneal edema, corneal infiltrates and eye inflammation to be related to Herpes Zoster vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of reactivation of Herpes Zoster stromal keratitis in 89-year-old male patient who was vaccinated with unspecified herpes zoster adjuvanted subunit (HZ/su) vaccine (manufacturer unknown) for prophylaxis. The patient had a history of herpes-zoster-associated stromal keratitis, controlled for 1 year on loteprednol etabonate 1% (topical corticosteroids) once a day. No information on patient's family history or concurrent condition was provided. On an unspecified date, the patient had received 1st dose of unspecified Herpes zoster adjuvanted subunit vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). The age of vaccination was not provided. On an unspecified date, 3 weeks after vaccination, the patient had developed diffuse stromal oedema, anterior stromal granular infiltrate, and keratic precipitates. The patient was diagnosed with recurrent herpes zoster stromal keratitis. The inflammation resolved with topical prednisolone acetate 1% therapy. The author stated "Both humoral and cell-mediated immune responses develop within 1 month of the first dose of the HZ/su vaccine. The authors concluded, "In patients with a history of inflammatory zoster-associated corneal disease, prophylactic increase in steroid therapy is recommended before administration of the HZ/su vaccine."
With in five hours post vaccination child developed fever, lethargy and diarrhea. Symptoms last 5 days
blood vessels to burst around eyes; severe swelling and itching in entire face, neck, ears, around eyes; severe swelling and itching in entire face, neck, ears, around eyes; growths that popped up in entire neck area; Dose number 1: 08Mar2021, dose number 2: 26Mar2021; This is a spontaneous report from a contactable consumer(patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 16:00 (Lot Number: EP6955) at her 48-year-old as 2nd dose, single dose for covid-19 immunization.  The patient medical history was not reported. She was not pregnant,no known allergies, no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 on 08Mar2021 12:00 PM (Lot number: EN6208) in left arm at her 48-year-old for COVID-19 immunization. On 30Mar2021 10:00, the patient experienced severe swelling and itching in entire face, neck, ears, around eyes (causing blood vessels to burst around eyes) and growths that popped up in entire neck area that wasn't there before and still exists to date 01Jun2021. Treatment Steroids received for all events and physician office visit required. Outcome of blood vessels to burst around eyes, severe swelling and itching in entire face, neck, ears, around eyes, and growths that popped up in entire neck area was not recovered. Case was assessed as non-serious.
Numbness and tingling in left leg within 15 minutes of receiving shot. Symptoms continue to persist up until now (July 13 and on-going)
Patient returned to the pharmacy complaining of itching within 10 mins the area was slightly raised, red, and hot to the touch - it extended about 3" diameter from the site of injection (size of a baseball) 25 mg BENADRYL im opposite deltoid (right) at 12:45 pm.
received a pediatric dose of VAQTA instead of the adult dose; received a pediatric dose of VAQTA instead of the adult dose; This spontaneous report was received from a registered nurse and refers to a 45-year-old female patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 05-OCT-2020, the patient was vaccinated with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) injection, vial, 0.5 ml, lot # T001419 was confirmed to be valid, expiration date was 06-JAN-2021 (route of administration, anatomical location were not reported) for prophylaxis instead of the an adult dose.
Patient states he feels achy, Joint pain, headaches and also rash at injection site. States he took ADVIL (OTC) for headaches and that resolved pain.
Day after Vaccination: Chills, Muscle aches. Warmth and rest solved in 1 day. 4th day after Vaccination: Soreness at injection site, itching and rash extended from about 1 inch above injection site down to elbow mostly on inside of arm. 23rd day after vaccination: Still have very slight itching and rash in same area, hardly noticeable.
This spontaneous prospective pregnancy report as received from a medical assistant refers to a 20 year old female patient without pertinent medical history, drug reactions or allergies. On 27-AUG-2014, the patient was vaccinated with the first dose of GARDASIL 120 Y, lot # J015378, expiration date 09-APR-2016 (dose and route were not reported) and on 29-OCT-2014, the patient was vaccinated with the second dose of GARDASIL 120 Y, lot #J015378, expiration date 09-APR-2016 (dose and route were not reported. There was no concomitant therapies. The medical assistant reported that the patient became pregnant. On an unknown date in 2015, the patient performed a pregnancy test. No treatment was received for the event. It was reported that the patient sought medical attention by visiting the physician's office. The patient became pregnant with Last Menstrual Period (LMP) of 06-MAR-2015, estimated date of conception on approximately 20-MAR-2015 and Estimated Date of Delivery (EDD) of 11-DEC-2015. The pregnancy outcome was pending. The event did not required intervention to prevent serious criteria, did not produce significant disability or incapacity, did not required hospitalization and it was not life threatening for the patient. No product quality complain was reported. Additional informaiton has been requested.
ActHIB that has been diluted with sterile water instead of the 0.4% Sodium Chloride diluent that comes with the ActHIB/no AE; Initial information received on 12-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves Infant male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] hat has been diluted with sterile water instead of the 0.4% Sodium Chloride diluent that comes with the ActHIB  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 12-Jun-2019, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot U19648A via intramuscular route.  It was of actual medication error case due to Inappropriate dilution of medication.  No adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Pt was admitted on 3/27/2021 with c/o chest pain and new sob and new sinus tachycardia x 3 days. saw pcp who felt she had an abnl ekg and sent her to ER. troponin was neg. She was found to have new sinus tachycardia with out cause associated with chest pain. she will be following up with cardiology for echo and stress test.