chrisvoncsefalvay/vaers-outcomes huggingface dataset:
getting the second dose on 12 February 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (The first dose was received on 21 September 2018).  On 12-FEB-2023, the patient received the 2nd dose of Shingrix. On 12-FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: getting the second dose on 12 February 2023). The outcome of the drug dose administration interval too long was unknown.  Additional Information: GSK Receipt Date: 08-MAR-2023 The patient had reported that he had received a dose of Shingrix vaccine and since he does not remember getting the second dose on 12 February 2023 and therefore, he had got a new dose. He had asked if he should get the second dose and if so when and was there any problem having had already a dose back in 2018.  The reporter had denied to provided further contact details. The patient had received the second dose later than the recommended interval, which had led to lengthening of vaccination schedule.
Received shot Tuesday 9 April 13, that evening arm red from armpit to elbow and swollen. On Wednesday the red and swollen moved to bicep and forearm, and Thursday red and swollen in forearm area.
T105, listless x 8hrs; Tx APAP, Pediaprofen, tepid baths; Mom reported ADR w/next DTP vax;
Generalized muscle aches, low grade temp (99.5 - 100 degrees) headache for 12 hr after injection.  Localized redness, swelling ( 3" long X 1" wide area) at injection site, started day of injection, lasted 4-5 days.
Fainted; Fever; Blindness; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received second dose of bnt162b2 (COMIRNATY COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 15Aug2021 05:45 PM (Batch/Lot number was not reported) as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Jul2021 05:45 PM as single dose for COVID-19 immunization. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 16Aug2021, at 07:30 AM the patient experienced Fever, fainted, blindness, complete loss of vision for about 15 minutes. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment for the events with some Examinations, EKG, blood work. The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: unknown results, investigation: unknown results on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from a physician and refers to a 26 year old female patient. The patient's pertinent medical history and concomitant medications were not reported. She did not have any known drug reactions or allergies. She was not pregnant. Approximately in 2008 (reported as "about 9 or 10 years ago), the patient was vaccinated with a dose of GARDASIL injection (exact does, route of administration, lot # and expiry date were not reported) for prophylaxis. In December 2016, upon the physician office visit, the patient was diagnosed with a genital wart. During the same office visit, the patient had a biopsy of the genital wart done and the results showed the genital wart to be human papilloma virus (HPV) positive, with HPV types 6 and 11. The patient received an unspecified treatment for the events. The outcome of the genital wart was reported as recovered on an unknown date. The outcome of HPV infection was not reported. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
PATIENT REPORTED STARTING TO FEEL FAINT AND BLACKED OUT FOR 30-45 SECONDS WITHIN 1-2 MINUTES AFTER RECEIVING VACCINE. HE EXPERIENCED DIAPHORESIS AND FELT HE WAS GOING TO PASS OUT.  DENIED SOB, HIVES, SWELLING, STOMACH PAIN. REPORTED HE HAD NO HEALTH CONDITIONS BUT THAT THIS HAD HAPPENED TO HIM BEFORE BUT THIS WAS WORSE - SAID HE HAD NOT EATEN THAT DAY OR DRANK WATER. RPH GAVE PATIENT WATER AND LEMONADE ABOUT 2 MINUTES OR SO INTO REACTION  AND PATIENT SAID HE STARTED TO FEEL BETTER AFTERWARD. 911 WAS CALLED AND PARAMEDICS RESPONDED WITH TAKING BLOOD PRESSURE AND BLOOD SUGAR - BP A LITTLE LOWER THAN AVERAGE BUT UNSURE WHAT PT TYPICALLY RAN AT. BLOOD SUGAR NORMAL AFTER DRINKING LEMONADE. PATIENT TAKEN TO ER FOR FURTHER CARE
Pain from the shoulder to the elbow; Redness from the shoulder to the elbow; Swelling from the shoulder to the elbow; Consumer wants to know which ingredients does Fluad have that maybe caused the allergic reaction.; Fluad Quadrivalent administered to a 59-year-old patient; This spontaneous case was received on 19-Sep-2023 from a consumer via agency (reference number: SEQW23-02392) and concerned a 59-year-old, female patient.  The patient had no relevant medical history. The patient's concomitant medications included Synthroid (levothyroxine sodium), Liothyronine (liothyronine sodium), simvastatin, and Fosamax (alendronate sodium), all used for unreported indications.  On 18-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) (explicitly coded as 'inappropriate age at vaccine administration'), for travel, as reported. The batch number reported was 371593.  On 19-Sep-2023, one day after receiving Fluad Quadrivalent, the patient experienced pain, redness, and swelling from the shoulder to the elbow, but received no treatment. As reported, the patient wanted to know the ingredients of Fluad Quadrivalent that might have caused an allergic reaction.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 59-year-old female patient was vaccinated with Fluad Quadrivalent (explicitly coded as: 'Product administered to patient of inappropriate age'). One day after receiving Fluad Quadrivalent, patient experienced pain, erythema, swelling and hypersensitivity. Medical history was not provided. Due to plausible temporal relationship, causality for the events including pain, erythema, swelling and hypersensitivity is assessed as possibly related. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: A 59-year-old female patient was vaccinated with Fluad Quadrivalent (explicitly coded as: 'Product administered to patient of inappropriate age'). One day after receiving Fluad Quadrivalent, patient experienced pain, erythema, swelling and hypersensitivity. Medical history was not provided. Due to plausible temporal relationship, causality for the events pain, erythema, swelling, and hypersensitivity is assessed as possibly related. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
Was administered 3 doses of vaccine. Stated she was informed by "someone" that she needed to restart the series since she couldn't attend her second dose appointment after her first dose. After her 3rd dose yesterday, she was tired (took a nap) and had a bad headache. When she woke this morning, her symptoms had all resolved.
Tingling of fingers tips of lt hand; spread up to elbow, also nose & lips w/numbness of lips; h/a; pt recovered in 30 mins;
A spontaneous report was received from a consumer concerning an unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red pigmentation on her injection site/vaccination site erythema and itchy/vaccination site pruritus.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter  On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route of administration for prophylaxis of COVID-19 infection.   On 05 Feb 2021, the patient experienced red pigmentation on her injection site and itchy but does not interrupt her. The second dose is scheduled on 25 Feb 2021.  Lab details were not provided by the reporter.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, red pigmentation on her injection site and itchy were unknown.
Initial unsolicited report received from a consumer on 16 October 2015. This case involves a 51-years-old male patient who was vaccinated with a dose of FLUZONE QIV (batch number, expiry date, dose, dose in series were not reported) intramuscularly in right deltoid on 09 October 2015. The patient's illness at time of vaccination reported as no, pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as allergic to dust mites and lactose. Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 09 October 2015, same day following the vaccination, the patient had developed right shoulder pain. On 09 October 2015, few hours following the vaccination (in the evening), the patient had experienced body aches, myalgia, headache, lethargy, fever, night sweats. On an unknown date, following the vaccination (in the morning), the patient had experienced cold. Relevant diagnostic tests/laboratory data was reported as none and corrective treatment was not reported. The patient was not recovered from the events. The patient's symptoms persisted on and off for 01 week. List of documents held by sender: none.
Difficulty Breathing, low oxygen saturation, cough, eye swelling, facial redness.
Patient received the Pfizer booster from DPH on Thursday 1/13/2022. On Friday 1/14 he complained of general malaise and weakness s/p booster shot from yesterday. Temp that morning was 99.6; Tylenol 650 mg given with effect = 97.8. Later that day on 1/14 temp temp 101.7 at 1553 medicated with tylenol 650mg at that time with +effect follow up temp at 2000 99.1 At 2200 99.7 np made aware of elevated temp s/p receiving booster injection. New order for cxr in the AM on 1/15.  At 2300 patient found lying on bathroom floor alert with baseline mentation & no injuries noted. Denied pain/disc at that time BP 142/82 pulse 80 regular resp 20 slight increase sob noted with transfer o2 sat 88-92% room air temp 97.9  At ~midnight- O2 sat 85% room air, lungs diminished to bilateral upper and lower lobes with occasional upper lobe wheeze placed in o2 at 2/l vnc with little effect. Increased to 3/l with little effect increase 4/l o2 sat 93% no s/s acute resp distress neuros maintained through out shift without incident. 1/15/22 Patient continues to Desat despite supplemental O2 at 5liters/min via nasal cannula. temp 99.8 NP notified and order to send to a local Hospital via ambulance for evaluation and treatment.  At 0430 Dyspnea worsening. De sat into 70's LS with bilateral rhonchi. temp 99.8 Very SOB, placed in O2 at 15 liters/min via non-rebreather with no relief. NP c/f Dr. notified. 0450 Transferred to a local Hospital ER via EMS. Wife notified of transfer. He was admitted with sepsis pneumonia on 1/15/22. Facility was notified of patients expiration on 1/16/22.
This non-serious spontaneous case, was initially received on 08-Oct-2017, reported by other non-health professional and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. The patient's historical drug included Influenza vaccine. On an unspecified date, the patient received AFLURIA (dose, route of administration, anatomical location: left arm, batch number: 14649211A and expiry date: 30-Jun-2018). On an unspecified date, after receiving the vaccine, the patient experienced severe pain on left side of neck and shoulder. It was reported that, the patient felt bad that it has been limiting his range of motion, particularly of his neck. It was reported that, the patient has been getting flu vaccine every year of the past 15 years and have never experienced this. The patient was worried that this is a usual side effect of this particular vaccine or lot. The outcome of the events was not reported. Non-significant case correction received 08-Oct-2017: Batch number (14649211A) was added on the screen. The narrative was amended accordingly. Non-significant case correction received with 08-Oct-2017: The narrative was corrected in a comprehensive manner.
24 hrs p/vax; pt devel erythematous mac pap rash on face-progressed to head & neck;
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored (Oka/Merck) VARIVAX, lot number K007783, expiration date 28-MAY-2016 and lot number reported as L011084 expiration date 01-APR-2017, (dose and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient reports that her arm is swollen from the top to the elbow, and is very sore.
R facial numbness with inability to fully open R eye onset 1/13/21. Seen in urgent care, Dx Bell's Palsy, treated with steroids.
Intermittent swelling and pain at injection site (no longer). Doctor appointment made for 05/20. She stated she has elevated feet and taking Lasix (helps very little).
Difficulty breathing, dizziness, somnolence, difficulty concentrating, severe headache.  Benadryl taken.
Body Aches and Headache when I woke up the next day at 10 AM.  Around 1 PM started to notice ringing in ears that has become very noticeable and prevalent. Ear ringing or tinnitus has been serious side effect today. No treatment has been given just drinking lots of water.
1/16/2021 1:30 AM constant chills throughout the day, body aches,  trouble breathing,  coughing, congestion, severe fatigue for 3 1/2 days. Symptom s have resolved since
Patient complained of onset of body aches, headache, temperature, diaphoreses, myalgias.
Patient is a 71 y.o. female with past medical history of essential hypertension, OSA on CPAP and oxygen at bedtime, hypertension, chronic diastolic heart failure, and morbid obesity who presented to an outside hospital on 8/16/2023 with fevers and generalized weakness, was found to have hypoxia and COVID-19, and she was transferred to  Hospital for further care.           Assessment and Plan   Acute hypoxic respiratory failure COVID-19 - Presented with: generalized weakness and headache - Symptom onset: 8/14/23 - Positive COVID-19: 8/16/23 at Med ED - Vaccination status: Received first to Pfizer shots but no boosters due to reaction to initial vaccination. - CXR on admission showed CXR on admission showed normal - Oxygen status: Room air during the day as of 8/19/2023 - Decadron: Yes. Expected end date 8/26/23 - Remdesivir: Yes. Expected end date 8/20/2023stopped due to resolution of hypoxia - DVT prophylaxis:Lovenox - Serial COVID labs ordered: Yes - Case Management/Social Services consulted: Yes -Procalcitonin only 0.07 on 8/18/2023, hence low likelihood for bacterial infection. -Continue albuterol and Tessalon perles as needed for cough/congestion -As of 8/19/2023 weaned to room air during the daytime and back to baseline. -Discharged on 8/20/2023.   Chronic heart failure with preserved ejection fraction -Mentioned in her history from OSU however per cardiology note from July 2022 there is "no evidence of heart failure/HFpEF". -Home medications include Coreg 3 mg twice daily, lisinopril 10 mg daily, and Lasix 40 mg daily. -Last echocardiogram 1/23/2023 demonstrated ejection fraction of 60% -Stable and home medications continued as before.   Bigeminy/trigeminy -Intermittent on telemetry and she had this previously at OSU on 3/31/2023 per review of their rhythm strips. -Chronic and no further evaluation warranted as she was asymptomatic and this is not a new finding.   Type 2 diabetes mellitus without complications -Patient is not on any medications for diabetes  (Patient was on metformin in the past). -A1c was 5.9 in November 2022. -Continue ongoing outpatient monitoring as before.   Essential hypertension -Home medications include Coreg 25 mg twice daily, hydralazine 25 mg 3 times daily, lisinopril 10 mg daily. -Stable and home medications continued as before.   Major depression in remission -Patient continue with home Wellbutrin 450 mg daily   OSA -Secondary to morbid obesity -She wears CPAP with 3.5 L of oxygen at bedtime at baseline. -Stable and no acute issues.   History of chronic pain syndrome Peripheral neuropathy OA -Continue with gabapentin 600 mg TID   Morbid obesity -History of gastric stapling in 1980 that was later reversed in 1981. -BMI 54.21 -Advised lifestyle changes -Patient has been getting Wegovy injections every week
Hives & bumps all over, intense itching, turned red from head to toe, slightly swollen lips, lasted several hours until BENADRYL kicked in. Pt was fine the next morning.
NO ADVERSE REACTION....... PT RECEIVED 2ND DOSE ON DAYS 14 IN STEAD OF DAY 21
Tested positive for Smooth Muscle AB; This spontaneous case was reported by a consumer and describes the occurrence of SMOOTH MUSCLE ANTIBODY POSITIVE (Tested positive for Smooth Muscle AB) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced SMOOTH MUSCLE ANTIBODY POSITIVE (Tested positive for Smooth Muscle AB). At the time of the report, SMOOTH MUSCLE ANTIBODY POSITIVE (Tested positive for Smooth Muscle AB) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, Smooth muscle antibody: positive (Positive) Positive (Routine testing).         No concomitant medications were provided. The patient reported that he is a healthy person and the test was a routine test. No treatment medications were provided.
Began to have facial flushing and hives about 5 minutes after the injection, followed by itchy throat, hoarse voice, abdominal cramping, joint pain.
Breakthrough case admission after three vaccines Moderna 4/2/21 Lot# 047A21A;  Moderna 4/30/21 Lot# 017B21A;  Moderna 12/21/21 Lot# 032H21A
Severe stiff neck, locked up completely, extreme pain lasting for 30 hours so far.  No left, right, up or down movement.
Rash on feet, under right arm, on right side of arm; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on 03May2021 at 16:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 19:45, the patient experienced rash on feet, under right arm, on right side of arm. The clinical outcome of the event rash on feet, under right arm, on right side of arm was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous case reported by a consumer, describes the occurrence of pruritus (itching), pain in extremity (arm feels achy and a little bit tender), myalgia (felt soreness) and lymphadenopathy  (underneath her arm was swollen) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On Jan 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 7, 2021, patient experienced myalgia (felt soreness). On Jan 9, 2021, patient experienced lymphadenopathy (underneath her arm was swollen). On Jan 14, 2021, patient experienced pruritus (itching). On an unknown date, patient experienced pain in extremity (arm feels achy and a little bit tender). At the time of the report, pruritus (itching), pain in extremity (arm feels achy and a little bit tender), myalgia (felt soreness) and lymphadenopathy (underneath her arm was swollen) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments.
was very sick; splitting headaches; chills; aches; freezing; she has a 102 fever; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was very sick from the vaccine. The patient stated that there must be something wrong with either screening or the Pfizer was not getting the word out. The patient received the first dose on a Thursday around 06:00 hours and by Friday at 04:00 hours, the patient experienced splitting headaches, chills that the patient never felt before, and aches. The patient was freezing on an unspecified date but took Ibuprofen and felt a little better. The patient believed to have COVID around the holidays, but she did not get tested before because the testing was a joke around there. The patient experienced a 102 fever around the holiday time. The patient underwent lab tests and procedures which included body temperature: 102 fever around the holiday time on an unspecified date. Therapeutic measures were taken as a result of freezing. The patient also stated that if she knew that she was going to be as sick as she was, she would have never gotten the vaccine. The clinical outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.