chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after shingrix administration swelled up like large bump; after shingrix administration big red mark; after shingrix administration allergic rxn; might be having allergic to shingles shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced swelling (Verbatim: after shingrix administration swelled up like large bump), erythema (Verbatim: after shingrix administration big red mark), allergic reaction (Verbatim: after shingrix administration allergic rxn) and allergy to vaccine (Verbatim: might be having allergic to shingles shot).  The outcome of the swelling was unknown and the outcome of the erythema, allergic reaction and allergy to vaccine were not reported.   It was unknown if the reporter considered the swelling, erythema, allergic reaction and allergy to vaccine to be related to Shingrix.     It was unknown if the company considered the swelling, erythema, allergic reaction and allergy to vaccine to be related to Shingrix.   Additional Information: GSK receipt date: 11-Oct-2023 The patient stated that after shingrix administration swelled up like large bump big red mark allergic reaction and might be having allergic to shingles shot. The reporter consented to follow-up.
Fully vaccinated patient tested positive for COVID-19 on 8/4/2021. Associated symptoms included malaise, myalgias, congestion, headache, sore throat, chills, loss of taste/smell.
Client received 1st COVID vaccine of Pfizer (Lot #EW0187, expiration 06/28/21). Client reported pressure on left side of head near left ear at 1333. RN and EMT responded to this event. At 1334, vital signs are blood pressure 144/78, heart rate 87, oxygen saturation 95%. Client reported he was clenching his jaw during vaccine administration. At 1339, vital signs are blood pressure 136/79, heart rate 79, oxygen saturation 97%. RN and PHN responded to this event. Client reports a history of anxiety and fainting after needles. Client reports no medication usage. Client reports no chest pain, no dizziness, no shortness of breath, no blurred vision, no nausea. At 1349, vital signs are blood pressure 131/76, heart rate 88, oxygen saturation 91%. Client reports that the pressure on the left ear started at the time of administration. At 1351, Client reports that the pressure as subsided and no new symptoms. At 1354, vital signs are blood pressure 138/76, heart rate 88, oxygen saturation 90%. Client reports a history of fainting after vaccinations. Client was educated about ED precautions and common adverse effects of COVID vaccine. At 1358, Client stood up with no complaints and a steady gait. Client walked out of facility at 1358.
Swelling , tenderness, and redness of injection site , fever, muscle aches, and tiredness lasting 48 hrs
Pain, injection site reaction. It was reported that a female pt received vax on 09/09/1999. Reportedly sometime post vax, the pt experienced redness and pain down arm at the injection site. From additional information received on 09/20/99, it was reported that the pt recovered from the experience.
Moderna COVID?19 Vaccine EUA- given 6 hours and 36 minutes post vial puncture (vial was punctured at 830am, Use by time was 230pm).
On 29MAY91 mom reported that pt slept for 20 hrs following DPT inject 14FEB91;
The patient describes muscle weakness especially when she walks. She received the vaccine on 07/14/20 and noticed weakness the following day on 07/15/20. She notified me on 07/22/20 that she is still experiencing these symptoms and that it has gotten worse.
The second day it felt like a Marble at the injection site; the third day (today) it is swollen to the size of a golfball and bright red with heat and pain to touch; the third day (today) it is swollen to the size of a golfball and bright red with heat and pain to touch; the third day (today) it is swollen to the size of a golfball and bright red with heat and pain to touch; the third day (today) it is swollen to the size of a golfball and bright red with heat and pain to touch; This is a spontaneous report from a contactable Other Health care Professional (Patient, reported for self). A 34-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date were UNKNOWN), via an unspecified route of administration, administered in Arm Right on 24Feb2021 16:45 (at the age of 34 years) as dose 1, single for COVID-19 immunisation. (lot unknown reason: Not available/provided to reporter at the time of report completion). Patient's medical history included congestive heart failure, lupus, cardiomyopathy, sjogrens, inappropriate sinus tach, raynauds, fibromyalgia, rheumatoid arthritis. Known allergies include allergy to Penicillin, iodine, paper tape. Prior vaccination patient had COVID-19 from an unknown date and unknown if ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks: Prescription medications. Request list. The patient reported that the second day, on 25Feb2021 08:00 patient felt like a marble at the injection site, the third day (today) it was swollen to the size of a golfball and bright red with heat and pain to touch. Patient was not tested for COVID post vaccination. No treatment received. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I95.9 HYPOTENSION 2/11/2023 DIVERTICULITIS I95.9 HYPOTENSION 2/11/2023 RECTAL BLEEDING
Leading up to the date of 6-18-2015, patient had several episodes of ear infections treated with Amoxicillin. On 6/18, his pediatrician at that time injected pt with 8 combination vaccines (listed above) while pt still had an active ear infection. After this, pt slowly lost his ability to verbally communicate. Before the vaccines, pt had a vocabulary of around 50 words and after he is only able to verbalize about 5 words. By the beginnning of 2016, pt lost verbal communication and social skills. He began stimming, spinning in circles and engaging in repetitive behavior. Today, he is still almost completely nonverbal and struggles with social skills. He was diagnosed by Hospital with Encephalopathy and by Dr. with Encephalitis.
4 days p/vax pt had weakness lt arm;pt was given warm compress & APAP & referred to neuro;
Throwing up; Diarrhea; chills; low energy; Bad taste on mouth; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ewo168) via an unspecified route of administration in the left arm on 15May2021 at 14:45 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included unspecified birth control pill from an unknown date. 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. The patient had no known allergies to medications, food or other products. On an unknown date in May2021 at 15:30, the patient experienced throwing up, diarrhea, chills, low energy and bad taste on mouth. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events of throwing up, diarrhea, chills, low energy and bad taste on mouth were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
L leg swollen, but no fever , patient's mom  sent to patient to hospital  urgent care same day night , the provider said it is vaccine reaction.
Pt. had c/o chest pain x 1 d. Approx. 4 pm on 11/18/09, pt collapsed in parking lot at MD office. Resuscitation attempted at office, during EMS transport and hospital. Pt. died of MI.  12/21/09 Death Certificate received. DOD 11/18/09. Cause of death: Myocardial infarct due to High Cholesterol, Hypertension, Hypothyroidism.  Additional information abstracted: Had c/o of chest pain at doctor's office, nurse found in cardiac arrest. EMS upon arrival found patient pulseless and apneic, CPR being performed. Resusitation including IV meds and defibrillation. Transported to hospital.   12/21/09 ER records received, service date 11/18/09. Assessment: Cardiopulmonary resusitation unsuccessful. Patient had C/O of chest pain. Found unresponsive, no respirations, no pulse, cyanotic, pupils fixed and dilated.
FLU-LIKE SYMPTOMS; ACHE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced flu-like symptoms. On 01-MAY-2021, the subject experienced ache. On 01-MAY-2021, the subject experienced fever. On 01-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, ache, fever, and headache. This report was non-serious.
felt very sick for 8 days gradually improving after 4 days. 1st dose given, was ok. Booster was one I had a lot of difficulty with. My main concern is if I should have any other vaccinations i e flu shot Covid when approved.
Patient had reaction to ZOSTAVAX. She stated her arm was swollen 6 inches in diameter. Complained of sinus/chest congestion. Provider prescribed hydroxyzine.
This spontaneous report was received form a nurse referring to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates after 24-MAR-2015 the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (batch # K001957 with an expiry date 24-OCT-2016, doses, frequencies and route were not reported). No adverse effects were reported. It was reported that vaccines were not discontinued. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Breastfeeding mother; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother) and PAIN IN EXTREMITY (sore arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother) and PAIN IN EXTREMITY (sore arm). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included birth control.  Treatment information was not provided.
Pfizer COVID-19 Vaccine EUA  Patient presented 3/23/21 for medical monitoring of ""feeling lightheaded"" s/p COVID - 19 vaccine # 1. Reports not eating prior to her vaccine this morning.  Past medical history is significant for DM, type II, obesity and asthma.      BS via fingerstick = 165.      Patient was monitored for a total of 30 minutes.  Patients vital signs remained stable.  Patient reported improvement in symptoms prior to being discharged.
No adverse event; apparently for her 3rd shot patient received a booster instead of a full dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (apparently for her 3rd shot patient received a booster instead of a full dose) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (gluten), Sjogren's syndrome, Polyarthropathy, Allergic reaction to antibiotics (Sulfas), Drug allergy (Amlodipine), Drug allergy (Cymbalta), Drug allergy (Lyrica), Drug allergy (Atorvastatin), Allergy to vaccine (influenza vaccine), Drug allergy (Gabapentin), Allergic reaction to analgesics (Hydrocodone), Drug allergy (Lisinopril), Drug allergy (NSAIDs), Allergic reaction to analgesics (Oxycodone), Allergic reaction to analgesics (Tolmetin) and Allergic reaction to analgesics (Tramadol). Concomitant products included LEFLUNOMIDE (ARAVA) and HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) for Immunosuppression.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced ACCIDENTAL UNDERDOSE (apparently for her 3rd shot patient received a booster instead of a full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (apparently for her 3rd shot patient received a booster instead of a full dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (apparently for her 3rd shot patient received a booster instead of a full dose).    It was reported that an immunocompromised patient asked for her 4th dose of the Moderna COVID-19 Vaccine, but apparently for patient's 3rd shot patient received a booster instead of a full dose.  No treatment details were provided.
On day 10 after SPV, developed rash on chest and shoulder with appearance typical for non-viral pustolosis.  Seen at urgent care center, who contacted Health Dept, who contacted CDC, who contacted Healthcare team.  Healthcare team followed and rash resolved with observation over 2 days.  Patient remained well.  Notably, right arm vaccine site had robust take.  This was 2nd SPV for patient who received original SPV at same site in 2005 -- with typical take, Jennerian scar, and no problems.
Nerve pain; really bad dizziness; severe pain like burning in arms and legs; Muscle spasm; Burning arms and legs; a pretty bad rash on her chest and neck; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (really bad dizziness), PAIN (severe pain like burning in arms and legs), BURNING SENSATION (Burning arms and legs), MUSCLE SPASMS (Muscle spasm) and NEURALGIA (Nerve pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism since 07-Jan-2010 and Drug allergy (Phenergan). Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, CALCIUM, MULTIVITAMIN [VITAMINS NOS] and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced BURNING SENSATION (Burning arms and legs) and RASH (a pretty bad rash on her chest and neck). On 08-Apr-2021, the patient experienced DIZZINESS (really bad dizziness), PAIN (severe pain like burning in arms and legs) and MUSCLE SPASMS (Muscle spasm). On an unknown date, the patient experienced NEURALGIA (Nerve pain). The patient was treated with CORTISONE at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; GABAPENTIN (NEURONTIN) for Adverse event, at an unspecified dose and frequency and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) for Adverse event, at an unspecified dose and frequency. On 19-Apr-2021, DIZZINESS (really bad dizziness) and RASH (a pretty bad rash on her chest and neck) had resolved. At the time of the report, PAIN (severe pain like burning in arms and legs), BURNING SENSATION (Burning arms and legs), MUSCLE SPASMS (Muscle spasm) and NEURALGIA (Nerve pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported the patient visited the ER on 05-Apr-2021 and visited a doctor's office/urgent care on 08-Apr-2021   This case was linked to MOD-2021-073955 (E2B Linked Report). This case was linked to MOD-2021-073955 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Updated patient demographics, current conditions and concomitant medications.Updated event outcome from unknown to recovered for following events: Rash and dizziness. On 19-Jul-2021: Follow up contains no new information. On 19-Jul-2021: Event outcome updated for muscle spasm, burning, rash and dizziness updated.  New event nerve pain added, treatment medications added.  Sought medical care.; Sender's Comments:  MOD-2021-073955:
Pt received 1st dose of the Moderna COVID-19 immunization series on 03/09/2021, and received her 2nd dose of the Moderna COVID-19 immunization series on 03/23/2021. Pt reports she experienced arm soreness, mild nausea, and headache with the first dose, and more amplified arm soreness, nausea, and headache with her second dose and that her side effects for after receiving the second dose lasted much longer. Reports she feels much better now. Advised pt that in order for her second dose to be counted as valid, she will need to have an additional dose at least 4-6 weeks after her dose on 03/23/2021. Pt was very understanding, and agrees with the plan of care.
This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 28-JAN-2016, the patient was vaccinated (expired [product administered) with VAQTA 50/1.0 U/ML, lot # J007800 (expiration date 15-JAN-2016) (dose number, dose and route were not provided). No adverse symptoms were reported. Concomitant medications were not reported. The reporter stated that the VAQTA did not have any previous temperature excursions. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Child developed non-specific, non-generalized rash over back and abd on 1/29/03-8wks post most recent vaccinations. Some itching was (+), no fever. Rash resolved spont on 2/28/03. No crusting noted thru healing process; no lab work or treatment was needed.
After my second dose, about 12 hours later, I developed a racing heart beat and I immediately went to a local ER where they admitted me. They gave me an Ativan to relax but my heart beat never went down. After one night I was sent to another hospital on 09/04 where I stayed for another day because my heart beat was still racing. When I asked for something to bring it down, they gave me metoprolol which brought the heart beat down. After that, they kept me at that facility for testing on my heart. They gave me a stress test which came back normal. They then informed me that they wanted to give me an angiogram the next morning because there were some blockages in my heart. They ran that and found five blocked arteries. I had open heart surgery four days later on 9/10. A quintuple bypass.
This case was reported by a consumer via call center representative and described the occurrence of injection site irritation in a 70-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site irritation, headache, nausea and fever. On an unknown date, the outcome of the injection site irritation, headache, nausea and fever were recovered/resolved. It was unknown if the reporter considered the injection site irritation, headache, nausea and fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but it could be 69 or 70 years old. The patient experienced symptoms which lasted for 5 days.
My face is swollen; This is a spontaneous report from a contactable Consumer or other non health professional (Patient).  A patient of unspecified age and gender received bnt162b2 (COVID VACCINE, Formulation: Solution for injection, Batch/Lot number FA74 believed 85) via an unspecified route of administration on 21Jul2021 as dose unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that the face was swollen on 22Jul2021. Consumer stated that the COVID Vaccine was received yesterday, the Pfizer. On the day of report had facial swelling and face was swollen. NDC number, UPC number and Expiry Date of COVID Vaccine were unknown. Consumer wanted to ask is there anything need to worry about. The outcome of event was reported as unknown.  LOT#: Consumer stated, "FA74 I believe 85."  Information on lot/ batch number has been requested.
red firm lump in R arm Narrative: After administration of the Pfizer Covid vaccination patient reported a red, firm lump in the R arm where the Covid vaccination was administered. Patient stated that she felt fine and opted to discharge from clinic. She declined Ice Pack or cool cloth. VSS when monitored x2.
This was my second Moderna booster.  Originally given J&J vaccine, followed by two Moderna boosters.